Federal Court of Australia

Sanofi v Amgen Inc. (No 2) [2023] FCA 1156

ORDERS

THE COURT ORDERS THAT:

1.    The interlocutory application dated 1 September 2023 be dismissed.

2.    The applicant pay the respondent’s costs of and incidental to the interlocutory application.

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

REASONS FOR JUDGMENT

YATES J:

Introduction

1    By an interlocutory application dated 1 September 2023, the applicant, Sanofi, who is the appellant in the principal proceeding, seeks orders pursuant to r 5.04 of the Federal Court Rules 2011 (Cth) (the Rules) limiting the evidence which the respondent, Amgen Inc., can adduce at the hearing of this proceeding.

2    The proceeding is an appeal from a decision of a delegate of the Commissioner of Patents (the delegate) in opposition proceedings. The respondent is the applicant named in Patent Application Nos. 2013203677, 2013203685, 2013203689, 2013203748, and 2013203751 (the patent applications).

3    The appeal is a hearing de novo in which the applicant bears the onus of making out its grounds of opposition. The applicant has raised a significant number of grounds of opposition, including an additional ground (lack of inventive step) that was not raised in the opposition before the delegate. The amended notice of appeal is complex and lengthy (79 pages).

4    The hearing of the proceeding is listed to commence on 6 November 2023.

Background

5    The claims of the patent applications are directed to, amongst other subject matter, isolated monoclonal anti-PCSK9 antibodies that have particular features. The claims in three of the patent applications are directed to isolated monoclonal antibodies that bind to one or more specific residues, or an epitope comprising one or more specific residues, on the PCSK9 protein and block the protein’s interaction with the LDL receptor. Other claims in the patent applications are directed to isolated anti-PCSK9 monoclonal antibodies that compete with a specific reference antibody, and block PCSK9’s interaction with the LDL receptor.

6    The patent applications disclose: (a) a number of specialised techniques for the production of monoclonal antibodies and various assays relating to their function and characteristics (which fall within the field of those with expertise in antibodies); and (b) techniques for the characterisation of protein:protein interactions, such as x-ray crystallography (which fall within the field of those with expertise in structural biology/crystallography). The patent applications discuss multiple methods by which the antibodies of the invention can be generated, including phage display and hybridoma technology.

7    Before the delegate, the applicant raised a number of grounds of opposition and relied on a number of declarations made by Professor Stephen Mahler (an expert in antibodies) and Professor Michael Parker (an expert in structural biology and crystallography) in chief and in reply.

8    The respondent relied on declarations made by Professor Angel Lopez (an expert in antibodies with particular expertise in hybridoma technology for the production of antibodies) and Professor Gregory Petsko (an expert in structural biology and crystallography). The respondent also relied on a declaration made by Professor Peter Hudson. Professor Hudson has experience in structural biology and crystallography as well as in antibodies (with particular expertise in phage display technology for the production of antibodies). Professor Hudson was the respondent’s only expert who addressed particular evidence given by Professor Parker.

9    In addition, the respondent relied on declarations made by Professor Hudson and Professor Lopez that were filed under reg 5.23 of the Patents Regulations 1991 (Cth). In response, the applicant also relied on declarations made by Professor Parker.

10    The notice of appeal was filed on 17 October 2022. The proceeding came before the docket judge, Nicholas J, for a case management hearing on 24 November 2022. At the case management hearing, the question of whether the parties intended to rely on the declarations that were before the delegate was addressed. At that time, both parties advanced draft orders that permitted them to rely on those declarations. The respondent also informed the Court that it intended to call evidence from the same witnesses—Professor Lopez, Professor Petsko, and Professor Hudson.

11    Rule 34.31 of the Rules provides:

34.31    Evidence

(1)     Material before the Commissioner for the purpose of the decision appealed from is, with the leave of the Court, admissible in evidence on the hearing of the appeal.

(2)     In an appeal from a decision under the Patents Act, a party may apply at a directions hearing for an order under section 160(a) of that Act in relation to the giving of further evidence.

