FEDERAL COURT OF AUSTRALIA

Abbott Laboratories v Corbridge Group Pty Ltd (No 2)

[2001] FCA 810

PATENTS – invalidity of – novelty – sufficiency of specification – fair basing – ambiguity – utility – manner of manufacture – prior claim – obviousness

TRADE PRACTICES – misleading and deceptive conduct – s 52 Trade Practices Act 1974

Patents Act 1990 (Cth) ss 18(1)(c), 40(1), 40(2)(a), 40(3), 138(3)(a), 138(3)(b), 233(4)

Patents Act 1952 (Cth) ss 100(1)(c), 100(1)(e), 100(1)(f), 100(1)(h)

Trade Practices Act 1974 (Cth) s 52

Abbott Laboratories v Corbridge Group Pty Ltd [2000] FCA 1713 referred to

Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 followed

Biogen Inc v Medeva plc [1997] RPC 1 followed

Advanced Building Systems Ltd v Ramset (1998) 194 CLR 171 followed

NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655 followed

NV Philips v Mirabella International Pty Ltd (1993) 44 FCR 239 referred to

Aktiebolaget Hassle v Alpha Farm Pty Ltd (1999) 44 IPR 593 referred to

Old Digger v Azuko (2000) AIPC 91-571 followed

Alcatel NV v Commissioner of Patents (1996) 68 FCR 8 referred to

Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 referred to

Graham Hart (1971) Pty Ltd v SW Hart & Co Pty Ltd (1978) 141 CLR 305 followed

Minnesota Mining & Manufacturing Company v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 followed

The Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 followed

ABBOTT LABORATORIES and ABBOTT AUSTRALASIA PTY LIMITED v CORBRIDGE GROUP PTY LIMITED and SELFCARE PTY LIMITED

N 1252 OF 1999

GYLES J

SYDNEY

29 JUNE 2001

THE COURT ORDERS THAT:

The proceeding stand over to enable short minutes of order to be brought in to give effect to these reasons.

Note:    Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

REASONS FOR JUDGMENT

1                     This is a cross-claim for revocation of patent and for other relief.  I shall deal with the question of other relief at the end of this judgment.  I dismissed the claim for infringement of the patent in relation to which the cross-claim for revocation relates in my judgment in Abbott Laboratories v Corbridge Group Pty Ltd [2000] FCA 1713.  In that judgment I explained the background and I construed certain of the claims alleged to have been infringed by the respondent cross-claimants.  The applicants (cross-respondents) subsequently proposed to amend Claim 4.  That proposal was opposed by the cross-claimants.  After preparation of that matter for hearing had proceeded for some time, the applicants indicated that they did not wish to pursue that application.  I therefore proceed to consider the validity of the claims of the patent in suit as they stand.  I will not repeat what I said in my previous judgment as to background or my conclusions as to construction of the claims, which are of some significance in considering issues going to validity.  This judgment should be read in conjunction with my previous judgment. 

2                     The parties tendered a considerable volume of evidence on affidavit, including evidence from a number of experts, each of the witnesses annexing or referring to many documents.  Further documents were tendered in addition to those documents.  Many of the witnesses were cross-examined.  Although there are a number of contested issues, much of the background is relatively uncontroversial.  I will not attempt to reproduce or summarise all of this evidence or, indeed, all of the many arguments advanced by the parties.  The written submissions which counsel provided are comprehensive and a verbatim transcript of the oral argument is available.  I will be as economical as reasonably possible in expressing my conclusions and reasons for them.

patentee not entitled to the patent

3                     This ground of revocation is set out in s 138(3)(a) of the Patents Act 1990 (Cth) (“the 1990 Act”).  The basis put forward for this ground is that each of Professor Turner and Professor Cass was an inventor and neither had assigned his entitlement to the patent to the cross-respondents.  Absence of assignment is common ground between the parties.

4                     Professor Turner gave evidence as to his association with the development of the technology relevant to the patent.  Ironically, his evidence was directed to proving that there was no invention rather than proving that he was a co-inventor.  I accept the submission of counsel for the cross-respondents that the evidence establishes that Professor Turner was responsible to the first named inventor, Irving John Higgins, in all that he relevantly did as part of the Cranfield University team, and claims no separate inventive work of his own.  Assuming that there is an invention, he was not an inventor.

5                     Professor Cass did not give evidence.  There is no direct evidence of the work he did.  It is known that he was a member of a team working under the named inventor, Hugh Allen Oliver Hill.  This does not establish that he was an inventor.

section 40

6                     The cross-claimants’ case is that the specification fails to comply with s 40 of the 1990 Act in various respects which overlap and that, as there is no relevant difference between that section, on the one hand, and ss 100(1)(c) and 40(1) of the Patents Act 1952 (Cth) (“1952 Act”), on the other, there is no need to revert to the 1952 Act.  The cross-respondents do not submit to the contrary of the latter proposition and I shall proceed accordingly.

