FEDERAL COURT OF AUSTRALIA
Novozymes A/S v Danisco A/S [2013] FCAFC 6
| IN THE FEDERAL COURT OF AUSTRALIA | |
ON APPEAL FROM THE FEDERAL COURT OF AUSTRALIA
| BETWEEN: | First Appellant NOVOZYMES AUSTRALIA PTY LTD (ACN 001 420 677) Second Appellant |
| AND: | First Respondent DANISCO AUSTRALIA PTY LTD (ACN 096 139 392) Second Respondent |
| DATE OF ORDER: | 4 FebruaRY 2013 |
| WHERE MADE: |
THE COURT ORDERS THAT:
1. The declaration made in paragraph 1, the orders made in paragraphs 2 and 6, and the certificate given in paragraph 14, of the orders made by the primary Judge on 20 April 2011 be set aside.
2. So far as it relates to Claims 1 and 7, Australian Patent No 752215 be revoked.
3. The parties file and serve written submissions with respect to the following issues:
(a) what, if any, further orders should be made with respect to the orders made by the primary Judge other than those referred to in Order 1 above;
(b) whether any, and if so which, of the other claims in the said patent should be revoked in the light of the revocation of Claims 1 and 7 and of the reasons given by the Full Court this day; and
(c) what, if any, orders should be made as to costs, in relation both to the proceeding before the primary Judge and to the appeal.
4. Those submissions be filed and served as follows:
(a) by the appellants, within 21 days;
(b) by the respondents, within a further 21 days; and
(c) by the appellants in reply if necessary, within a further 7 days.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011
| NEW SOUTH WALES DISTRICT REGISTRY | |
| GENERAL DIVISION | NSD 605 of 2011 |
ON APPEAL FROM THE FEDERAL COURT OF AUSTRALIA
| BETWEEN: | NOVOZYMES A/S First Appellant NOVOZYMES AUSTRALIA PTY LTD (ACN 001 420 677) Second Appellant |
| AND: | DANISCO A/S First Respondent DANISCO AUSTRALIA PTY LTD (ACN 096 139 392) Second Respondent |
| JUDGES: | GREENWOOD, JESSUP AND YATES JJ |
| DATE: | 4 FebruaRY 2013 |
| PLACE: | SYDNEY |
REASONS FOR JUDGMENT
GREENWOOD J
1 I have had the benefit of reading the final draft reasons for judgment of Justice Jessup. I agree with the proposed orders and I agree with his Honour’s reasons in support of those orders subject only to the following observations.
2 In the proceedings before the primary judge the appellants contended, among other grounds of challenge to the validity of claims 1 to 9, 14 and 15 of the patent in suit that in construing, according to settled principle, the language of the public monopoly defined by claims 1 and 7 of the patent in suit, those claims lack clarity and are thus invalid for the purposes of s 40(3) of the Patents Act 1990 (Cth). The appellants also contended before the primary judge that claims 1 to 9, 14 and 15 are invalid as the claims do not concern a patentable invention for the purposes of s 18(1) of the Patents Act as the claimed invention is not a manner of manufacture; the claims lack novelty; and that which is claimed reflects no inventive step.
3 The appellants’ cross-claim for a declaration of invalidity of the claims and an order for revocation of the claims under ss 121 and 138(3) of the Patents Act was dismissed.
4 In the proceedings before the primary judge, and on the hearing of the appeal in which the appellants challenged the primary judge’s findings on the construction of the claims and the issues of clarity, novelty and manner of manufacture, very considerable argument was devoted to the questions of construction and clarity. In determining the proper construction to be attributed to claims and particularly claims 1 and 7 of the patent in suit, the primary judge was assisted by evidence given by two experts, Professor Darryl Small, called by the respondents (“Danisco”) and Professor Russell Hoseney called by the appellants (“Novozymes”).
5 The primary judge describes the scientific and applied research expertise of Professors Small and Hoseney in the following way.
6 Professor Small obtained a Bachelor of Agricultural Science with Honours from the University of Sydney in 1974. In 1981 he obtained a PhD from the University of Sydney studying “metabolism of storage polysaccharides”. From 1978 to 1982, Professor Small worked as a Scientific Research Officer at the Biological and Chemical Research Institute within the NSW Department of Agriculture. Professor Small was then employed by the Australian Wheat Board (“AWB”) from 1982 to 1992, first as Chief Chemist and subsequently as Manager of the Grain Quality Laboratory. In 1989, he was appointed Assistant Director of the AWB’s Academy of Grain Technology. His responsibilities at the Academy involved questions relating to baking, the testing of wheat and flour, and protein and enzyme analysis. From 1993 to 1995, Professor Small held the position of Senior Food Technologist with the National Food Authority in Melbourne. From 1995 to 2002, he lectured at Victoria University in Food Science and Technology. During this time, Professor Small became involved in various projects and publications relating to enzymes. From 2002, Professor Small was employed by the Royal Melbourne Institute of Technology University (“RMIT”), first as a Senior Lecturer in Food Chemistry and, since 2009, as an Associate Professor. Professor Small’s research at RMIT has involved investigations into the practical outcomes of the use of enzymes in food production and food processing, including the use of enzymes in baking.
7 Professor Hoseney obtained a Bachelor of Science in 1957 and a Master of Science in 1960, specialising in Grain Science and Chemistry. Both degrees were obtained from Kansas State University. From 1956 to 1970, Professor Hoseney worked as a chemist and subsequently as a research chemist at the United States Department of Agriculture. He was awarded a PhD in 1968. His thesis was entitled “Determination of Biochemical and Bread Making Properties of Wheat Flour Components”. Professor Hoseney accepted a position as Associate Professor in the Department of Grain Science and Industry at Kansas State University in 1970. Professor Hoseney was promoted to the position of full Professor in 1975 and held this position until his retirement in 1997. He was then appointed Professor Emeritus, an appointment which he continued to hold at the date of the trial. During his period at Kansas State University, Professor Hoseney conducted research and published papers in matters relevant to cereal chemistry, as well as teaching courses such as “Wheat and Flour Quality” and “Advanced Cereal Chemistry”. From 1971, Professor Hoseney provided consultancy services and regularly consulted with various milling companies and baking companies on a range of different matters relating to the milling of grains and the preparation of baked goods. Professor Hoseney has also attended annual conferences of the American Association of Cereal Chemists since 1961. Australian researchers have been prominently represented at these conferences. Professor Hoseney has also attended and presented papers at a number of meetings of the Cereal Division of the Royal Chemical Society of Australia, including at least five annual meetings of that society from 1986 to 2006. Through these meetings, Professor Hoseney came to know many researchers in the field of cereal chemistry working at various Australian institutes, universities and companies. Professor Hoseney has maintained regular correspondence with many of these individuals.
8 Neither Professor Hoseney nor Professor Small had any demonstrated familiarity with the techniques of molecular biology.
9 The parties accepted that both experts were skilled in the relevant art subsisting at the priority date of 21 July 1998 and skilled in the relevant art as it stood at the date of the hearing. The relevant art was described by the primary judge at [32] as “the preparation of baked goods (in particular bread) including the use of enzymes in the preparation of bread”. The skilled addressee of the patent was described by the primary judge as “a baker”.
10 At [37], the primary judge had regard to 14 statements of principle (said not to be in issue) to be applied in claim construction derived from the authorities and at [39] the primary judge observes (accepting Danisco’s emphasis on the authority) that having regard to the decision of the Full Court of this Court in H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 at [118] to [120], the words used in a claim are to be given the meaning a person skilled in the art would attach to them, having regard to his or her own general knowledge and to contextual disclosures in the body of the specification, which together with the claims, must be read as a whole.
11 The patent specification is addressed to an addressee who is skilled in the art in which the invention is applied. The addressee is the person who will put the invention into effect when the patent expires and the claim must be read through the eyes of the notional addressee who is the man or woman who is going to carry out the invention described. The addressee is generally unlikely to be a pure academic. The person skilled in the art is considered to be equipped with relevant general technical knowledge subsisting immediately before the priority date when reading the specification and the complete specification must not be read in the abstract. The skilled person is understood to be educated by the patent specification. The words used are to be given the meaning which the normal person skilled in the art would attach to those words both in the light of his or her own general knowledge and in the light of that which is disclosed in the body of the specification. The person skilled in the art is considered to be practical: Rodi & Wienenberger AG v Henry Showell Ltd [1969] RPC 367 at 391; Populin v HB Nominees Pty Ltd (1982) 59 FLR 37 at 42 and 43; 41 ALR 471 at 476 and 477; DÉcor Corp Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 at 391.
12 In addition to the observations of Dixon CJ in Martin v Scribal Pty Ltd (1954) 92 CLR 17 at p 59, the well known remarks of Dixon CJ, Kitto and Windeyer JJ in Welch Perrin & Co. Pty. Ltd. v Worrel (1961) 106 CLR 588 at 610 might usefully be recalled on the question of approaches to construction:
If it is impossible to ascertain what the invention is from a fair reading of the specification as a whole, that, of course, is an end of the matter. But this objection is not established by reading the specification in the abstract. It must be construed in the light of the common knowledge in the art before the priority date. [As to] the criterion to be applied when it is said that a specification is ambiguous [we should remember that], we are … construing … a public instrument which must, if it is to be valid, define a monopoly in such a way that it is not reasonably capable of being misunderstood. Nevertheless, it is to be remembered that any purely verbal or grammatical question that can be resolved according to ordinary rules for the construction of written documents, does not, once it has been resolved, leave uncertain the ambit of the monopoly claimed … The specification must be read as a whole. But it is a whole made up of several parts, and those parts have different functions. Courts have often insisted that it is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim by adding to those words glosses drawn from other parts of the specification. Similarly, if a claim be clear it is not to be made obscure simply because obscurities can be found in particular sentences or other parts of the document.
13 It is also useful to recall in a more contemporary sense the observations of Lord Hoffman in Kirin-Amgen Inc. and Others v Hoechst Marion Roussel Ltd (2004) 64 IPR 444 at 453-455 and particularly Lord Hoffman’s remarks at [32] to [35] on questions of construction. At [32] to [34], Lord Hoffman said this:
[32] Construction, whether of a patent or any other document, is of course not directly concerned with what the author meant to say. There is no window into the mind of the patentee or the author of any other document. Construction is objective in the sense that it is concerned with what a reasonable person to whom the utterance was addressed would have understood the author to be using the words to mean. Notice, however, that it is not as sometimes said, “the meaning of the words the author used”, but rather what the notional addressee would have understood the author to mean by using those words. The meaning of words is a matter of convention, governed by rules, which can be found in dictionaries and grammars. What the author would have been understood to mean by using those words is not simply a matter of rules. It is highly sensitive to the context of and background to the particular utterance. It depends not only upon the words the author has chosen but also upon the identity of the audience he is taken to have been addressing and the knowledge and assumptions which one attributes to that audience. …
[33] In the case of a patent specification, the notional addressee is the person skilled in the art. He (or, I say once and for all, she) comes to a reading of the specification with common general knowledge of the art. And he reads the specification on the assumption that its purpose is both to describe and to demarcate an invention – a practical idea which the patentee has had for a new product or process – and not to be a textbook in mathematics or chemistry or a shopping list of chemicals or hardware. It is this insight which lies at the heart of “purposive construction”. If Lord Diplock did not invent the expression, he certainly gave it wide currency in the law. But there is, I think, a tendency to regard it as a vague description of some kind of divination which mysteriously penetrates beneath the language of the specification. Lord Diplock was in my opinion being much more specific and his intention was to point out that a person may be taken to mean something different when he uses words for one purpose from what he would be taken to mean if he was using them for another. … The purpose of a patent specification, as I have said, is no more or less than to communicate the idea of an invention. An appreciation of that purpose is part of the material which one uses to ascertain the meaning. But purpose and meaning are different. … There is no presumption about the width of claims. A patent may, for one reason or another, claim less than it teaches or enables.
[34] “Purposive construction” does not mean that one is extending or going beyond the definition of a technical matter for which the patentee seeks protection in the claims. The question is always what the person skilled in the art would have understood the patentee to be using the language of the claim to mean. And for this purpose, the language he has chosen is usually of critical importance. The conventions of word meaning and syntax enable us to express our meanings with great accuracy and subtlety and the skilled man will ordinarily assume that the patentee has chosen his language accordingly. As a number of judges have pointed out, the specification is a unilateral document in words of the patentee’s own choosing. Furthermore, the words will usually have been chosen upon skilled advice. The specification is not a document inter rusticos for which broad allowances must be made. On the other hand, it must be recognised that the patentee is trying to describe something which, at any rate in his opinion, is new; which has not existed before and of which there may be no generally accepted definition. There will be occasions upon which it will be obvious to the skilled man that the patentee must in some respect have departed from conventional use of language or included in his description of the invention some element which he did not mean to be essential. But one would not expect that to happen very often.
[bold emphasis added]
14 In Sartas No 1 Pty Ltd v Koukourou & Partners Pty Ltd and Another (1994) 30 IPR 479 at 485 and 486, Gummow J accepted, as applicable in Australia, a number of propositions as to construction drawn from Glaverbel SA v British Coal Corporation (1994) RPC 443 at 485-6 to the following effect (among others): it is for the Court, not any witness, however expert, to decide the questions of construction in accordance with the meaning of the language used; evidence can be given by experts to enlighten the primary judge on the meaning which those skilled in the art would give to technical or scientific terms and phrases and on unusual or special meanings given by such persons to words which might otherwise bear their ordinary meaning; in reading the specification as a whole, the different functions of the claim and the rest of the specification should be observed; the claim, cast in precise language, marks out the legal limits of the monopoly granted by the patent: and “what is not claimed is disclaimed”; although the claims are construed in the context of the specification as a whole, it is not permissible to restrict, expand or amend the clear language of a claim by reference to a limitation or gloss in the language used in the earlier part of the specification but not repeated in the claim itself; it is legitimate however to refer to the rest of the specification to explain the background to the claims, to ascertain the meaning of the technical terms and resolve ambiguities in the construction of the claims.
15 The point of these references to the primary judge’s description of the art and the skilled addressee, the standing of the experts, and contextual statements of principle concerning claim construction derived from at least two of the leading authorities, is this.
16 In examining the evidence of Professors Small and Hoseney and the analytical treatment of their evidence by the primary judge in assisting her Honour in the construction of claims 1 and 7 and the relationship claim 9 bears to claims 1 and 7, it is not clear to me whether the evidence of the experts is evidence of the understanding of the skilled notional addressee reading the specification with common general knowledge in the art of the preparation of baked goods (in particular, bread) including the way in which enzymes are or might be used in the preparation of bread at the priority date; whether the evidence is opinion evidence of the experts of their hypothesis or postulation of the understanding of such a person; or whether the evidence is opinion evidence of the experts of the state of the art at the priority date based upon or informed by their own theoretical and applied expert scientific knowledge of the art at the priority date which is very likely to be a much more sophisticated understanding of the art than that of the notional skilled addressee who, in principle, would read the specification and, in principle, seek to put the invention into effect.
17 If the skilled addressee is an experienced artisan skilled in the art of baking (a person described by the primary judge as “a baker”) infused with the common general technical knowledge in the art at the priority date, the state of knowledge of the art reflected in the academic qualifications and experience of Professors Small and Hoseney is unlikely to be the benchmark against which the common general technical knowledge of the skilled addressee at the priority date is to be measured, when determining the construction to be attributed to the specification and the claims defining the public monopoly, read as a whole.
18 I appreciate, of course, as I have already mentioned, that the parties conducted the trial on the footing that Professors Small and Hoseney were skilled in the relevant art subsisting at the priority date of 21 July 1998 and skilled in the relevant art as it stood at the date of the hearing. There was and is no controversy on foot about those matters. There is however substantial controversy about the construction to be attributed to the claims and the evidence of the experts has been called in aid by the primary judge in deciding that controversy. It is in that context in which I say that the precise foundation upon which the evidence of experts was given and applied on each issue of construction arising in the proceeding is not clear to me, and then agitated on this appeal. On some issues, however, the method of treatment of the evidence is clearer than others.
19 The expression of the difficulty emerges in relation to the debate about the proper construction to be attributed to claims 1 and 7 and the relationship claim 9 bears to the construction of those claims.
20 Claim 1 of the patent in suit is in these terms:
A process for preparing a foodstuff suitable for consumption comprising an emulsifier, the process comprising the steps of
(i) providing a food material containing a fatty acid ester and a second constituent;
(ii) contacting the food material with an enzyme such that an emulsifier is generated by the enzyme from the fatty acid ester and a second functional ingredient is generated from the second constituent;
(iii) inactivating or denaturing the enzyme to provide the foodstuff comprising the emulsifier, the fatty acid ester and the enzyme in an inactive form or a denatured form.
21 Claim 7 is in these terms:
A process according to any one of the preceding claims wherein the foodstuff comprises at least the emulsifier and the second functional ingredient, and wherein the emulsifier and the second functional ingredient have been generated from the fatty acid ester and the second constituent of the food material by the enzyme.
22 Claim 9 is in these terms:
A process according to any one of the preceding claims wherein the second constituent is selected from a constituent comprising a hydroxy group (-OH), polyvalent alcohols, including glycerol; water, ethanol, sugars including sucrose, fructose, glucose (dextrose), lactose, and galactose; dextrins including maltodextrin, sorbitol, mannitol, fruit acids and hydroxy acids including citric acid, tartaric acid, lactic acid and ascorbic acid; mixtures and derivatives thereof.
23 The patent in suit is entitled “Foodstuff”.
24 The invention, as described in the specification, is a process for the preparation of a “foodstuff” (the end food product presented to members of the public for human or animal consumption) from “food material” (the foundation food matter or ingredients) comprised of “constituents” drawn from the field of ingredients or compounds described at p 8, lines 13-24 of the specification, utilising a “conversion agent” (such as an enzyme) during the production of a foodstuff so as to generate (as the conversion agent engages with or works upon at least one constituent of the food material selected from the nominated field), in situ, (that is, without the need to introduce “additives” that perform the function of the conversion agent) at least one “functional ingredient” (but one or more functional ingredients), that is to say, an ingredient of the foodstuff that performs a specific function in the foodstuff.
25 The specification recites these matters:
By the term “functional ingredient” we mean a constituent of the foodstuff which performs a specific function in the foodstuff. Preferably by the term “functional ingredient” we mean an emulsifier, hydrocolloid, preservative, antioxidant, colouring, flavouring and/or viscosity modifier. Preferably by the term “functional ingredient” we mean a constituent of the foodstuff which has one or more surface active properties, antioxidative effect, anti-bacterial effect …
(p 3, ln 28; p 4, ln 1 of the specification)
The present invention utilises a conversion agent, such as an enzyme, during the production of a foodstuff to generate one or more functional ingredients, for example emulsifiers, antioxidants or preservatives, from a constituent of the food material (i.e. ingredients) from which the foodstuff is prepared. The constituent(s) may be a fat, for example. Thus, instead of adding food additives produced by traditional chemical synthesis, the present invention provides for the in situ synthesis of a required functional ingredient.
(p 4, ln 10 of the specification)
Preferably, the conversion agent is a catalyst.
(p 6, ln 9 of the specification)
In a preferred aspect, the conversion agent is an enzyme … enzymes may be denatured by heat ... [the] enzyme will be denatured and may then constitute protein. This is advantageous because the denatured enzyme need not be declared on the foodstuff/food material ingredients.
(p 6, ln 11 of the specification)
In one aspect of the present invention the at least one functional ingredient may be generated from the at least one constituent of the food material by two or more conversion agents. The at least one constituent may be contacted with the two or more conversion agents at the same time or in series or a combination thereof.
(p 8, ln 8 of the specification)
Preferably, the at least one constituent of the food material is selected from esters [an extensive range of ingredients are recited] … a constituent comprising a hydroxy group (-OH), polyvalent alcohols, including glycerol; water, [other ingredients].
(p 8, ln 13 of the specification)
Preferably, the functional ingredient is generated from at least two constituents of the food material. In this aspect at least two constituents of the foodstuff may interact and/or react and/or combine together to generate at least one functional ingredient. Preferably, the functional ingredient is generated from a first constituent and a second constituent of the food material.
(p 9, ln 11 of the specification)
Preferably, the first constituent and the second constituent are constituents of the foodstuff. In this aspect, the functional ingredient is generated from a first constituent and a second constituent of the food material and the first constituent and second constituent are also present in the foodstuff. Thus the functional ingredient may be generated from constituents/ingredients of the food material which are only partially used to generate the functional ingredient. The remainder of the constituents/ingredients may be present in the foodstuff.
(p 9, ln 16 of the specification)
Preferably, the first constituent of the food material/foodstuff is selected from esters [and the ingredients thereafter recited] … More preferably, the first constituent of the food material/foodstuff comprises or is an ester or a triglyceride [a fatty acid ester].
(p 9, ln 28; p 10, ln 1 of the specification)
In a preferred aspect of the present invention the second constituent of the food material/foodstuff is hydrophilic ... In a preferred embodiment, the second constituent of the food material/foodstuff may be selected from proteins, amino acids, protein hydrolysates, peptides (partly hydrolysed protein), mixtures and derivatives thereof.
(p 10, ln 19 of the specification)
Preferably, the second constituent of the food material/foodstuff is selected from a constituent comprising a hydroxy group (-OH) [a sequence of ingredients], water [further ingredients].
[emphasis added]
(p 11, ln 29 of the specification)
26 Claim 1, according to the language defining the monopoly read in conjunction with the specification, seems to suggest a process for preparing a foodstuff comprising an emulsifier, in which the preparation process involves three steps consisting of: starting with food material containing a fatty acid ester (first constituent, C1) and a second constituent, C2; contacting the food material (comprising C1 and C2) with an enzyme such that an emulsifier (the first functional ingredient, Fy1) is generated by the enzyme from C1, and a second functional ingredient, Fy2 is generated from C2; inactivating or denaturing the enzyme to provide the foodstuff comprising the emulsifier, the fatty acid ester (C1) and the catalytic enzyme in an inactive or denatured form.
27 Claim 7 is a process, according to Claim 1 (and any of the preceding six claims) in which the foodstuff comprises at least the emulsifier (Fy1) and Fy2 and in which Fy1 and Fy2 have been generated from C1 and C2 of the food material by the enzyme.
28 In the proceedings before the primary judge and in the course of the appeal, much debate centred upon the question of whether Claims 1 and 7 describe a “single reaction” or a “dual reaction” or both. The experts took the position that Claim 1 describes the action of a single catalytic enzyme engaging two reactions although, with differing degrees of emphasis, they also accept that Claim 1 describes a single reaction. The primary judge accepted that Claim 1, as a matter of grammatical construction, comprehends a reaction in which a single enzyme acts on a fatty acid ester (C1) to generate an emulsifier (Fy1) and in the same reaction Fy2 is generated from C2. The appellants accept the finding that Claim 1 comprehends both a single and a dual reaction. A single reaction process involves a process in which a fatty acid ester (C1) plus C2, are brought into contact with an enzyme which acts upon C1 to produce an emulsifier (Fy1) and in the process of that reaction, Fy2 is generated from C2.
29 A dual reaction process involves two distinct reactions characterised in this way:
| Fatty acid ester | + | A missing reactant | enzyme → | Emulsifier | + | Other product(s) |
| 2nd Constituent | + | Another missing reactant | enzyme → | 2nd Functional Ingredient | + | Other product(s) |
30 The experts construe the language of Claim 1 in the context of the specification as defining this dual reaction as well as a single reaction.
31 The construction of Claim 1 on the footing that it describes a dual reaction is dependent upon finding within the language of the claim (informed contextually by the specification), either expressly or by implication arising out of the received chemistry, an element, or perhaps an integer, of the claim described as “a missing reactant” and then finding in the second reaction, “another missing reactant”, in order to give meaning to the claim.
32 The appellants say that Claim 1 describes a single reaction and that water can be C2 in that reaction, and moreover the specification recognises that C2 is preferably selected from constituents that expressly includes water. The appellants say that because Claim 7 is dependent on Claim 1, that construction is carried into Claim 7, the differentiating circumstances being that in Claim 7, Fy1 and Fy2 are present in the foodstuff.
33 As to Claim 1, the respondents accept that Claim 1 describes a single reaction although they say that Claim 1 does not claim the use of a process in which water can be C2 in a single reaction (an hydrolysis reaction), and in a dual reaction, water might well be one or other of the “missing reactants” found lying within the language of Claim 1, in each of the dual reactions, but as a matter of chemistry the enzyme (contacting the food material containing C1 and C2) and engaging the missing reactants cannot operate on water to generate the emulsifier (Fy1) or Fy2. The respondents say that if, on the other hand, C2 is water in a single reaction (as, in a single reaction C1 must be a fatty acid ester), Fy1 would necessarily have to be generated from water.
34 The respondents say that this is impossible because the received chemistry is such that the skilled addressee infused with the common general technical knowledge in the art at the priority date could not properly read Claim 1 in that way as to do so would require a functional ingredient to be generated from water in circumstances, put simply, in which the catalytic enzyme would be called upon to act upon water as a substrate in the generation of that functional ingredient. The action of the enzyme in this way was described as something akin to “magic”.
