FEDERAL COURT OF AUSTRALIA

Boehringer Ingelheim Animal Health USA Inc v Zoetis Services LLC (No 2) [2024] FCA 291

ORDERS

THE COURT ORDERS THAT:

1.    The appeal be allowed.

2.    The cross-appeal be dismissed.

3.    The decision of a delegate of the Commissioner of Patents made on 28 August 2020 in relation to Patent Applications 2013243535 (the 535 Application), 2013243537 (the 537 Application) and 2013243540 (the 540 Application) be set aside.

4.    The Appellant's oppositions to claims 1 to 18 of the 535 Application, claims 1 to 24 of the 537 Application and claims 1 to 25 of the 540 Application be upheld.

5.    The 535 Application, the 537 Application and the 540 Application be refused.

6.    The Respondent pay the Appellant's costs of this proceeding as determined in accordance with the lump sum costs procedure in the Court’s Costs Practice Note (GPN-COSTS), with a 10% discount for all costs incurred before 19 August 2022 being the date on which the Appellant was granted leave to further amend its Notice of Appeal and Notice of Contention to introduce the "lack of best method” ground.

7.    The Respondent pay the Appellant's costs of the opposition proceedings before the Commissioner of Patents in relation to the 535 Application, the 537 Application and the 540 Application, in each case in accordance with Sch 8 to the Patents Regulations 1991 (Cth).

8.    The Respondent is granted leave to appeal these orders, and any notice of appeal must be filed within 28 days after the date of these orders in accordance with r 36.03 of the Federal Court Rules 2011 (Cth).

9.    In the event that a notice to appeal is filed in accordance with order 8, orders 3 to 7 be stayed until 28 days after the determination of that appeal.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

ROFE J:

1.    INTRODUCTION

1    On 21 September 2023, I handed down my reasons in the appeal and cross-appeal from a decision of the delegate of the Commissioner of Patents in respect of three related patent applications: Boehringer Ingelheim Animal Health USA Inc v Zoetis Services LLC [2023] FCA 1119 (Reasons or J). These reasons adopt the defined terms of the Reasons.

2    The three Australian Patent applications the subject of the appeal and cross appeal are the:

(a)    535 Application, entitled “Mycoplasma hyopneumoniae vaccine”;

(b)    537 Application, entitled “PCV/Mycoplasma hyopneumoniae combination vaccine”; and

(c)    540 Application, entitled “PCV/Mycoplasma hyopneumoniae/PRRS combination vaccine”.

3    I ultimately concluded that the opposition to the grant succeeded in respect of all the claims of the Applications, except claim 2 of the 535 Application.

4    In particular, I concluded that the invention claimed in claim 1 of each Application lacked an inventive step.

5    I concluded that the following claims lacked support:

(a)    535 Application: claim 3 (and the claims dependent on claim 3); and

(b)    537 Application: claim 8 (and the claims dependent on claim 8).

6    I concluded that the following claims fail to comply with s 40(2)(a) of the Patents Act 1990 (Cth) in that they did not disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art:

(a)    535 Application: claims 3, 8 and 12; and

(b)    537 Application: claims 8, 13 and 17.

7    I concluded that the patent applicant failed to disclose the best method known to the applicant of performing the invention claimed in the following claims:

(a)    535 Application: claims 3, 7, 8 and 11;

(b)    537 Application: claims 1 to 24; and

(c)    540 Application: claims 1 to 25.

8    I concluded that the following claims lacked a manner of manufacture:

(a)    535 Application: claims 16 and 17;

(b)    537 Application: claims 21 and 22; and

(c)    540 Application: claims 19, 20, 22 and 23.

9    Following publication of the Reasons, the parties requested that I provide supplementary reasons in relation to the validity of the dependent claims (found to be invalid as set out above) on the other grounds of invalidity. At a hearing on 20 November 2023, I agreed to provide supplementary reasons. I did not accept further submissions from the parties as I considered that I had sufficient material before me from the trial to make the necessary findings.

10    For the purposes of the discussion of the further grounds of invalidity below, I assume each of the dependent claims to be valid.

11    There is also the issue of the costs of the appeal and cross-appeal, which I will deal with at the end of these reasons.

2.    CLAIM STRUCTURE OF THE THREE APPLICATIONS

12    Each Application has a series of dependent claims, usually claiming the composition of claim 1 or claim 2 (and in some cases several other claims) with a further integer such as an adjuvant, a ready-to-use form, single dose administration or the addition of a further antigen selected from a lengthy list. For several of the claims, there are many permutations of invention depending on the chain of dependencies followed.

13    The claims of the Applications proceed in familiar fashion with a progressive narrowing of the invention claimed, “the patentee hoping that somewhere along the line he may find a claim sufficiently narrow to be valid and sufficiently wide to catch an infringer”: Dean, Sir Arthur, “Claiming Clauses” (1949) 4 Res Judicatae 144 at 148, quoted in Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 11 IPR 289 at 294 (per Gummow J).

14    Claim 1 of each Application is a broad claim to an immunogenic composition comprising the M. hyo platform plus, in the case of the 537 Application, a PCV-2 antigen, or in the case of the 540 Application, a PCV-2 antigen and a PRRS antigen. I found the invention claimed in claim 1 of each Application to be obvious (J[514], [523], [530]).

15    Dependent claim 2 of each Application adds the requirement in relation to the composition of claim 1 that the soluble portion has been treated with Protein A or Protein G prior to being added to the immunogenic composition.

16    I found that the use of Protein A or Protein G in the reverse manner to treat a supernatant to remove antibodies and immunocomplexes, and thereby overcome the issue of both assay and immunological interference, was inventive (J[518]). I therefore found that the invention claimed in claim 2 of the 535 Application involves an inventive step.

17    Each of the Applications also has claims to a “kit” for use in carrying out the method of earlier claims, comprising a bottle (or two bottles in the 540 Application) and further including an instruction manual.

18    Zoetis did not dispute that in the event particular independent claims were found to lack an inventive step, that certain dependent claims were not independently valid: those claiming a particular PCV-2 or PRRS antigen, or a pharmaceutically acceptable carrier. I have noted, where appropriate, the particular claims of each Application to which Zoetis’ concession applies.

19    Zoetis is particularly concerned with the inventiveness of the “single dose” claims:

(a)    535 Application: claim 7 (except as dependent on claim 2) and claim 11;

(b)    537 Application: claim 12 (except as dependent on claim 2) and claim 16; and

(c)    540 Application: claim 13 (except as dependent on claim 2) and claim 16.