12    Section 160 of the Patents Act 1990 (Cth) provides:

160    Powers of Federal Court

On hearing an appeal against a decision or direction of the Commissioner, the Federal Court may do any one or more of the following:

(a)     admit further evidence orally, or on affidavit or otherwise;

(b)     permit the examination and cross-examination of witnesses, including witnesses who gave evidence before the Commissioner;

(c)     order an issue of fact to be tried as it directs;

(d)     affirm, reverse or vary the Commissioner’s decision or direction;

(e)     give any judgment, or make any order, that, in all the circumstances, it thinks fit;

(f)     order a party to pay costs to another party.

13    On 30 November 2022, Nicholas J made orders which included the following orders:

Evidence

1.    Each party has leave to tender any declaration filed by that party in the opposition proceedings subject to all proper objections and the deponent being available to give oral evidence if so ordered.

2.    The appellant is to file and serve by 28 April 2023 a written notice specifying which declarations, or parts of declarations, it will tender at the hearing.

3.    The respondent is to file and serve by 28 July 2023 a written notice specifying which declarations, or parts of declarations, it will tender at the hearing.

4.    Any additional written evidence on which either party seeks to rely at the hearing be given by affidavit filed and served in accordance with these orders.

5.    Each party is granted leave to file and serve any affidavit made by any witness who has made a declaration referred to in order 1 which includes any supplementary evidence not included in the witness’ declaration upon which the party will seek to rely at the hearing.

6.    Any affidavit on which the appellant will seek to rely pursuant to order 5 must be filed and served by 28 April 2023.

7.    Any affidavit on which the respondent will seek to rely pursuant to order 5 must be filed and served by 28 July 2023.

8.    If the appellant seeks to rely at the hearing on any written evidence in chief from any witness who did not make a declaration referred to in order 1 then it must file and serve an affidavit made by that witness by 28 April 2023.

9.    If the respondent seeks leave to rely at the hearing on any written evidence in answer from any witness who did not make a declaration referred to in order 1 then it must file and serve an affidavit made by that witness by 28 July 2023.

10.    For the avoidance of doubt, orders 2–9 (inclusive) are not orders under s 160(a) of the Patents Act 1990 (Cth). What orders should be made pursuant to s 160(a) will be the subject of consideration at a later date.

14    On 1 May 2023, the applicant filed affidavits by Professor Mahler and Professor Parker. The applicant also gave notice of the declarations and parts of declarations of Professor Mahler and Professor Parker which it intended to tender at the hearing of the appeal. The applicant said that it would tender: (a) all the declarations made by Professor Mahler and Professor Parker that had been filed as the applicant’s evidence in support; (b) certain paragraphs of the declarations of Professor Mahler and Professor Parker that had been filed as the applicant’s evidence in reply; and (c) certain paragraphs of the declarations made by Professor Parker that had been filed under reg 5.23.

15    On 4 August 2023, the respondent gave notice that it intended to rely on the declarations made by Professor Petsko, Professor Lopez, and Professor Hudson that it had filed as the respondent’s evidence in answer to the applicant’s evidence in support.

16    The respondent has also filed two affidavits made by Professor Petsko, one affidavit made by Professor Hudson, and one affidavit made by Professor Lopez. The respondent says that these affidavits are intended to: (a) supplement the evidence given by the deponents in their declarations (including by clarifying certain statements made in the declarations); (b) respond to statements made by Professor Parker and Professor Mahler in their affidavits filed on 1 May 2023; and (c) address anticipated objections to admissibility of some statements made in the declarations on which the respondent proposes to rely.

17    On 14 August 2023, the applicant raised a number of concerns about the respondent’s intended evidence in the appeal. In a letter to the respondent’s solicitors, the applicant’s solicitors said:

[O]ur client considers that the Affidavit evidence upon which your client ought be permitted to rely on in the present proceeding should be confined to that of experts whose evidence does not duplicate that of your client’s other experts.