Sufficiency

7                     The complete specification must describe the invention fully, including the best method known to the applicant of performing the invention (s 40(2)(a) of the 1990 Act).  The arguments as to this provision have been partly overtaken by the decision of the High Court in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 (“Kimberly-Clark”).  The “invention” referred to in s 40(2)(a) is the embodiment which is described and around which the claims are drawn, rather than the other meanings of that word (Kimberly-Clarkat pars 19-21).  As stated in Kimberly-Clark, it is not necessary that the description be as detailed as instructions to a manufacturer (at par 25):

“The question is, will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty.” (emphasis added)

The addressee of the specification is taken to be skilled:  a person acquainted with the surrounding circumstances as to the state of the art and manufacture at the priority date     (Kimberly-Clarkat par 24).

8                     The cross-claimants’ argument is that the claims are very wide and too much experimentation, study and investigation by a skilled addressee is called for in order to perform the invention.  They support this by pointing to a number of parts of the descriptions in the specification which do not precisely specify dimensions, chemical substances, relationships and characteristics, thus necessitating the skilled addressee to make choices without clear guidance.  This argument was backed up with references to the expert evidence.  The point was particularly illustrated by pointing out that in Claims 1 and 3 there is no identification of the substrate, the mediator compound, the enzyme or the characteristics of the reference electrode material, and no means of choosing any of them is identified.

9                     It is submitted for the cross-respondents that:

(1)               The specification assumes (and acknowledges) the state of electro-chemical knowledge as to the relevant reaction, the use of electrodes for the relevant purpose and the appropriate chemical substances.  The invention provides the platform for those electro-chemical mediation techniques which actually work with particular substrates;

(2)               The specification does in fact identify particular substrates, mediators, enzymes and reference electrode material.  For example, it is accepted by the cross-claimants that the patent nominates ferrocene as a type of mediator compound which will work for the purposes of a glucose cell.  There is no pleading and no submission that the patentee has failed to give a valid working example of the mediator compound or, indeed, of the other compounds.

10                  As I said in my previous judgment (at par 10) the patent relates to analytical equipment or apparatus and does not purport to disclose any new electro-chemical principle or any novel chemistry.  The sensor electrodes which are disclosed and claimed are devices for use in conjunction with the analytical equipment or apparatus.  The sensor electrodes are the invention, and the claim is that they are adapted to work with the appropriate electro-chemical combination, whatever that may be.  Apart from references to the existing art in the specification (both directly and by reference to other specifications) the cross-claimants led a considerable body of evidence to establish the state of electro-chemical knowledge in the United Kingdom at the priority date, much of which was not controversial.

11                  The cross-claimants submit that in Biogen Inc v Medeva plc [1997] RPC 1 (“Biogen”) at 47-48 the House of Lords held that where a patentee claims products (rather than a principle) the patentee must provide sufficient information to enable the invention to be performed across the full width of the claim, that is, all embodiments included in the claim (see also Terrell on the Law of Patents, Sweet & Maxwell 15^th ed, 2000 at pars 7.44-7.47).  What Lord Hoffman said in Biogen (at 48) was:

“If the invention discloses a principle capable of general application, the claims may be in correspondingly general terms.  The patentee need not show that he has proved its application in every individual instance.  On the other hand, if the claims include a number of discrete methods or products, the patentee must enable the invention to be performed in respect of each of them.” (emphasis added)

12                  The cross-respondents are correct in submitting that the specification does give examples which would enable the addressee to produce something within each claim as required by Kimberly-Clark and sufficient instruction to enable each discrete method or product to be performed, albeit not every manifestation of them.  In my opinion, this complies with the passage from Biogen to which I have referred.  In any event, if there is a difference between Biogen and Kimberly-Clark, I am bound to follow the latter.

13                  In my opinion, none of the defects of description raised in argument are made out.  The embodiments are sufficiently described.

Fair basing

14                  Under s 40(3) of the 1990 Act the claims must be fairly based on the matter described in the specification.

15                  The principal argument for the cross-claimants was that the patent is a classically “covetous” patent.  To the extent that there is a patentable invention disclosed in the specification, which is denied by the cross-claimants, it is limited to the matters actually taught.  Therefore to the extent that the patent claims a monopoly over the mediator compounds, enzymes, substrates and methods of immobilisation other than as properly disclosed in the specification, it is submitted that those claims are not fairly based on the matter described in the specification and are invalid.  It was argued that the evidence of the experts, including Professor Bartlett, clearly suggested that significant experimentation would be required to develop an effective device incorporating elements other than those disclosed in the specification.