20    For the reasons set out in the next section, I do not consider that these single dose claims involve an inventive step.

3.    INVENTIVENESS OF DEPENDENT CLAIMS

21    The relevant invention is the invention “so far as claimed in any claim”: Insta Image Pty Ltd v KD Kanopy Australasia Pty Ltd (2008) 78 IPR 20 at [80] (per Lindgren, Bennett and Logan JJ). It is that invention which is taken to involve an inventive step when compared with the prior art base, unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge and, in this case, together with the s 7(3) information.

22    It is not correct to consider whether the particular integer added in the narrower, dependent claim adds anything inventive to the invention claimed in the broader, independent claim. It is not permissible to treat the additional integer in isolation, since inventiveness is to be determined by considering the combination as a whole: Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2007) 235 CLR 173 at [69] (per Gummow, Hayne, Callinan, Heydon and Crennan JJ). However, nor is it correct to conclude that a dependent claim is necessarily obvious just because the broader claim on which it depends is obvious: Lockwood at [150]-[168].

23    In these supplementary reasons, I am concerned with the validity of the claims of the Applications in the form that they are currently drafted. What I am not doing is providing a preliminary view on the validity of the claims if they were to be amended, for example, to remove invalid dependencies.

4.    535 Application

4.1    Inventive step

24    The invention claimed in claim 2 of the 535 Application involves an inventive step. The invention claimed in claim 1 does not.

4.1.1    Claim 3 – range of antigens

25    Claim 3 claims a composition of claim 1 or claim 2, wherein the composition further comprises at least one additional antigen selected from a large list of specified pathogens, including the 5 Pathogens and PRRS.

26    To the extent that claim 3 is dependent on claim 1 and the additional antigen is against PRRS, I consider that the invention claimed lacks an inventive step. Once arriving at the improved M. hyo vaccine that falls within claim 1, I do not consider that it would be inventive for the person skilled in the art to use it in the existing commercial combinations available at the priority date (J[528]). I do not consider that it would be inventive for the person skilled in the art to combine two of the known antigens (M. hyo and PRRS) in combination without PCV-2.

27    To the extent that claim 3 is dependent only on claim 2, I consider that the invention claimed would likely be inventive. However, as I do not propose to set out a road map of the potentially validating amendments that may be open to the patentee, I will only comment on the claims as drafted that I consider to be invalid due to their dependence on invalid claim 1. I will not speculate as to whether other claims, for example based on claim 2, might be valid.

4.1.2    Claims 4 and 5 – composition of any of claims 1 to 3 plus adjuvant

28    Claims 4 and 5 relate to the addition of an adjuvant to the composition of any of claims 1 to 3. In claim 5, the adjuvant is selected from a group of listed adjuvants.

29    As I explained at [271]-[272] of the Reasons:

Adjuvants are compositions containing certain substances that enhance the immune response to an antigen(s). There were many types of adjuvants available by the priority date, including some of those listed in claim 5: oil or polymer-in-water, water-in-oil or aluminium hydroxide adjuvants. The type of adjuvant used was important in improving the immunogenic response to an antigen, and in improving the duration of immunity.

Most vaccines, except attenuated vaccines and some inactivated viral vaccines, (and mRNA vaccines, which were not commonly known or used at the priority date), require an adjuvant.

30    There was no suggestion in the 535 Application that the use of an adjuvant was inventive, or that a new and inventive adjuvant was being employed.

31    I consider that the use of an adjuvant in vaccines was known at the priority date, and that it would be routine for the person skilled in the art to add an adjuvant to any new or improved M. hyo vaccine.

32    Accordingly, to the extent that claims 4 and 5 claim a composition of claim 1 comprising the addition of an adjuvant, the inventions claimed do not involve an inventive step.

4.1.3    Claim 6 – pharmaceutically acceptable carrier

33    Claim 6 claims the composition of any one of claims 1 to 5 wherein the composition further comprises a pharmaceutically acceptable carrier.

34    Zoetis accepted for the purposes of the Australian proceeding (and only the Australian proceeding) that if the Court found each of claims 1 to 5 of the 535 Application to lack an inventive step, Zoetis would not dispute that the Court would find that claim 6 of the 535 Application lacked an inventive step. Zoetis adopted a similar position in relation to the equivalent claims of the 537 Application (claim 11) and the 540 Application (claim 12).

35    I found the invention in claim 1 to lack an inventive step. Accordingly, Zoetis would accept that the invention claimed in claim 6 based on claim 1 does not involve an inventive step.

4.1.4    Claim 7 – single dose administration

36    Claim 7 claims the composition of any one of claims 1 to 6 wherein the composition elicits a protective response against M. hyo when administered as a single dose.

37    Claim 1 claims an immunogenic composition comprising the supernatant of a M. hyo culture. The invention claimed in claim 1 is designed to elicit an immune response to one pathogen: M. hyo.

38    Single dose M. hyo vaccines were available at the priority date (in the form of bacterins). A one-dose bacterin was the state of the art vaccine for M. hyo as at the priority date (J[309]). The person skilled in the art seeking to make a new or improved M. hyo vaccine would be motivated to make it the same as, or better than, the existing state of the art M. hyo vaccine.

39    I consider that the obvious place for the person skilled in the art to start would be to administer a composition of claim 1 (a vaccine against M. hyo alone) as a single dose to elicit a protective response against M. hyo (see Okada 2000a). The person skilled in the art would have an expectation that a single dose would be successful in eliciting a protective immune response against M. hyo.

40    Claim 7 as drafted therefore includes an invention which is obvious.

4.1.5    Claim 8 – single dose administration of composition of claim 3 (M. hyo and at least one additional microorganism)

41    At its simplest, claim 8 encompasses an immunogenic composition of claim 3, dependent on claim 1 (the M. hyo platform) with at least one additional antigen and administered as a single dose. The list of potential additional antigens in claim 3 is extensive but does not include PCV-2. It does, however, include PRRS.

42    I concluded at [26] above that claim 3 lacked an inventive step.

43    At the priority date, there were single dose M. hyo/PCV-2 combination vaccines supplied in two bottles. There were also ready-to-use M. hyo/PCV-2 combination vaccines that required two doses. However, there was no one-dose, one-bottle, ready-to-use M. hyo/PCV-2 vaccine available at the priority date. Such a product was considered desirable and animal health companies were attempting to develop such a product (J[315]).