18    The applicant also contended that the respondent’s intended evidence was, as a whole, embarrassing.

19    In response, the respondent’s solicitors advanced a proposal that it would not read: (a) certain parts of Professor Lopez’s declaration made on 21 September 2017; (b) all of Professor Lopez’s declaration made on 4 May 2018; and (c) paragraph 216 of Professor Lopez’s affidavit made on 3 August 2023. As I understand it, this body evidence is directed to Professor Lopez’s comments on the quality of the crystallography experiments in the patent applications.

20    This proposal has not found favour with the applicant.

The orders sought

21    The interlocutory application seeks the following orders:

1     An order pursuant to r 5.04 of the Federal Court Rules that the Respondent is not permitted to adduce at trial:

(a)     any evidence of Professor John Hudson (Hudson) and Professor Angel Lopez (Lopez) filed in this proceeding or the patent office proceeding that is duplicative or substantially duplicative of any evidence of Professor Gregory Petsko (Petsko); and

(b)     any evidence of Hudson filed in this proceeding or the patent office proceeding that is duplicative or substantially duplicative of any evidence of Lopez.

2     An order pursuant to r 5.04 of the Federal Court Rules that the Respondent is not permitted to adduce at trial any evidence given by a deponent in a declaration in the patent office proceeding except where a specific paragraph or paragraphs or a segment or section of that evidence is expressly referred to by the deponent in an affidavit filed in this proceeding.

3    An order that within 3 days of the date of this order, the Respondent is required to file and serve on the Appellant a schedule indicating those paragraphs of all affidavits and declarations that it will contend it is entitled to rely on at the trial, given the terms of paragraphs 1 and 2 of this order.

4    The Respondent pay the Appellant’s costs of this application.

The applicant’s submissions

22    The applicant contends that the affidavits of Professor Petsko, Professor Lopez, and Professor Hudson are “wholly unsatisfactory” because they are “substantially duplicative” and because the affidavits are both embarrassing and fail to comply with the orders made on 30 November 2022.

23    As to the first matter, the applicant submits that substantially duplicative evidence should not be permitted. It calls in aid various observations made in Novartis AG v Pharmacor Pty Ltd [2022] FCAFC 58; 290 FCR 345 (Novartis).

24    The applicant contends that there is no substantial difference in the evidence given by Professor Hudson compared to the evidence given by Professor Lopez and Professor Petsko respectively. Although Professor Hudson has particular expertise in phage display technology, the applicant contends that this expertise is “largely irrelevant” and that Professor Hudson’s evidence on this topic is “minimal”. The applicant goes even further to contend that, in “some respects”, the evidence of Professor Hudson and Professor Lopez is substantially duplicative of the evidence of Professor Petsko.

25    One of the applicant’s concerns is that permitting the respondent to rely on all this evidence will have the effect of affording the respondent a superior advantage in terms of the number of witnesses who will participate in expert conclaves and in concurrent evidence sessions. The applicant submits that this raises serious questions as to the fair, efficient, and effective conduct of the appeal.

26    The applicant also contends that the “volume” of the duplicative evidence is such that “serious questions” are raised as to the “viability of the currently allotted 8 hearing days for oral evidence”.

27    The applicant contends that it did not, and could not, know that the respondent intended to deploy all the declarations on which it had relied at the hearing before the delegate together with further “summarising” affidavits from the declarants.

28    This leads to the applicant’s second complaint which is that, in their respective affidavits, Professor Petsko, Professor Lopez, and Professor Hudson adopt the technique of “summarising” statements made in their declarations. The applicant contends that, by preparing affidavits in this form, the respondent has disregarded the orders made on 30 November 2022 and created “real uncertainty” as to the evidence on which it relies. According to the applicant, there is a “disconformity” between the declarations and the affidavits because: (a) some declarations are not referred to in some affidavits; (b) some affidavits do not address some matters addressed in the declarations; and (c) some affidavits do not respond to the applicant’s evidence where the declarations do respond to that evidence. The applicant contends that, by summarising aspects of the declarations, the deponents have “duplicated” or “recast” their evidence leaving it uncertain as to whether the summary, or the part of the declaration said to have been summarised, stands as the deponent’s evidence. The applicant submits that this is embarrassing because it does not know which part of the respondent’s evidence it is required to respond to.