16                  In addition, it was submitted that the cross-respondents’ case appears to be that there is some innovation in the size and configuration of the reference electrode.  If such a step was inventive, which is denied, it is submitted that the patent is silent as to any problem that may have been expected in relation to such a reference electrode and does not teach the skilled addressee how to perform the “invention” so as to overcome these apparent problems.  The cross-claimants also submitted that in the context of inventive step, this failure results in the strong inference that the skilled addressee knew as at the priority date that such problems were not significant and the skilled addressee was already equipped with the knowledge to overcome them.  Alternatively, if the skilled addressee did not have the requisite knowledge at the priority date, the patent does not provide it and any attempt to claim a monopoly in respect of such an alleged invention is not fairly based.

17                  The flaw in the cross-claimants’ main argument is that the patent does not claim a monopoly over mediator compounds, enzymes, substrates and methods of immobilisation.  It claims devices which incorporate them.  The monopoly is in the device.  It does not prevent other use of the compounds, enzymes and so on.  The specification explains the area of operation of the device and the principle of operation of the device.  The claims do not go beyond those explanations.

18                  I have difficulty in understanding the additional argument made by the cross-claimants as a fair basis point.  It appears to use “invention” in a sense other than that which accords with the meaning of that word as set out in Kimberly-Clark.  The question is not about a defined, or undefined, inventive step:  it is whether what is claimed is based upon the matter described in the specification.  In my opinion, it is.

Ambiguity

19                  Under s 40(3) of the 1990 Act the claims of a complete specification must be clear and succinct.  The cross-claimants have given instances of the use of words or phrases in the claims which are imprecise and are not terms of art as such.  These include:

(1)               “of small dimension”;

(2)               “adjacent to but non-contiguous with”;

(3)               “small withdrawn sample of body fluid”;

(4)               “glucose enzyme”;

(5)               “electrode”;

(6)               “electrode material”;

(7)               “separate electrical connection”;

(8)               “elongate”;  and

(9)               “both electrodes extending as an elongate member”.

Whilst, standing alone, there is a degree of imprecision as to the meaning of these words and phrases, I have had no difficulty in giving a meaning to and operation of them, taken in context, particularly with the assistance of the body of the specification.

Inutility

20                  It is a ground of objection that the invention, so far as claimed by the cross-respondents, is not useful (ss 18(1)(c) and 138(3)(b) of the 1990 Act;  s 100(1)(h) of the 1952 Act).

21                  Insofar as this argument reflects the sufficiency and ambiguity arguments, I reject it.  It is also submitted by the cross-claimants that products made in accordance with the claims will not work as a “sensor means” or as a “sensor” without additional integers which are not claimed.  The most obvious example is that Claim 1 does not include any reference to the electrical connection or read-out means.  That is like saying that an electric refrigerator will not work without a lead to the electric power source.  It is useful when connected.  So are these devices.

22                  Utility depends upon whether, by following the teaching of the complete specification, the result claimed is produced, not upon the commercial utility of the end product (see Advanced Building Systems Ltd v Ramset (1998) 194 CLR 171 at 187 (“Advanced Building Systems”)).  I am not persuaded that a sensor or sensor means would not result from following the claims.

No manner of manufacture

23                  In this respect attention should be concentrated upon the 1952 Act in case it is considered that the decision of the High Court in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655 establishes a difference between the 1952 Act and the 1990 Act.

24                  The argument is that, as the specification discloses no inventive step, no invention is disclosed on the face of the specification.  With all respect to the cross-claimants’ argument, I cannot see any basis upon which it can be concluded that lack of invention was admitted on the face of the specification (as required by Advanced Building Systems at 192).  The argument also suffers from the same misuse of the meanings of “invention” as was exposed in Kimberly-Clark.  I accordingly reject this ground .

Claim 4

25                  In my opinion, Claim 4 is an exception to my conclusions as to the operation of s 40 of the 1990 Act because there is no reference at all to the first electrode material, to the enzyme and, most importantly, the mediator.  The presence of an appropriate mediator is an essential integer of the invention disclosed and described.  This, it seems to me, means, at least, that the claim is not fairly based, is not useful and may not be a manner of manufacture.  It does not comply with s 40 and will be revoked.

prior claiming

26                  The cross-claimants submit that the ground in s 100(1)(f) of the 1952 Act is carried forward to the 1990 Act by virtue of the definition of “prior act base” (referring to sub-par (b)(ii) of that definition in Schedule 1 of the 1990 Act).  The cross-respondents’ primary submission is that the effect of s 233(4) of the 1990 Act is that, as prior claiming is not a ground of invalidity as such under the 1990 Act, s 100(1)(f) of the 1952 Act has no relevant continuing operation.  This question involves the transitional provisions of the 1990 Act.  The parties have referred me to what was said by Lockhart J in NV Philips v Mirabella International Pty Ltd (1993) 44 FCR 239 (at 253), by Lehane J in Aktiebolaget Hassle v Alpha Farm Pty Ltd (1999) 44 IPR 593 (at 601), by von Doussa J in Old Digger v Azuko (2000) AIPC 91-571 (at 37,572) (“Old Digger”) and by Burchett J in Alcatel NV v Commissioner of Patents (1996) 68 FCR 8 (at 11).  As the issue is obviously controversial, I shall consider the matter on the basis that s 100(1)(f) applies in substance for the purposes of this proceeding.  I agree with von Doussa J in Old Digger that the disclosure required to defeat a later patent must be in a claim rather than in the complete specification of the former patent and I will follow his general approach to the issue.