35 On this footing, the respondents contended that the imperatives of the chemistry informed the construction of the claims such that water cannot form part of a single reaction for the purposes of Claim 1 and nor can water be one or other of the missing reactants in the dual reaction contemplated by Claim 7. The respondents also contend that Claim 7 is confined to a dual reaction.
36 In the course of his Honour’s reasons, Jessup J has closely analysed the chemistry and the questions of construction relating to Claims 1 and 7 and the relationship that Claim 9 bears to those claims. Ultimately, Jessup J concluded that the claims were capable of a construction which although put in substantial controversy between the parties nevertheless results in a view being reached which gives clarity of meaning to the claims. I accept those views and adopt them. The only qualification I would put upon the formulation of those views is that the starting point for me suggests that seeking to define Claim 1 and in consequence Claim 7 by reference to a dual reaction process which requires, firstly, the isolation of two reactions and, secondly, in each reaction the isolation of a “missing reactant” which is never able to be identified and which may or may not be one of a number of compounds, prima facie, suggests insufficient clarity to sustain the claims of a public monopoly for the purposes of s 40(3) of the Patents Act. Moreover, such a construction depends upon the reception of expert views at a sophisticated level of expertise in the field of the art which may go beyond the state of common general technical knowledge of the skilled addressee at the priority date. Nevertheless, having regard to the considerations addressed by his Honour and the exposed reasoning in support of the conclusions reached, I join with him in his views in concluding that the claims are sufficiently clear to sustain, at least on that ground, compliance with s 40(3).
37 As to the matters of manner of manufacture and novelty, I agree with the views expressed by Jessup J without wishing to add any further observations.
| I certify that the preceding thirty-seven (37) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Greenwood. |
Associate:
Dated: 4 February 2013
| IN THE FEDERAL COURT OF AUSTRALIA | |
| NEW SOUTH WALES DISTRICT REGISTRY | |
| GENERAL DIVISION | NSD 605 of 2011 |
| ON APPEAL FROM THE FEDERAL COURT OF AUSTRALIA |
| BETWEEN: | NOVOZYMES A/S First Appellant NOVOZYMES AUSTRALIA PTY LTD (ACN 001 420 677) Second Appellant |
| AND: | DANISCO A/S First Respondent DANISCO AUSTRALIA PTY LTD (ACN 096 139 392) Second Respondent |
| JUDGES: | GREENWOOD, JESSUP AND YATES JJ |
| DATE: | 4 February 2013 |
| PLACE: | SYDNEY |
REASONS FOR JUDGMENT
Jessup J
38 This is an appeal by Novozymes A/S and Novozymes Australia Pty Ltd from a judgment given by a single Judge of the court on 20 April 2011, for which her Honour had published reasons on 29 March 2011, in favour of the respondents, the then applicants, Danisco A/S and Danisco Australia Pty Ltd. The proceeding below concerned Australian Patent No 752215, entitled “Foodstuff”, the priority date of which was 21 July 1998. With respect to Claims 7 and 14 in the patent, the primary Judge found for the respondents, declared that the appellants had infringed those claims in certain respects, and made corresponding injunctions. The appellants’ cross-claims that the patent was relevantly invalid for want of clarity, for want of novelty, for want of an inventive step and as not amounting to a manner of manufacture were dismissed.
39 In the present appeal, the appellants challenge the primary Judge’s conclusions on clarity, novelty, and manner of manufacture. The construction of the contentious claims formed a significant part of the case before her Honour, bearing especially upon questions of clarity and novelty, and the appellants challenge her Honour’s conclusions in those respects also. The respondents defend her Honour’s conclusions in all respects, but they have also filed a Notice of Contention in which they say that those conclusions may, in some areas, be upheld on other grounds. Those contentions fall into two groups: one which relates to the construction of the patent in suit, and one which relates to the extent of the disclosures made in certain prior art citations relied on by the appellants. The nature of those contentions will become clear in my reasons which follow.
40 Although expressed in different ways in the specification, at the centre of the invention in the present case was the preparation of a foodstuff from food material in which a conversion agent was involved. The terms “food material”, “foodstuff” and “conversion agent” are used repeatedly in the specification to refer to the starting material, the food as it would be presented to consumers and an agent used in the process of preparation, such as an enzyme, respectively. The food material is to contain at least one constituent, upon which the conversion agent is to work in order to produce at least one “functional ingredient” in the resultant foodstuff. The “functional ingredient” is described as such because it “performs a specific function in the foodstuff”. An example which is most relevant to the controversy between the parties would be an emulsifier, but preservatives, antioxidants, colouring and other ingredients are also referred to. By establishing a means by which an emulsifier, for example, might be generated from the constituents of the starting food material itself, and by then providing for the inactivation of the conversion agent, the inventors claimed to have achieved a desirable modification of food properties without there being any “additive” in the foodstuff as consumed, amongst other benefits.
41 The constituent or constituents of the food material is or are to be selected from –
… esters, monoglycerides. [sic] diglycerides, triglycerides, fats, including lard, tallow and butter fat; fatty acids, fatty acid esters, waxes, wax esters, oils including oils extracted from or derived from palm oil, sunflower oil, soya bean oil, safflower oil, cotton seed oil, ground nut oil, corn oil, olive oil, peanut oil, coconut oil and rape seed oil, proteins, amino acids, protein hydrolysates, peptides (partly hydrolysed protein), a constituent comprising a hydroxy group (-OH) polyvalent alcohols, including glycerol; water, ethanol, sugars including sucrose, fructose, glucose (dextrose), lactose, and galactose; dextrins including maltodextrin, sorbitol, mannitol. [sic] fruit acids and hydroxy acids including citric acid, tartaric acid, lactic acid and ascorbic acid; proteins, amino acids, protein hydrolysates, peptides (partly hydrolysed protein); mixtures and derivatives thereof.
The specification provides that, preferably –
… the functional ingredient is generated from at least two constituents of the food material. In this aspect at least two constituents of the foodstuff may interact and/or react and/or combine together to generate at least one functional ingredient. Preferably, the functional ingredient is generated from a first constituent and a second constituent of the food material.
And:
Preferably, the first constituent and the second constituent are constituents of the foodstuff. In this aspect, the functional ingredient is generated from a first constituent and a second constituent of the food material and the first constituent and second constituent are also present in the foodstuff. Thus the functional ingredient may be generated from constituents/ingredients of the food material which are only partially used to generate the functional ingredient. The remainder of the constituents/ingredients may be present in the foodstuff.
Having thus made it preferable that the first and second constituents of the food material are also constituents of the foodstuff, the specification then describes these as constituents “of the food material/foodstuff”.
42 It is provided that, preferably –
… the first constituent of the food material/foodstuff is hydrophobic and/or lipophilic … [and] ... is selected from esters, monoglycerides, diglycerides, triglycerides, fats, including lard, tallow and butter fat; fatty acids, fatty acid esters, waxes, wax esters, oils including oils extracted from or derived from palm oil, sunflower oil, soya bean oil, safflower oil, cotton seed oil, ground nut oil, corn oil, olive oil, peanut oil, coconut oil and rape seed oil; derivatives and mixtures thereof. More preferably, the first constituent of the food material/foodstuff comprises or is an ester or a triglyceride … [and] … is in liquid form.
With respect to the second constituent, it is provided that, preferably, it is hydrophilic and, in a preferred embodiment, that constituent –
… may be selected from proteins, amino acids, protein hydrolysates, peptides (partly hydrolysed protein), mixtures and derivatives thereof.
The specification provides that, preferably –
… the second constituent of the food material/foodstuff is selected from a constituent comprising a hydroxy group (-OH), polyvalent alcohols, including glycerol; water, ethanol, sugars including sucrose, fructose, glucose (dextrose), lactose, and galactose; dextrins including maltodextrin, sorbitol, mannitol, fruit acids and hydroxy acids including citric acid, tartaric acid, lactic acid and ascorbic acid; mixtures and derivatives thereof. More preferably, the second constituent of the food material/foodstuff is glycerol … [and] is in liquid form.
43 It is further provided that, preferably, the conversion agent is a catalyst, and –
In a preferred aspect, the conversion agent is an enzyme. This aspect is particularly preferred because enzymes are readily available, may be chosen to convert a specific constituent of the food material and/or may be chosen to generate a specific functional ingredient. Yet further, enzymes may be denatured by heat. Thus in a further preferred aspect, the foodstuff/food material is heated after generation of the functional ingredient. The enzyme will be denatured and may then constitute protein. This is advantageous because the denatured enzyme need not be declared on the foodstuff/food material ingredients.
The use of enzymes is advantageous because denatured enzymes are considered, particularly under food labelling regulations, to constitute a processing aid. Inactivated enzymes are not considered to be additives; the addition of additives to foodstuffs is undesirable to many consumers.
The specification makes it preferable to select the enzyme from “lipases, esterases, amylases, xylanases, proteases, lyases, including glucan lyases and Α-1,4-glucan lyase, derivatives and mixtures thereof”.
44 Of the 17 claims in the patent, the following are relevant for present purposes:
1. A process for preparing a foodstuff suitable for consumption comprising an emulsifier, the process comprising the steps of
(i) providing a food material containing a fatty acid ester and a second constituent;
(ii) contacting the food material with an enzyme such that an emulsifier is generated by the enzyme from the fatty acid ester and a second functional ingredient is generated from the second constituent;
(iii) inactivating or denaturing the enzyme to provide the foodstuff comprising the emulsifier, the fatty acid ester and the enzyme in an inactive form or a denatured form.
2. A process according to claim 1 wherein the fatty acid ester comprises at least two ester groups.
….
7. A process according to any one of the preceding claims wherein the foodstuff comprises at least the emulsifier and the second functional ingredient, and wherein the emulsifier and the second functional ingredient have been generated from the fatty acid ester and the second constituent of the food material by the enzyme.
….
9. A process according to any one of the preceding claims wherein the second constituent is selected from a constituent comprising a hydroxy group (-OH), polyvalent alcohols, including glycerol; water, ethanol, sugars including sucrose, fructose, glucose (dextrose), lactose, and galactose; dextrins including maltodextrin, sorbitol, mannitol, fruit acids and hydroxy acids including citric acid, tartaric acid, lactic acid and ascorbic acid; mixtures and derivatives thereof.
10. A process according to any one of the preceding claims wherein the second constituent is glycerol.
11. A process according to any one of claims 1 to 9 wherein the second constituent is a sugar or a sugar alcohol.
12. A process according to any one of claims 1 to 9 wherein the second constituent is ascorbic acid.
….
14. A process according to any one of the preceding claims wherein the foodstuff is selected from baked goods, including breads, cakes, muffins, doughnuts, biscuits, crackers and cookies; confectionery, including candies, caramels, chocolate and puddings; frozen products, preferably frozen dairy products, including ice cream and ice milk; dairy products, including coffee cream, whipped cream, custard cream, milk drinks and yoghurts; meat products, including processed meat products; edible oils and fats, including w/o emulsions, o/w emulsions, margarine shortening and spreads; fine foods, including sauces and mayonnaise.
45 The respondents alleged that the importation, promotion and supply by the appellants of a product called “Lipopan Xtra” amounted to an infringement of Claims 7 and 14 of the patent in suit. Although those claims are process claims rather than product claims, it was alleged that the appellants’ product was capable of being used, and that the appellants (by instructions, for example, as to the use of the product) had induced their customers to use the product, in ways that would infringe those claims. The appellants challenged the validity of Claims 1-9, 14 and 15 of the patent in suit, both by way of Defence and by way of Cross-Claim. They said that what was there claimed was not a manner of manufacture, that the claims lacked novelty and that there was no relevant inventive step. The appellants also contended that, to the extent that it related to Claims 1 and 7, the specification lacked clarity. They sought declarations of invalidity and the revocation of Claims 1-9, 14 and 15.
46 In orders made on 20 April 2011, the primary Judge gave the respondents substantially the relief they sought on their infringement case, and dismissed the appellants’ Cross-Claim. In the present appeal, there is no challenge to her Honour’s findings on infringement (save, of course, by way of a challenge to her Honour’s finding on the validity of the patent itself); neither is there a challenge to her Honour’s conclusion on obviousness. The grounds of appeal, and the submissions made in support of them, were organised according to the following categories: construction and clarity; novelty; and manner of manufacture. I shall arrange my reasons accordingly.
47 The primary Judge had the considerable assistance of the evidence of two leading scientists in the area with which she was concerned, Prof Darryl Small, called by the respondents and Prof Russell Hoseney, called by the appellants. Prof Small had a background in food science and food technology, including a period of employment with the Australian Wheat Board with responsibilities which involved baking, the testing of wheat and flour and protein, and enzyme analysis. At the time of giving evidence, he was an associate professor at the Royal Melbourne Institute of Technology University, his research interests including the practical outcomes of the use of enzymes in food production and food processing, including the use of enzymes in baking. Professor Hoseney was Professor Emeritus of Kansas State University, having had a lengthy career in grain science and chemistry. His research interests and teaching activities included matters relevant to cereal chemistry. Since 1971, and after his retirement in 1997, he had consulted with various milling and baking companies on a range of different matters relating to the milling of grains and the preparation of baked goods. In her reasons, the primary Judge noted that neither Prof Hoseney nor Prof Small was familiar with the carrying out of molecular biology techniques.
Construction and Clarity
48 In her reasons of 29 March 2011, the primary Judge identified six issues that had emerged from the cases put to her on the construction of Claim 1. Although dependent on Claim 1, Claim 7 then had its own constructional issues with which her Honour dealt. I shall commence by identifying the six issues which arose under Claim 1, and by setting out, in brief summary, how her Honour resolved those issues and the extent to which each such resolution is subject to challenge in the present appeal.
49 The first issue was whether the claim encompassed a process in which more than one enzyme was used. The primary Judge held not, and that conclusion has not been challenged.
50 The second issue was whether the claim described a single reaction, two reactions, or both a single reaction and two reactions. The primary Judge held that it described both. The experts who gave evidence before her Honour were agreed that a one enzyme – two reactions scheme was within the terms of the claim, and there appeared to be little doubt as to that. Her Honour accepted that “claim 1 may also, as a matter of grammatical construction, describe a single reaction in which the enzyme acts on the fatty acid ester to generate the first functional ingredient” and, in the same reaction, “a second functional ingredient is generated from the second constituent.” The appellants accept the primary Judge’s decision on this question. In their primary case, so do the respondents. However, in the alternative, they contend that a single hydrolysis reaction in which the second constituent is water is not claimed in Claim 1.
51 The third issue related to the meaning of “generated from”. The primary Judge rejected the view that this connoted no more than that the ingredient should “come from” the constituents in the reaction which gave rise to it, holding that it was necessary that the ingredient have derived its chemical functionality from the constituent from which it was said to be generated. This aspect of her Honour’s reasons, doubtless a little opaque as I have briefly summarised it here, should become clearer in due course. Her Honour’s view of the matter, and the reasoning associated with it, are challenged by the appellants.
52 The fourth issue was whether there were any limitations on the “second constituent”, and specifically whether that constituent could be water. The primary Judge held that it could be water, and that conclusion is supported by the appellants. At least in a situation in which there is a single reaction, her Honour’s conclusion is challenged by the respondents. There was also a question whether the second ingredient could be a fatty acid ester, but that point of construction related to the matter of infringement, and does not arise for consideration on the appeal.
53 The fifth issue related to the meaning of “functional ingredient”. The primary Judge held that the intention was to provide “a functional ingredient which performs a specific, desired function in the foodstuff”. The appellant challenges that conclusion to the extent that it introduced the requirement that the function performed by the ingredient in the foodstuff was “desired”.
54 The sixth issue was whether the enzyme had to be completely, or only substantially, denatured. The primary Judge held that the enzyme would be “denatured and inactivated sufficiently to ensure that it has no remaining activity and is not present in an active state, which would require labelling.” There is no challenge to this holding.
55 On the facts of the present case, the construction of Claim 1 was important not in its own right, but because it fed into the meaning of Claim 7, which is dependent on Claim 1. But Claim 7 gave rise to its own constructional questions, and it is these that have taken centre stage in the construction debate before the Full Court. The primary Judge held that, as a dependent claim, Claim 7 fell within the ambit of Claim 1, but was limited in several ways: first, it described a two-reaction process only; secondly, it required the second functional ingredient to have been generated by the enzyme from the second constituent; and thirdly, it excluded water from being the second constituent.
56 The appellants support the primary Judge’s conclusion that Claim 1 encompasses – although they accept that it is not limited to – a single reaction in which water is the second constituent. They proceed from there to the submission that Claim 7, which is dependent on Claim 1, likewise encompasses such a reaction. Claim 7 was one of the two claims under which the respondents alleged infringement, and it was and is important for their case that it does not encompass a single reaction in which water is the second constituent. So they support the primary Judge’s conclusions that the claim is confined to a dual-reaction process, and that water cannot be the second constituent. However, in the alternative, the respondents contend that the same result might be achieved, and ought to have been achieved in the reasons of the primary Judge, by excluding from Claim 1 a single reaction in which water is the second constituent, and then carrying that construction through into Claim 7.
57 For the purposes of understanding the parties’ differences under Claim 1, and ultimately also Claim 7, it is useful to lay out schematically the way in which chemical reactions of the relevant kind proceed. The primary Judge did so, and it convenient to use her Honour’s examples for the purpose. A single-reaction process would proceed according to the following scheme:
| Fatty acid ester | + | 2nd Constituent | enzyme → | Emulsifier | + | 2nd Functional Ingredient |
A dual-reaction process would proceed according to the following scheme:
| Fatty acid ester | + | A missing reactant | enzyme → | Emulsifier | + | Other product(s) |
| 2nd Constituent | + | Another missing reactant | enzyme → | 2nd Functional Ingredient | + | Other product(s) |
The experts in the case agreed, and it is not disputed on the present appeal, that Claim 1 is apt to describe a dual-reaction process. The appellants say that it is also apt to describe a single-reaction process.
58 If the appellants’ submission is to be addressed purely by reference to the terms of the claim through the eyes of the skilled addressee, it derives some support from the expert evidence in the case: although both Prof Hoseney and Prof Small considered that a dual-reaction process was readily to be perceived as covered by Claim 1, they also accepted that a single-reaction process was also covered by that claim. Neither does the contrary position derive much support from the terms of the specification. In what is on any view a description of the invention in the most general terms (and therefore potentially apposite to the construction of Claim 1), it is stated in the specification as follows:
Preferably, the functional ingredient is generated from at least two constituents of the food material. In this aspect at least two constituents of the foodstuff may interact and/or react and/or combine together to generate at least one functional ingredient. Preferably, the functional ingredient is generated from a first constituent and a second constituent of the food material.
As pointed out on behalf of the appellants, that appears to be a description of a single reaction. It is true that it does not require the generation of two functional ingredients, but it allows for it (“… at least one functional ingredient …”) and, in such a context, admits of a single reaction in which, by the interaction, reaction or combination of the two or more constituents, those ingredients are generated.
59 As indicated above, the primary Judge held that Claim 1 was apt to describe a single reaction. In so doing, her Honour rejected the respondents’ then case, which was that only a dual-reaction process was permissible under that claim. But it is important to understand why her Honour reached that conclusion. She said:
I accept that, in addition to describing two reactions catalysed by the one enzyme, claim 1 may also, as a matter of grammatical construction, describe a single reaction in which the enzyme acts on the fatty acid ester to generate the first functional ingredient. In the same reaction, a second functional ingredient is generated from the second constituent. This would depend on the nature of the second constituent. In one way, the second functional ingredient could be seen as a by-product of the action of the enzyme on the first constituent.
Critical to her Honour’s reasoning was the circumstance that the qualifying phrase “by the enzyme” was included in the terms of step (ii) of the claim internal to the requirement that the emulsifier be generated from the fatty acid ester. At least in the verbal architecture of the claim, there was no such qualifier attached to what the respondents described as the second limb of step (ii), namely, that the second functional ingredient be generated from the second constituent. Thus her Honour described this construction as a “grammatical” one. What her Honour perceived as being at least a permissible reaction under Claim 1 was a single one in which the enzyme operated only upon the fatty acid ester, but a product of the reaction was the generation of a second functional ingredient from the second constituent.
60 The respondents’ challenge to the primary Judge’s construction of Claim 1 in this respect was a limited one. In their Notice of Contention, they said that “[C]laim 1 does not claim the use of a process in which water is the ‘second constituent’ in a single hydrolysis reaction”. Aside from such a context, the respondents did not maintain the position that, either grammatically or scientifically, there could not be a single-reaction process under Claim 1. Indeed, they accepted that the following two situations, given in the specification as examples of an aspect of the invention where the food material and the conversion agent were substantially free of water, were both single reactions:
| Triglyceride + glycerol | lipase → | mono- diglyceride and triglyceride |
| Triglyceride + glycerol/sugar | lipase → | mono- diglyceride and triglyceride + sugar esters |
However, these examples did not involve water as the second constituent.
61 The respondents’ point was that, if there were two reactions, water might be one or other, or both, of the missing reactants (see para 57 above), but it would not be a reactant from which either the emulsifier or the second functional ingredient was “generated” as required by Claim 1. On the other hand, if there were only one reaction with water as the second constituent, it would have to be the water from which the second functional ingredient was “generated”. According to the respondents, the skilled addressee would never read the claim in that way, because it was scientific nonsense – “alchemy” as put by the respondents – to say that the second functional ingredient could be “generated from” water. The exclusion of water from performing service as the second constituent was critical to the respondents’ case under Claim 1 (and, ultimately more significantly, Claim 7), and their proposition that it was alchemy to have the second functional ingredient generated from water was the constructional means by which they sought to achieve that.
62 The primary Judge devoted a section of her reasons to the meaning of the phrase “generated from”. Her Honour said:
Professor Hoseney said that he read “generated from” simply to mean “comes from”. His view was that everything on the right side of an equation is “generated from” everything on the left side of the equation. Professor Hoseney said that in a single reaction parts of the product material “come from” each reactant; that is, in the single reaction A + B = C + D, each of C and D “come from” each of A and B. However, if the claim uses “generated from” in that simple sense, there would be no need to spell out that the first functional ingredient came from the first constituent and the second functional ingredient came from the second constituent. Indeed, it is inconsistent with the requirement of the claim that certain products on the right side of the equation are “generated from” specific constituents on the left side. The claim must mean something different.
And:
In any reaction involving two reactants combining to yield a product or products, the products “come from” both reactants – yet the claims speak of a product being “generated from” one reactant. The claim is using “generated from” in conjunction with “functional” to mean other than the broader notion that something in the product comes from each of the reactants. Professor Hoseney agreed that chemists would not normally use the terminology of “generated from water”. Certainly Professor Small would not do so. In context, where the product is a functional ingredient, the claim is saying that the functional ingredient comes from, or takes its functional part from, the named constituent, generated by the enzyme.
Functionality, that is, the functional part of the product, is relevant. For example, in the reaction:
| AR1 | + | BR2 | enzyme → | CR2 | + | DR1 |
where R1 and R2 are functional groups, assume that only R2 conveys functionality. It is correct to say that C “comes from” A and B. So too does D. However, if C is the functional ingredient and R2 confers that functionality, while it is strictly correct to say that C “comes from” or is “generated from” A and B, the functional ingredient of C can be said to have been generated by the enzyme from B. In my view, this is the meaning conveyed in the claims by the requirement that the functional ingredient be generated from the constituent by the enzyme.
Claim 1 requires that there be generation of a second functional ingredient from the second constituent as a result of the action of the enzyme on the fatty acid ester as a substrate of the first constituent (in a single reaction) or on the second constituent as a substrate (in a second reaction).
63 The appellants criticised her Honour for introducing concepts of functional groups into the construction of Claim 1, such concepts finding no mention either in the claim itself or in any possibly relevant passage in the specification. From a technical perspective, that criticism was accepted by the respondents. In the course of submissions made on appeal on their behalf, senior counsel said:
Now, your Honours, we, with respect, see the force of our friend’s criticism of her Honour’s phrase – “functional groups.” She’s really using it as a sort of lay shorthand to mean “the business end of the thing that’s being broken up by the enzyme.” I accept that is not a correct technical analysis ….
That was, in my opinion, a concession well-made. What the inventors meant by “functional” in the expression “functional ingredient” was made clear in the specification itself: “By the term ‘functional ingredient’ we mean a constituent of the foodstuff which performs a specific function in the foodstuff.” Included amongst the examples given were emulsifiers, preservatives and flavouring. That is a quite different invocation of the notion of functionality from that used in the term “functional groups” in organic chemistry. Whether this problem in her Honour’s reasons may be deflected as simply as attempted by senior counsel for the respondents in the above passage may be a question, but for the moment I propose to turn to what her Honour said in the final such paragraph (commencing “Claim 1 requires …”).
64 In that paragraph the primary Judge (implicitly to an extent) reached the significant conclusion that Claim 1 operated somewhat differently depending on whether the process involved two reactions or one reaction. If it involved two reactions, it was required that the second functional ingredient be generated by the action of the enzyme on the second constituent as a substrate. If it involved one reaction, it was required that the second functional ingredient be generated “as a result of” the action of the enzyme on the fatty acid ester as a substrate. The latter did not require that the second functional ingredient be generated by the enzyme from the second constituent in the sense that the second constituent was the substrate for the enzyme. That approach by her Honour was consistent with what I have described (in para 59 above) as critical to her Honour’s reasoning, namely, that the qualifying phrase “by the enzyme” applied to the first, but not to the second, limb of step (ii) of Claim 1.