44    At the priority date, there was an M. hyo, PCV-2 and PRRS combination vaccine available commercially (J[318]). That vaccine, Boehringer’s 3FLEX, was supplied in three vials and prepared for administration by rehydrating the lyophilized PRRS virus component with the M. hyo and PCV-2 components. Professor McVey and Professor Chase agreed that 3FLEX was a single dose trivalent vaccine that was supplied in three bottles.

45    The experts agreed that, as at the priority date, there was a desire for a ready-to-use single dose M. hyo/PCV-2 combination vaccine and also a desire for a ready-to-use single dose combination M. hyo with PCV-2 and PRRS vaccine (J[319]). As such, I consider it was obvious at the priority date to administer any M. hyo combination vaccine as a single dose and therefore the invention claimed in claim 8 is obvious.

4.1.6    Claim 9 – method of immunising a pig against M. hyo using the composition of claim 1

46    The invention claimed in claim 1 is obvious. The immunogenic composition claimed in claim 1 includes a vaccine. As at the priority date, vaccines were being administered to pigs to immunise them against M. hyo. I consider that it would be obvious to administer the composition of claim 1 to immunise a pig against M. hyo as a vaccine to elicit a protective immune response, so as to immunise the pig against M. hyo.

4.1.7    Claim 10 – the method of claim 9 wherein the composition is administered intramuscularly, intradermally, transdermally or subcutaneously

47    Claim 10 claims the method of claim 9 wherein the composition (including a composition of claim 1) is administered intramuscularly, intradermally, transdermally or subcutaneously.

48    The administration of swine vaccines through intramuscular administration to piglets from three weeks of age was part of the common general knowledge as at the priority date (J[266]).

49    I consider that it would be obvious to administer the composition of claim 1 to a pig intramuscularly to immunise a pig against M. hyo. The invention claimed in claim 10 is obvious.

4.1.8    Claim 11 – the method of claim 9 or 10 administered as a single dose

50    Claim 11 encompasses a method of claim 9 or claim 10, which in turn encompasses a method of immunising a pig against M. hyo which comprises administering a composition of claim 1.

51    Single dose administration of a composition of claim 1 is not inventive for the reasons set out above in relation to claim 7. Therefore, the invention claimed in claim 11 is obvious.

4.1.9    Claim 12 – the method of any of claims 9 to 11 administered in conjunction with at least one antigen selected from the list (not including PCV-2)

52    Claim 12 claims the same invention in claim 3 — a vaccine of claim 1 together with an additional antigen, which may be PRRS — in addition to a method for administering that vaccine based on the methods in claims 9 and 10.

53    Claim 12 claims dependence through the method of claim 9, back to the composition of claim 1.

54    Claim 12 lacks an inventive step for the same reasons given in relation to claim 3. The addition of a method to claim 12 based on claims 9 and 10 does not change that conclusion because, as I explained above for claims 9 and 10, it would be obvious to administer a combination vaccine, including through the methods listed in claim 10, to elicit a protective immune response.

4.1.10    Claim 13 – the method of claims 9 to 12, wherein the composition is administered to pigs having maternally derived antibodies against M. hyo

55    At [292]-[293] of the Reasons, I stated:

As at the priority date, it was known that maternal antibodies (transmitted to the piglet via the colostrum) might interfere with a vaccine’s effectiveness in the piglet. PCV-2 antibodies strongly interfered whereas PRRS antibodies did not. Professor Browning explained that PCV-2 being a small, very regular virus induced a very high antibody response.

The maternal antibodies in piglets are relatively short lived (persisting in the piglet for around 3-4 weeks) so the timing of the piglet vaccination is a way to mitigate interference from maternal serum antibodies.

56    M. hyo was known at the priority date to be the primary pathogen responsible for enzootic pneumonia. It was known that M. hyo was highly prevalent worldwide, endemic in almost all commercial swine herds (J[278]).

57    The person skilled in the art would therefore have an expectation that piglets, other than colostrum deprived piglets, would have maternally derived antibodies to M. hyo as the pathogen is endemic to swine herds.

58    As such, the invention claimed in claim 13 is not inventive.

4.1.11    Claim 14 – the method of claim 12, wherein the composition is administered to pigs having maternally derived antibodies against M. hyo and at least one other microorganism

59    The inclusion of at least one additional microorganism adds nothing inventive to claim 14 as compared with claim 13. The invention claimed in claim 14 is therefore not inventive for the same reasons given for claim 13.

4.1.12    Claim 15 – the method of one of claims 9 to 14 wherein the composition is administered to pigs three weeks of age or older

60    According to Dr Nordgren and Dr Chase, it was common knowledge at the priority date to immunise pigs at three weeks or older (see also J[266]). The addition of the integer in claim 15 to the invention as claimed in claim 15 (as dependent on claims 9 to 14, which in turn are dependent on claim 1) is not inventive.

4.1.13    Claim 16 – a kit for use in carrying out the method of claim 9, comprising a bottle

61    Claim 16 is not inventive. As I said at [766] of the Reasons, set out again below:

Claim 16 of the 535 Application claims a kit for use in carrying out the method of claim 9. Claim 9 claims a method of immunising a pig against M. hyo via administering a composition of claim 1. The single bottle in this claimed invention has no role other than containing the solution prior to administration. There is no purposeful and functional interaction between the bottle and the immunogenic composition contents to immunise a pig against M. hyo.

4.1.14    Claim 17 – the kit of claim 16 further including an instruction manual

62    The addition of an instruction manual adds nothing to the combination of the invention. I consider that it would be obvious to include instructions for use with a vaccine for administration to pigs. The invention claimed in claim 17 is therefore not inventive.

4.1.15    Claim 18 – a method for preparing an immunogenic composition of M. hyo, not requiring the use of Protein A and/or Protein G

63    The method claimed in claim 18 encompasses the preparation of an immunogenic composition of the type claimed in claim 1 which, for the same reasons relating to the invention claimed in claim 1, I consider is obvious.

4.2    Lack of support and lack of disclosure

64    I concluded at [389] of the Reasons that the breadth of claim 3 was:

not limited to an immunogenic composition consisting of the M. hyo platform and one additional antigen from the list. It covers the spectrum from the one additional antigen to the M. hyo platform, plus all those antigens in the list, and all combinations thereof, with and without adjuvants. It also includes immunogenic compositions which elicit a protective effect – ie vaccines.

65    The breadth of claim 3 exceeds the technical contribution of the specification because the claim covers ways of achieving a result, being the spectrum of possible antigen combinations, which owe nothing to the disclosure of the specification (J[597]).