27                  The cross-claimants rely upon what is known as the “Mediator Patent” for its contention of prior claiming.  It is submitted that cll 1, 13, 15 and 16 of the Mediator Patent claim the same invention as cll 1, 3, 19, 22 and 23 of the patent in suit.

28                  It is submitted by the cross-respondents, and accepted by the cross-claimants, that none of the claims of the Mediator Patent has a reference electrode as an integer.  The cross-respondents submit that no claim of the Mediator Patent refers to the structural or spatial relationship between the working electrode and the reference electrode, which is an integer of the claims of the patent in suit.

29                  The cross-claimants submitted that:

(a)        the reference electrode is either mere trimming or within the common general knowledge of the skilled addressee in Australia before the priority date of the patent in suit;  and in the alternative

(b)       if there is any inventive step in the reference electrode as described in the claims of the patent in suit, those claims are not fairly based on the body of the specification.

They submitted that trivial additions will not save a patent from invalidity for prior claiming.

30                  In my opinion, a reference electrode, and the relationship between it and the working electrode, are essential integers of the claims in the patent in suit which are not found in the Mediator Patent.  These are no trivial additions.  Arguments based upon common general knowledge and fair basing are not relevant to the ground being considered.  Furthermore, I do not agree that a mosaic or combination of claims or parts of claims can be made from the prior patent, as some aspects of the cross-claimants’ submissions suggested.  Even if available, this ground is not established.

LACK OF novelty

31                  The cross-claimants allege that each of Claim 1 and Claim 3 of the patent in suit is anticipated by US Patent No 4225410 (“the Pace Patent”).  This describes and claims an integrated array of chemical sensors for rapidly performing concurrent multiple analyses of anolytes in a fluid sample of minimal volume.  It claimed to combine the best of two techniques: electro-chemistry and semiconductors, to achieve integration of sensors.  It contemplated “the structure and fabrication of a micro-miniaturised multi-functional, electro-chemical, integrated circuit chip or array of improved electro-chemical sensors”.

32                  It is accepted that this question is to be tested by reference to the 1952 Act.  There is no dispute that for anticipation to destroy novelty all essential integers of the claim must be disclosed in the prior publication.  This is often described as the reverse infringement test (Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 235).

33                  The invention described in the Pace Patent is very different in configuration to either Claim 1 or 3 of the patent in suit, as it relates to the integration of an array of sensors.  However, the cross-claimants claim that to the extent that any one sensor in the array is described, it is disclosed by the Pace Patent for the purposes of destroying novelty.  In the summary of the invention it is said that:

“… other sensors may be adapted to measure a redox reaction for the detection of glucose, LDH, etc, by amperometric/voltammetric methods.”

The cross-claimants’ case is that some of the sensors disclosed in the Pace Patent are the same, in essence, as each of Claims 1 and 3 of the patent in suit.

34                  On behalf of the cross-respondents it is submitted that none of the individual sensors, including the glucose sensor, disclose a mediator compound being part of the first electrode material as required by each of the relevant claims.

35                  The cross-claimants refer to evidence from its experts and from the cross-examination of the cross-respondents’ expert, Dr Sanghera, to suggest that a process similar to that of Claims 1 and 3 is described in the Pace Patent in that a substance which operates as the functional equivalent of a mediator is present.  This is not accepted by the cross-respondents, but even if it were, in my opinion it does not provide a satisfactory answer.  The presence of a mediator compound as part of the first electrode material is an essential integer of each of Claims 1 and 3, and a functional equivalent is not sufficient.  I do not understand Dr Sanghera as conceding that the system for the measurement of lactate dehydrogenase described in the Pace Patent is akin to the system utilised in the claims in suit.  I do not think that he conceded that NADH was part of the first electrode material.   He certainly contrasted the role of NAD as part of the enzyme with that of a redox mediator, and, in my opinion, there was no convincing answer to that distinction.

36                  It was also submitted for the cross-respondents that there are a complex series of layers or membranes in the relevant sensors described in the Pace Patent, which have the net effect that none of the electrodes in the Pace Patent sensors are directly exposed to and, hence, in contact with, the blood sample.  These layers are not present in Claims 1 and 3.   Claims 1 and 3 certainly do not expressly include any membrane and this is a distinction between each of them and the Pace Patent sufficient, in my opinion, to avoid anticipation.  I do not need to consider whether sensors with a membrane could infringe Claim 1 or Claim 3.

