Boehringer Ingelheim Animal Health USA Inc v Zoetis Services LLC - [2024] FCA 291 - FCA 2024 case summary — Zoe

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Boehringer Ingelheim Animal Health USA Inc v Zoetis Services LLC

[2024] FCA 291

Federal Court of Australia|2024-03-26|Before: Mr P, Rofe J

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Source facts

Court

Federal Court of Australia

Decision date

2024-03-26

Before

Mr P, Rofe J

Source

Original judgment source is linked above.

Judgment (58 paragraphs)

[1]

The appeal be allowed.
The cross-appeal be dismissed.
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.
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.
The 535 Application, the 537 Application and the 540 Application be refused.
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.
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).
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).
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.

[2]

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.

[3]

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.

[26]

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.

[56]

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.

[57]

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.

[58]

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. I certify that the preceding one hundred and sixty-three (163) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Rofe.

Boehringer Ingelheim Animal Health USA Inc v Zoetis Services LLC

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