66    The 535 Application did not provide an enabling disclosure for the claims to combinations. Further, I found that it was not plausible that the invention could be worked across the scope of the claims and working the invention across the scope of the claims would require undue burden, requiring a significant research project (J[617]).

67    Any claim which claims an immunogenic composition consisting of the spectrum from the one additional antigen to the M. hyo platform, plus all those antigens in the list, and all combinations thereof, will similarly lack support and disclosure. In the case of the 535 Application, to the extent that any of the subsequent dependent claims claim a composition of claim 3, they will suffer from a lack of support and disclosure. This includes claims 4, 5, 6, 7 and 8.

68    Claim 12 independently claims a method wherein the composition of claim 1 is administered in conjunction with at least one additional antigen, selected from a list which is the same as the list in claim 3. For the same reasons that apply to claim 3, claim 12 also lacks support and disclosure, as do claims 13, 14 and 15 to the extent that they claim the method of claim 12.

5.    537 APPLICATION

5.1    Inventive step

69    Claim 1 of the 537 Application, like claim 1 of the 535 Application, claims a multivalent immunogenic composition comprising the supernatant of a M. hyo culture, wherein the supernatant of the M. hyo has been separated from insoluble cellular material by centrifugation, filtration or precipitation and is substantially free of both IgG and immunocomplexes, the difference being the addition of a PCV-2 antigen. I found the invention claimed in claim 1 to be obvious (J[523]).

70    Like claim 2 in the 535 Application, claim 2 in the 537 Application claims the use of Protein A or Protein G in the reverse manner to treat a supernatant to remove antibodies and immunocomplexes, and thereby overcome the issue of both assay and immunological interference. I found that the invention as claimed in claim 2 of the 537 Application was inventive (J[524]).

5.1.1    Claim 3 – ready-to-use liquid composition of the composition of claim 1 or 2

71    Claim 3 encompasses a composition of claim 1. A multivalent immunogenic composition of claim 1 includes a vaccine against M. hyo and PCV-2.

72    The term “ready-to-use” in the vaccine context means that the immunogenic composition is already pre-mixed and is ready to be applied to the target animal without further mixing or preparation steps being required (J[313]).

73    I consider that it was obvious for the multivalent composition of claim 1 to be in a ready-to-use form, as M. hyo/PCV-2 combination vaccine products were available at the priority date in a ready-to-use form. As I explained at [520] of the Reasons:

There were several M. hyo/PCV-2 combination vaccines commercially available at the priority date. The available M. hyo/PCV-2 combination vaccine products were either one dose, two vial vaccines, or one ready-to-use vial which required two doses. There was no one-dose, one-bottle, ready-to-use M. hyo/PCV-2 vaccine available as at the priority date. Such a product was considered desirable.

74    Accordingly, the invention claimed in claim 3 lacks an inventive step.

5.1.2    Claim 4 – composition of any one of claims 1 to 3 wherein the composition elicits a protective immune response in a pig against M. hyo and PCV-2

75    Claim 4 claims a composition of claim 1. I found that claim 1 encompassed a vaccine (J[182] and [254]) and therefore I consider it is obvious for the composition in claim 1 to elicit a protective immune response against M. hyo and PCV-2. As such, the invention claimed in claim 4 is obvious.

5.1.3    Claims 5 to 7 – composition of any of claims 1 to 4 with different forms of PCV-2 antigen

76    Claims 5 to 7 each encompass a composition of claim 1, which I found to include a vaccine and be obvious.

77    Claim 5 claims such an invention “wherein the PCV-2 antigen is in the form of a chimeric type-1-type 2 circovirus, said chimeric virus comprising an inactivated recombinant porcine circovirus type 1 expressing porcine circovirus type 2 ORF2 protein”.

78    Claim 6 claims a composition of claims 1 to 4 wherein the PVC-2 antigen is in the form of a recombinant ORF2 protein.

79    Claim 7 claims the composition of claim 6 wherein the recombinant ORF2 protein is expressed from a baculovirus vector.

80    As explained at [282] of the Reasons:

The PCV-2 capsid protein “ORF-2” was known to be antigenic, and suitable for inducing immunity in vaccinated animals. As at the priority date, the ORF-2 protein was routinely produced using a modified baculovirus vector containing the gene encoding the PCV-2 ORF-2 protein. This virus was used to infect an insect cell line and cause it to produce the ORF-2 protein. The insect cells were then cultured to the required volume and the ORF-2 protein isolated and mixed with an adjuvant. This composition was then used for the final vaccine product.

81    Zoetis accepts for the purposes of the Australian proceeding that if the Court found claims 1 to 4 of the 537 Application to lack an inventive step, it would not dispute that the Court would also find that claims 5, 6 and 7 of the 537 Application lack an inventive step. It adopted a similar position in relation to claims 7, 8 and 9 of the 540 Application.

82    As such, I consider that the invention claimed in each of claims 5 to 7, so far as they claim the composition of claim 1, to be obvious.

5.1.4    Claim 8 – composition of claims 1 to 7 further comprising at least one additional antigen from those listed including the 5 Pathogens but not PRRS

83    Claim 8 encompasses a composition of claim 1 together with at least one further antigen selected from those listed. The list does not include PRRS. I assume for the purposes of this consideration that the range of antigens listed is sufficiently supported and disclosed for the purposes of s 40.

84    A multivalent immunogenic composition of claim 1 includes a vaccine against M. hyo and PCV-2.

85    Further, as at the priority date, commercial vaccines against the four viral pathogens of the 5 Pathogens were not available (J[557]). The questions to the experts in the joint session, and their responses and ensuing cross-examination, focussed on the 5 Pathogens.

86    It was not suggested that there were commercially available combination vaccines available at the priority date other than those for M. hyo/PCV-2 and M. hyo/PCV-2/PRRS.

87    The experts gave evidence that developing a vaccine for each of the four viruses of the 5 Pathogens would have its own set of challenges. I set out those challenges at J[564].

88    At [565], [571] and [572] of the Reasons, I stated:

565    The experts’ evidence was that vaccine development was not predictable and that trial and error experiments are required because it is not possible to predict that an experimental composition which develops an antibody response in the target animal will be safe and efficacious. The source of the antigen, the formulation and type of adjuvant, the presence of additional antigens and the age of the intended target animal are significant variables that must be evaluated in order to produce a safe and efficacious vaccine.

…

571    I accept that the development of an antigen for each of the 5 Pathogens (and the others listed)is not part of the claimed invention of the Applications. However, the extensive nature of the process of work involved to identify and produce an appropriate vaccine for each antigen, and the unpredictable nature of the vaccine ultimately produced, is highly relevant to whether there is support in the specifications for the claimed combination of such antigens with the M. hyo platform (and PCV-2 and/or PRRS).