65 The significance of that conclusion by the primary Judge, in the context of the “generated from” point, is that her Honour accepted that the second functional ingredient could be “generated from” the second constituent under Claim 1, even where the second constituent was not the substrate for the enzyme. As shall appear presently, that was ultimately a crucial point of distinction as between Claim 1 and Claim 7. Before getting to that, however, I should move on to the consequences of her Honour’s conclusion to the construction of Claim 1 itself.
66 The main such consequence was that water was not disqualified from standing as the second constituent under the claim. It is here that I should return to the respondents’ alchemy point, and initially to the second paragraph from the primary Judge’s reasons set out in para 62 above. As her Honour there noted, both of the experts accepted, perhaps with varying degrees of conviction, that “generated from water” was not within the range of customary terminology for chemists in the relevant field. Prof Hoseney read Claim 1 in an uncomplicated way, without, it seems, notionally interrogating it to discern what it might connote in situations in which various things were inserted as the second constituent. He considered that “generated from” carries the sense of “comes from”. However, as to the isolated expression “generated from water”, Prof Hoseney said, in his oral evidence:
The terminology is wrong when you say it’s generated from water. That brings up something in my mind magical. We’re talking chemistry here.
It was at this point that senior counsel for the respondents suggested that it would be “more like alchemy”, and the witness agreed. But he also made it clear that this conclusion did not dissuade him from the view that water could be the second constituent in the sense that it was “part of the reaction”. He also disagreed with counsel’s suggestion that “the focus is on the substrate whose reaction with water is catalysed by the enzyme”, adding: “Water is one of the constituents, one of the reactants.” Looking at all of this evidence, I am disposed to accept the appellants’ characterisation of what Prof Hoseney meant when he said that to say that something was generated from water brought up, in his mind, something magical, namely, that it was magical to make the isolated statement that a product could be generated from water simpliciter. He did, however, in my reading of it, allow for the conclusion that a product could have been generated in the course of a reaction between water and another reactant, and so generated no less from the water than from the other.
67 That was how the primary Judge interpreted Prof Hoseney’s evidence, but she came to the nub of the problem in that part of her reasons which considered whether the second constituent could be water, not in the (earlier) part which considered the meaning of “generated from” as an expression in itself. That approach was, in my view, inevitable in the light of the respondents’ arguments. Her Honour commenced by noting that it was apparent from the specification as a whole that water could be the second constituent, and continued:
That is, the second functional ingredient may be generated by the action of the enzyme on a second substrate or may come from a second constituent of the food material as a result of the reaction in which the enzyme acts on the first constituent as a substrate.
It will be seen that this passage was a reflection of what her Honour had earlier said in the final passage set out at para 62 above.
68 Her Honour continued:
The skilled reader would understand the enzyme responsible for catalysing the reaction whereby a fatty acid ester is the substrate and an emulsifier is the product to be a lipase. This is confirmed by the specification, which states that the enzyme responsible is preferably selected from a group including lipases. Lipases are classified, as a matter of nomenclature, within class 3 of the IUBMB classification system, that is as a class of hydrolases. Hydrolases are enzymes that split molecules in the presence of water, liberating the hydroxyl (or –OH group) from water through the process of hydrolysis. A lipase is a hydrolase that acts on a lipid as a substrate and reacts with water. This would be understood by the skilled reader. As noted by Professor Small, lipases are typically able to catalyse hydrolysis and transesterification reactions.
As Professor Hoseney pointed out, claim 1 does not explain how the second functional ingredient is generated. From Professor Hoseney’s and Professor Small’s evidence, the skilled reader would not understand the claims to be referring to a functional ingredient in a hydrolysis reaction such as a monoglyceride being “generated from” water. As Professor Small said, he could not think of a molecule which might be a mono- or diglyceride being generated from water. While the –OH or hydroxy group of the monoglyceride may have come from water in the reaction in which the lipase acts on a triglyceride, it is not normal language to describe a functional ingredient such as a monoglyceride (the second functional ingredient in the context of the claims) as having been “generated from” water. That, according to Professor Hoseney, would be to bring up something ‘magical’ rather than applying chemistry. However, he also said that, if the reaction were a hydrolysis reaction where a di- or triglyceride was hydrolysed, that is where water was a reactant, it would not be correct to say that one product was generated from the di- or triglyceride and the other from water. The products are each generated from the combination rather than one from one reactant (the substrate) and the other from the second reactant, the water. It follows that it is not correct to say that a monoglyceride is generated from either the diglyceride or from water; it is generated from the triglyceride and water.
In such a context, the skilled reader would not need to be told that water was a necessary constituent. The presence of water is, as Professor Hoseney acknowledged, ‘a given’ and ‘taken for granted’ in hydrolysis reactions. The specification describes the generation of one functional ingredient, such as an emulsifier, from one constituent, such as a fat, by the enzyme without needing to state that water participates in the reaction.
However, although it is not appropriate or the normal language of the skilled addressee to say that the water “generates” the functional ingredient, water is a reactant, as Professor Hoseney emphasised, even though it is not something from which the functional ingredient is “generated”. On this basis, water would not be the second constituent as it does not provide the functional groups, nor is it a substrate for the lipase, the enzyme of the claim that acts on the fatty acid ester. Water is not, in the words of Professor Small, ‘acting to generate’ the second functional ingredient.
69 In this passage, the primary Judge commenced by acknowledging that water may be the second constituent from which the second functional ingredient is generated, albeit not by the enzyme, but ultimately came to the position that water could not be the second constituent because it was not something from which the second functional ingredient could be generated. The reason for that conclusion was that water “[did] not provide the functional groups, nor [was] it a substrate for the lipase”. I have already commented on the introduction of “functional groups” into her Honour’s analysis and, as to the substrate point, I must say, with respect, that I understood her Honour to have earlier accepted that a second functional ingredient might have been generated from a second constituent notwithstanding that the constituent may not have acted as a substrate for the enzyme in the setting of a single reaction in which the fatty acid ester was the substrate. However that may be, the essence of her Honour’s conclusion that water could be the second constituent under Claim 1 lay in the passages in her reasons which followed those set out above.
70 That conclusion turned upon the terms of Claim 9, which is dependent on Claim 1. Absent Claim 9, the primary Judge considered that water could not be the second constituent under Claim 1. However, Claim 9 specified water as within the range of permissible second constituents, and was consistent with the specification in doing so. It followed, according to her Honour, that the skilled addressee would understand that at least a permissible second constituent under Claim 1 would be water. Her Honour gave instances, within the compass of the claim, in which water would be the second constituent: “simple hydrolysis in a single reaction …. interesterification between a fatty acid and a proteinaceous second constituent … [and] the conversion of triglyceride and glycerol/sugar by a lipase to mono-, di- and triglyceride plus sugar esters.”
71 “Simple hydrolysis in a single reaction” was the very thing that, under their Notice of Contention, the respondents submitted (albeit in the alternative) was not permissible under Claim 1. It is apparent from those submissions, however, that the respondents would travel with the primary Judge to the point of her conclusion that, absent Claim 9, water could not be the second constituent under Claim 1. They supported that position substantially on the basis of Prof Hoseney’s acceptance (and Prof Small’s assumed position to the same effect) that it would be “magical” for the second functional ingredient to be generated from water as such. In their written outline, the respondents sought to overcome the effect of Claim 9 by proposing that “the skilled addressee would not read the reference to ‘water’ in claim 9 as describing a process within claim 1 involving a single hydrolysis reaction”. They submitted that the reference to water in Claim 9 “must either be an error … or speaking to other kinds of reactions”.
72 Our attention was drawn to no aspect of the evidence of either of the experts in which the opinion was expressed that the reference to water in Claim 9 must be speaking of kinds of reactions other than hydrolysis. Indeed, the second of these possibilities – that Claim 9 might be speaking of a reaction in which water was the second constituent but which was not hydrolysis – brought forward a response from the appellants that it amounted to a departure from the way the respondents had run their case below and, in any event, that there was, in the context of the reactions described in the patent, “no non-hydrolysis reaction which could satisfy the integers of the claims where water is a second constituent”. In their outline in reply, the respondents invited the court to disregard their earlier passage “or speaking to other kinds of reactions”. In their case as presented at the hearing of the appeal, the respondents’ only point by way of challenge to the use which the primary Judge made of Claim 9 in the construction of Claim 1 was that the reference to water in Claim 9 must have been in error, and that Claim 9, being invalid (counsel left open the question why it was invalid) would have to be revoked.
73 I do not accept that Claim 9 can be airbrushed out of the patent as simply as the respondents propose. First, although it was submitted on their behalf that the skilled addressee would readily accept that the reference to water in Claim 9 must have been in error, our attention was drawn to no evidence to that effect. Neither Prof Hoseney nor Prof Small, in his affidavit, advanced such a reading of Claim 9. Secondly, it is not as though the reference to water in Claim 9 is isolated. There is a corresponding passage in the specification, as follows:
Preferably, the second constituent of the food material/foodstuff is selected from a constituent comprising a hydroxy group (-OH), polyvalent alcohols, including glycerol; water, ethanol, sugars including sucrose, fructose, glucose (dextrose), lactose, and galactose; dextrins including maltodextrin, sorbitol, mannitol, fruit acids and hydroxy acids including citric acid, tartaric acid, lactic acid and ascorbic acid; mixtures and derivatives thereof. More preferably, the second constituent of the food material/foodstuff is glycerol.
That is to say, not only was water contemplated by the inventors as a permissible second constituent in the very kind of reaction that is claimed in Claim 9, it was preferably so. When the inventors went to the length of stating that a particular aspect of the invention was preferable, I would be very slow to reach the conclusion that their words involved a scientific oversight or a slip of the pen.
74 For the above reasons, I would reject the respondents’ challenge to the primary Judge’s construction of Claim 1.
75 The next matter to consider is the appellants’ challenge to her Honour’s construction of Claim 7. Here the appellants commenced with the circumstance that Claim 7 was dependent on Claim 1 and, they submitted, should be construed consistently with it. In particular, they submitted that Claim 7, like Claim 1, encompassed a single-reaction process in which water was the second constituent. The primary Judge did not accept that. Her Honour perceived the following limitations in Claim 7, by reference to the broader terms of Claim 1:
• the emulsifier and the second functional ingredient must be present in the final foodstuff; and
• each of the emulsifier and the second functional ingredient are required to have been generated from the constituents (of which the first is a fatty acid ester) by [her Honour’s emphasis] the enzyme.
Her Honour elaborated upon the second of these limitations in the following passage of her reasons:
Each of the fatty acid ester and the second constituent from which the emulsifier and the second functional ingredient are generated are substrates for the enzyme. The enzyme must act on each constituent to generate a functional ingredient. Claim 1 does not require the second functional ingredient to have been generated by the enzyme from the second constituent. Claim 7, a dependent claim, adds a further requirement or limitation to claim 1. Claim 7 describes two reactions of the enzyme. Claim 7 also restricts the second constituent of claim 1 by providing that it be a constituent on which the enzyme can act to generate the second functional ingredient.
Claim 7 makes it clear that water cannot be the second constituent in that claim. To the extent that claim 9 is said to be dependent on, inter alia, claim 7 as a preceding claim, the specificity of claim 7 would be understood to exclude water, even though it was one of the broad class of second constituents of claim 9. The skilled reader would not read claim 7 to include the generation of the second functional ingredient from water where the claim is only describing two reactions in each of which the enzyme acts on the constituent as a substrate to generate a functional group. The skilled reader would not consider water such a substrate, as water is not understood as the source of the functionality or of the functional group of the required product generated by the enzyme which acts as a lipase on the fatty acid ester.
76 Her Honour’s construction of Claim 7 involved both grammatical and scientific considerations. The starting point was a grammatical one. Her Honour treated the adverbial phrase “by the enzyme” as referable both to the generation of the emulsifier from the fatty acid ester and to the generation of the second functional ingredient from the second constituent. This was to be contrasted with step (ii) of Claim 1, where the phrase “by the enzyme” was to be found immediately after the passage which required the emulsifier to be generated from the fatty acid ester, and was not repeated after the passage which required the second functional ingredient to be generated from the second constituent. The next point had both grammatical and scientific aspects, and was that, for something to be generated by an enzyme from a reactant, the reactant must have been the substrate for the enzyme. It followed that each of the fatty acid ester and the second constituent referred to in Claim 7 must be a substrate for the enzyme. From that it followed that the claim must have been referring only to a dual-reaction process. Additionally, as it seems to me, her Honour’s reasoning involved the purely scientific proposition that water could not be a substrate for an enzyme, from which it followed, as a matter of logic, that water could not be the second constituent. It could be present in the reaction or reactions contemplated by the claim, but it could not be the second constituent.
77 With respect to the primary Judge, an immediate problem with the above conclusion is that it directly contradicts the proposition upon which she relied to have water as the second constituent under Claim 1, namely, that it is explicitly included as a permissible second constituent under Claim 9. The latter, it will be recalled, is dependent not only on Claim 1 but also on Claim 7. As is apparent from the passage from her Honour’s reasons set out most recently above, there may be a constructional solution to that problem, and I shall return to it presently. At this stage it is my project simply to point out that Claim 7 by no means admits of an obvious construction. It is apparent from her Honour’s analysis, and from the submissions which were made on appeal, that much depends on one’s starting-point. Her Honour’s was that, grammatically, “by the enzyme” referred to each of the “generations” mentioned in the claim. If that proposition were bolted down, the next three points followed more or less in sequence. But the end result was an apparent inconsistency with Claim 9. The appellants’ starting point, by contrast, was that, because of Claim 9, water had to be a permissible second constituent in a single-reaction process under Claim 7. The end result of their construction, however, was that Claim 7 was given no different a construction from that given to step (ii) in Claim 1, notwithstanding the (presumably conscious) placement of the adverbial qualifier “by the enzyme” in a different position in the text.
78 Although the primary Judge invoked the perspective of the skilled addressee in certain respects in her construction of Claim 7, her Honour did not do so in relation to what I have described as her first, purely grammatical, point. Neither were we referred to any expert evidence to the effect that such an addressee would see the words “by the enzyme” in Claim 7 as referable to both of the “generations” in the claim in the sense of requiring both the fatty acid ester and the second constituent to be substrates for the enzyme. If the parties, following her Honour, perceived this as being a purely grammatical aspect of the construction of the claim, I would join in that perception. I do not, however, regard her Honour’s conclusion as self-evidently correct. For my own part, I do not see why the words in Claim 7 following “wherein” might not equally be seen as a rolled-up description of one reaction qualified by the words “by the enzyme”; that is to say, as describing a single enzymatic reaction in which the emulsifier is generated from the fatty acid ester and the second functional ingredient is generated from the second constituent. Grammatically, I would not regard the placement of the words “by the enzyme” at the end of the text of the claim as sufficient to exclude that as a realistic and sensible construction.
79 As mentioned above, by the end of the trial at least the experts were of the view that Claim 7, no less than Claim 1, was apt to describe a single reaction (as well, of course, as a dual reaction). During the running of the appeal, the respondents came to the same position. Clearly, any such single reaction was catalysed by the enzyme. Her Honour accepted that a single-reaction process in which the fatty acid ester was the substrate for the enzyme but, as part of that one reaction, a second functional ingredient was also produced from a second constituent, itself not a substrate, was encompassed by Claim 1. As a matter of terminology, I would not regard the placement of the words “by the enzyme” at the end of Claim 7 as sufficient to establish a grammatical starting-point for the construction of that claim which differed from that employed under Claim 1. As it happens, on the appeal, counsel for the respondents accepted that the only difference between Claim 1 and Claim 7 was the requirement that the second functional ingredient be present in the final foodstuff.
80 I would next add that there is nothing in the specification which provides any insight into the thinking of the inventors as they moved from Claim 1 to Claim 7. In particular, there is no teaching as to why it was either advantageous with respect to, or even different from, the process described in Claim 1 for each of the “generations” of functional ingredients to be done “by the enzyme”, in the sense of requiring the two constituents each to be a substrate for the enzyme. So far as I can see, the closest the specification comes to dealing with the process claimed in Claim 7 is in the following very general passage:
Thus, in a further broad aspect of the present invention there is provided a foodstuff prepared from a food material, wherein the foodstuff comprises at least two functional ingredients, and wherein the [sic] at least two functional ingredients have been generated from a first constituent of the food material and a second constituent of the food material by a conversion agent. Preferably, the first constituent is a constituent comprising at least two ester groups, preferably a triester, more preferably a triglyceride. Preferably, the second constituent is a sugar or a sugar alcohol, more preferably ascorbic acid.
The final sentence in this passage picks up, of course, Claims 11 and 12. But the first sentence corresponds broadly with Claim 7 (upon which, amongst others, Claims 11 and 12 are dependent). There is no message conveyed anywhere here that the words “by the enzyme” in Claim 7 must be referable to the second constituent as well as to the fatty acid ester.
81 Indeed, as pointed out on behalf of the appellants, there is scarcely anything in the specification which requires or implies the existence of a dual reaction, rather than a single reaction, in any of the workings of the invention. Counsel for the appellants submitted that only with respect to the identification of one part of the prior art did the specification depart from the single-reaction model. Counsel for the respondents seized upon that one instance, but the present question is not whether Claim 7 allows for a dual-reaction process: it is whether it is confined to it. To the extent that the specification is of any assistance, it provides no support for an affirmative answer to that question.
82 Neither was her Honour’s conclusion, to the extent that it involved scientific considerations, based squarely on the expert evidence in the case. In his affidavit, Prof Hoseney, said that Claim 7 was “not entirely clear” because it was capable of meaning either that there were two reactions, each catalysed by the enzyme, or one reaction catalysed by the enzyme. That is to say, it was because the claim allowed for a single as well as for a dual reaction that it was not entirely clear. Prof Small accepted under cross-examination that, if the second constituent were water (a possibility with which he had some difficulty), Claim 7 was apt to describe a single hydrolysis reaction. It seems that neither of these experts laid down the foundation for the primary Judge’s conclusion that Claim 7, because of the double activity of the enzyme which it required, necessarily implied the existence of two substrates and therefore of two reactions.
83 It was an important aspect of her Honour’s construction of Claim 7 that “[t]he skilled reader would not consider water such a substrate”, ie as “a substrate to generate a functional group”. We were referred to no expert evidence such as would provide a basis for that finding. To the contrary, in their written outline the appellants referred us to some passages in the transcript of the concurrent evidence of Profs Small and Hoseney which make it tolerably clear that they both regarded it as uncontroversial that water could operate as a substrate in an enzymatic reaction. The respondents did not join issue with the appellants at that level.
84 Indeed, if there was a reservation which the experts shared about the wording of Claim 7, it related to the notion that a second functional ingredient might be “generated from” water. That was the same reservation as I have dealt with above in relation to Claim 1, in which context, it will be recalled, the primary Judge held that water could be a second constituent. It was not, therefore, because the skilled addressee would necessarily reject water as a chemical entity from which an ingredient could be “generated” that her Honour excluded water from the range of permissible second constituents under Claim 7.
85 It will be clear from the foregoing that the construction of Claim 7 was difficult. However, the primary Judge perceived in the claim a clarity and, it must be said, an obviousness of meaning in the eyes of the skilled addressee, that would be sufficient, of itself, to overcome the problem presented by the terms of Claim 9. In my respectful view, such a conclusion does not withstand examination. I do not regard the terms of Claim 7, considered without reference to Claim 9, as sufficiently clear to justify the conclusion that the claim cannot be speaking of a single-reaction process in which water is the second constituent. I accept that the proper construction of the claim is a matter upon which different views might legitimately be taken, but, as the foregoing discussion shows, there are several considerations which count against the conclusion reached by her Honour: the grammatical consistency of the terms of the claim with a single-reaction process; Prof Small’s acceptance that, if water could be the second constituent, the claim encompassed a single reaction; the respondents’ (now) acceptance that, aside from hydrolysis, the claim is apt to cover a single reaction; the experts’ apparently uncontroversial view that water can be a substrate for an enzyme; and the tenor of aspects of the specification, which appear to be associated with that aspect of the invention which is claimed in Claim 7, that a single reaction is contemplated.
86 In the result, I cannot accept the primary Judge’s conclusion that the skilled addressee would read Claim 7 as excluding a process in which there was one reaction only and water was the second constituent.
87 That brings me back to Claim 9, the passage in the specification corresponding to which is set out in the third extract in para 42 above. Under Claim 9, what is claimed, amongst other things, is a process according to Claim 7 in which water is permitted as a second constituent. If we are to read the claims sensibly, it would seem to follow that any ambiguity in Claim 7 must be resolved by allowing water to be the second constituent. The primary Judge deflected that conclusion by reasoning that, in the eye of the skilled reader, “the specificity of claim 7 would be understood to exclude water, even though it was one of the broad class of second constituents of claim 9”. The point was, it seems, that, although the wording of other claims might aid in the construction of the claim of interest, that was only an aid to construction, and had to yield to specific indications as to the meaning of the latter. In the context of the present debate, according to her Honour, it was clear from the words of Claim 7 itself that water could not be the second constituent, and that conclusion was not to be displaced by the more indirect constructional indications that might be derived from another claim. A submission along these lines was also made by the respondents before the Full Court.
88 It should be clear that I do not share her Honour’s perception as to the clarity of the specific meaning of Claim 7 itself. But there is, in my respectful view, a more direct, and less tractable, impact which the terms of Claim 9 have upon the construction of Claim 7. Claim 9 bears upon the issue not merely because it provides a point of reference for the achievement of consistency of meaning within the patent as a printed document. More importantly, there is a structural relationship between Claim 7 and Claim 9: that the patent claims a process according to Claim 7 in which water is the second constituent is the inevitable result of the way Claim 9 is expressed. Claim 9 could not be clearer in relevant respects. It tells the reader, both scientific and lay, that water must be within the class of second constituents permissible under each of the preceding claims, including Claim 7.
89 It was submitted by the respondents that the inclusion of water in Claim 9 was a mistake, and they indicated that they would consent to a revocation of that claim. In the light of the references to water which appear (albeit occasionally) in the specification, I could not accept that submission. I would hold that the inventors consciously included water as within the class of permitted second constituents because that was what they intended. But it is not necessary to decide that point. The present task is the construction of Claim 7 and, as counsel for the respondents accepted, the terms of Claim 9 were there in the patent with the potential to make an appropriate contribution to the completion of that task. The primary Judge did not base her reasoning upon the presence of a word or words in Claim 9 that could, in effect, be ignored under the slip rule, and we were not invited to do so on appeal.
90 For the above reasons, I would hold that Claim 7 in the patent in suit claims, amongst other things, a single-reaction process in which water is the second constituent.
91 That leaves the question of the clarity of Claims 1 and 7 of the patent in suit. Section 40(3) of the Patents Act 1990 (Cth) (“Patents Act”) requires that the claims be “clear and succinct”. It is said on behalf of the appellants that the scientific content of the claims is uncertain, in the sense that different, apparently tenable, connotations might be derived from them, with the result that the skilled addressee would be left in a state of doubt as to what was being claimed. They supported this by reference to the differing views expressed by the experts in the present case, and to what was said to be the primary Judge’s adoption of a route to the construction of Claim 7 which was not that followed by either of the experts.
92 Since I have differed from the primary Judge on the construction of Claim 7, I would necessarily approach the question of clarity, with respect to that claim at least, from a somewhat different perspective. However, her Honour’s general approach is not such as could attract, in my respectful view, any valid criticism. Her Honour said:
The construction of the claims of the Patent has been particularly difficult. This can, in part, be attributed to the use of the expression “generated from” and the fact that the specification describes more than is claimed. However, as stated in Blanco White TA, Patents for Inventions (5th ed, Stevens, 1983) at [4-701]:
Certainly a claim is not invalid merely because it might have been better drafted, nor merely because the patentee puts forward a construction that the court is not prepared to adopt; nor merely because it is capable of more than one construction, even though it be difficult to decide which is the right one.
The respondents supported that approach, and I did not understand the appellants to take issue with it.
93 The problem of locating the dividing line which separates a claim which is bad for want of clarity from a claim which, though troublesome in its construction, is sufficiently clear to be valid, is scarcely less difficult than the problem of construction itself. In the present case, both sides have been able to draw upon general statements in the cases which provide some support for the opposite positions which they take. For my own part, I would find it sufficient for present purposes to refer to Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588, in which the High Court said (at 610):
If it is impossible to ascertain what the invention is from a fair reading of the specification as a whole, that, of course, is an end of the matter. But this objection is not established by reading the specification in the abstract. It must be construed in the light of the common knowledge in the art before the priority date. The general principles governing the construction of specifications are well known, and no lengthy reference to them is necessary. It is, however, fitting that we remind ourselves of the criterion to be applied when it is said that a specification is ambiguous. For, as the Chief Justice pointed out in Martin v Scribal (1954) 92 CLR 17, at p 59, referring to Lord Parker's remarks in National Colour Kinematograph Co Ltd v Bioschemes Ltd (1915) 32 RPC 256, we are not construing a written instrument operating inter partes, but a public instrument which must, if it is to be valid, define a monopoly in such a way that it is not reasonably capable of being misunderstood. Nevertheless, it is to be remembered that any purely verbal or grammatical question that can be resolved according to ordinary rules for the construction of written documents, does not, once it has been resolved, leave uncertain the ambit of the monopoly claimed (see Kauzal v Lee (1936) 58 CLR 670, at p 685).