37                  I have another difficulty in regarding the Pace Patent as anticipating the devices reflected in Claims 1 and 3 of the patent in suit, as I interpreted those claims in my previous judgment.  Both the patent in suit and the Pace Patent claim devices, not any electro-chemical principle or chemical compound.  The devices are quite different: the Pace Patent is looking to concurrent multiple analysis and is designed accordingly.  A glance through the figures depicted in the Pace Patent specification demonstrates how different such a device is when compared with a device in accordance with Claim 1 or Claim 3 of the patent in suit, even if such comparison is concentrated upon figures 5, 6 and 7a-7d of the Pace Patent.  In my opinion, it is artificial to select some features of some of the individual sensors described and then extrapolate them to quite a different form of device with a different configuration for the purposes of anticipation.

38                  The cross-respondents have failed to establish lack of novelty.

obviousness

39                  This brings me to the issue which occupied much of the debate between the parties and their experts.  It is accepted that s 100(1)(e) of the 1952 Act is the relevant provision, namely:

“… that the invention, so far as claimed in any claim, was obvious and did not involve an inventive step, having regard to what was known or used in Australia on or before the priority date of that claim.”

40                  The question is whether, at the relevant date, the claimed invention would have been obvious to the unimaginative and non-inventive skilled technician in the trade in Australia.   That person is taken to have common general knowledge, namely, that which is known or is used by those in the relevant trade.  It forms the background knowledge and experience which is available to all in the trade.  That state of common general knowledge in Australia at the priority date must be established by evidence (see generally, Graham Hart (1971) Pty Ltd v SW Hart & Co Pty Ltd (1978) 141 CLR 305 at 330-331 (“Graham Hart”);  Minnesota Mining & Manufacturing Company v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 at 292-295 (“Minnesota Mining”);  The Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 at 270;  and Advanced Building Systems at 181).

41                  In the present case, the only evidence which was led which directly addressed the state of knowledge in Australia at the priority date were some literature searches and the evidence of Professor Alexander, to which I shall return.  The cross-claimants also sought to establish that the relevant field was international, and that Australia was part of that international field, with the consequence that what was known in England or the United States, for example, would be taken to be known in Australia.  On this basis, the cross-claimants called evidence from experts who were working at the relevant time in the United States and England, who referred to many publications from around the world.  The cross-claimants tendered dozens, if not hundreds, of publications from around the world.

42                  The effect of the evidence of Professors Hibbert, Guilbault and Turner is that there was sporadic and infrequent attendance of Australian academics at overseas conferences, and very limited knowledge of and discourse with Australian academics.  There is no satisfactory evidence as to the particular activities of the Australian academics, apart from Professor Alexander.  Professor Alexander adds little to that general picture save for his own efforts to keep up with international literature.  I accept that persons such as he would refer to international textbooks and periodicals which were available in Australia and would be familiar with some of them as a matter of routine.  I accept that there would also be a body of literature available in Australia available to be searched, although, as counsel for the cross-respondents point out, electronic searching techniques have improved enormously since 1983.

43                  In my opinion, the evidence falls far short of establishing that Australian common general knowledge as properly understood included relevant knowledge throughout the world, or that it included all that could be gleaned by searching through all the international texts and periodicals in Australia at the time. Even if that approach were valid, counsel for the cross-respondents submitted, in my opinion correctly, that:

(a)        it was never shown that there was a community of relevant people in Australia (of whom Professor Alexander was representative) integrated into the larger international community;  and

(b)       it was never established that such people as might have been in Australia and otherwise in the relevant art were exposed to some identifiable common fund of knowledge existing elsewhere.

44                  The cross-respondents are correct in submitting that the addressee is a skilled but unimaginative non-inventive party wishing to construct a device or devices for the purposes disclosed in the patent in suit for clinical or consumer use.  There was no commercial entity involved in that field in Australia at the priority date.  There is no evidence of any other organisation working in that field at the time.  Professor Alexander was then the Head of the Department of Analytical Chemistry at the University of New South Wales.  His work was pure research, not related to constructing devices for clinical or consumer use. His most relevant work related to rapid flow analysis, which is quite distinct from the methodology in the patent in suit.  Furthermore, his research interests had principally related to potentiometric rather than amperometric analysis.

45                  In my opinion, Professor Alexander was not the required skilled but unimaginative non-inventive technician and was not representative of such a party.  On the one hand, he was not skilled as a manufacturer or designer of devices for clinical or consumer use.  On the other hand, he was not unimaginative and non-inventive.  He was a research scientist.  In my view, his knowledge at the time does not represent relevant common general knowledge.  I do not think that it is legitimate to incorporate the knowledge  of Professor Alexander as part of the knowledge of any party wishing to develop a relevant device on the basis that he could, or would, have been engaged as a consultant.  That reasoning, apart from being speculation, simply elides the difference between common general knowledge properly understood and specialised knowledge contrary to the High Court authorities to which I have referred. 