572     Where there is a combination of antigens, there is the prospect of interference between those antigens leading to a poor immune response in respect of the “overpowered” antigen. Antigen interference (also known as efficacy interference or vaccine interference) can occur in a number of ways when antigenic compositions are combined. A dominant antigen could distract the immune system from raising a response to another antigen of interest in the multivalent vaccine.

89    The experts agreed that it was not possible to say definitively ahead of time whether there would be interference between previously uncombined antigens and that it would be necessary to test the combination of antigens to determine whether there was interference (J[574]). The experts agreed that there are some antigens that cannot be stably combined at all (J[575]).

90    In light of the matters set out at [563]-[580] of the Reasons, I found at [581] that the process of developing a vaccine for a single virus in combination with the M. hyo platform, even when an antigen had been identified and developed, would involve a substantial research project with empirical work involving trial and error. This would be even more so for a combination of the M. hyo platform, PCV-2 and one of the 5 Pathogens.

91    I consider that the invention claimed in claim 8 involves an inventive step.

5.1.5    Claims 9, 10 and 11 – composition of claims 1 to 8 with an adjuvant or pharmaceutically acceptable carrier

92    I repeat my comments made in respect of claims 4, 5 and 6 of the 535 Application. These claims encompass inventions which do not involve an inventive step.

93    The Zoetis concession set out at [34] also applies to claim 11 of the 537 Application.

5.1.6    Claim 12 – composition of claims 1 to 11 wherein the composition elicits a protective immune response against both M. hyo and PCV-2 when administered as a single dose administration.

94    There were several combination vaccines for protection against M. hyo and PCV-2 available at the priority date. As I explained at [312] of the Reasons:

One such product was Ingelvac’s FLEXCombo (from Boehringer Ingelheim). Ingelvac FLEXCombo consisted of two components: an M. hyo component (Ingelvac MycoFLEX) consisting of an inactivated M. hyo bacterin; and a PCV-2 component (Ingelvac CircoFLEX) consisting of inactivated baculovirus-expressed PCV-2 ORF2. This product required only one dose, but was not provided in a single “ready-to-use” pre-mixed vial. Instead, it was supplied in two separate bottles and required mixing of the two components from the separate bottles immediately before injection.

95    I consider if the person skilled in the art were making an M. hyo/PCV-2 combination vaccine, it would be obvious to make a single dose vaccine against M. hyo and PCV-2 as there was an existing M. hyo/PCV-2 single dose combination vaccine already commercially available as at the priority date. As such, the invention claimed in claim 12 is obvious.

5.1.7    Claim 13 – composition of claim 8 which elicits a protective immune response

96    For the reasons set out in relation to claim 8, I consider that the invention claimed in claim 13 involves an inventive step.

5.1.8    Claim 14 – method of immunising a pig against M. hyo and PCV-2 comprising administering the composition of claim 1

97    Claim 14 is dependent on claim 1 and is obvious for the same reasons (and those given for claims 3 and 4 of the 537 Application). The reasons given in relation to claim 9 of the 535 Application are also applicable to why claim 14 of the 537 Application is obvious.

5.1.9    Claim 15 – method of claim 14 administered intramuscularly, intradermally, transdermally or subcutaneously

98    I find that the invention claimed in claim 15 of the 537 Application is obvious for the same reasons given in relation to claim 10 of the 535 Application.

5.1.10    Claim 16 – method of claim 14 or 15 wherein the composition is administered as a single dose

99    I have already said in relation to claim 12 of the 537 Application that it is obvious to administer the composition in claim 1 as a single dose because single dose products existed at the priority date.

100    There were no single dose ready-to-use products available at the priority date, but that is not what is claimed by claim 16.

101    Accordingly, I consider that the invention claimed in claim 16 is obvious.

5.1.11    Claim 17 – method of any one of claims 14 to 16 wherein the composition is administered in conjunction with at least one additional antigen from those listed, including the 5 Pathogens, but not PRRS

102    For the reasons set out in relation to claim 8, I consider that the invention as claimed in claim 17 involves an inventive step.

5.1.12    Claims 18, 19 and 20 – method of claims 14 to 17 administered to pigs having maternally derived antibodies against M. hyo and/or PCV-2, administered to three-week-old or older piglets

103    I find that claims 18, 19 and 20 of the 537 Application are obvious for the same reasons given in relation to claims 13 to 15 of the 535 Application.

104    The invention claimed in claims 18 to 20 are dependent upon claims 14 to 16 which I consider each of which claims an invention without an inventive step. I consider that the inventions claimed in claims 18 to 20 are obvious.

5.1.13    Claims 21 and 22 – claims to kits including instructions

105    For similar reasons given in relation to claims 16 and 17 of the 535 Application, it is obvious to administer M. hyo and PCV-2 in a bottle for storage prior to administration, whether or not accompanied by an instruction manual. Claims 21 to 22 do not claim a single dose of the composition in a ready-to-use bottle and therefore whether such a product would have been obvious is immaterial.

5.1.14    Claim 24 – method for preparing an immunogenic composition of M. hyo and PCV-2

106    Claim 24 claims a method of preparing the immunogenic composition of the kind claimed in claim 1. There is nothing inventive in that method. For example, there is no reference to the reverse use of Protein A or Protein G (claimed in claim 2). As such, I consider that the invention claimed in claim 24 is obvious.

5.2    Lack of support and disclosure

107    Claim 8 suffers from a lack of support and disclosure for the same reasons given at [64]-[66] in relation to claim 3 of the 535 Application.

108    These findings in relation to claim 8 of the 537 Application also apply to claim 17 of the 537 Application which claims a method wherein the composition of claim 1 is administered with at least one additional antigen protective against the pathogens listed, including the 5 Pathogens, and not including PRRS. Claim 17 independently claims a method wherein the composition of claim 1 is administered in conjunction with at least one additional antigen, selected from a list which is the same as the list in claim 8. For the same reasons that apply to claim 8, claim 17 also lacks support and disclosure.

109    Any claim which claims an immunogenic composition consisting of the spectrum from the one additional antigen to the M. hyo platform/PCV-2 combination, plus all those antigens in the list, and all combinations thereof, will similarly lack support and disclosure. In the case of the 537 Application, to the extent that any of the subsequent dependent claims that claim a composition of claims 8 or 17, they will suffer from a lack of support and disclosure. This includes claims 9, 10, 11, 12, 13, 18, 19 and 20.