94 How did the primary Judge resolve the question of construction which confronted her? Having set out the passage from Blanco White referred to in para 92 above, but before she embarked upon the constructional questions which arose, her Honour said:
Despite the difficulties associated with the construction of the Patent I have found, as detailed below, that there is a clear construction available. Accordingly, the claims of the Patent cannot be revoked for lack of clarity under s 40(3) of the Act.
That is to say, her Honour was sufficiently confident of the construction which she preferred to exclude the prospect of there being such want of clarity as would produce consequences under s 40(3). I cannot find in her Honour’s reasons any further treatment of the subject.
95 It is implicit in her Honour’s approach that the giving of a meaning to a claim in a patent as the result of a conventional constructional exercise by the court will leave little scope for further debate on the matter of clarity. Put differently, a conclusion that a claim lacks clarity is proper to be made only if the court, using all the properly available aids and looking at the matter through the eyes of the skilled addressee, is unable to give a clear meaning to the claim. This kind of thinking also informed the cases of the parties in the present appeal. The respondents resisted any suggestion that the claims were unclear, but the “clear” meaning for which they contended lay at the centre of the constructional dispute in the case. The appellants likewise contended for their own meaning, but they submitted also (and not merely in the alternative) that the claims were unclear. In these circumstances, the court must, in my view, be astute to avoid perceiving a forensic controversy about construction as the equivalent of an absence of clarity in the claims to which it relates. The claims concerned may indeed be unclear, but that conclusion is not reached simply because the parties in a particular case are unable to agree on the construction to be given to them.
96 In the present case, I would not resolve the dispute about Claims 1 and 7 of the patent in dispute by reference to s 40(3) of the Patents Act. With respect to Claim 1, it is only the appellants who contend that the claim is unclear, yet they support the construction given to it by the primary Judge, at least to the extent that her Honour held that it encompassed a single reaction in which water could be the second constituent. Since I have upheld the appellants’ position on this point, it would be asynchronous, to say the least, were I now to withdraw from that holding and declare that the claim was, in effect, “reasonably capable of being misunderstood”. Perhaps the two positions are not theoretically inconsistent, but, the constructional question having been fiercely contested by the parties in the present appeal, and having been determined in a particular way, I would not be disposed to view the outcome as attended by such want of clarity as would lead to non-compliance with s 40(3).
97 With respect to Claim 7, as will be clear from what has gone before in these reasons, there is a significant grammatical aspect to the basis upon which I would decide the construction of this claim in favour of the appellants, namely, the structural arrangement of the claims as a verbal artefact, and the relationship between Claims 7 and 9. That aspect was, of course, informed by the scientific context, but the conclusion was ultimately one which I found myself able to express with sufficient confidence to exclude any finding of want of clarity in Claim 7.
98 For the foregoing reasons, I would reject the appellants’ case under s 40(3) of the Patents Act.
Novelty – The Johnson patent
99 The first piece of prior art on which the appellants relied in their novelty case was US Patent No 3,368,903 (“the Johnson patent”), dated 13 February 1968. The abstract in the specification described the invention as follows:
A lipase preparation exhibiting activity in the pH range of 4.0 to 6.5, substantially free from deleterious amounts of proteinases, amylases and reducing substances, and which has the ability to increase the extractable monoglyceride content of a dough is added to a dough to retard the tendency of the baked goods obtained from the dough to become stale.
The following passages appear in the body of the specification:
This invention relates to the production of improved baked products and more particularly to the production of bread, rolls and sweet goods that remain soft longer.
And:
In an effort to combat the bread staling problem, most baked goods today contain one or more additives which, to a greater or lesser extent, will retard staling. One such additive consists largely of monoglycerides. Although these materials provide improved results, they may give undesirable changes in the cell structure of the bread. This is often associated with the use of monoglycerides made from fats having a high iodine number. The effect is more noticeable as the products containing monoglycerides are permitted to age.
It has now been found that the use of certain lipase preparations in a bread dough mixture will significantly retard the tendency of bread to become stale. At the same time, bread made in this manner exhibits none of the disadvantages usually encountered when monoglycerides are used as bread staling retarding additives. The lipase preparation is added to the bread dough along with flour, water, shortening, yeast and the other conventional ingredients. The dough is mixed until smooth and is thereafter handled in the conventional manner.
Lipases are enzymes which accelerate decomposition of triglyceride fats. The decomposition products are mainly diglycerides, monoglycerides, fatty acids and glycerine, the relative amounts and proportions of each depending upon the characteristics of the lipase preparation and the length of time over which it is permitted to act.
The lipases are individualistic in their behaviour according to their source, conditions of preparation and use. Some produce an abundance of one end product at the expense of another. Some lipases are more effective in acid medium while others are more effective with fatty acids of a particular type and are relatively or completely ineffective with others. Some may be crystallized as pure materials; others, as extensive trials have shown, are not pure materials but are mixtures of active components which are ineffective when separated. Most commercial lipase preparations contain, in addition to lipase, other types of enzymes in appreciable quantities.
Lipase preparations which are useful according to this invention must contain lipases of the type which are capable of splitting triglyceride fats containing fatty acids having 12 or more carbon atoms. Also the lipase preparation must be one which is active at the pH of bread, which generally ranges from 4.0 to 6.5.
The lipase preparations of this invention may contain minimum amounts of extraneous active materials such as enzymes other than the lipases. Extraneous enzymes usually found in lipase preparations include proteinases and amylases. Although these may be desirable for some purposes, they are not essential to or related to the present invention. Lipase preparations also often contain reducing substances which are detrimental and should be kept at a minimum level.
And:
The use of the lipase preparations according to this invention has a softening effect when used in doughs having no added shortening increment. While the exact mechanism is not known, it is thought that the lipase splits the natural flour lipids to form monoglycerides, and that these monoglycerides are, to some extent, preferentially bound by the flour protein, displacing the lipid component. The increased softness therefore is thought to be the added effect of the monoglyceride on the starch and the possible lipo-protein modifying action resulting from an increase in solvent-extractable lipids.
100 In her reasons, the primary Judge noted that the respondents had submitted that the Johnson patent was not anticipatory because a claim of the patent in suit was limited to a dual reaction, because water could not be the second constituent in the patent in suit and because the patent in suit claimed the use of a single enzyme only. As noted earlier in these reasons, her Honour held that Claim 7 was, but Claim 1 was not, limited to a dual reaction and that water could be the second constituent under Claim 1, but not under Claim 7. In each of these respects, I have held that her Honour ought to have decided the Claim 7 questions consistently with the way she decided the Claim 1 questions. As to the use of a single enzyme, the primary Judge held that the Johnson patent did disclose the use of a single enzyme, albeit that it existed in a mixture of enzymes. In their Notice of Contention, the respondents challenged that finding. They pointed to the passage in the specification in the Johnson patent, included in the section extracted above, to the effect that some lipase preparations were “mixtures of active components which are ineffective when separated”. It followed, according to the respondents, that “[t]he skilled addressee … [had] no way of knowing how many enzymes are responsible for the ‘softening effect’ reported in Johnson ….” I would not accept that criticism of her Honour’s reasons. I agree with her Honour that the Johnson patent discloses the use of a lipase to produce monoglycerides from the decomposition of triglyceride fats, and that it is the monoglycerides that are responsible for the softening, or anti-staling, effect in bread. The presence of other enzymes in the lipase preparation was recognised as a realistic possibility, but the patent neither depended on them for the working of the invention nor disclosed their invariable efficacy in producing the softening effect which lay at the centre of the invention.
101 To this point, the findings which I would make with respect to the construction of Claims 1 and 7, together with the conclusions of the primary Judge which I would leave undisturbed, should have produced the result that those claims were anticipated by the Johnson patent. But there was a further, substantial, holding which her Honour made, favourably to the respondents, about the Johnson patent and which, of itself, was sufficient to justify the conclusion that that patent was not anticipatory, even with respect to Claim 1. Her Honour said:
The claims of the Patent do require the generation of an emulsifier from the fatty acid ester. What is required is that the prior publication disclose the generation of an emulsifier to the skilled reader as at the priority date. The monoglycerides of the Johnson patent may in fact be emulsifiers but their use as an emulsifier is not disclosed, nor is the mechanism of action of the monoglycerides. There is no disclosure to tell the skilled reader that they are acting as, or should be characterised as, emulsifiers. The evidence of the experts does not establish that this would have been clear to the skilled reader of the Johnson patent.
This conclusion is challenged by the appellants. They say that, at the priority date of the patent in suit, the skilled addressee would not need to be told that a monoglyceride was an emulsifier.
102 In his affidavit sworn on 8 October 2009, Prof Hoseney referred to so much of Claim 1 of the patent in suit as required the contact of the food material with the enzyme “such that an emulsifier is generated by the enzyme from the fatty acid ester”. He referred to so much of the specification in the Johnson patent as described the addition of lipase to dough, resulting in the production of, amongst other things, monoglycerides. He said: “In paragraph 45 above, I have referred to the use of monoglycerides as emulsifiers in baked goods”. In that paragraph, Prof Hoseney said:
The inclusion of surfactants/emulsifiers in the recipes of breads and other baked goods is also a well established practice in the baking industry. Exhibited to this affidavit and marked “RCH-5”, is a paper which I co-authored in 1983, which discusses the use of emulsifiers in baked goods. The article particularly relates to an emulsifier called DATEM (diacetyltartaric acid esters of monoglycerides).
The 1983 paper referred to opened with the following paragraph:
The inclusion of emulsifiers/surfactants in bread is a well established practice in the baking industry. In the 1930s mono- and diglycerides were added to shortening to improve the dispersibility of shortening in dough. The addition of the mono- and diglycerides to the formula resulted in perceptibly softer bread crumb. Since then, many other surfactants have been developed.
103 In his affidavit sworn on 17 February 2010, Prof Small said:
Emulsifiers that I was aware were commonly used in 1998 and are still used today are DATEM (Diacetyl Tartaric (Acid) Esters of Monoglyceride), SSL (Sodium stearoyl lactylate) and distilled monoglycerides. DATEM is primarily used as a softener whilst SSL is used to combat staling and increase volume and distilled monoglycerides for staling.
Prof Small commented on the Johnson patent, but did not enter upon the subject whether he would have read that patent as disclosing the production of an emulsifier. He gave critical attention to Prof Hoseney’s affidavit and, in relation to the Johnson patent, said the following:
At paragraph 131 of the Hoseney Affidavit, Professor Hoseney states “Accordingly, US patent number 3,386,903 describes a process which is included within claim 7 of the Danisco Patent, in which:
i. the fatty acid ester is a triacyl glycerol;
ii. the second constituent is water;
iii. a lipase generates monoacyl glycerol (monoglyceride), which is an emulsifier;
iv. the lipase also generates diacyl glycerols (see column 2, line 29 of US patent number 3,386,903), which have emulsifying properties, and are therefore a functional ingredient within the meaning of the Danisco Patent.”
When Prof Hoseney’s affidavit was (later) read in court, the quoted passage from para 131 was treated as a submission only. However, it was part of the material upon which Prof Small commented, and he said nothing about the statement that the Johnson patent described a process in which “a lipase generates … monoglyceride … which is an emulsifier”.
104 Before giving evidence, Profs Small and Hoseney conferred, and prepared a joint report, which was admitted into evidence. A question which they addressed in that report was what the Johnson patent would have disclosed to them on 21 July 1998, particularly with respect to the features in Claims 1 and 7 of the patent in suit. They said:
Points of agreement:
The reactions being catalysed by the enzymes disclosed is:
Triglyceride +H2O -----→ monoglyceride, diglyceride + FFA
________________lipase
Paragraph 13 also refers to inactivation of the lipase, consistent with claim 1 of the patent.
Additional points from Professor Hoseney
Thus the triaclglycerol is constituent one, water is constituent 2, the monoacyl glycerol is the emulsifier and diacyl glycerol or free fatty acid is the second constituent functional ingredient in accordance with claim 1 of the patent.
Additional points from Professor Small
I do not believe this patent describes a second functional ingredient being generated from the second constituent, which is water.
Here Prof Hoseney, speaking with reference to the priority date, made it clear that he would then have understood that the monoglyceride (which he called “monoacyl glycerol”) was an emulsifier. Although Prof Small did not join in that statement, neither did he say anything to contradict it. Under examination by counsel for the respondents, Prof Small was taken to the joint report, in the context of which he said that monoglycerides and diglycerides had “emulsification properties”. He added:
… the reason monoglycerides and diglycerides are of interest to us in this context, I believe, are [sic] that they do have this polar and non-polar parts of the molecule, and as such they can function as emulsifiers for us.
105 From this evidence, there does not seem to be much doubt that the skilled reader, in 1998, would have understood that the monoglycerides, in terms disclosed in the Johnson patent, were emulsifiers. If the requirement was, as proposed by the primary Judge, that “the prior publication disclose the generation of an emulsifier to the skilled reader as at the priority date”, the evidence referred to above would seem to indicate that that requirement was uncontroversially satisfied by the Johnson patent. Yet her Honour held otherwise, noting that that patent did not inform the skilled reader that the monoglycerides were “acting as, or should be characterised as, emulsifiers”. That is so and, as pointed out by counsel for the respondents, the specification in the Johnson patent informed the reader that “the exact mechanism [was] not known”, but that it was thought that the monoglycerides were, “to some extent, preferentially bound by the flour protein, displacing the lipid component”. Counsel submitted that this amounted, if anything, to teaching away from the process the subject of Claim 1 in the patent in suit.
106 This state of things brought the debate before the Full Court to the area of implicit disclosure, and to the authorities dealing with that concept. I shall come to them next, but I first desire to observe that it is unfortunate that, in a case which was as hard and meticulously fought as the present one, no-one, apparently, thought to ask the experts the very question the answer to which may now lie between the appellants and a finding that the Johnson patent was anticipatory. That question was: looking at the matter in July 1998, would you have understood that the Johnson patent was, expressly or implicitly, disclosing the production of emulsifiers as a result of the addition of lipases during the bread making process? The failure of the parties to confront that issue head-on during the concurrent evidence of the experts left her Honour with nothing but the bare terms of the Johnson specification with which to work.
107 The appellants relied on the judgment of Black CJ and Lehane J in Bristol-Myers Squibb Co v FH Faulding & Co Ltd (2000) 97 FCR 524, in which their Honours considered the leading authorities on the question of what was required in a prior publication to constitute anticipation, and continued (97 FCR at 548 [67]):
What all those authorities contemplate, in our view, is that a prior publication, if it is to destroy novelty, must give a direction or make a recommendation or suggestion which will result, if the skilled reader follows it, in the claimed invention. A direction, recommendation or suggestion may often, of course, be implicit in what is described and commonly the only question may be whether the publication describes with sufficient clarity the claimed invention or, in the case of a combination, each integer of it.
It is significant that none of the five publications which, in this part of their reasons, their Honours held to be non-anticipatory, was a patent. Rather, they were medical publications reporting on the results of research and trials. It was in this setting that Black CJ and Lehane J held (97 FCR at 549 [67]) that –
… though methods falling within the claims of the patents were used in each trial, none of the reports can be said to teach (a word which in this context encompasses direct, recommend and suggest) that which the petty patents claim.
Thus their Honours held that the publications did not give a direction or make a recommendation or suggestion which would result, if followed, in the claimed invention. By contrast, in the present case, if a baker followed the directions given in the Johnson patent to the letter, he or she would have worked a process as described in the patent in suit, including by producing a foodstuff which contained an emulsifier.
108 The respondents would rejoin, as I understand their position, by protesting that the appellants did not run an “inevitability” case below: see H Lundbeck A/S v Alphapharm Pty Ltd (2009) 177 FCR 151 at 192 [182] and 193 [184]. That is so, but the appellants’ case did involve the proposition that the Johnson patent disclosed a method which would be understood by the skilled addressee, in July 1998, as involving the production of an emulsifier from a reaction catalysed by the lipase. If that were to be established on the evidence, I think that the appellants would have done enough to overcome this particular objection to their anticipation point. I cannot see anything in the authorities that would require the prior citation to have made explicit the chemical features of the ingredient produced by the reaction disclosed where the skilled addressee would have perceived the existence of those features from his or her reading of that citation. Just as the photograph considered by the House of Lords in C Van der Lely NV v Bamfords Ltd [1963] RPC 61 did not need to portray a mechanism in which the turning of the wheels was activated by contact with the ground because the skilled addressee would have perceived that that was the intended method of working, so too here it would be sufficient if the skilled addressee were able to perceive that the monoglyceride in terms disclosed in the Johnson patent was working as an emulsifier point.
109 This brings me back to the evidence in the present case. At one point it was submitted on behalf of the appellants that it was not in dispute that the skilled addressee, in 1998 if not in 1968, would recognise that it was an emulsifier that was being produced under the Johnson patent. That submission was later withdrawn, but the issue does seem to have evaded the attentions of counsel in their questions to the expert witnesses at trial. In this state of things, was the primary Judge justified to have decided the point as she did in the passage set out at para 101 above? In my respectful view, her Honour was not. Both in his affidavit and in the joint report, Prof Hoseney had, in my view, said enough to make it clear that he would have read the Johnson patent as teaching the production of an emulsifier, and no challenge to his opinion on the subject was forthcoming. Even Prof Small, in the passages of his evidence referred to at paras 103 and 104 above, seemed to regard the point (arising in the context of the Johnson patent) as quite uncontroversial. Having let this evidence go through to the keeper, as it were, it was too late for the respondents to submit at the end – if they did submit – that there was a distinction between the experts’ understanding that monoglycerides were emulsifiers, on the one hand, and their appreciation that the Johnson patent taught the generation of an emulsifier as a desired ingredient, on the other hand. Neither, in my respectful view, was it open, in the circumstances to which I have referred, for her Honour to reach the conclusions set out in the passage of her reasons cited at para 101 above.
110 For the reasons I have attempted to explain, I take the view that the invention in suit, insofar as claimed in Claims 1 and 7, was not novel in the light of the information contained in the Johnson patent.
Novelty – The Qi Si patent
111 The next piece of prior art on which the appellants relied in their novelty case was International Patent Application No WO94/04035 (“the Qi Si patent”), published under the Patent Co-operation Treaty in March 1994. According to the abstract, the invention was –
A method of improving properties of a dough and/or a baked product made from dough by adding an enzyme preparation to the dough and/or to any ingredient of the dough and/or to any mixture of the dough ingredients, in which method: a) the enzyme preparation comprises a lipase of microbial origin and is added in an amount corresponding to at the most 2100 LU/kg of flour, or b) the dough is substantially free from added fat or contains only low amounts of added fat and the enzyme preparation comprises a lipase.
The primary Judge described the Qi Si invention as follows:
The disclosure of the invention describes the finding that the use of lipase without addition of bread improving agents may result in improvements in the dough and in the baked products. Such improvements are in the increased volume and improved softness of the baked product, the improved anti-staling effect and colour of the crumb of the baked product, as well as improved consistency in the dough.
The lipase used in the Qi Si patent is of microbial origin. This is said to result in lipases of higher purity than other types of lipases, reducing the amount of undesirable non-lipase enzymatic activity. The preparation may comprise lipase as the only or major enzymatic activity. A substantially pure form of enzyme preparation comprising lipase is preferred. Alternatively, an enzyme preparation may comprise one or more enzymes, such as amylase, in addition to the lipase.
The lipase is said to act on triglycerides in the flour components of the dough. As the experts agreed, the reaction is, again, triglyceride + H2O → mono-/diglyceride + free fatty acid.
It is said in the Qi Si patent that the action of the lipase is “presently believed” to be by modification of the interaction between lipid and gluten protein. Specifically, it is stated that it is believed that the lipase forms an in situ emulsifier comprising mono- and diglycerides in dough. Examples include a direction to bake the dough mixture after proofing at 225°C, 20 minutes for rolls and 30 minutes for loaf.
112 Two of the controversies arising below in connection with the Qi Si patent related not to the scope or terms of that patent as such but to integers of Claims 1 and 7 of the patent in suit: whether those claims involved the use of a single enzyme, and whether, under those claims, water may be the second constituent. I have dealt with those controversies above. There remain two issues arising in the context of the Qi Si patent: whether that patent disclosed the generation of a second functional ingredient from the second constituent, and whether it disclosed the inactivation, or denaturing, of the enzyme. The primary Judge decided the former issue in favour of the respondents, which decision is challenged by the appellants, and her Honour decided the latter issue in favour of the appellants, which decision is challenged by the respondents.
113 With respect to the disclosure of the generation of a second functional ingredient, the primary Judge said:
There is no suggestion in the Qi Si patent that anything other than the monoglyceride produced by the action of the lipase constitutes a possible functional ingredient or that a second ingredient is of any relevance. The evidence does not establish a clear disclosure of a second product of the single reaction or of any such product as a second functional ingredient. The evidence does not establish that the skilled reader would imply such an understanding from the Qi Si patent.
The appellants challenge this reasoning on the basis that it was accepted elsewhere by her Honour that the respondents did not dispute “that mono- and di-glycerides and free fatty acids are capable of functioning as functional ingredients”, and that “[t]he skilled addressee would know that mono- and diglycerides and free fatty acids are functional ingredients, whether or not they are disclosed as desirable in the process there described in varying proportions.” These findings were not made in the context of the Qi Si patent, but the appellants’ point is that they were sound, and that they should likewise have informed her Honour’s approach to the matter of anticipation under that patent.
114 It will be noted that the primary Judge’s decision on this issue was essentially an evidentiary one. By contrast, the appellants’ submissions on appeal invite us to reverse her Honour in effect by making logical links between elements of the evidence, or concessions, that related to other aspects of the case, on the one hand, and the disclosures in the Qi Si patent, on the other hand. The appellants did not draw our attention to any direct evidence by either of the experts that he would have read the patent as disclosing the generation not only of a second ingredient but of such an ingredient that was functional in the sense relevant to the patent in suit, namely, that it performed a specific function in the foodstuff. No such evidence was contained in the joint report of the experts, and, as mentioned, we were not referred to any other place in the evidentiary record where the point was addressed.
115 The appellants submitted that her Honour had “applied too high a legal standard for disclosure”. I do not agree. Had there been expert evidence that some ingredient generated by the process described in the Qi Si patent in addition to the emulsifier was functional in the relevant sense, for her Honour to have reached the conclusion that she did may well have been to set the bar too high. But her Honour did not reach the point of applying a legal standard at all: the evidence which would have provided a foundation for a submission of this kind on the part of the appellants simply was not there. I would, therefore, reject the appellants’ challenge to her Honour’s conclusion with respect to the generation of a second functional ingredient under the Qi Si patent.
116 With respect to the requirement that the enzyme be inactivated or denatured, there was no statement to that effect in terms in the Qi Si patent. However, that patent contained examples which required dough to be baked at high temperatures. Her Honour said:
Neither the Qi Si patent nor claim 1 of the Patent [in suit] is limited to a process for the baking of bread. If, however, the process were read by a baker armed with common general knowledge as at the priority date and the baker was told to bake the dough at 225°C for 20 or 30 minutes, the baker would read that step, as did Professor Hoseney, to result in the inactivation or denaturation of the lipase present. There is nothing in the Qi Si patent to suggest that the lipase has any unusual property of thermotolerance. He or she might not be able to state with scientific certainty that there had been total inactivation, which was a matter that concerned Professor Small. However, while the extent of that inactivation or denaturation might not be understood to be 100% of the enzyme present, it would be sufficient to the standard that no significant or material amount of the enzyme would remain. It would be to a sufficient standard for the baker to say that the enzyme was inactivated and to say that the product could be sold under a “clean label”, without reference to any remaining enzyme. The fact that the baker might wish to substantiate such experiments in baking trials does not alter the effect of the disclosure of the method described.
While accepting that the Qi Si patent included a direction to bake the dough at 225°C for 20 or 30 minutes, the respondents submitted that her Honour went too far in finding that the baker would read that as resulting in the inactivation or denaturation of the lipase.
117 In his affidavit of 8 October 2009, Prof Hoseney referred to the examples in the Qi Si patent that required the bread to be baked at 225°C for 30 minutes, and said that the “baking process would inactivate the lipase used in the experiments described”. He also said (using the terminology of the patent in suit) that the foodstuff would comprise the emulsifier, the fatty acid ester and the enzyme in an inactive or denatured form. Responding to this in his affidavit of 17 February 2010, Prof Small observed that the Qi Si patent did not “say that the enzyme is inactivated during the baking process”. He said that he was, in 1998, aware of thermostable enzymes that could survive the baking process. Without clear instructions, Prof Small considered that he “could not be certain that the baking process would inactivate the enzyme preparation ….” In a further affidavit sworn on 5 August 2010, Prof Hoseney said that, in his experience, most enzymes were denatured at temperatures of less than 100°C, and that the only exceptions were enzymes isolated from bacteria that inhabited hot springs. He added that, in baking, it was usual to use enzymes that were denatured by heat, and that the centre of a loaf conventionally baked would reach 95°C or more, at which temperature the enzymes used would normally be denatured after “only a few minutes”.