46                  Therefore, the cross-claimants have failed to establish the relevant common general knowledge which is the baseline from which to judge the obviousness of the invention.  This is not surprising in a field which was entirely theoretical in Australia at the relevant time.  The statutory baseline is what was known or used, not potentially known or used.

47                  It is worth noting that although Professor Alexander referred in his evidence to several commercial devices and electrodes in use in Australia prior to the priority date, no case has been made that any claim of the patent in suit is obvious when compared with any of those devices and electrodes.  The same may be said in relation to devices which were undoubtedly constructed for the purpose of teaching and research.  As the basic research was published in the 1950s and taught by Professor Alexander, and others no doubt, for many years prior to 1983, the absence of evidence of any similar devices being used in Australia by 1983 tells against obviousness.

48                  This conclusion is strengthened when the existence of the other commercial devices, particularly the colourmetric strip with which Professor Alexander was familiar, referred to in the specification of the patent in suit, shows that there was a market.  Commonsense would also indicate that there would be a market for a device suitable for use by lay persons or for clinical use without extensive technical back-up services.  The commercial success of the products of each of the parties, albeit in later years, bears this out.  The need served in those later years no doubt existed before the priority date.

49                  In relation to a purely paper case, it is necessary to recall the caution of Aickin J in Minnesota Mining at 293:

“An allegation of want of inventive step is not made out by saying you may take one or two, or twenty-one or twenty-two, prior publications and then select from them appropriate extracts or pieces of information, which will add up to the invention claimed and so demonstrate that it was obvious.  So to proceed is to mistake the nature of an invention and the nature of the objection of obviousness.  The question is, is the invention itself obvious, not whether a diligent searcher might find pieces from which there might have been selected the elements which make up the patent.”

That caution was given in the case of a combination patent.  It has even more force here, as although the cross-claimants submit that the patent in suit is a combination patent, it can only be so described in a strained fashion.

50                  Prior art does not equate to common general knowledge.  A publication is not part of common general knowledge unless evidence establishes that it is (Minnesota Mining at 292).  It is not appropriate to make a mosaic of prior publications to compare with the invention in order to test obviousness (Minnesota Mining at 293).  Indeed, as Aickin J pointed out (at 294):

“It may be observed that in the cases where obviousness is in issue very often the larger the number of prior publications which are relied upon as together establishing absence of an inventive step, the more likely it is that the alleged invention was not obvious for the wider one has to look to find all the integers the less likely it is that it would have been obvious to put them together in the particular manner in which the inventor did.

It may be noted that even in England where the process of making a mosaic out of prior publications is regarded as permissible under the Patents Act 1949 it is still necessary that the mosaic must be one which “can be put together by an unimaginative man with no inventive capacity”.”

51                  Even if, contrary to my opinion, the knowledge of Professor Alexander were to represent Australian common general knowledge, he identified a much smaller number of published sources than has been tendered in evidence and were referred to by others.  It is to be noted that he referred to no patent specification.  There is, therefore, no evidence that any specifications formed part of common general knowledge, and are thus irrelevant on the issue of obviousness.

52                  I can deduce from the evidence of Professor Alexander as to his undergraduate lectures that there would be a number of graduates who would have had a basic understanding of the applicable principles of electro-chemistry.  I am also prepared to assume that there would have been a number of those graduates who would know of at least some of the seminal papers, such as that by Clark and that by Updike & Hicks, and would be aware of the principles behind two and three electrode amperometric analysis.  Such persons are closer to the skilled but non-inventive worker than Professor Alexander.

53                  I cannot be satisfied that it would be a routine non-inventive exercise for such a person to proceed from that knowledge to any of the devices claimed.  I am not even satisfied that it would have been a routine, non-inventive exercise for Professor Alexander to have done so.  His evidence to that effect, if admissible, has little weight.  He said in cross-examination that it was speculation.  That is a fair description.  Amperometric analysis was not his primary field of work or interest and he had done no research to speak of in connection with it.  In cross-examination, he was taken through the prior art which he had identified and was unable to point to any embodiment with the features of the patent in suit.  Furthermore, although there was some equivocation, I find from the whole of his evidence that there would have been serious contraindications at the time in relation to choice of a two-electrode system and in relation to the electrodes being in direct contact with the solution to be analysed, particularly blood and particularly if the electrodes were on the one support member of roughly the same size.  Even in the case of Claim 3, I am not satisfied that the choice of a two-electrode system was obvious, that having two electrodes of roughly the same size was obvious, that having the two electrodes on the same support member was obvious, or that having both electrodes in direct contact with the solution (particularly blood) was obvious.  It is also fair to say that his speculation was carried out in the full glare of hindsight.  I share the scepticism of Aickin J and other judges as to evidence of this character (see Minnesota Mining at 294; Graham Hart at 332).