6.    540 APPLICATION

6.1    Inventive step

110    Claim 1 of the 540 Application, like claim 1 of the 535 and 537 Applications, claims an immunogenic composition comprising the supernatant of an M. hyo culture, wherein the supernatant of the M. hyo has been separated from insoluble cellular material by centrifugation, filtration or precipitation and is substantially free of both IgG and immunocomplexes, the difference being the combination of the M. hyo platform with the PCV-2 antigen and the addition of a PRRS antigen. I found claim 1 to be obvious (J[530]).

111    Like claim 2 in the 535 and 537 Applications, claim 2 claims the use of Protein A or Protein G in the reverse manner to treat a supernatant to remove antibodies and immunocomplexes, and thereby overcome the issue of both assay and immunological interference. I found that the invention as claimed in claim 2 of the 540 Application was inventive (J[531]).

6.1.1    Claim 3 – ready-to-use liquid composition of claim 1 or 2

112    Claim 3 claims a composition of claim 1 in which the M. hyo platform and the PCV-2 antigen are in the form of a ready-to-use composition.

113    At the priority date, there were commercially available M. hyo/PCV-2 combination vaccine products, including Ingelvac’s FLEXCombo (which I have described above at [94]) and Circumvent PCV-M from Intervet/Merck Animal Health.

114    Like Ingelvac FLEXCombo, Circumvent PCV-M also consisted of two components: an M. hyo component consisting of an M. hyo bacterin and a PCV-2 component consisting of baculovirus-expressed PCV-2 antigen. Circumvent PCV-M was supplied in a single bottle ready-to-use format but required two doses (J[314]).

115    At the priority date, there was also a commercially available M. hyo/PCV-2/PRRS combination vaccine: Boehringer’s 3FLEX. 3FLEX was supplied in three vials and prepared for administration by rehydrating the lyophilized PRRS virus component with the M. hyo and PCV-2 components (J[318]).

116    I considered at [527] and [528] of the Reasons that:

as at the priority date, there was a motivation for the skilled person to look for an improved M. hyo vaccine, or an alternative to a bacterin, because the existing state of the art M. hyo vaccines were bacterins, and bacterins were known to have variable efficacy.

Once arriving at an improved M. hyo vaccine, it would be obvious to use it in the existing commercial combination vaccines available at the priority date.

117    For those reasons, I consider that it would be obvious to the skilled person to combine the M. hyo platform with the PCV-2 antigen in a ready-to-use form to be used to reconstitute the PRRS lyophilisate in an M. hyo/PCV-2/PRRS combination vaccine. Accordingly, I find that the invention claimed in claim 3 is obvious.

6.1.2    Claims 4 and 5 – composition of claims 1 to 3 wherein the PRRS antigen is a genetically modified live virus; in the form of a lyophilized composition

118    I consider that the inventions claimed in claims 4 and 5 are obvious. At the priority date, there were no successful purified sub-unit vaccines against PRRS available, and vaccines against PRRS were generally made from modified live PRRS viruses, which were lyophilized for stability, and reconstituted immediately prior to administration (J[283]).

119    The majority of PRRS vaccines on the market as at the priority date were lyophilized modified live PRRS vaccines, the first being introduced on the market in approximately the mid-1990s (J[317]). I have already mentioned one such vaccine, Boehringer’s 3FLEX.

120    Zoetis accepts for the purposes of the Australian proceeding that if the Court finds claims 1 to 3 of the 540 Application to lack an inventive step, it would not dispute that the Court would also find that claim 4 of the 540 Application lacks an inventive step.

121    Claim 4 claims the composition of claim 1. As I found the invention claimed in claim 1 to lack an inventive step, Zoetis’ concession applies to claim 4. Claim 5 must also lack an inventive step on that basis. The experts all agreed that most modified live virus vaccines are lyophilized, including PRRS vaccines. It would therefore have been obvious to the person skilled in the art to use that form for a modified live PRRS antigen.

6.1.3    Claim 6 – composition of any one of claims 1 to 5 wherein the composition elicits a protective immune response in a pig against M. hyo, PCV-2 and PRRS

122    I consider it would be obvious to use the trivalent composition claimed in claim 1 to elicit a protective immune response to M. hyo, PCV-2 and PRRS in a pig. The invention claimed in claim 6 is therefore obvious.

6.1.4    Claims 7, 8 and 9 – composition of any of claims 1 to 6 with different forms of PCV-2 antigen

123    Claims 7, 8 and 9 claim a composition of claim 1. Following my conclusion that the invention claimed in claim 1 is obvious, Zoetis’ concession would apply and these claims also lack an inventive step.

6.1.5    Claims 10 and 11 - composition of claims 1 to 9 plus adjuvant

124    For the reasons given in relation to claims 4 and 5 of the 535 Application, it was obvious to add an adjuvant to the composition of claim 1 and therefore claims 10 and 11 of the 540 Application lack an inventive step.

6.1.6    Claim 12 – composition of claims 1 to 11 wherein the composition further comprises a pharmaceutical carrier

125    Claim 12 claims a composition of claim 1 wherein the composition further comprises a pharmaceutical carrier. I found the invention claimed in claim 1 did not involve an inventive step.

126    By reason of Zoetis’ concession, it does not dispute that the Court would find that claim 12 also lacks an inventive step.

6.1.7    Claim 13 – composition of claims 1 to 12, wherein the composition elicits an immune response against M. hyo, PCV-2 and PRRS when administered as a single dose administration

127    I consider that the invention claimed in claim 13 of the 540 Application lacks an inventive step, including for the reasons given at [43]-[45] above in relation to claim 8 of the 535 Application.

128    Further, as I stated at [527] of the Reasons:

Professor McVey gave evidence that if he was going down the route of developing an M. hyo supernatant vaccine in combination with a PCV-2 antigen and a PRRS antigen, he would have an expectation that dealing with a PRRS virus antigen in the same way as the 3FLEX product might well produce a useful result. Professor Chase and Dr Nordgren agreed. Professor Browning agreed that it was a reasonable approach if the M. hyo supernatant route was being pursued.

129    I consider that once arriving at an improved M. hyo vaccine, it would be obvious to the person skilled in the art to use it in the existing commercial combination vaccines available at the priority date (J[528]). Accordingly, I consider that the person skilled in the art would be directly led to try the composition of claim 1 in the combination used in the 3FLEX vaccine, with an expectation that it may well produce an improved combination vaccine. Such a combination would be provided in the same manner as the 3FLEX vaccine: three bottles administered as a single dose.