118 Whether the non-inventive skilled baker would necessarily read the Qi Si patent as implying the denaturing of the enzyme as a result of baking at 225°C for 30 minutes became the focus of the oral evidence of the experts. To the extent to which there was uncertainty, it resolved around the temperature which would necessarily be reached at the centre of a loaf of bread baked under those conditions, and the time during which it would remain at that temperature. Prof Small’s position was that, without knowing anything about the enzyme being used, he would not be confident that it would necessarily be denatured as the result of the baking process. He said:
In the very centre of a dough, there is a very short period of time that the dough is approaching a high temperature, and that high temperature is generally thought of as 95, maybe 97, degrees C.
Prof Hoseney’s position was that, as a practical matter, he would never have contemplated the use of a thermostable enzyme in baking, and would, reading the Qi Si patent, have assumed that the intention was that the enzyme there referred to would be denatured as the result of commercial baking under normal conditions.
119 There was a passage in the reasons of the primary Judge where her Honour dealt with another issue that brought up the evidence about denaturing which was relevant also to her understanding of the Qi Si patent. Her Honour said:
Professor Hoseney and Professor Small agreed that if the centre of a loaf of bread does not reach a temperature of 95 to 99°C during baking, a product defect termed “key holing” can result, which is not acceptable in the baking industry. The products of the baking process in the Poulsen patent were examined at the completion of that process. The fact that no such defect was recorded would tell the skilled reader that such a temperature was achieved. It was part of common general knowledge, as acknowledged by Professor Small, that most enzymes would be inactivated within a few minutes at that temperature. Both experts were aware of the exception of thermostable alpha-amylases that were used in baking and retained activity. As at 1998, neither expert was aware of any lipase enzyme that could survive the baking process.
I mention this not to import into my consideration of the Qi Si patent findings which her Honour made in another context, but as a convenient, and perhaps more enlightening, summary of what was a single axis controversy about the prospect of the enzyme surviving baking.
120 The present subject of controversy was essentially one in which a difference of emphasis existed as between the two experts who gave extensive evidence before the trial Judge. The subject was, of course, not whether the Qi Si patent disclosed a process in which the enzyme would inevitably be denatured in baking. It was whether, in 1998, the denaturing of the enzyme would have been perceived by the skilled addressee as implicitly part of the process disclosed in that patent. The standard of denaturation, or inactivation, by reference to which her Honour was working – previously having been determined under the construction of the patent in suit – was that “there must be no significant or material amount of active enzyme in the foodstuff”. The only reason why her Honour might not have found in favour of the appellants on this implicit disclosure point was the refusal of Prof Small to accept that, absent knowledge of the enzyme being used, one could confidently predict that the enzyme would in all circumstances be totally denatured. In the passage set out in para 116 above, her Honour clearly accepted the more robust, less categorical, opinion of Prof Hoseney. I consider, with respect, that it was amply open to her Honour to have proceeded in that way. Indeed, particularly in the light of the passage from her Honour’s reasons set out in the previous paragraph, which was not placed into controversy by the respondents on the present appeal, I would have reached the same conclusion for myself.
121 Because I would uphold the primary Judge’s conclusion that the Qi Si patent did not disclose a second ingredient which was functional in the foodstuff, I would reject the appellants’ challenge to her Honour’s finding that that patent was not anticipatory.
Novelty – The Novo patent
122 The next piece of prior art on which the appellants relied in their novelty case was International Patent Application No WO98/26057 (“the Novo patent”), published under the Patent Co-Operation Treaty in June 1998. The “field of the invention” under the Novo patent is described as follows:
The present invention relates to a method for reducing the content of phosporous [sic] containing components in an edible oil comprising a high amount of non-hydratable phosphorus, by the use of a phospholipase.
Further, the present invention relates to an enzyme with phospholipase activity, a cloned DNA sequence encoding the enzyme with phospholipase activity, a method of producing the enzyme, and the use of said enzyme for a number of industrial applications.
It was the second aspect of this field, specifically so much thereof as was involved in the closing words of this passage – “the use of said enzyme for a number of industrial applications” – that occupied the attentions of the parties before the primary Judge. The appellants submitted that the patent disclosed an enzyme which had a dual activity, which could catalyse the constituents of a foodstuff to an emulsifier and at least one other functional ingredient and which was then inactivated in the industrial applications referred to.
123 At the centre of the invention under the Novo patent was the development of an enzyme from the fungus Fusarium oxysporum which was active as a phospholipase. Such an enzyme was said to be particularly useful in the process of the degumming of edible oils, which is the subject of the first aspect referred to in the passage set out above. But the enzyme was also said to be useful in baking and similar applications. In the specification under the heading “Use of phospholipase”, it was stated:
The phospholipase of the invention can be used in any application where it is desired to hydrolyse the fatty acyl group(s) of a phospholipid or lyso-phospholipid, such as lecithin or lyso-lecithin. The phospholipase is preferably used at pH 3-10 and at 30-70°C (particularly 40-60°C). If desired, the phospholipase may be inactivated after the reaction by subjecting it to heat treatment, e.g. at pH 7, 80°C for 1 hour or 90°C for 10 minutes.
As an example, the phospholipase of the invention can be used in the preparation of dough, bread and cakes, e.g. to improve the elasticity of the bread and cake. Thus, the phospholipase can be used in a process for making bread, comprising adding the phospholipase to the ingredients of a dough, kneading the dough and baking the dough to make the bread.
In the following section under the heading “Use of a phospholipase of the invention in baking”, it was stated:
The phospholipase of the invention also may be used in bread-improving additives, e.g. dough compositions, dough additives, dough conditioners, pre-mixes, and similar preparations conventionally added to the flour and/or the dough during processes for making bread or other baked products to provide improved properties of bread or other baked products.
Therefore, an embodiment of the invention relates to a bread-improving and/or a dough-improving composition, and further, to the use of a phospholipase of the invention in such compositions, and to a dough or baked product comprising a bread-improving and/or dough-improving composition of the invention.
And:
The bread– and/or dough-improving composition of the invention may further comprise another enzyme. Examples of other enzymes are a cellulase, a hemicellulase, a pentosanase (useful for the partial hydrolysis of pentosans which increases the extensibility of the dough), a glucose oxidase (useful for strengthening the dough), a lipase (useful for the modification of lipids present in the dough or dough constituents so as to soften the dough), a peroxidase (useful for improving the dough consistency), a protease (useful for gluten weakening, in particular when using hard wheat flour), a peptidase and/or an amylase, e.g. Α-amylase (useful for providing sugars fermentable by yeast).
124 The disclosure of an enzyme with phospholipase activity only would not, however, anticipate the invention covered by the patent in suit. For that purpose, the appellants needed an enzyme with dual activity. It was agreed by the experts that the enzyme disclosed in the Novo patent also had lipase activity. Indeed, under the heading “Use of lipase activity of an enzyme of the invention”, the following was stated:
As shown in working examples herein a phospholipase of the invention may further exhibit lipase activity.
Accordingly the invention further relates to use of this lipase activity in standard uses of a lipase, in particular for use in cleaning and detergent compositions. Such cleaning and detergent compositions are well described in the art and reference is made to WO 96/34946; WO 97/07202; and WO 95/30011 for further description of suitable cleaning and detergent compositions.
125 There followed 21 examples of the invention, three of which were of particular importance in the appellants’ case. The first was Example 9, headed “Characterisation of a recombinantly expressed and purified phospholipase obtained from Fusarium oxysporum”. Under that heading, the assays used to characterize the enzyme were described, being both phospholipase assays and lipase assays. The enzyme was characterised for its pH profile, the patent stating in that regard:
Although the enzyme shows an alkaline pH-profile on phospholipid with an optimum at pH 9 or higher, the activity is still sufficiently high to provide degumming of oils at low pH and performance in baking ….
The enzyme was characterised for temperature stability at pH 5 and at various temperatures ranging from 5°C to 55°C, the results being reported in normalized activity units, where activity at 5°C was 1.00. At 50°C, the result was 0.65 and at 55°C, the result was 0.00. From this, the specification stated:
The low stability of the enzyme is [sic] may be advantageously to register an eventual product as a process aid as the active enzyme should not be expected in the final product in either degumming of edible oils or baked products.
126 There followed an aspect of Example 9 which was emphasised by the appellants. The specification stated that “[t]he phospholipase obtained from Fusarium oxysporum of the invention has both phospholipase and lipase activity.” The activity of the enzyme on various phospholipase and lipase substrates was investigated and compared with the activity of a commercially available phospholipase and a commercially available lipase. Because this aspect of the specification was controversial on appeal, I shall set out the passage which explains the comparison referred to:
The F. oxysporum phospholipase/lipase has high activity on both tributyrin and olive oil at pH 7 and 9 (Table 7). For comparative reasons the specific activity of Lipolase® is around 5000 LU/mg. However, contrary to Lipolase®, the F. oxysporum lipase exhibits a much broader specificity with considerable phospholipase activity and also thioesterase activity (see monolayer example 6 above, showing that Lipolase® does not have a measurable phospholipase activity).
The F. oxysporum phospholipase/lipase of the invention has a specific activity on lecithin considerably higher than that of the phospholipase LecitaseTM (pig pancreatic pla2) at pH 7 (Table 7).
Compared to LecitaseTM the F. oxysporum enzyme has a 100 fold higher activity at pH 7. The phospholipase:lipase ratio for the F. oxysporum enzyme is around 0.225 (1000 LU/mg / 225 PHLU/mg) under similar conditions (pH 7 and 30°C).
Table 7
Activity of the F. oxysporum lipase/phospholipase – comparison to LecitaseTM.
| Enzyme | LU/mg | PLU1/mg | PHLU/mg | SLU/m | PLA1/m |
| F.oxysporum | 1000 | 73 | 225 | 3090 | 2.04 |
| Lecitase | < 0.25 | 2.5 | 1.2-3.2 | 0.6 | 0 |
1PLU was measured like PHLU but in 20 mm citrate, pH 5 and at 37°C instead of 50 mm HEPES, pH 7 at 30°C
I shall return to this passage.
127 The next example to which the appellants referred was Example 20, headed, “Use of a phospholipase obtained from F. oxysporum as a bread improving agent.” There followed a standard bread-making recipe, with a direction to bake rolls for 22 minutes and panned bread for 35 minutes, at 230°C in each case. The results, after baking, were evaluated by reference to a “specific volume index” and a “roll standing” index (the latter to evaluate “dough stickiness”). There were eight samples tested, namely, three samples with 500, 1500 and 3000 lipase units of the enzyme (respectively) added per kilogram of flour; three samples with 500, 1500 and 3000 lipase units of the enzyme (respectively), together with (in each case) one gram of a commercial lecithin preparation, added per kilogram of flour; a control; and a control with one gram of the commercial lecithin preparation added per kilogram of flour. The results were reported as follows:
The results show a clear volume increasing effect of the Fusarium oxysporum phospholipase on both rolls and panned bread, in the recipe not containing lecithin. If lecithin is included in the recipe, even better volume effects are obtained, although the lecithin does not contribute to volume itself. A statistical analysis (ANOVA, Α=0.05), performed in Statgraphics Plus, release 3.0, shows a significant positive synergy between the phospholipase and the lecithin.
Both with and without lecithin in the recipe, a significantly improved shape of rolls (roll standing) is obtained with the F. oxysporum phospholipase. In this example, the best roll standing was obtained by combining lecithin and phospholipase (1500 LU/kg flour).
128 Example 21 was the third example in the Novo patent on which the appellants relied. It was similar to Example 20, save that the characteristic of the bread being tested was staleness over a period of a week subsequent to baking. The results were reported as follows:
… the breads treated with phospholipase were slightly softer than the control up to 3 days of storage. In combination with lecithin, a significant anti-staling effect could be obtained through the whole storage (not obtainable with lecithin or phospholipase alone).
129 The appellants relied on the Novo patent for their anticipation case in two ways: first, as disclosing to the skilled addressee, and by reference to his or her understanding of the art as at the priority date, the process claimed in Claim 1 in the patent in suit, and secondly (ie alternatively), as disclosing, in Example 20, a method of baking that, if followed, would inevitably involve every integer of the process claimed in Claim 1 in the patent in suit. The evidence given by Prof Hoseney, in his affidavits of 8 October 2009 and 5 August 2010, provided support for the appellants’ case in these respects. However, that case was controversial in a number of ways, and was not accepted by the primary Judge.
130 With respect to the first of the ways in which the appellants put their case below, it was contentious whether the Novo patent provided sufficient disclosure to constitute anticipation in three respects: the use of a single enzyme, the generation of a second functional ingredient, and the inactivation of the enzyme as a result of the industrial application referred to. Her Honour decided the first and third of these points in favour of the appellants, but the second in favour of the respondents, the result of which was a finding that the Novo patent was not anticipatory. All three conclusions have been challenged, either in the appellants’ Notice of Appeal or in the respondents’ Notice of Contention.
131 Commencing with the respondents’ point that the Novo patent did not disclose the use of a single enzyme, her Honour held, rejecting the point, that “[t]his integer of the relevant claims of the [p]atent [in suit] is disclosed by the Novo patent”. The integer to which her Honour was here referring was the requirement under the patent in suit that it be a single enzyme which catalysed the reaction, or the two or more reactions, with which Claim 1, and the claims dependent on that claim, were concerned. If that were the extent of the inquiry under the Novo patent, there seems to be little doubt but that the use of a single enzyme in the processes referred to was disclosed. There are, indeed, places where the specification allows for the use of additional enzymes, but that does not detract from the fairly unambiguous disclosure referred to. Indeed, I do not understand it to have been submitted – at least on appeal – that the Novo patent did not disclose the use of a process in which a single enzyme (as opposed to there being a requirement for two or more enzymes) was, to use the wording of the patent in suit, the conversion agent.
132 The respondents’ point, rather, was that the Novo patent did not specify unambiguously the particular enzyme that was to be used in the processes to which it referred, but left it open to the addressee to select from a range of enzymes, or, more correctly in my view, from alternative polypeptides that were identified within the amino acid sequence by which the enzyme cloned by the inventors had been characterised. The amino acid sequence, as set out in the specification, was identified as “SEQ ID No 2”. There were 346 positions in that sequence, and the respondents’ submission was that “the phospholipase of the [invention] is not [SEQ ID No 2]; it’s either the amino acids 31 to 346 or 31 to 303”.
133 The respondents derived support for this submission from the way some of the (70 in total) claims in the Novo patent were expressed. The following claims were relevant in this context:
35. An isolated polypeptide having phospholipase A activity which is obtained from a strain of the genus Fusarium and has
i) PLA activity in the pH range 3-10, measured at 40°C;
ii) a molecular mass of 29 ± kDa, as determined by SDS-PAGE;
iii) an isoelectric point (pI) in the range 4.5-8;
iv) a temperature optimum for phospholipase activity in the range between 25-55°C, measured with lecithin as substrate at pH 5; and/or
v) a phospholipase activity pH optimum in the pH range between 6-12, measured with lecithin as substrate at 37°C.
36. An isolated polypeptide exhibiting phospholipase A and/or B activity selected from the group comprising of:
(a) a polypeptide encoded by the phospholipase A and/or B enzyme encoding part of the DNA sequence cloned into plasmid pYES 2.0 present in Escherichia coli DSM 11299;
(b) a polypeptide having an amino acid sequence as shown in positions 31-346 of SEQ ID NO 2;
(c) a polypeptide having an amino acid sequence as shown in position 31-303 of SEQ ID NO 2;
(d) a polypeptide which is at least 70% homologous with said polypeptide defined in (a), (b) or (c); and
(e) a fragment of (a), (b), (c) or (d).
….
58. Use of a phospholipase obtained from a strain of the genus Fusarium, such as a strain of F. culmorum, F. heterosporum, F. solani, or in particular a strain of Fusarium oxysporum, in a process comprising treatment of a phospholipid or lysophospholipid with the phospholipase so as to hydrolyze fatty acyl groups.
59. Use of the phospholipase according to any of claims 35-50 and 57 in a process comprising treatment of a phospholipid or lysophospholipid with the phospholipase so as to hydrolyze fatty acyl groups.
….
65. Use according to any of claims 58-61 in a process for making a baked product, comprising adding the phospholipase to a dough, and baking the dough to make the baked product.
66. A dough or baked product comprising the phospholipase according to any of claims 35-50 and 57.
Of these claims, in their written outline on appeal, the respondents said:
The claims that relate to the use of an enzyme in baking are claims 65 and 66. By way of example, claim 65 is a method claim which is dependent on claims 58 to 61. Of these, claim 58 is a method claim for the use of a phospholipase obtained from any strain of Fusarium. This covers a potentially large number of enzymes. Claim 59 is a method claim claiming the use of a phospholipase according to any one of claims 35 to 50 and 57. Of these, claims 35 and 36 are product claims which encompass whole families of isolated polypeptides defined in different ways (activity and other physicochemical properties in claim 35, and polypeptide sequence in claim 36). These claims, and by definition the baking claims 65 and 66, encompass a large number of potential enzymes, as Professor Hoseney also confirmed in cross-examination.
It was said that Examples 20 and 21, on which the appellants relied, did not specify that it was SEQ ID No 2, in toto, which was the enzyme that was required to be used, with the result that a number of options would have been open to the skilled addressee.
134 The primary Judge rejected the respondents’ submission, even in this more sophisticated formulation. Her Honour said:
While the disclosure of the DNA sequence for the phospholipase includes sequences that encode parts only of a polypeptide and, Danisco says, it is not made clear whether the ‘phospholipase encoding region’ encodes for only one phospholipase, this does not mean that the Novo patent fails to disclose a purified phospholipase. Both of the witnesses understood that the enzyme disclosed in the Novo patent was the enzyme having the amino acid sequence identified as SEQ ID No 2. Professor Hoseney understood that the enzyme used in example 20 was in a substantially pure form and his opinion was not challenged in cross-examination. The specification, read as a whole, refers to and discloses the use of an isolated, purified enzyme, cloned and characterised.
With respect to Example 20, her Honour said:
It is not stated that the enzyme to be used is of the whole of the sequence of SEQ ID No 2. The Novo patent says that other fragments of that sequence may have phospholipase activity and that the use of ‘a phospholipase’ may have been intended to allow for the use of such fragments. However, I accept that the skilled reader, a baker and not a molecular biologist, would, as did Professor Small, assume that the enzyme was the enzyme of that sequence.
Her Honour also dealt with this question in that part of her reasons (to which I shall come) which concerned the appellants’ point that Example 20 was anticipatory by inevitable outcome. It is useful to set out here what her Honour then said:
Danisco relies on the fact that example 20 says to use “a phospholipase” rather than specifying the enzyme of SEQ ID No 2. Other examples in the Novo patent do so specify. Danisco also contends that the precise polypeptide sequence of the enzyme to be used is not clear, because the Novo patent says that the active enzyme sequence is contained within SEQ ID No 2. However, for the purposes of both following example 20 and understanding the Novo patent to ascertain whether it anticipates the Patent, Danisco and Novozymes accept that the skilled addressee is not a molecular biologist but a baker. Professor Small read example 20 as referring to the enzyme the subject of the Novo patent: a phospholipase of the sequence SEQ ID No 2. Professor Hoseney also said this in an affidavit but conceded in cross-examination that he was not certain. I accept that the skilled addressee would know to use the enzyme of SEQ ID No 2 in the baking process of example 20.
135 Based as it substantially was on the reading of the Novo patent by both of the experts, her Honour’s conclusion that the use of SEQ ID No 2 was disclosed in Example 20 would seem to be on fairly solid ground. Counsel for the respondents sought to challenge it, however, at two levels. First, with respect to the evidence of Prof Small, they submitted that the opinion that SEQ ID No 2 would be used was given in answer to leading questions under cross-examination, and was manifestly wrong. Secondly, with respect to the evidence of Prof Hoseney, they submitted that it was here that the true picture emerged, and it did so when they themselves cross-examined that witness. This was, it must be said, a somewhat unconventional way of making good an evidentiary case, but the respondents sought to do so, and I shall consider the point.
136 The single-enzyme aspect of the Novo patent was not mentioned by the experts in their joint report. In his affidavit sworn on 5 August 2010, Prof Hoseney had said that, on his understanding, the patent related to “a particular enzyme, with phospholipase activity, which may be used in a number of industrial applications”, and that the inventors had cloned “a single enzyme which has phospholipase A activity”. Under cross-examination, these understandings were not directly challenged. Rather, senior counsel for the respondents took Prof Hoseney to Claims 35 and 36, thence to Claim 59, and thence to Claims 65 and 66, of the Novo patent, the end result of which was that, in baking applications, different polypeptides were referred to in the claims, depending upon, for example, the selection that the addressee made under Claim 36. Where the subject was, as here, scientific discourse, I would not regard the answers which Prof Hoseney thus gave to counsel’s questions as sufficient to qualify his clear evidence in chief that the Novo patent disclosed the use of a single enzyme. Prof Hoseney was not, in terms, invited to reconsider what he said in chief, and her Honour was, in my view, amply entitled to decline to join the dots of scientific propositions as apparently invited to do by the respondents. And no sufficient basis for the Full Court to overturn her Honour’s conclusion has been established.
137 Professor Small also gave evidence on this subject when cross-examined by counsel for the appellants. As accepted by counsel for the respondents, the witness answered simply and unequivocally in the affirmative to a number of questions which sought to have him confirm that the enzyme used in baking – the “phospholipase of the invention” as referred to in the specification – in the Novo patent was SEQ ID No 2. So far as I can see, this was not the subject of re-examination by counsel for the respondents (although they did re-examine Prof Small briefly on the following day). In these circumstances, it was not open to counsel to submit, either before her Honour or on appeal, that Prof Small’s answers under cross-examination were wrong.
138 In the light of the evidence before the primary Judge to which I have referred (both of Prof Hoseney and of Prof Small), and the way the respondents’ case was then conducted, I would reject the respondents’ challenge to her Honour’s conclusion that the Novo patent disclosed the use of a single enzyme in the processes which were relevant to the appellants’ novelty case.
139 The next point with which the primary Judge dealt under the Novo patent related to the question whether the patent disclosed the generation of a second functional ingredient in its description of the use of the enzyme in the context of foodstuffs, essentially in baking. Here her Honour accepted, favourably to the appellants, that the enzyme which was disclosed in that context was SEQ ID No 2 and that that enzyme had both phospholipase and lipase activities. However, her Honour held that there was no disclosure, in the context of baking, of use being made of the lipase activity of the enzyme. Thus, there was no disclosure of the generation of a second functional ingredient by the reaction catalysed by the enzyme. Her Honour said:
The specification does disclose an enzyme with dual phospholipase and lipase activity. However, no use of lipase activity and phospholipase activity of the enzyme is described in the production of a foodstuff and there is no disclosure of such a use. The use that is referred to in the context of the dual activity is ‘in standard uses of a lipase, in particular for use in cleaning and detergent compositions’. The description of the use of the enzyme in a process for the preparation of a foodstuff, exemplified in the use in baking, is in terms of phospholipase activity. [Her Honour’s emphasis]
….
From the evidence, the disclosure in example 20, in the context of the Novo Patent specification, teaches away from the disclosure of the generation of a second functional ingredient by the enzyme acting on a second constituent.
Novozymes draws attention to isolated parts of the extensive Novo patent specification, combining passages and information to support a submission of disclosure of the invention of the claims of the Patent. Many of these disclosures require the skilled reader to draw conclusions as to, for example, activity at different pHs and a comparison of the enzyme’s activity as a phospholipase and a lipase. This is not straightforward. The evidence from Professor Hoseney and Professor Small was to the effect that if the level of lipase activity is too low, it is not a simple matter of increasing the level of enzyme to obtain more lipase activity because increasing the dose to increase the impact of a minor activity could result in problems in the resulting product from the major activity, as demonstrated in Example 20. There are also some general statements that the phospholipase may also exhibit lipase activity. Relying on and adding together the statements to which Novozymes draws attention requires the reader to ignore other observations in the specification, such as the statement that ‘the bread- and/or dough-improving composition of the invention may further comprise another enzyme. Examples of other enzymes are… a lipase (useful for the modification of lipids present in the dough or dough constituents so as to soften the dough)’ and the fact that the example of the use of the enzyme in baking refers only to its phospholipase activity.
During cross-examination, Professor Small was taken to some of these passages individually and together, and asked to agree on what they revealed. I did not find that helpful. There is no single linear protocol disclosed in the Novo patent that can be unambiguously followed in the knowledge that all steps are explicitly defined. No such route was put to Professor Small. I am not satisfied that the skilled reader, as at the priority date and, therefore, without having read the Patent or having been alive to the issues in these proceedings, would have put together the various references relied on such that they amounted to the process of the claims of the Patent or, indeed, the use of an enzyme to obtain the functional ingredients of the claims in the process of preparing a foodstuff such as in baking. As both Professor Hoseney and Professor Small said, the skilled addressee’s focus is on the look and taste of the loaf produced. In example 20, it is assessed by reference to the use of varying levels of an enzyme with phospholipase activity together with varying levels of its substrate, a phospholipid.