54                  Counsel for the cross-claimants sought to persuade me that I could find obviousness by comparing the prior art with the patent in suit.  He particularly suggested that Claim 3 was vulnerable, without limiting himself to that claim.  He argued that if I construed the invention as relating to devices and apparatus rather than electro-chemistry, as I have, so that the electro-chemistry was a given, I could conclude that the arrangement claimed in Claim 3 was perfectly obvious.  He drew attention to the lack of dimensions or size limitations, in addition to lack of information concerning the particular substances involved in the analysis.  He drew attention to the diagram in a paper by P Schlapfer, W Mindt and PH Racine titled “Electrochemical Measurement on Glucose Using Various Electron Accepters”.  Such an invitation is seductive, but dangerous.  A judge is not a skilled but non-inventive technician.  In my case, I have no independent scientific or industrial qualifications, knowledge or experience.  In fact, having considered the whole of the evidence of Professor Alexander, including cross-examination on the Schlapfer publication, I have held that a two-electrode system, with both electrodes of roughly equal size in direct contact with the solution on the one support, was not obvious.  The dimensions do not matter.

55                  This means that it is not possible to be satisfied that the solutions reflected in Claims 1 and 3 would have obviously been chosen at the time.  I should add that the assessment of obviousness in relation to Claims 1 and 3, as I have construed them, has not been made any easier by the natural concentration of the parties (and myself) during the hearing upon a miniaturised external flat strip embodiment along the lines of the present commercial products of the parties.

56                  It follows from my view as to Australian common general knowledge that I regard the evidence of the experts, apart from Professor Alexander, as essentially irrelevant, as none of them can assist as to the Australian position at the priority date.  There is no real debate about the underlying scientific principles.  In any event, I regard Professor Guilbault as quite unlike any person in Australia for the purposes of this case.  He is, and was at the priority date, a real expert in the field.  What may have been obvious to him gives no indication as to what would be obvious to the ordinary skilled but non-inventive worker, even leaving aside geographical considerations.

57                  I regard the evidence of Professor Turner with some reserve.  He puts himself forward as a member of the team of inventors, or at least as a member of part of the team, albeit junior member.  His evidence establishes that apparently highly powered teams from two English universities and an American corporation were working on the project which led to this (among other patents) for some years.  This does not make it easy to trivialise what was done, as he now seeks to do.  He retained commercial links with the American corporation until the takeover by one of the present cross-respondents and now has commercial links associated with the cross-claimants.  He was junior at the time and cannot help as to Australia.

58                  Professor Hibbert was a lecturer in chemistry in the United Kingdom at the priority date, with little real association with the precise field and none with Australia.  His evidence is very much the product of hindsight.

59                  Professor Bartlett has had long-standing links with the cross-respondents.  However, if it were considered relevant, I would accept the substance of his evidence.  The gist of this evidence was that the solutions in Claims 1 and 3 of the patent in suit were counter-intuitive at the time because:

(1)               the three-electrode system had taken over from the two-electrode system as the received wisdom, and

(2)               this was certainly so if the electrodes were to be in direct contact with the solution to be tested, particularly if it was whole blood.

In the first place, the views he expresses now are consistent with views he expressed in a memorandum in 1984, when he was actually confronted in real life with the kind of exercise that others are now attempting, some seventeen years after the event, with litigation on foot.  At the time, he was more like the skilled but non-inventive worker than he and the other experts are today.   In the second place, Professor Alexander was not, in the end, able to give any satisfactory answer to the points made by Professor Bartlett.  Whether he, or any expert, would have made the counter-intuitive choice is a matter of conjecture.  It would not have been routine to do so.  In the third place, in my opinion, his specialty as a physical electro-chemist is the most apt of the experts in dealing with the design of devices and apparatus.

60                  Dr Sanghera is closest of the experts to the commercial “coalface”, but he has a strong commercial interest and no direct knowledge of the state of the art in Australia at the priority date.  He obtained his undergraduate degree in the United Kingdom in 1983.

61                  I should deal with one aspect of the matter relied upon by counsel for the cross-claimants at various points during the hearing and in address, namely, the difficulty of discerning from the complete specification of the patent in suit what the inventive step was claimed to be and the reluctance of the cross-respondents to commit themselves to a position on that matter.  While there is a sound foundation for the argument, it leads nowhere.

62                  It is helpful to go back to the analysis of the various meanings of “invention” in Kimberly-Clark (at pars 20 and 21) and of “inventive step” and “inventive merit” in Advance Building Systems (at 186-187 and 191-192).  If the complaint is, in substance, encompassed by the s 40 arguments, then I have dealt with it.  It may be that the complaint is that the specification does not clearly identify precisely how the “invention” differs from, and improves upon, what went before:  what is unique about it.  In one sense that is correct.  The specification refers to the prior art (some of it by incorporation), states objectives and describes the various embodiments of the invention.  If there is, in fact, no advance, then the patent will be invalid on the grounds of lack of novelty or obviousness.  The fact that the “advance” is not expressly identified does not lead to invalidity.