6.1.8    Claims 14 and 15 – method of immunising a pig against M. hyo, PCV-2 and PRRS using the composition of claim 1, including intramuscularly, intradermally, transdermally or subcutaneously

130    Claim 1 claims a trivalent composition and I consider that for the reasons set out in relation to claim 3, it would be obvious to the person skilled in the art to use it as a vaccine. As such, the invention claimed in claim 14 is obvious.

131    As I said in relation to claim 10 of the 535 Application, the most common method of administration of vaccine to a pig as at the priority date was intramuscularly. As such, the invention claimed in claim 15 of the 540 Application is obvious.

6.1.9    Claim 16 – method of claim 14 or 15 wherein the composition administered as a single dose

132    3FLEX, the trivalent vaccine (M. hyo/PCV-2/PRRS) commercially available at the priority date, was administered as a single dose (albeit in three separate bottles). As such, and for the same reasons given in relation to claim 13 of the 540 Application, I consider that the invention claimed in claim 16 lacks an inventive step.

6.1.10    Claim 17 - method of claims 14 to 16 administered to pigs with maternally derived antibodies against at least one of M. hyo, PCV-2 and PRRS

133    I find the invention claimed in claim 17 to be obvious for the same reasons given in relation to claim 13 of the 535 Application. Further, the ‘Indications’ on the 3FLEX package provides that the vaccine is “[i]ndicated for use in PRRS virus positive herds only”. Piglets are likely to have maternally derived antibodies against PRRS if they are born into a PRRS positive herd. Therefore, I do not consider that it is inventive to administer the trivalent composition in claim 1 to pigs with maternally derived antibodies to M. hyo, PCV-2 and PRRS.

6.1.11    Claim 18 – methods of claims 14 to 17 administered to pigs at three weeks of age or older

134    I find the invention claimed in claim 18 to be obvious for the same reasons given in relation to claim 15 of the 535 Application.

6.1.12    Claims 19 to 23 – kits for carrying out the method of claim 14 comprising one bottle (M. hyo and PCV-2) and a second bottle comprising PRRS antigen, including the first bottle in a ready-to-use liquid form, the second bottle in lyophilized form, and the addition of an instruction manual or directions

135    It was obvious to use a combination vaccine in two components at the priority date. As I have discussed above at [113]-[117], vaccines commercially available at the priority date such as Circumvent PCV-M consisted of two components and 3FLEX was supplied in three vials.

136    Further, commercially available PRRS combination vaccines at the priority date, such as 3FLEX, had PRRS antigen in the form of a lyophilized composition in a separate bottle. I found at [117] that it would be obvious to the skilled person to combine the M. hyo platform with the PCV-2 antigen in a ready-to-use form to be used to reconstitute the PRRS lyophilisate in an M. hyo/PCV-2/PRRS combination vaccine. As such, the inventions claimed in claims 19, 20 and 21 of the 540 Application are obvious.

137    An instruction manual with directions in how to combine the two bottles and administer them to a pig adds nothing to the combination of the invention. As such, claims 22 and 23 claim inventions which are also obvious.

6.1.13    Claim 24 – method for preparing an immunogenic composition

138    The method claimed in claim 24 encompasses the preparation of an immunogenic composition of the type claimed in claim 1 which, for the same reasons relating to the invention claimed in claim 1, is obvious.

6.1.14    Claim 25 – method of claim 24 wherein vi) comprises combining a ready-to-use liquid composition comprising both the PCV-2 antigen and the M. hyo supernatant with lyophilized PRRS

139    For the reasons given above at [135]-[136], it was obvious at the priority date to administer a combination vaccine in multiple components. The invention claimed in claim 25 is therefore obvious.

7.    BEST METHOD

140    I concluded at [770] of the Reasons that claim 2 of the 535 Application was the only valid claim, including because Boehringer initially made no best method challenge to the invention claimed in claim 2, and therefore I did not consider whether the specification of the 535 Application disclosed the best method of performing the invention claimed in claim 2. Boehringer’s Second Further Amended Notice of Contention revised its position and challenged claim 2 of the 535 Application on the ground of lack of best method. The parties concur that my findings at [726]-[744] of the Reasons regarding lack of best method apply to claim 2 of the 535 Application and therefore that claim is invalid. I agree.

8.    COSTS OF THE PROCEEDING

141    Boehringer has been successful in its opposition on the grounds of inventive step, support and disclosure, and best method. On one ground or another, Boehringer has been successful in invalidating all of the claims of the 535, 537 and 540 Applications.

8.1    Proposed costs orders

142    Boehringer submits that the appropriate orders as to costs are:

(a)    Zoetis pay Boehringer’s costs of the proceeding in an amount as agreed or as determined in accordance with the lump sum costs procedure in the Court’s Costs Practice Note (GPN-COSTS); and

(b)    Zoetis pay Boehringer’s costs of the opposition proceedings before the Commissioner of Patents in relation to each Application in accordance with Sch 8 to the Patents Regulations 1991 (Cth).

143    Zoetis submits that the appropriate orders as to costs are:

(a)    Each party bears its own costs up to the date that Boehringer was granted leave to amend its notice of appeal and notice of contention to introduce the “lack of best method” ground; and

(b)    Zoetis pay Boehringer’s costs on a party-party basis incurred after that date.

144    As to the costs of the opposition proceeding, Zoetis submits that the appropriate orders are that each party bears its own costs.

145    In the event that its proposed orders are adopted, Zoetis agrees to the determination of costs by agreement or in accordance with the lump sum procedure in the Court’s Costs Practice Note.

8.2    Costs submissions

146    In support of its proposed orders, Zoetis noted the following matters:

(a)    Although Boehringer has been substantially successful on the “best method” ground, that ground was raised for the first time late in the appeal proceeding (after reply evidence) by way of pleading amendments allowed on the condition that Boehringer pay Zoetis’ costs thrown away by reason of the amendment.

(b)    Boehringer abandoned a number of grounds of challenge to the Applications after the close of evidence, including its:

(i)    contention that the claims of the Applications lack an inventive step over the common general knowledge alone;

(ii)    s 7(3) lack of inventive step case based on the WO 612 Application;

(iii)    utility challenge; and

(iv)    clarity objections.

(c)    In relation to the remaining grounds of invalidity advanced by Boehringer, such as inventive step based on s 7(3) information (the Okada papers), lack of disclosure and support, and manner of manufacture, Boehringer has been only partially successful, with a number of claims in each Application found to be not invalid on those grounds.