Further, while there is disclosure of a “dual activity enzyme” in the Novo patent, there is no disclosure that mono- or diglycerides generated by lipase activity perform some desired function in a foodstuff, whether as an emulsifier or otherwise as a functional ingredient. There is no disclosure of the use of such an enzyme in the preparation of a foodstuff. The use of the enzyme in such a process refers only to its phospholipase activity.
140 The appellants submitted that the primary Judge was in error not to have held that the Novo patent disclosed, either expressly or in terms that would be so understood by the skilled addressee, a baking process in which the phospholipase of the invention had lipase activity sufficient to generate a functional ingredient. There was little doubt but that the reaction catalysed by the enzyme in its phospholipase activity generated an ingredient (or ingredients); nor, as I understand it, but that the ingredient so generated would be functional. Rather, the problem concerned the sufficiency of the disclosure of the lipase activity. To the extent that there was such activity, I do not understand any issue to have been taken with Prof Hoseney’s evidence that, acting on triacyl glycerols (naturally present in flour) in the presence of water, the enzyme would produce (amongst other things) monoacyl glycerols, that is to say, emulsifiers. So, if the Novo patent was to be understood as disclosing to the skilled addressee a lipase activity in the baking context, that would line up with the integer of Claim 1 in the patent in suit which required the generation of a second functional ingredient.
141 The appellants did not draw our attention to any passage in the Novo patent specification in which a lipase activity of the enzyme in baking was in terms disclosed. They pointed out that the specification disclosed that the enzyme had a dual (ie phospholipase and lipase) activity, and that it was useful in baking. In terms, however, the specification goes no further than to disclose the phospholipase activity in baking. The appellants pointed to the data in Example 9 which demonstrated the existence of a significant lipase activity of the enzyme. So much may be accepted, but those data were not reported at the pH of baking (5-6). Unhelpfully for the appellants, where the specification dealt specifically with the lipase activity, it gave as the only “particular” instance an application which involved cleaning and detergent compositions. Equally unhelpfully, in the context of a discussion of the “bread- and or dough- improving composition of the invention”, the specification suggested that another enzyme might be used in conjunction with the phospholipase, including a lipase. As her Honour pointed out, this tended to teach away from the anticipatory position for which the appellants contended. I agree with her Honour that, considered overall, there is no “single linear protocol disclosed in the Novo patent” with respect to the lipase activity of the enzyme in baking, and that the skilled reader would have “to draw conclusions as to … activity at different pHs and [make] a comparison of the enzyme’s activity as a phospholipase and a lipase” if he or she were to come to such a position.
142 Turning to what the skilled addressee would readily have understood from the specification in the Novo patent (even if only implicitly), Prof Hoseney accepted that, in choosing a dosage of the enzyme which was sufficient to achieve a lipase effect, “it’s difficult to be sure when you have two activities and you don’t have a way of separating them”. I understood the witness there to be dealing with the circumstance that, while the data reported under Example 9 did show the existence of lipase activity, that was not at the pH of bread making. Prof Hoseney took the view that the lipase activity would be somewhat less at pH 5-6, albeit still occurring. If, in the baking context, one wanted to be confident of obtaining lipase activity, one would adjust the dosage of the enzyme added, but that in itself may not be uncomplicated as it would, at the same time, increase the potential for phospholipase activity beyond what might be desired.
143 In the light of this and the other evidence to which I were referred, I consider that the primary Judge was well-justified in her conclusion that the Novo patent did not, even implicitly, disclose to the skilled addressee the generation of a second functional ingredient from the addition of a lipase to a bread making process. Such an addressee might well have thought that such an outcome was within the range of reasonable possibilities, but the specification did not give him or her a clear direction, even an implicit one, towards that outcome.
144 That brings me to what was probably the appellants’ main challenge to the primary Judge’s conclusion that the Novo patent did not anticipate Claim 1 of the patent in suit. It was that a skilled addressee, instructed by Example 20 of the Novo patent at the priority date, would inevitably have followed a process which would, had it been done after that date, have amounted to an infringement of Claim 1. If so, Example 20 was anticipatory: Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 235. If such an outcome would have been inevitable, it would make no difference that the skilled addressee had not been expressly or implicitly instructed to seek it, or even that he or she did not understand what was being done: The General Tire and Rubber Co v The Firestone Tyre and Rubber Co Ltd [1972] RPC 457 at 485-486; Lundbeck 177 FCR at 192 [182].
145 Because of the importance of the concepts involved in the parties’ cases on appeal under the Novo patent, it is useful to commence with what the UK Court of Appeal said on the subject of anticipation by inevitable outcome in General Tire ([1972] RPC at 485-486):
If the prior inventor's publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee's patent, the patentee's claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated.
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee's claim, but would be at least as likely to be carried out in a way which would not do so, the patentee's claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee's claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented: Flour Oxidizing Co. Ltd. v. Carr & Co. Ltd. (1908) 25 R.P.C. 428 at 457, line 34, approved in B.T.H. Co. Ltd. v. Metropolitan Vickers Electrical Co. Ltd. (1928) 45 R.P.C. 1 at 24, line 1). A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.
In Lundbeck, this was accepted as stating the law in Australia (177 FCR at 192 [182]) and, in the present case, was accepted as applicable to the present question by both parties.
146 Although her Honour observed that the present case was not, as was General Tire, concerned with a product patent, I do not understand her to have proposed that the Court of Appeal’s statement was inapplicable to a patent that was one for a process. Neither did the respondents develop any argument that that statement was irrelevant to the circumstances of the present case on account of such a distinction. Indeed, in the terms employed by their Lordships to express the principle, “if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated” (emphasis added).
147 Turning next to the reasons of the primary Judge, having dealt with the three points of contention referred to above (single enzyme, generation of a second functional ingredient, and inactivation), under the heading “Inherency”, her Honour said:
A claimed invention is deprived of novelty if it has been given to the public prior to the priority date. One way of this occurring is if a product or a process has been prior used. Another is if information that equates to the claimed invention has been published. To constitute an anticipation, a prior publication must, before the priority date of the claims of the Patent, disclose all of the integers of the claimed invention. There are, however, circumstances in which a prior publication does not expressly make that complete disclosure but still deprives the subsequently claimed invention of novelty (see generally Lundbeck at [180]–[182] per Bennett J, Middleton J agreeing). One example is where the skilled reader understands the disclosures of the prior publication to include a missing integer. Another is where the prior publication contains a direction to use a process that inevitably or inexorably results in something within the claim (General Tire; Lundbeck at [181]–[182]).
Senior counsel for the appellants accepted this as a correct statement of the law. What might be noted at this stage is that the primary Judge treated the inclusion of an otherwise “missing integer” by reference to the understanding of the skilled reader and the inevitability of a particular outcome as but two examples of anticipation by “inherency”.
148 After some other general observations under the heading “Inherency”, her Honour proceeding to deal with the subject under the following subheadings:
• Is there anticipation by inevitable outcome?
• Is there anticipation by reason of the inherent activity of the enzyme disclosed in the Novo patent?
• Is there anticipation by reason of the use of Lipopan F in example 20 of the Novo patent?
• Could the disclosure have been complete before the priority date?
As I shall attempt to explain, the use of these subheadings did not involve the corollary that the subjects dealt with under each were separate and distinct bases for the examination of the question whether a relevant claim of the patent in suit was anticipated by the Novo patent.
149 Under the subheading “Is there anticipation by inevitable outcome?”, the primary Judge first concluded that the skilled addressee would know to use the enzyme of SEQ ID No 2 in the baking process of Example 20. That followed upon her Honour’s conclusion on the single enzyme point to which I have referred. She continued:
However, there is no information in example 20 concerning lipase activity and the testing for lipase activity that is reported in the Novo patent was not conducted under baking conditions. Novozymes has not established that even if the enzyme used in example 20 had both phospholipase and lipase activity, the use of the enzyme in each possible dosage would result in a non-de minimis amount of mono- or diglyceride being generated as a second functional ingredient. Novozymes led no evidence to establish that the skilled addressee, following example 20, would inevitably produce the subject matter of the claims of the Patent.
In the appellants’ case on appeal, this was a critical passage in her Honour’s reasoning, and I shall return to it. I should first, however, address the subjects dealt with under the succeeding subheadings in this part of her Honour’s reasons, and how they related, if at all, to this passage.
150 Under the subheading “Is there anticipation by reason of the inherent activity of the enzyme disclosed in the Novo patent?”, the primary Judge recorded that the appellants had submitted “that the disclosure of the enzyme of SEQ ID No 2 in the Novo patent with directions to use the enzyme in example 20 will, by reason of the inherent activity of the enzyme in baking, inevitably result in the process of the claims of the Patent.” Her Honour’s use of the word “inevitably” in this context appears not to be consistent with the thrust of the balance of the paragraph of her reasons where it appears, from which it is tolerably clear that she was dealing here with disclosure (express or implied) rather than with inevitability in the General Tire sense. Her Honour continued:
However, this would not necessarily disclose to the public or the skilled reader the claimed process. The disclosed enzyme is not the claimed process. Even if the use of the enzyme in baking disclosed an end result of a denatured or inactivated enzyme as I found above, it would not disclose the action of the enzyme to generate the emulsifier and the second functional ingredient by the enzyme in the claimed process. No such information was available from the disclosures of the Novo patent. No such information would be disclosed by the use of the enzyme. Novozymes’ contention that the use of the enzyme as directed in example 20 equates to the disclosure of claim 1 of the Patent is therefore incorrect.
151 Her Honour next referred to the test for novelty under s 7(1) of the Patents Act, which invokes the concept of “information in a document made publicly available.” Her Honour continued:
Where sufficient information is not present in a publicly available document and the party alleging the anticipation relies on the use of the information in that document, it must be shown that information equivalent to the claimed invention was publicly available prior to the priority date. Novozymes is relying on directions to use an enzyme in order to complete a disclosure of information that is of itself insufficient to anticipate the invention of the claims. It is not sufficient for the purposes of Novozymes’ claim of anticipation by reason of the inherent activity of the enzyme only to provide information that enables the use of an enzyme in baking that will “inherently” result in the claimed process where, at the end of that use, the public will be none the wiser as to the integers of the claims.
Senior counsel for the appellant described the last sentence in this passage as being based on “a clear error of law”, namely, the statement of a requirement, in a case involving so-called inherent disclosure, that the public must thereby become aware of the integers of the claims presumptively being anticipated.
152 The primary Judge next set out the well-known passage from the speech of Lord Westbury in Hill v Evans (1862) 1A IPR 1, 6–7, which senior counsel for the appellants accepted as stating the law in Australia so far as it went, but which, in the submission of counsel, did not “deal with this issue at all”; the issue, of course, being whether the relevant claims in the patent in suit were inevitably (in the General Tire sense) disclosed by Example 20 in the Novo patent.
153 The primary Judge continued:
The information disclosed in example 20 of the Novo patent is a direction to use an enzyme in baking. Even if the enzyme was the polypeptide of SEQ ID No 2 and had the requisite activity and would in fact have yielded two functional ingredients by generating them from the two constituents, there is no provision, disclosure or recognition of the reaction or of the fact that the products of the reaction had functionality in the foodstuff. This is not the case of an inevitably produced product of a disclosed process, as in General Tire, but of an alleged inevitable carrying out of a process with identified results. Where the Novo patent did not itself disclose the claimed process or the products of that process, there is no necessary disclosure of that information after the directions are followed. As discussed in Lundbeck at [180]–[190] per Bennett J (Middleton J agreeing), it is necessary for anticipation that the skilled addressee would add missing information as a matter of course, or that the prior disclosure of a process would lead inexorably to the product, or that a skilled addressee may observe on inspection sufficient to enable him or her to comprehend the complete invention. There is no sufficient evidence here that the performance of example 20 would necessarily infringe the claims of the Patent. In view of the limited information about any lipase activity of the phospholipase of the Novo patent, it cannot be said that the disclosure enables the skilled addressee to perceive, understand or apply that disclosure necessarily to obtain the claimed invention.
Put another way, the Novo patent does not contain clear and unmistakable directions to the process of the claims – a process with a specified result. The direction is to use the enzyme in baking. Without further direction, the skilled addressee who used that enzyme would not know that the result was the process. That information would not necessarily be made available to the skilled addressee or to the public. There is no suggestion in the Novo patent that the use of the enzyme in example 20 revealed that information to the inventors of the Novo patent.
Therefore, accepting for this aspect of consideration that:
• the use of the enzyme described in the Novo patent has inherent phospholipase, glycolipase and lipase activity;
• the Novo patent gives clear and unmistakable directions to use the enzyme of SEQ ID No 2 in baking; and
• the use of the enzyme in baking would give the results specified in the claims of the Patent;
I do not accept that this resulted in anticipation of the invention of the claims of the Patent prior to the priority date. Novozymes emphasises that the information is all contained in the Novo patent: that is, after obtaining the enzyme and following the direction to use it in baking, the skilled addressee would then obtain the foodstuff of the claims of the Patent. However, the information equating to the process of the claims was not disclosed in the Novo patent. There was no disclosure of the generation of the two ingredients or of two functional ingredients, one of which was an emulsifier. There is no prior information in the Novo patent as required to deprive the claims of the Patent of novelty under the Act. The skilled reader following example 20 would not inevitably obtain the products of the process of those claims. Even if, in the dosages used, the enzyme inherently generated those products, there is no evidence that this would have been ascertained or understood by the skilled addressee at the priority date. [Her Honour’s emphasis.]
These passages were also criticised by counsel for the appellants as involving the importation by her Honour of “a requirement, in addition to inherency, that the public knows what is there.” Counsel submitted that “the very point of inherency [is] that you don’t see it on the page, but when you follow it, you end up doing it.”
154 It is convenient here to return to the passage in her Honour’s reasons set out at para 149 above, and to the appellants’ criticism of it. In order to understand what her Honour – seemingly – meant by “non-de minimis”, it is necessary to return to the treatment given in her Honour’s reasons to Example 9 in the Novo patent.
155 I have set out the relevant extracts from Example 9 at paras 125-126 above. The tests, and the data, there referred to were the subject of the following passage in the reasons of the primary Judge:
The specification of the Novo patent then provides experimental results purporting to demonstrate dual activity by comparison with a commercial phospholipase and a commercial lipase. Professor Hoseney read those results as demonstrating that the enzyme had more lipase than phospholipase activity. Professor Small said that he would not accept the comparison quantitatively because different methods were used to measure the two activities. The Novo patent specification describes an enzyme which has 100 fold higher phospholipase than lipase activity at pH 7. There is no disclosure that, in the dosages used, the enzyme will generate mono- or diglycerides from any ester above de minimis.
It is the penultimate sentence, and the final sentence which seemingly flowed from it, in this passage that have become problematic.
156 The data from Example 9 were not to the effect that, at pH 7, the enzyme had 100 times more phospholipase activity than lipase activity. The reference to “100 fold higher activity” was to a comparison between the enzyme in question and a commercially-available phospholipase. To the extent that the data justified any comparison between the phospholipase activity and the lipase activity of the enzyme in question (a matter to which I shall turn in the next paragraph), it disclosed a ratio of 225 PHLU/mg : 1000 LU/mg. This was said, by the appellants, to disclose a more than fourfold higher activity of the lipase than the phospholipase. For their part, the respondents did not seek to defend her Honour’s “100 fold higher phospholipase” statement, but contended that it was not central to her reasons on inevitability. To the extent that, in the submission of the respondents, anything could be derived from these data, it was that, compared with a commercially-available lipase, the enzyme had one-fifth of the lipase activity while, compared with a commercially-available phospholipase, the enzyme had 100 times the phospholipase activity.
157 In Example 9 of the Novo patent, assays of the activities of the enzyme as a phospholipase and as a lipase were set out. For this purpose, phospholipase units (PHLU) were a measurement of “the release of free fatty acids from lecithin” under conditions there defined, wherein “1 PHLU equals the amount of enzyme capable of releasing 1 Μmol of free fatty acid/min under these conditions”. Lipase units (LU) were a measurement referred to in a publication of a company described as “Novo Nordisk” – presumably associated with the appellants – whereby “1 LU equals the amount of enzyme capable of releasing 1 Μmol butyric acid/min under standard conditions”. In the proceeding below, there was extensive attention given to the question whether Example 9 justified the generalisation that, under conditions of pH 7 and 30°C, the activity of the Novo patent enzyme as a lipase was about 4.5 times (ie 1000/225=4.44) higher than its activity as a phospholipase. To put the matter as succinctly as the subject-matter permits, it was the project of counsel for the appellants to have Prof Small accept that this was a valid generalisation because, although different substrates were used for these assays, each was concerned with the amount of the enzyme required to release one micromole of a fatty acid per minute. Prof Small accepted that the words of the Novo patent seemed to be saying this, but he had quite serious reservations about the validity of the comparison. At the end of a lengthy period of cross-examination on this subject – which included an overnight adjournment – Prof Small expressed his position as follows:
So it’s saying to me there is both lipase activity and there is also phospholipase activity. I would not be particularly keen to do the calculation and get 4.25 or whatever it was. I would say it has both activities based on the analyses. Now, if I was wearing a biochemistry enzymology hat, I would do what I did last night and look back at the methods and feel frustrated and think I’m not convinced I can do this comparison precisely, but it wouldn’t change the fact that both activities are there and they may be useful to me if I’m a baker.
Senior counsel for the appellants pressed Prof Small to indicate whether he would agree that Example 9 showed “a higher lipase activity”, even if not as the result of a precise comparison. At this point her Honour intervened by saying:
I think Professor Small has answered that. I mean, you’ve asked him that question on a number of occasions yesterday and today and I think he has answered it, Ms Howard. I don’t think repeating it assists. He has given an answer. It’s not susceptible to a yes, no, answer in his view, and he’s given you an answer. I mean, you heard that last question, Professor Small, are you able to answer any more than you already have?
Prof Small was unable to answer any more than he had already. Asked (by her Honour) if he would be prepared to draw the conclusion that the Novo enzyme had far more lipase activity than phospholipase activity (“in other words, that those are directly comparable”), Prof Hoseney responded: “Within limits I would think yes, you have more lipase activity than you have phospholipase activity.”
158 Returning to the passage from her Honour’s reasons set out at para 149 above, several things need to be said. First, our attention was drawn to no place in the evidence where either of the experts used the term “de minimis”. Whether the relevant field of science, like the law, does not concern itself with trivialities does not seem to have been the subject of attention. Secondly, assuming that her Honour’s meaning was that there was no disclosure in the Novo patent of anything more than trivial lipase activity – and here it should be borne in mind that her Honour’s de minimis finding was made in the context of a discussion of the results obtained under Example 9 – I would have to say that such a finding was contrary to the evidence. The point ultimately reached by the experts was that Example 9 disclosed an enzyme that had both activities. Prof Hoseney was prepared to make the limited observation that the lipase activity was more than the phospholipase activity. Prof Small was prepared only to say that there were both activities. Neither said, and neither was asked to accept, that the activity of the enzyme as a lipase was de minimis, or any relevant scientific equivalent of that.
159 Thirdly, as the respondents pointed out, the assays in Example 9 were carried out under specified conditions which were not, or at least were not necessarily, those found in baking, or in the preparation of foodstuffs of any kind. Amongst other differences, the assays were carried out at pH 7, whereas the typical range encountered by an enzyme used in baking would be between pH 5 and pH 6. It is at this point that the primary Judge, with respect, was on firmer ground in the conclusions which she expressed in the passage set out in para 149 above. However, on the appellants’ case on appeal, her Honour declined to give effect to what was said to have been an admission by the respondents as to the lipase activity of the Novo enzyme in a baking context. It is now convenient to turn to the matters dealt with in her Honour’s reasons under the third of the subheadings under “Inherency”, namely, “Is there anticipation by reason of the use of Lipopan F in example 20 of the Novo patent?”.
160 As the primary Judge pointed out in her reasons, originally the respondents had sued the appellants for infringement of the patent in suit by the distribution of a product called “Lipopan F”, an enzyme produced by the appellants for use in baking. An aspect of the appellants’ response to that was to contend that Lipopan F was the commercial embodiment of the enzyme described in the Novo patent, and that the respondents had thereby provided, by their own allegations, the basis for a successful defence of anticipation: Gillette Safety Razor Co v Anglo-American Trading Co Ltd (1913) 30 RPC 465. In reaction to this development, according to the appellants, the respondents withdrew their allegations about Lipopan F, and focussed then on Lipopan Xtra. Notwithstanding that, the appellants’ reliance upon the Novo patent, in their Fourth Further Amended Particulars of Invalidity, included the following particulars:
(e) the Fusarium oxysporum phospholipase described in [the Novo patent] is the Lypopan F enzyme …
(f) Lipopan F has lipase, glycolipase and phospholipase activity in dough in baking applications …
(g) [i]n the premises of (e) and (f) above, the process described in claims 1 and 7 of the Patent [in suit] would inevitably be performed by a person skilled in the art following the directions in [the Novo patent] to use the enzyme in baking ….
The subject covered by (f) was to have been supported by extensive evidence referred to in an earlier version of the appellants’ particulars of invalidity, but the respondents admitted (f) and references to that evidence were excised from the particulars. This development was the subject of orders and directions made by the primary Judge on 30 September 2010, which were prefaced by a note to the effect that the respondents had confirmed that they admitted, for the purposes of the proceeding only, “that the commercial product Lipopan F has lipase, glycolipase and phospholipase activity in dough in baking applications”.
161 The appellants also referred to a product sheet for Lipopan F which was before the primary Judge. It contained instructions to use a dosage of 400-900 LU of the enzyme for each kilogram of flour. Although it is not suggested that that sheet predated the priority date of the patent in suit, when read in conjunction with the admission referred to above, it would justify the conclusion that, when used at the dosages indicated, Lipopan F would have lipase, glycolipase and phospholipase activity. The appellants then pointed out that the three dosages used in Example 20 in the Novo patent were 500, 1500 and 3000 LU/kg. They submitted that it was therefore established that a skilled addressee, following Example 20 in 1998, would inevitably follow a process in which the enzyme was having lipase, glycolipase and phospholipase activity in baking.
162 On the appellants’ case, the enzyme commercialised as Lipopan F was the enzyme disclosed in the Novo patent, and that patent disclosed, in Example 20, a standard baking application in which that enzyme was used in dosages known to be efficacious in baking, and, consistently with the admission referred to above, that enzyme would, in such an application, have lipase, glycolipase and phospholipase activity. In those circumstances, according to the appellants, it was not open for the primary Judge to reach the conclusion, as she did in the passage set out in para 149 above, that the appellants had not “established that even if the enzyme used in example 20 had both phospholipase and lipase activity, the use of the enzyme in each possible dosage would result in a non-de minimis amount of mono- or diglyceride being generated as a second functional ingredient.”
163 How did the primary Judge deal with this aspect of the appellants’ case? Her Honour’s reasons under the subheading “Is there anticipation by inevitable outcome?” were relatively brief. Save for her treatment of the respondents’ point about the identity of the enzyme, those reasons were confined to what is set out at para 149 above. It will be seen that that passage contained no reference to Lipopan F, to the respondents’ admission, or to the development of the appellants’ argument in the way described above. However, as noted above, her Honour did address these matters under the subheading “Is there anticipation by reason of the use of Lipopan F in example 20 of the Novo patent?”. If one were to go by the subheadings only, one would get the impression that this section of the reasons was not concerned with inevitability in the General Tire sense, that being the required context for a consideration of this aspect of the appellants’ anticipation case (it not being suggested that Lipopan F itself was introduced before the priority date for the patent in suit). But that would not be an accurate, or a fair, impression as to the scope of the matters with which her Honour dealt under this subheading.
164 The primary Judge said that the appellants relied on –
… the following admissions by and evidence of [the respondents]:
• SEQ ID No 2 is the enzyme identified as SP 972 in the Novo patent, although [the respondents qualify] this admission as accepting that the amino acid sequence identified as SP 972 appears in SEQ ID No 2.
• The only enzyme identified by its amino acid sequence is the enzyme SEQ ID No 2, which is the enzyme used in example 20 of the Novo patent.
• SP 972 is the enzyme present in the commercial product Lipopan F.
• Lipopan F has lipase, glycolipase and phospholipase activity in dough in baking applications.
• Example 20 of the Novo patent is a baking application involving common ingredients and a basic recipe.
• [The respondents] originally claimed infringement by the use of Lipopan F in baking. That allegation has not been withdrawn.
• Some of the documents relied upon to establish infringement by the use of Lipopan Xtra contain references to Lipopan F which are consistent with the characteristics of Lipopan F as set out above and evidence the inactivation of Lipopan F by baking.
• [The respondents] sought an admission from [the appellants], which was made, that Lipopan F is completely inactivated by baking.
Her Honour referred to the parties’ submissions on the point, and noted her earlier conclusion that the skilled addressee would have understood that the reference to “a phospholipase” in Example 20 would be read as a reference to the enzyme of the amino acid sequence disclosed in SEQ ID No 2. However, her Honour said that, “[e]ven if that translated into an understanding that the enzyme was that identified as SP 972, that was the only information of the identity of the enzyme in the Novo patent.” Her Honour said that it was now known that Lipopan F had both lipase and phospholipase activity in the dosages recommended for use, and that it was inactivated by the baking process. However, “that information was not available to the skilled addressee before the priority date.” Her Honour concluded: “The necessary information was not disclosed in the Novo patent and the subsequently available information does not assist Novo to establish anticipation by reference to the prior art base.”