63                  It may be that the complaint was directed to the forensic difficulty of establishing obviousness or lack of novelty without a statement of the “advance” in the specification or in the pleadings.  I can see that point but, forensically, it could cut both ways, as it could make it more difficult for a patentee to rebut attacks upon lack of novelty and obviousness.  The issue simply reflects the fact that the party seeking revocation carries the onus.

conclusion on validity

64                  I have held Claim 4 to be invalid.  It follows that Claims 5 and 6 are invalid.  Each will be revoked.  It also follows that Claims 23, 24, 25 and 26 cannot stand in their present form.  I shall hear submissions as to what should happen to these claims.  Argument has centred otherwise on Claims 1 and 3, and therefore also the claims dependent upon them.  As I have rejected the grounds of invalidity, revocation will be refused.  No separate argument has been directed to Claims 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 and revocation will be refused.  The matter will stand over for short minutes to be brought in.  At that time the parties can draw to my attention any necessary issue which I have overlooked or agreed mistake of fact which I have made.  I will then hear the parties on costs.

further cross claim

65                  The cross-claimants alleged as follows:

“11.    At all material times the First Cross-Respondent and/or the Second Cross-Respondent has, or has procured, the distribution in Australia in trade or commerce of a booklet entitled “MediSense ExacTech User’s Manual” (the “Manual”).

12.              the Manual includes on page 2 the following statements (the “Statements”):

                        “NOTE:  The ExacTech Blood Glucose Sensor can only be used with ExacTech Blood Glucose Test Strips.  The use of any other test strips will give incorrect results.”

13.              The Statements are and have at all material times been false or misleading or likely to mislead or deceive.

Particulars

            The ExacTech Blood Glucose Sensor can be used with the Respondents’ Product.  The use of the Respondents’ Product with the ExacTech Blood Glucose Sensor gives correct results.

14.              By engaging in the conduct referred to in paragraphs 11 and 12 the First Cross-Respondent and/or the Second Cross-Respondent has contravened sections 46 and 52 of the Trade Practices Act 1974.”

66                  Paragraphs 11 and 12 are admitted by the cross-respondents. 

67                  As to par 14, the cross-claimants submit that:

“… In his affidavit sworn 4 February 2000 … at para 6.1.7 … Dr Sanghera said with the authority and on behalf of the first Applicants …:

            “As indicated in paragraph 5.5 blood testing was conducted.  The results of the blood testing indicated to me that the glucose level of a sample of my blood measured by the ExacTech Meter using a New ExacTech strip was substantially the same as the glucose level of a sample of my blood measured by the ExacTech Meter using an EXCEL ET Test Strip.  These results are consistent with the statement at (22) in Exhibit GS-4 that “EXCEL ET Glucose Test Strips will provide reliable and accurate results when used with ExacTech … Meters.”

(Exhibit GS4 is the leaflet that is distributed with the Respondents’ test strips.)

Accordingly, it follows that the use of other test strips – ie the Respondents’ EXCEL ET strips – with the ExacTech Blood Glucose Sensor does not give incorrect results and the statement at page 2 of the Users’ Manual is false.”

68                  The cross-claimants’ submissions in this respect are plainly correct and warrant the conclusion that the statements were false or misleading or likely to mislead or deceive. 

69                  The cross-respondents submit, however, that:

1.         There is no evidence of circulation of that manual at a point in time after the respondents commenced to supply the Selfcare strip to the Australian market.  In this respect, although Mr Sullivan, a senior executive of the second applicant was called to give evidence, he was not cross-examined to show that there was any overlap between the publication of that manual and the presence of the respondents’ Selfcare strip in the Australian market;

2.         The revision date of the manual is November 1997.  There is no evidence that as at that date there was any glucose strip in the market other than a MediSense strip which worked with the applicants’ meter.

70                  The cross-claimants submit that that argument is not open to the cross-respondents in view of the admissions as to pars 11 and 12.  I agree that it is not open to the cross-respondents to take the point outlined above.  The allegation in par 11 is that distribution of the booklet has been “at all material times”.  Whilst there may be some imprecision in the meaning of that phrase, the time to raise the imprecision was before pleading to it.  Once admitted, it precludes any argument as to the timing of the distribution. 

71                  The cross-claimants have established contravention of s 52 of the Trade Practices Act 1974 (Cth) as alleged.  The minutes of order to be brought in should reflect this finding, including directions as to the hearing in relation to further relief.  In connection with the latter, it should not be assumed that the admissions which have been acted upon to make the finding of contravention are sufficient to establish damage for the purpose of an award of damages.  Costs will be dealt with as part of the general argument as to costs.

72                  No submissions have been made concerning another foreshadowed claim for breach of s 52.

Associate:

Dated:              29 June 2001