147    Boehringer submits that it had complete success in the oppositions in that each of the claims of the three Applications were found to be invalid. The opposition was also successful on multiple grounds of invalidity. Following that success, Boehringer submits that the usual order as to costs is appropriate and that costs should follow the event, both in this proceeding and the opposition before the delegate.

148    Boehringer contends that this is not a case in which the event of success is readily contestable by reference to how separate issues have been determined by the Court. In those circumstances, it is preferable for costs to follow the outcome of the proceedings. Further, Boehringer submits that there are no special circumstances such as to warrant a departure from the general rule. Rather, there are good reasons not to encourage applications for costs on an issue-by-issue basis, involving apportionments based on degrees of difficulty of issues, time taken to argue certain issues or proportion of written and oral evidence directed to those issues.

149    Boehringer observed that although it did not pursue its inventive step case based solely on the common general knowledge, the common general knowledge was still relevant to the inventive step case based on common general knowledge plus the s 7(3) information. It further observed that the inventive step grounds on which it succeeded had been particularised from the outset and were run before the delegate.

150    Finally, Boehringer noted that Zoetis did not read all the affidavit evidence it filed. Zoetis filed an affidavit from Mr Nitzel, the inventor, which it ultimately did not read at the trial. Boehringer submits that it wasted time and resources preparing to cross-examine Mr Nitzel.

8.3    Consideration

151    Ultimately Boehringer was successful in invalidating all the claims of the three Applications, on a combination of grounds of invalidity for most claims.

152    Boehringer added best method fairly late in the process. I consider that Boehringer must pay Zoetis’ costs thrown away by reason of the amendment, as this argument was not run in the opposition before the delegate. Without the best method ground, claim 2 of each Application would have been held to be valid.

153    However, many of the claims as drafted lacked an inventive step as they claimed dependency through claim 1 which was found to be invalid for lack of inventive step. For want of a better shorthand, many of the dependent claims did not add anything to the invention claimed such that the combination was inventive compared to the invention claimed in claim 1. Aside from claim 2 of each Application (the Protein A and Protein G claims), only the inventions claimed in claims 8, 13 and 17 of the 537 Application were found to involve an inventive step.

154    Although Boehringer dropped its inventive step case based on common general knowledge alone, it retained its s 7(3) case, which adds the information from the s 7(3) documents to the common general knowledge. Thus, the evidence as to the common general knowledge was still highly relevant to the inventive step case propounded by Boehringer. As such, I reject that Boehringer should bear its own costs for inventive step.

155    I consider that Zoetis should pay Boehringer’s costs of the proceeding on a party-party basis. However, Zoetis should receive a 10% discount for all costs incurred prior to the best method amendment on 19 August 2022 to account for the abandonment of several issues.

156    As agreed by the parties, the costs are to be agreed or determined by the lump sum procedure set out in the Court’s Costs Practice Note.

157    Further, Zoetis must pay Boehringer’s costs of the opposition proceedings before the Commissioner of Patents in relation to each Application in accordance with Sch 8 to the Regulations. Although best method was not raised in that proceeding, Boehringer has ultimately had complete success in opposing the Applications. Further, Boehringer succeeded in invalidating the vast majority of claims on the grounds of inventive step based on common general knowledge in combination with the Okada papers, and also some claims on the ground of lack of disclosure, both of which were raised before the Commissioner.

9.    LEAVE TO APPEAL

158    These proceedings are an appeal pursuant to s 60(4) of the Act from a decision of a delegate of the Commissioner of Patents by the opponent, Boehringer, and a cross-appeal by the patent applicant, Zoetis. Although styled as an appeal, the present proceeding is in the original jurisdiction of this Court and involves a hearing de novo on the grounds and evidence before the Court.

159    This case involves technical subject matter and complex legal arguments. Therefore, I consider that it is appropriate to grant leave to appeal.

160    The Full Court in Pfizer Corp v Commissioner of Patents (2007) 70 IPR 559, in the context of an unsuccessful appeal from an opposition by an opponent to the grant of a patent, observed at [8] and [9] (per Emmett, Allsop and Greenwood JJ):

…

Leaving aside applications for leave on a question of pure law, in the context of essentially undisputed facts, and subject always to considerations of fairness and the interests of justice raised by a particular case, leave to appeal against a decision rejecting a pre-grant opposition will often be granted only where the applicant has demonstrated a clear prima facie case of error in the decision appealed from, such that the likely effect of that decision would be to allow an invalid patent to proceed to grant: see Genetics Institute Inc v Kirin-Amgen Inc (1999) 92 FCR 106; 163 ALR 761; 44 IPR 257; [1999] FCA 742 at [23] and Renaud Cointreau v Cordon Bleu International Ltd (2001) 193 ALR 657; 52 IPR 382; [2001] FCA 1170 at [39]–[45].

On the other hand, the court should be studious in its examination of the questions likely to arise on appeal, before refusing leave to appeal from an order of a single judge where an opponent has been successful. The court should be slow to shut out an applicant for a patent or a trade mark who has had only one judicial consideration of entitlement to a grant. Before refusing leave, the court should be satisfied that it is clear, beyond doubt, that there has been no error and that any patent or trade mark, if granted, should be revoked or expunged: see Lomas v Winton Shire Council [2002] FCAFC 413 at [16]–[19].

161    In Energy Beverages LLC v Cantarella Bros Pty Ltd (2023) 170 IPR 281, a trade mark case, the Full Court said at [13] that it would be rare to grant leave to appeal where both the Commissioner of Patent’s delegate and the primary judge reached the same conclusion on the opposition (as occurred in that case) “in the absence of a clear prima facie case of error on the part of the primary judge” (per Yates, Stewart and Rofe JJ). Otherwise, a leave to appeal application would, in substance, be “an invitation to the Full Court to embark on yet a further examination of the facts” after two failed contested hearings (at [13]). However, the Court also noted at [15] that leave to appeal should be granted where the alleged error of the primary judge “involves an issue which the Registrar’s delegate did not overtly consider or determine”.

162    In this case, Zoetis, the patent applicant, seeks leave to appeal. Unlike the situation in Energy Beverages, Zoetis seeks leave to appeal from the one judicial consideration of its entitlement to the grant of a patent on the three Applications. That is, the parties have had mixed fortunes in the two proceedings and a key issue that will likely be the subject of any appeal, best method, was not raised before the delegate.

163    Accordingly, I grant leave to appeal.

Associate:

Dated:    26 March 2024