165 To this point, the primary Judge was not concerned to address the appellants’ case on inevitability. So much is clear from her Honour’s references to the skilled addressee. It is clear also from the opening words of the next succeeding paragraph in her reasons:
As to [the appellants’] alternative submissions on inherency and inevitable result, even if the skilled reader were armed with the polypeptide sequence of SEQ ID No 2, there is no certainty that he or she would choose SP 972 to use in example 20. [The appellants point] out that the recommended dosage of Lipopan F in [the appellants’] literature ranges from 100 LU/kg to 750 LU/kg. Whether or not the reference to LU in example 20 in connection with phospholipase activity is an error (a matter as to which the experts were not certain), there is no information in example 20 that establishes that the skilled addressee before the priority date would have understood to use a dosage of the enzyme that would, inevitably, have provided the lipase activity to generate the functional ingredients of the process of the claims of the Patent or that the dosage chosen would inevitably have yielded the results of that process.
As it seems to me, it is in this paragraph that the primary Judge came to grips with, and rejected, the appellants’ case that, because of what is now known about Lipopan F, a skilled addressee working Example 20 in the Novo patent (ie as at the priority date) would inevitably have followed a process described in Claims 1 and 7 of the patent in suit.
166 On the face of it, it is difficult to see, with respect, where the basis is for what lies at the core of her Honour’s reasoning in the passage set out above, namely, that “there is no information in example 20 that establishes that the skilled addressee before the priority date would have understood to use a dosage of the enzyme that would, inevitably, have provided the lipase activity to generate the functional ingredients of the process of the claims of the Patent or that the dosage chosen would inevitably have yielded the results of that process”. Her Honour’s concern was with dosage, and dosages were set out explicitly in Example 20. They included dosages known to be, and apparently accepted by her Honour as being, efficacious in baking when Lipopan F was used. It is true that Example 20 set out a range of doses, but one of them (500 LU/kg) fell squarely within the range referred to in the appellants’ product sheet for Lipopan F (400-900 LU/kg) and also within the range for Lipopan F referred to by her Honour (100-750 LU/kg). The proposition that, if followed at a dosage of 500 LU/kg, Example 20 would inevitably involve a baking process in which a single enzyme had both phospholipase and lipase activities would seem, in my respectful view, to have been made good by the appellants.
167 On appeal, the respondents made it clear that they did not seek to resile from their admission. Their main point related to the identity of the enzyme to which the skilled addressee would turn when working Example 20. What her Honour described, in the first bullet point in the passage set out in para 164 above, as a qualification to the respondents’ admission was not, the respondents submitted, a qualification at all, but was, rather, what might be called a clarification. SP 972 was, it seems, the enzyme used in Lipopan F, and the respondents’ point was that it was not the whole of the sequence identified as SEQ ID No 2 in the Novo patent. They submitted that the skilled addressee would not know which enzyme was the one to use under Example 20. This was the point which her Honour decided against the respondents, and in relation to which I would uphold her Honour’s decision (see paras 131-138 above). I would hold, therefore, that the appellants’ inevitability case, to the extent that it depended upon Lipopan F, was not compromised by any insufficiency of enzyme identification in the terms of Example 20. The same conclusion was at least implicit in the reasons of her Honour.
168 Senior counsel for the respondents submitted on appeal that his clients’ admission did not cover a situation in which “the tiniest amount” of enzyme was used, but accepted that, if we were to hold that the admission covered “every possible amount”, they would “lose on that point”. For myself, I do not regard it as very fruitful to contemplate the circumstances of a skilled addressee who used only a “tiny amount” of the enzyme under Example 20, since the example itself provided dosages that fell within the range of efficacious use as shown in relation to Lipopan F. The admission was that Lipopan F had lipase, glycolipase and phospholipase activity in dough in baking, and clearly related to dosages which fell within those which a skilled addressee would use when working Example 20.
169 The respondents also pointed to the caution with which the expert witnesses expressed their conclusions about the lipase activity of the enzyme under the baking conditions prescribed in Example 20. The assays in Example 9 were not carried out under baking conditions, and neither Prof Small nor Prof Hoseney (although, it must be said, more obviously Prof Small) was prepared to express a quantitative view with respect to Example 20. That is true so far as it goes, but, in this aspect of their case, the appellants were not seeking to extract such a view from the expert evidence, or relying on it. Rather, they relied on the admission as such.
170 I am not, therefore, persuaded by the respondents’ submissions that the conclusion which I provisionally expressed in para 160 above should not be drawn. There is only one further aspect of the matter that should be mentioned at this stage. Although in terms concerned with dosage, it may be that the critical passage in the reasoning of the primary Judge was intended (or intended also) to refer back to her Honour’s earlier conclusion that the appellants had not established that the use of the enzyme disclosed in the Novo patent would result in a non-de minimis amount of mono- or diglyceride being generated as a second functional ingredient. With respect to the quantitative aspect of this proposition, I refer to what I have said at para 158 above. In the light of the admission, it was not for the appellants to establish that the lipase activity of Lipopan F was more than de minimis. With respect to her Honour’s reference to the production of monoglycerides or diglycerides, it was not suggested by the respondents that the lipase activity of the enzyme, in a baking context, would not be such as would produce monoglycerides or diglycerides from fatty acid esters, nor that such monoglycerides or diglycerides, when produced, would not be functional in the relevant sense. Once it is accepted, as in my view it ought to be, that the respondents’ admission was relevant to the appellants’ case of inevitability under Example 20, it ought also be accepted that the lipase activity so admitted was such as to generate functional ingredients, and to do so to an extent that was relevant to that case.
171 Subject only to the final matter in this part of the primary Judge’s reasons to which I shall next turn, I take the view that the appellants had done enough to demonstrate that, as at the priority date, if a skilled addressee had followed Example 20 in the Novo patent according to dosages of the enzyme there stated, he or she would inevitably have worked a process in which a single enzyme with a phospholipase activity and a lipase activity was generating two functional ingredients from the constituents being used.
172 That final matter related to the practical ability of the respondents, for example (or, for that matter, anyone else), to obtain the enzyme under the Novo patent in the limited period between the publication of that patent on 18 June 1998 and the priority date of the patent in suit, 21 July 1998. The respondents’ point was that, in that period, it was fanciful to suggest that anyone beyond the Novo inventors and those with whom they worked, or with whom they were commercially associated, might have obtained the Fusarium oxysporum microorganism – which had been deposited on 25 November 1996 in Germany in accordance with the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, with a notation that until grant of a European patent, a sample was only to be provided to independent experts – cloned the enzyme of interest from it, and then applied that enzyme in the working of Example 20. This was said to be fatal to the appellants’ inevitability case.
173 The primary Judge accepted the respondents’ case in this respect. Her Honour said:
A patent is invalid for want of novelty if it has, by a prior publication, been given or disclosed to the public, prior to the priority date. Just as a prior existing document that has not been published before the priority date will not anticipate, a direction to use an enzyme which cannot be obtained prior to the priority date does not complete the necessary steps to have given the invention of the result of a process involving its use to the public. The disclosure, by way of the invention itself or the information that constitutes the invention, is not complete.
Even on a hypothetical basis, the hypothetical use of the enzyme is as directed in the prior publication. In this case, that is a direction to use an enzyme that was not commercially available at the relevant time. The information in the Novo patent would have required a person wishing to use the enzyme first to obtain the enzyme or to make the polypeptide of SEQ ID No 2 or of SP 972. That is, the only alternatives available to the skilled addressee were to seek to obtain the enzyme from the deposit as set out in the Novo patent or to attempt to make the enzyme of the amino acid sequence described in the Novo patent.
Her Honour said that it was for the appellants “to establish that the enzyme would have been available to the skilled worker seeking to follow example 20 prior to the priority date.” But, according to her Honour, there was “no evidence as to whether the skilled addressee could simply produce a functional enzyme from the given DNA or amino acid sequence or whether he or she could obtain it in sufficient quantities to use it in baking.” Her Honour continued:
[I]n this case, the fact is that the hypothetical skilled addressee had only 32 days in which to complete the disclosure by following the directions to use the required enzyme in baking. [The respondents assert] that the evidence is that it could not have been done. [The appellants have] not adduced evidence to demonstrate how a skilled addressee would follow the Novo patent teaching to obtain the process of the claims of the Patent before the priority date.
Her Honour’s conclusion on this point was as follows:
It follows that even if I had found that the skilled addressee, following the instructions of example 20, would have been chosen to use the enzyme of SEQ ID No 2 and that such use would inevitably result in the process of the claims of the Patent [in suit], this disclosure could not have been complete before the priority date.
174 In my opinion, any consideration of the appellants’ challenge to this aspect of her Honour’s reasons must start in the terms of s 7(1) of the Patents Act, which provides:
For the purposes of this Act, an invention is to be taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately:
(a) prior art information (other than that mentioned in paragraph (c)) made publicly available in a single document or through doing a single act;
(b) prior art information (other than that mentioned in paragraph (c)) made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art would treat them as a single source of that information;
(c) prior art information contained in a single specification of the kind mentioned in subparagraph (b)(ii) of the definition of prior art base in Schedule 1.
The “prior art base” is “information” of the kinds referred to in the definition of that term, and “prior art information” is defined correspondingly. For present purposes, it is sufficient to note that it was and is common ground that the Novo patent was information in the required sense and was “prior art information” as defined.
175 The point presently under discussion was not said by the respondents to be an answer to so much of the appellants’ anticipation case as relied upon the terms of the Novo patent for the meaning they naturally conveyed to the skilled addressee (the appellants having failed on that case anyway). It was accepted by the respondents, therefore, that the Novo patent, although published only a little more than a month before the priority date of the patent in suit, was conventionally available as information for the purposes of s 7(1). But, at the point when the appellants contended that, even if the words of the Novo patent themselves did not convey, to the skilled addressee, a meaning which would anticipate the patent in suit, a working of Example 20 would inevitably give rise to a process which did so, the respondents rejoined that the General Tire approach was not available unless, as a practical matter, the example could in fact have been worked by someone whose first exposure to the subject had been a reading of the Novo patent on the day of its publication.
176 Her Honour accepted that the result which she was persuaded by the respondents to endorse was a “strange” one, in the sense that it would mean that any person who, at any time, did no more than follow the instructions in Example 20 would infringe the patent in suit, notwithstanding that he or she would be working according to information published before the priority date. It would also introduce a considerable area of uncertainty into the application of the General Tire test, in that it would require a judgment in each case on the question whether a sufficient time interval had passed between the prior publication and the priority date of the patent of interest to permit, in a practical way, the skilled worker to obtain the wherewithal to convert the published information into a realistic, working, artefact. As counsel for the appellants pointed out, the result of the application of the respondents’ test in any particular case would also depend, to an extent, upon chance circumstances, such as the market availability of materials, reagents, spare parts, etc.
177 Although General Tire is part of Australian jurisprudence in the relevant area, it must be accommodated to the terms of s 7(1) of the Patents Act, upon which everything depends. That is to say, the inevitability of outcome to which General Tire refers must be such as would arise from recourse to the information referred to in the section. At the expense of repetition, it is here useful to remind ourselves of what the Court of Appeal said in that case ([1972] RPC at 485-486):
… if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated. [Emphasis added]
This proposition is explicitly hypothetical. It is concerned not with what has happened or with what could have happened, but with what would have happened if the directions were carried out. As such, the proposition is in complete harmony with s 7(1), and with every other presently relevant aspect of the jurisprudence in this area. It is not the doing of it, nor even the ability to do it, that amounts to anticipation: it is the content of the information. If the information contains directions which, if carried out, would constitute an infringement of the patent in suit, the invention under the latter is not novel.
178 In the view I take, the appellants’ General Tire case was not compromised by the practical difficulties which would have confronted the skilled addressee putting Example 20 of the Novo patent into effect before the priority date of the patent in suit, and the primary Judge was in error to have held otherwise.
179 The remaining controversy with respect to the Novo patent relates to the requirement under the patent in suit that the enzyme be inactivated. The primary Judge decided this point favourably to the appellants, and the respondents have challenged that decision in their Notice of Contention. They relied on their submissions made in connection with the same point arising under the Qi Si patent, and I have said what needs to be said in that regard in paras 116-120 above. Additionally, the respondents directed some specific criticisms to her Honour’s reasoning in relation to this aspect of the Novo patent.
180 The resolution of the inactivation issue with respect to the Novo patent required a comparison of what was disclosed by that patent with the terms of the patent in suit. As to the latter, the standard of inactivation, as determined by her Honour as a matter of construction, was that there be “no significant or material amount of active enzyme in the foodstuff”. There was no challenge to that determination. As to the former, I would refer to what I have said at para 125 above as to the temperature stability of the enzyme under the Novo patent, and the statement, contained in Example 9, that “the active enzyme should not be expected in the final product in … baked products”. The “baked products” context was given content by the directions in Example 20 (see para 127 above).
181 The primary Judge held that the information in the Novo patent was that, if desired, the enzyme may be inactivated, under heating conditions less stringent than those of Example 20. This was a reference to the disclosure in Example 9 that the enzyme was inactivated at pH 5 and 55°C and to the direction in Example 20 that baking should be carried out at 230°C for 22 minutes (rolls) or 35 minutes (panned bread). Her Honour accepted that “the baking conditions would have caused inactivation and that the skilled reader would, taking the whole of the disclosure of the Novo patent into account, have understood that the enzyme would have no phospholipase activity after the baking process.” Her Honour was of the view that the Novo patent disclosed inactivation to the standard required, and that there was, in that patent, sufficient disclosure to the skilled addressee of the inactivation integer of the patent in suit.
182 The primary Judge continued:
The conditions of baking at which the enzyme is denatured are described variously in the specification, being in each case at lower temperatures and for shorter periods than as used in example 20. There can therefore be little doubt that, following the directions in example 20 of the Novo patent, the enzyme would be denatured or inactivated to the extent that no significant or material amount of active enzyme remains in the foodstuff.
Her Honour’s references to what the patent in suit said about the details of the inactivation process seem to have been to two passages in particular. In the specification, it is said:
Yet further, enzymes may be denatured by heat. Thus in a further preferred aspect, the foodstuff/food material is heated after generation of the functional ingredient. The enzyme will be denatured and may then constitute protein. This is advantageous because the denatured enzyme need not be declared on the foodstuff/food material ingredients.
One of the examples – and the only one which relates to baking – in the patent in suit related to a sponge cake. That example directed the preparation of a mixture of sugar, glycerol, soya bean oil and “a lipase from Rhizopus arrhizus”. That mixture was to be stirred for one day at 45°C, then “shortly treated at 100°C in order to inactivate the enzyme”. Only then was the mixture used as an ingredient, with others, in a sponge cake recipe. Her Honour said:
The conditions for denaturing the enzyme in the Patent involve a lower temperature than that of example 20. There was no suggestion that baking for 22 minutes and 35 minutes as directed in the Novo patent were less rigorous than the timing of “shortly” in the Patent.
183 The respondents criticised her Honour for making a simple comparison between the baking instructions contained in the Novo patent and the requirements of the patent in suit. In particular, they emphasised that the sponge cake recipe in the patent in suit involved the heating of a premix at 100°C, such that the baking process itself was not relied on to inactivate the enzyme. By contrast, the baking example in the Novo patent contained no free-standing inactivation step and relied upon the centre of the dough of a roll or loaf becoming sufficiently hot, for a sufficient period of time, to achieve inactivation. The appellants responded to this by referring to the evidence mentioned by her Honour in the passage I have set out at para 119 above. They submitted that the skilled addressee would understand the baking example in the Novo patent as involving a sufficient temperature at the centre of the roll or loaf to avoid key-holing, and therefore to produce inactivation of the enzyme. However, while that kind of approach may well take the appellants to their required destination with respect to the quality of the Novo patent’s disclosure of inactivation as such, it is no satisfactory answer to the respondents’ criticism of her Honour’s comparison between the Novo baking example and the sponge cake example in the patent in suit.
184 In my respectful view, the respondents’ criticism is a valid one. The matter of anticipation is to be judged by reference to what the claims provide. If there is some element of uncertainty in the claims, recourse may be had to other parts of the specification to assist in the process of construction. But the question whether the claims had been anticipated by the Novo patent was not to be resolved by a comparison of the efficacy of inactivation steps proposed in particular examples in each. The only question for her Honour was whether inactivation to the extent required on a proper construction of Claims 1 and 7 of the patent in suit was disclosed in the Novo patent. The issues surrounding the temperature under which, and the time during which, the baking experiment in the Novo patent was to be carried out was undoubtedly relevant to that question, but I do not think it took the matter anywhere to point to an example in the patent in suit in which different baking conditions had been employed.
185 But that does leave the question which I have just identified. Here the debate differed only in immaterial respects from that carried on with respect to the Qi Si patent, with which I have dealt above. Stripped of the sponge cake comparison, the primary Judge’s conclusion was that the Novo patent disclosed a process in which, in the eyes of the skilled addressee, the enzyme would be inactivated by the temperatures reached in baking. The experts would have so understood the direction given to bake in Example 20, and the references to inactivation in Example 9. I am not persuaded by the respondents that her Honour was in error in relevant respects.
186 That is not, however, the end of the matter apropos inactivation. In my reasons so far, the only respect in which I have departed from the primary Judge is that which relates to inevitability of outcome. I have agreed with her Honour that the Novo patent would not have disclosed to the skilled addressee the generation of a second functional ingredient. But I have taken the view that that deficiency would not compromise the appellants’ inevitability case, since I have held that a second functional ingredient would inevitably have been generated in the enzymatic reaction referred to. The question arises: can the appellants piece together a complete case on anticipation by reference to express or implied disclosure for some integers, and inevitable outcome for others? Specifically in relation to inactivation, if they otherwise have to resort to General Tire to make good their case, can they rely on what the skilled addressee would have understood on the matter of inactivation, or do they also have to establish, in point of hard fact, that the enzyme would have been inactivated by baking at the temperatures, and for the times, set out in Example 20? In a case otherwise heavily laden with factual and legal questions, this particular one appeared to go almost unnoticed in the parties’ submissions on appeal, although it was mentioned in passing by senior counsel for the respondents, who submitted, in relation to the passage in the Novo patent about “the low stability of the enzyme” (see para 125 above) that was “a better disclosure than the one in Qi Si … but it certainly does not establish the inevitability point”. The sufficiency of the respondents’ reliance on this point, if they are to be understood as relying on it, is something to which I shall return.
187 In my view, the General Tire approach, if taken at all, may be taken only with respect to the whole of any claim asserted to have been anticipated. The “precise destination” at which the flag must have been planted is one which includes every integer of the claim. The approach cannot, in my view, be taken for some integers only, leaving others to be dealt with by reference to the understanding of the skilled addressee. In the present context, what this means is that, to the extent that the appellants’ case is based on General Tire, it is not sufficient that they be able to point to passages in the Novo patent from which it would appear to the skilled addressee that inactivation was contemplated or intended by the earlier inventors. It is necessary that they show that, if Example 20 were worked as directed, it would inevitably, as a matter of hard fact, have involved inactivation of the enzyme (to the standard set up under Claims 1 and 7 of the patent in suit as identified by the primary Judge) at the baking stage.
188 Was the evidence below sufficiently categorical for those purposes? Here the appellants have the benefit of findings by the primary Judge that “the baking conditions would have caused inactivation” and that “[t]here can therefore be little doubt that, following the directions in example 20 of the Novo patent, the enzyme would be denatured or inactivated to the extent that no significant or material amount of active enzyme remains in the foodstuff.” These findings related to what would have happened in fact, not merely to the understanding which the skilled addressee would have derived from the terms of the Novo patent.
189 In his affidavit sworn on 8 October 2009, Prof Hoseney said:
In both cases [ie under Examples 20 and 21], as the bread is baked at 230°C …, the result of the process is a food stuff comprising an emulsifier, a fatty acid ester and the enzyme in a denatured and therefore inactive form.
In his affidavit sworn on 17 February 2010, Prof Small made no comment about this aspect of Prof Hoseney’s evidence (although he dealt extensively with Prof Hoseney’s affidavit in other respects), and, indeed, said nothing about inactivation in the context of the Novo patent. Possibly for that reason, the subject was not touched upon in Prof Hoseney’s second affidavit of 5 August 2010; nor, for that matter, in the joint report of the two experts. Those circumstances, I infer, were responsible for the way the subject was dealt with in the cross-examination of Prof Small by senior counsel for the appellants. She pointed to the fact that he had said nothing about it in his affidavit, and that he had not noted it to be an issue in the joint report. However, the subject having been raised, Prof Small said that the question “brings us back to the discussion we’ve had on numerous occasions about what happens inside a loaf”. Prof Small’s attention was drawn to the stability data (and accompanying passage) in Example 9 of the Novo patent (see paras 125-126 above), and it was put to him that he would “understand the patent to be telling you that this enzyme used would be inactivated in baking”. His response was, “It is, using the data provided, to indicate that they think it would be.” There was no re-examination directed to this subject.
190 I desire to say something next about the approach which the respondents took to this point. In part that approach is implicit from the structure of the evidence of Prof Small, to which I have just referred. In their Notice of Contention, the respondents sought to uphold the primary Judge’s conclusion under the Novo patent on grounds which included that the Novo patent did not “disclose the use of a process wherein the enzyme is inactivated or denatured”. That very broad way of putting may have been sufficient to accommodate a challenge to the findings of her Honour to which I have referred in para 181 above. That it should be so understood was not, however, conspicuous. In their outline of submissions in support of their Notice of Contention, no challenge was advanced to those findings, and no indication was given that the appellants’ inevitability case under the Novo patent should be regarded as compromised by their failure to establish, as a matter of fact, that the enzyme would necessarily be inactivated under Example 20. Neither was there any such indication given in the respondents’ outline in response to the appellants’ outline in support of their ground of appeal on inevitability. It is scarcely surprising, in the circumstances, that almost nothing was said about the point at the hearing of the appeal. This would have been consistent with a silent understanding that, if we were to uphold the primary Judge’s view about inactivation as disclosed in the Novo patent, it would carry the appellants the distance required to defend her Honour’s findings about inactivation in fact under that patent.
191 The position reached is, therefore, as follows. Prof Hoseney gave specific evidence on the subject of inactivation, in fact, under the Novo patent. No qualification to that was ventured by Prof Small until the matter was raised in the course of his cross-examination. That qualification was more negative than positive, and effectively left Prof Hoseney’s evidence untouched. As mentioned above with respect to the Qi Si patent, there appeared to be little doubt but that any enzyme under contemplation for a baking application would be incapable of surviving conventional baking conditions. If it did, as her Honour pointed out, “key-holing” would be a problem. The enzyme described in the Novo patent was inactivated, at pH 5 and at a temperature of 55°C. It is true that this was under laboratory conditions rather than in the oven, but it was done at a pH which was relevant to baking. And there did not, in the evidence before her Honour, seem to be any real doubt but that such an enzyme, even in the centre of a loaf, could not survive conditions which would exist after the loaf had been subjected to baking at 230°C for 35 minutes. When this is added to the approach taken to the matter by the respondents on appeal, which was equivocal at best, I would conclude that they have not done enough to displace the findings made by the primary Judge to which I have referred in para 181 above.
192 In my opinion the appellants are entitled to rely on those findings as part of their inevitability case under the General Tire principle. It follows that they have made good that case.
193 For the reasons I have given, I am of the opinion that the invention in suit insofar as claimed in Claims 1 and 7 was not novel in the light of the information contained in the Novo patent.
Novelty – the Poulsen patent
194 The final piece of prior art on which the appellants relied in their novelty case was International Patent Application No WO98/45453 (“the Poulsen patent”). It was filed before, but published after, the priority date of the patent in suit, which had the consequence that the appellants were obliged to rely on para (c) of s 7(1) of the Patents Act, which in turn called up para (b)(ii) of the definition of “prior art base”:
… information contained in a published specification filed in respect of a complete application where:
(A) if the information is, or were to be, the subject of a claim of the specification, the claim has, or would have, a priority date earlier than that of the claim under consideration; and
(B) the specification was published after the priority date of the claim under consideration; and
(C) the information was contained in the specification on its filing date and when it was published.
In her approach to subsubpara (A) of this provision, the primary Judge followed Emmett J in E I Du Pont de Nemours & Co v ICI Chemicals and Polymers Ltd (2005) 66 IPR 462 at 482-483 [80]-[85] in holding that it was necessary to formulate a notional claim which would then stand as the point of reference for considerations of novelty of the relevant claim in the patent presently of interest.
195 From a reading of the primary Judge’s reasons in the present case, this approach appears to have been a matter of common ground as between the parties, or at least uncontroversial. Indeed, the appellants themselves drafted two “notional claims” which, they submitted below, reflected the information contained in the Poulsen patent. I shall refer to the terms of those notional claims presently. My immediate concern is to note that, working substantially by reference to them, the primary Judge rejected this aspect of the appellants’ novelty case.
196 On appeal, the appellants sought to distance themselves from any approach which rested wholly on the formulation of notional claims, and from the notional claims which they had themselves drafted and handed up to her Honour. They sought to characterise their having proceeded in that way as “nothing more than a convenient summary of ‘the information’ contained in the Poulsen patent” on which they relied. They submitted that it was “not strictly necessary” for them to have done so; and that the “notional claim” mechanism was “superfluous”. In oral submissions, senior counsel for the appellants said that “drafting the notional claims really is a distraction”. Insofar as the appellants’ submissions contained a challenge to the way her Honour had approached the matter, it was that she had “placed undue emphasis upon the concept of a ‘notional claim’.” The appellants’ written outline also contained what could only be described as a muted suggestion that we should overrule Du Pont: it was said that “[t]he words chosen by Emmett J cannot substitute for the words of paragraph (b)(ii) themselves”.
197 As the respondents emphasised in their submissions, the appellants’ case on appeal constitutes an attempt to depart from the way they conducted their case before the primary Judge. I would regard it as quite unsatisfactory for the appellants to have drafted, and used in their submissions below, notional claims – and ostensibly following Du Pont in doing so – and then to seek to identify error on the part of her Honour constituted by the placement of “undue emphasis” upon the concept which they themselves invoked. Further, if we were to be invited to hold that the Du Pont approach was wrong, we might have expected to receive a properly developed submission on the subject. In the absence of any such submission, I do not believe that the Full Court is in any position to overrule, and it would be wrong to depart from, the decision of Emmett J in that case. The point I make is given added cogency by the choice apparently made by the appellants to conduct their case below by reference to the assumed correctness of that decision. I would, therefore, reject the submission that her Honour was in error to have to determined the novelty point arising under the Poulsen patent by reference to the notional claims which the appellants drafted.
198 That brings me to the notional claims themselves, and to the use which the primary Judge made of them. They are set out in her Honour’s reasons and there is no need to set them out again here, because one aspect only of them is controversial. There were two such claims. Each claimed “a method of preparing a baked product” which comprised three steps, the third of which was “baking the dough at 220°C”. The claims ended with a general qualifier, in different terms in each. The first claim ended, “… wherein the enzyme is active throughout at least part of the baking process”; and the second claim ended, “… wherein the enzyme is active throughout only part of the baking process”. It was these qualifiers, as I have called them, which were controversial, it ultimately being accepted – and it still being accepted on appeal – that, in all respects other than inactivation, the Poulsen patent anticipated Claims 1 and 7 of the patent in suit.
199 The primary Judge first considered whether the notional claims were fairly based. Her Honour held that the first claim was, but that the second claim was not. The Poulsen specification required that “[p]referably, the lipase has a thermostability which renders the enzyme active during at least part of the baking process”. It is readily apparent from this passage why her Honour took the view that the first claim was fairly based. As to the second claim, her Honour said:
In changing “at least part” as in the consistory clause to “only part” when talking about the thermostability of the enzyme, notional claim 2 changes not only the language but also the sense of the consistory clause. In a sense, notional claim 2 reverses the language of the consistory clause of the baking passage and changes the meaning.
Because the second claim would be invalid for failure to comply with s 40(3) of the Patents Act, it did not, according to her Honour, anticipate the claims of the patent in suit.
200 The appellants’ challenge to the recourse which the primary Judge had to s 40(3) was very much wound up with their challenge to her Honour’s notional claims approach, a challenge which, for reasons already given, I would reject. But the precise architecture of the appellants’ challenges does not, in my view, need to be further considered, since the essence of her Honour’s reasoning was that the second notional claim proffered by the appellants did not reflect the “information” in the Poulsen patent as required by para (b)(ii)(A) of the definition of “prior art base” in the Patents Act. That is to say, her Honour approached the matter, correctly in my respectful view, as though the only claim that might properly stand as a notional one under the Du Pont principle was a claim whose “subject” was the information in the published specification referred to in the statute. In the result, I do not think that anything turns on the question whether a “fair basis” approach to the question posed by para (b)(ii)(A) was correct in point of form and, since the matter was not dealt with in any systematic way in the appellants’ submissions on appeal, I would not be disposed to resolve the issues which arose under the Poulsen patent by reference to that question.
201 The real substance of those issues lay in the question whether the notional claims contained information that anticipated the claims of the patent in suit (which, in relation to the second claim, the primary Judge addressed in the alternative, as it were, to her Honour’s conclusion that that claim was not fairly based). Her Honour took the view that the requirement in the first claim that the enzyme be active for at least part of the baking process was consistent with it being active for the whole of that process. Thus the claim “teaches away from” Claim 1 in the patent in suit. Although formally challenged on appeal, there could not be much doubt about that conclusion.
202 The more difficult area of contention was that which lay under the appellants’ second notional claim. Although that claim was itself the child of the appellants, it seems that they found it immediately necessary to have resort to the Poulsen specification to give content to what the skilled addressee would understand by the term “active throughout only part of the baking process”. According to the reasons of the primary Judge, the appellants submitted that –
… the baking passage [in the specification] tells the reader that the enzyme should survive the proofing process and preferably the early stages of baking; that is, that the enzyme is able to act for a longer period before the early stages of baking. It does not … suggest to the reader that the enzyme will survive the entire baking process, nor that there would be any advantage to the enzyme having any activity after baking. [The appellants argue] that the Poulsen patent’s use of the relative term “thermostability” and description of the enzyme as having “good thermostability” does not imply that the enzyme is sufficiently thermostable to survive the baking process. [The appellants say] that of necessity every enzyme possesses some degree of thermostability and describing the thermostability of an enzyme does not necessarily imply that the enzyme is thermostable.
This led on to the passage about the evidence of the experts which I have set out in another context at para 119 above.
203 The “baking passage” to which the primary Judge referred, and on which the appellants relied, was the following:
To be practically useful, it is also advantageous that the polypeptide of the invention has a good thermotolerance and optimum temperature for activity, at least to an extent where it is fully active in a dough at least up to the proofed dough is heated in an oven. Preferably, the lipase has a thermostability which renders the enzyme active during at least part of the baking process. Specifically, the thermostability of the polypeptide is at a level where it retains at least 60% of its activity after 1 hour at 60°C in 100mM sodium acetate buffer at pH 5.0, including a polypeptide that retains at least 80% of its activity after 1 hour at 50°C under the same conditions.
The appellants relied on the evidence of Profs Hoseney and Small that, in 1998, they were unaware of any lipase that could survive the baking process, and on what they said in their joint report:
The enzyme being describe [sic] is clearly a lipase and this is described as having good thermotolerance. This means it has some activity in the dough during the baking stage within the oven. The data on thermal tolerance of the enzyme probably indicates that inactivation occurs during baking.
As her Honour pointed out, Prof Small added a rider to that statement, to the effect that he would have “some hesitation in extrapolating the data in the [Poulsen] patent from ‘test tube’ experiments run over an hour long period, to being confident that the lipase would have been inactivated in the dough during baking.”
204 The primary Judge took the view that this evidence was insufficient to sustain the conclusion that the Poulsen patent disclosed a process in which the enzyme was, as distinct from might well be, inactive as the result of the baking process. The appellants’ second notional claim did not so provide in terms, and the extra step – and it would, as a matter of language, have been a considerable step – of impressing upon the wording of it a meaning derived from the specification that inactivation would probably occur in baking could not, according to her Honour, justifiably be taken on the strength of that evidence. I agree with that conclusion.
205 In their written outline on appeal (which was the subject of but little elaboration orally), the appellants did not engage directly with her Honour’s reasoning on the question whether the second notional claim, understood in the light of the specification out of which it was born, was such as would have anticipated the relevant claims of the patent in suit. They approached the appeal as though her Honour was wrong to have operated only by reference to the notional claims, and proceeded to address the question whether the information in the Poulsen specification was such as would have anticipated those claims. This was what they called a “whole of contents” approach. As I have rejected the appellants’ challenge to her Honour’s treatment of the matter by reference to the notional claims which they drafted, I do not consider that this broader approach warrants attention on appeal.
206 I would reject the appellants’ challenge to the primary Judge’s conclusion that Claims 1 and 7 of the patent in suit were not deprived of novelty because of the Poulsen patent.
Manner of manufacture – The Poulsen Priority Application
207 Before the primary Judge, the appellants submitted that the invention described in the patent in suit was not, so far as claimed in Claims 1 and 7, a manner of manufacture as required by s 18(1)(a) of the Patents Act. Her Honour did not accept that submission, and the appellants now challenge that outcome.
208 According to the reasons of the primary Judge, the appellants submitted that the patent in suit disclosed “no new substance, no new characteristics of a known substance, no new use and no new method.” The appellants accepted that these conclusions must be apparent on the face of the specification of the patent in suit, and they submitted that they were. They relied on two passages in the specification, namely (on p 7 of the specification):
Preferably the enzyme is an enzyme as described in and/or as claimed in Danish Patent Application No. 0400/97.
And (on p 34 of the specification, just before the claims):
All publications mentioned in the above specification are herein incorporated by reference.
In her Honour’s reasons, the Danish application referred to was described as the “Poulsen priority application”, it being the priority application on which, it seems, the Poulsen application, subsequently made, was based.
209 The appellants’ manner of manufacture case had, therefore, two components: first, that the whole of the Poulsen priority application was incorporated by reference into the specification of the patent in suit, and secondly, that it appeared on the face of the specification, as so modified, that the invention was not new, that is, in the context of the present case, was no more than a new use (or, perhaps more appropriately, a new application) of an old process.
210 The primary Judge held that, by reason of the passages to which I have referred, the specification included at least so much of the Poulsen priority application as described or claimed the enzyme referred to therein, including the relevant activity of that enzyme in its different methods of use. The appellants challenged that, contending that it was unduly limited in the light of the incorporation of the whole of that application by reference. From the nature of the issues that were agitated both before her Honour and on appeal, however, nothing turns on this distinction. Our attention was drawn to nothing in the Poulsen priority application that actually mattered for the appellants’ manner of manufacture case that was not treated as incorporated. In my reasons which follow below, I am likewise prepared to treat as incorporated any part of the application upon which the appellants relied. For their part, the respondents were not heard to contend that, if the point generally were otherwise available to the appellants, the primary Judge was too generous to the appellants in the amount of material which she treated as incorporated.
211 With respect to the second aspect of the appellants’ case, the primary Judge summarised the submissions made on their behalf in two paragraphs of her judgment, the first of which was as follows:
[The appellants say] that the specification of the Patent (including the Poulsen Priority Application) discloses as known:
(a) the use of a lipolytic enzyme in the preparation of bread (a foodstuff) from dough (a food material);
(b) an enzyme that acts in situ:
(i) to hydrolyse triglycerides (fatty acid esters) naturally present in flour to produce mono- and diglycerides (each of which are emulsifiers); and
(ii) simultaneously with (i), to hydrolyse galactolipids (second constituents) naturally present in flour to produce MGMG and DGMG (each of which is an emulsifier, that is, a second functional ingredient);
(c) that the enzyme does not hydrolyse all of the triglycerides or galactolipids; some of them remain in the final baked product;
(d) baking of the dough to produce bread; and
(e) that enzymes, in general, may be inactivated by heating.
It was the aspect covered by subpara (e) that was contentious in the case below. It was common ground that, in each respect other than inactivation, Claim 1 of the patent in suit did not describe a manner of manufacture.
212 The second paragraph in which her Honour summarised the appellants’ submissions was as follows:
[The appellants submit] that, therefore, the Patent “discloses no new substance, no new characteristic of a known substance, no new use and no new method” as follows:
(a) no new substance disclosed – the preferred enzyme, the Poulsen enzyme, is disclosed in the Poulsen Priority Application;
(b) no new characteristic of a known substance – the “dual activity” of the Poulsen enzyme is identified in the Poulsen Priority Application, while it is apparent from the specification that inactivation of enzymes by heat is known;
(c) no new use – the use relevantly is for the in situ generation of functional ingredients, which is disclosed in the Poulsen Priority Application; and
(d) no new method – a method of preparing a foodstuff, that is, the preparation of bread from dough, is described in the Poulsen Priority Application.
The second aspect of subpara (b) – “while it is apparent from the specification that inactivation of enzymes by heat is known” – related, as will be clear from what I have already said, to the point that was contentious below, and remained contentious on appeal.
213 The primary Judge accepted that the specification of the patent in suit did not disclose, or claim, a new enzyme. But her Honour held that it disclosed and claimed “a new process for a new purpose”. The new process was that which involved the inactivation of the enzyme, and the new purpose was the avoidance of the need to list the enzyme as an additive on the label of the finished foodstuff. Her Honour said:
Although the Poulsen Priority Application contains examples of baking which would inactivate the Poulsen enzyme, the document is silent as to that fact and as to the importance of such inactivation. Therefore, there is no admission in the Patent that the relevant utility of the Poulsen enzyme and the necessary inactivation of the Poulsen enzyme were known, either expressly, by implication or when the specification is properly construed in the light of common general knowledge.
On appeal, the appellants criticised this line of thinking because it drew upon explanations and justifications to be found in the body of the specification of the patent in suit, whereas the requirement of s 18 of the Patents Act was that the invention must be a manner of manufacture “so far as claimed in any claim”. They submitted that, in considering that question, her Honour ought to have confined herself to what was claimed in the claims as such.
214 I consider, with respect, that there is substance in this criticism of her Honour’s reasoning. The question must be whether the claims (or the claim or claims that are relevantly contentious) claim an invention which is a manner of manufacture. The advantages, justifications and explanations in the specification stating why the claims are as they are cannot give the quality of newness or inventiveness which, on the authorities, are required by s 18(1)(a). That is not to say that recourse may not be had to the body of the specification, in the conventional way and subject to well-established limits, as an aid to construction of the claims, or to further one’s understanding of them. But it is to say that, if a claim, properly construed and thoroughly understood, does not amount to a manner of manufacture, it cannot be made otherwise by a passage in the specification which recites the advantages, for example, of the invention as embodied in that claim.
215 However, the question remains: was the invention under the patent in suit a manner of manufacture because it claimed the inactivation or denaturation of the enzyme? The appellants submit not, for two reasons: first, because the patent merely relied on “the known property of enzymes being inactivated by heating”, and secondly, because the Poulsen priority application, incorporated by reference, “treats this property as known”. The question will be answered favourably to the appellants if it is apparent on the face of the specification, including the Poulsen priority application, that the subject matter of the claim lacks the necessary quality of inventiveness under the Statute of Monopolies or is not new: see Merck & Co Inc v Arrow Pharmaceuticals Ltd (2006) 154 FCR 31 at 51-52 [63], and the authorities there referred to. In the context of the present debate, it is, in my view, crucial that the court is confined by the authorities to what appears on the face of the specification.
216 As to the first reason relied on by the appellants, they pointed to the passage in the specification which I have set out at para 43 above. I do not think this is sufficient for the appellants’ purposes. Granted that the passage conveys the idea that it was known at the time that “enzymes may be denatured by heat”, that was a very general statement of the possibilities, and it related only to denaturation by heat. What Claim 1 involved, relevantly to the present discussion, was that the enzyme be denatured, thereby requiring not merely the application of such heat that the enzyme “may be denatured”, but the actual denaturation of the enzyme, whether by heat or by some other means.
217 The appellants next pointed to a passage in the specification where a flow diagram of an aspect of the invention was explained. Part of the explanation was: “The enzyme present in the contacted food material is then inactivated with heat.” This was obviously not a revelation of what existed, or was known or practised, previously: it was, rather, an explanation of the invention itself. The same may be said of the third passage to which the appellants pointed, which was an instruction in one of the examples in the specification to the effect that a fat blend was reacted for 12 hours at 50°C “and then shortly heated to 100°C to denature the enzyme”. This instruction was for the implementation of the invention, not by way of a statement of what was previously known.
218 Turning to the Poulsen priority application, the appellants referred to three passages in the specification, but none disclosed the inactivation of the enzyme by heat: they were concerned, rather, with thermostability, or thermotolerance. The appellants’ submission was not that the application disclosed inactivation by heat as such, of course, but that it treated such a property of enzymes generally as “known”. As a lay reader, I would exercise some caution before concluding that the passages relied on by the appellants had to be read in that sense, but that is not the point. What the appellants required, to make good their manner of manufacture argument, was that it appeared on the face of the specification that there was a process which involved the inactivation of an enzyme used in the preparation of foodstuffs. Clearly the Poulsen priority application did not take the appellants to that point.
219 The appellants then submitted that it was understood in the common general knowledge that the enzyme described in the Poulsen priority application would be inactivated by the heating which occurred in the baking examples given in that application. They relied on what Profs Hoseney and Small had said in their joint report, namely: “The data on thermal tolerance of the enzyme probably indicates that inactivation occurs during baking.” This was, however, a statement of what probably happened in fact, as inferred by the experts from the data. It was not by way of identification of what the specification actually stated, or even (positively) implied. Indeed, as Prof Small pointed out in his evidence, the emphasis in the Poulsen patent (and, I take it, also in the Poulsen priority application) was on thermostability, not inactivation.
220 The appellants also relied on her Honour’s statement (see para 213 above) that “the Poulsen priority application contains examples of baking which would inactivate the Poulsen enzyme”. But that statement was of something that would happen, not of what appeared on the face of the application itself.
221 In essence, the appellants’ case on manner of manufacture involved an invitation to the court to look at the specification of the patent in suit, and at the Poulsen priority application incorporated by reference, to bring in the experts’ understanding of what probably would have happened under certain of the conditions described in the latter, and to join the dots necessary to draw an unbroken line to the conclusion that, as at the priority date, it involved no newness or inventiveness to describe a process in which an enzyme used in the preparation of a foodstuff was inactivated after the reaction in which it was involved. For the reasons I have given, I do not consider that that case was sufficiently based on what appeared on the face of the specification and the incorporated application, in the sense required by the authorities. I would reject the case.
Disposition of the Appeal
222 I have concluded that the invention the subject of the patent in suit, so far as claimed in Claims 1 and 7, is not novel when compared with each of the Johnson patent and the Novo patent. So far as it relates to those claims, the patent should be revoked. The appellants seek revocation of the patent also so far as it relates to Claims 2 – 6, 8, 9, 14 and 15. I would allow the parties now to make brief submissions upon the consequence of the revocation of the patent so far as it relates to Claims 1 and 7 for those other claims which the appellants assailed.
223 I would set aside the infringement declaration, and the corresponding injunction, made by the primary Judge on 20 April 2011. I would also set aside her Honour’s order dismissing the appellants’ cross-claim and the order granting a certificate of validity. I would lay out a timetable for the parties to make written submissions on the question of costs, both at first instance and on appeal.
| I certify that the preceding one hundred and eighty-six (186) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Jessup. |
Associate:
| IN THE FEDERAL COURT OF AUSTRALIA | |
| NEW SOUTH WALES DISTRICT REGISTRY | |
| GENERAL DIVISION | NSD 605 of 2011 |
| ON APPEAL FROM THE FEDERAL COURT OF AUSTRALIA |
| BETWEEN: | NOVOZYMES A/S First Appellant NOVOZYMES AUSTRALIA PTY LTD (ACN 001 420 677) Second Appellant |
| AND: | DANISCO A/S First Respondent DANISCO AUSTRALIA PTY LTD (ACN 096 139 392) Second Respondent |
| JUDGES: | GREENWOOD, JESSUP AND YATES JJ |
| DATE: | 4 February 2013 |
| PLACE: | SYDNEY |
REASONS FOR JUDGMENT
Yates J
224 I have had the considerable advantage of reading in draft the reasons for judgment prepared by Jessup J. His Honour’s careful and detailed exposition of the patent and claims in suit, the issues raised in the appeal, and the parties’ respective contentions, relieve me of the need to repeat the same detail in my reasons.
225 I agree with his Honour’s conclusions and reasons on the questions of construction of the claims in suit and on the compliance of those claims with the requirement of clarity imposed by s 40(3) of the Patents Act 1990 (Cth) (the Act).
226 I also agree with his Honour’s conclusions and reasons on the questions of whether the disclosures of the Johnson patent (US Patent No. 3,386,903) anticipate claims 1 and 7 of the patent in suit, and whether the disclosures of the Novo patent (International Patent Application No. WO98/26057) anticipate the same claims on the basis of “inevitable result”.
227 I wish to make some additional observations in relation to the question of “inevitable result” as it arose for determination at the hearing before the primary judge. This particular challenge to validity arose in factual circumstances that are special to the case at hand.
228 The claimed invention relates to chemical processes and outcomes. When a challenge to validity on novelty grounds arises in such a case – based on the claimed invention being the “inevitable result” of following an example set out in a prior published document – one is accustomed to seeing the tender of experimental proof to make good the existence of the “inevitable result”.
229 In the present case, the relevant example was Example 20 in the Novo patent. This example concerns the use of a phospholipase obtained from F. oxysporum as a bread improving agent in a particular baking application. The appellants did not tender experimental proof in respect of the working of Example 20. Rather, they relied on admissions made by the respondents.
230 In this connection the respondents admitted that the F. oxysporum phospholipase described in the Novo patent had the amino acid sequence referred to therein as SEQ ID No 2: see T209. They also admitted that this was the same as the enzyme referred to as the SP972 enzyme and that the SP972 enzyme is the enzyme in the commercial product Lipopan F: see Danisco A/S v Novozymes A/S [2010] FCA 995 at [11]. The respondents also admitted that Lipopan F has lipase, glycolipase and phospholipase activity in dough in baking applications.
231 The respondents did not admit, however, that this enzyme was the phospholipase referred to in Example 20. In that state of affairs, the chain of reasoning needed by the appellants was missing a vital link. However, the chain was made complete by a number of findings made by the primary judge, the ultimate effect of which was summarised by her Honour (at [262]) to be that the person skilled in the art would understand that the reference to “a phospholipase” in Example 20 was to the enzyme having the amino acid sequence disclosed in SEQ ID No 2.
232 For example, the primary judge made the following findings (at [225]):
… Both of the witnesses understood that the enzyme disclosed in the Novo patent was the enzyme having the amino acid sequence identified as SEQ ID No 2. Professor Hoseney understood that the enzyme used in [E]xample 20 was in a substantially pure form and his opinion was not challenged in cross-examination. The specification, read as a whole, refers to and discloses the use of an isolated, purified enzyme, cloned and characterised.
233 Similar findings were made by her Honour at [231] and [252].
234 In my view those findings were plainly open to her Honour. The position is clouded somewhat by an observation made by her Honour (at [267]) that there was no certainty that the person skilled in the art would choose SP972 to use in Example 20. That observation was made, however, in the context of discussing the dosage of the enzyme that would be selected by the person skilled in the art – a subject dealt with by Jessup J in his reasons – and cannot be taken as derogating from the otherwise unambiguous findings by her Honour as to the identity of the enzyme disclosed in the example.
235 The admissions made by the respondents were not qualified. They relieved the appellants from the burden of proving, by other means, a number of key facts relating to the working of Example 20, which might otherwise have been contentious or difficult to prove had the admissions not been made. In these circumstances, it does not assist the respondents to raise speculative possibilities and outcomes in relation to the working of the example when, in relevant respects, the admissions themselves, taken with her Honour’s findings as to the identity of the enzyme disclosed in the example, provided an unobstructed path.
236 Moreover, as Jessup J has also noted, it was not suggested by the respondents that the lipase activity of the enzyme, in a baking context, would not generate monoglycerides or diglycerides or that, when produced, these products would not be functional in the relevant sense. In this connection, it is not in dispute that monoglycerides are emulsifiers. Moreover, there seems to have been no issue between the parties about the function of monoglycerides in relation to the working of Example 20.
237 I would also add that the parties were in agreement that, for the purposes of the respondents’ case on infringement and the appellants’ case on invalidity, it was not necessary to show that the functional ingredient, so identified, had any particular level of activity: see the primary judge’s reasons at [102]-[103]. This shared position on construction had important consequences in respect of the proof of the parties’ respective cases.
238 Given the particular way in which this aspect of the hearing was conducted by the parties, I agree with his Honour that the appellants had done enough to demonstrate that, if the person skilled in the art had followed Example 20 at the priority date, inevitably he or she would have worked a process in which a single enzyme with a phospholipase activity and a lipase activity was generating two functional ingredients from the constituents being used.
239 I also agree with the balance of his Honour’s reasons for concluding that, at trial, the appellants had made good their challenge to the validity of claims 1 and 7 of the patent in suit based on the “inevitable result” of the hypothetical working of Example 20.
240 The process of Example 20 constituted prior art information that had been made publicly available in a single document by the publication of the Novo patent before the priority date of the relevant claims: see s 7(1)(a) of the Act.
241 Finally, I agree with his Honour’s reasons for concluding that:
the disclosures of the Qi Si patent (International Patent Application No. WO94/04035) and the disclosures of the Poulsen patent (International Patent Application No. WO98/45453), in each case, do not anticipate claims 1 and 7 of the patent in suit; and
the appellants’ case on invalidity based on non-compliance with s 18(1)(a) of the Act does not succeed.
242 I agree with the orders that his Honour has proposed.
| I certify that the preceding nineteen (19) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Yates. |
Associate:
Dated: 4 February 2013