Consideration

29    I am not persuaded that the applicant raises any matter that would warrant the granting of the relief sought in the interlocutory application.

30    Leaving to one side the applicant’s complaint about “summarising”, the problems it now raises (if they be problems) existed at the time of the first case management hearing in November 2022. At that hearing, the question of the parties’ desire to rely on the declarations deployed in the opposition hearing before the Commissioner’s delegate was specifically addressed. The applicant made no complaint about the number of expert witnesses that would be involved, or the duplication of evidence that would arise, if leave were to be granted to the parties to rely on those declarations, even though those matters must have been obvious to the applicant at that time, especially bearing in mind that the parties had already participated in a complex and lengthy hearing before the delegate. Nicholas J was obviously mindful of the extent of the evidence before the delegate but was nevertheless persuaded by the parties that it would be appropriate to grant them leave to rely on that evidence. This step has set the pattern for the filing of evidence in this appeal.

31    Circumstances have not changed since that time except for the applicant’s apparent change of mind as to the appropriateness of the respondent having the benefit of the leave that was granted. A change of mind, however, is not a sufficient reason to revisit the grant of leave that was made, no matter how inconvenient the applicant might find its present position to be.

32    I am far from persuaded that, in the present case, the applicant will suffer any actual or potential prejudice by the course that has been adopted to date. Whilst economy in the number of experts is always desirable, a particular course has been taken in the present case of permitting each party to rely on all the evidence given on its behalf in the opposition before the delegate if that party so chooses, subject to proper objections as to admissibility and the availability of the declarants for cross-examination. The parties having now made their elections, I perceive no problem in the appropriate experts participating in the appropriate conclaves and discussing their views on the matters on which they have been asked to opine with a view to preparing a joint report identifying and explaining (to the extent necessary) their areas of agreement and disagreement.

33    Similarly, I perceive no problem in the appropriate experts giving concurrent evidence. It is simplistic—indeed, wrong—to think (as some of the applicant’s submissions suggested) that questions of fact based on expert evidence are determined on a “majority” view (which is what the applicant appears to fear). That said, the conduct of the hearing, and how oral evidence will be dealt with efficiently and fairly, are matters for further case management, and remain under Nicholas J’s control.

34    As to these matters, the Full Court’s decision in Novartis deals with circumstances that are not analogous to the circumstances of the present case. The decision provides no useful support for the orders that the applicant seeks.

35    Further, I am not persuaded that the time allocated for oral evidence at the hearing of the appeal will not be sufficient. Once again, this is a matter that remains under Nicholas J’s control. Obviously, the current estimate of the time for oral evidence was arrived at on the basis that the expert evidence will include the five witnesses in the opposition below whose declarations are to be relied upon.

36    I am unpersuaded by the applicant’s contention that it did not, and could not, know that the respondent intended to deploy all the declarations on which the respondent relied at the hearing before the Commissioner’s delegate as well as supplementary affidavits. The orders made on 30 November 2022 permitted the respondent to adopt the course it has adopted. I have not been taken to any evidence that persuades me that the applicant was justified in thinking that the respondent would not do what the orders made on 30 November 2022 plainly permitted it to do.

37    I do not accept that the respondent has not complied with Order 5 made on 30 November 2022. The order specifically envisages that a declarant can supplement what he said in a declaration that was deployed in the hearing before the delegate. However, the order does not confine the nature or extent of the supplementation. Further, Order 5 does not preclude any party from putting into admissible form a statement previously made in a declaration that, arguably, is not in admissible form.

38    As to the complaint about uncertainty caused by the form of the affidavits made by Professor Lopez, Professor Petsko, and Professor Hudson, I am not persuaded that the applicant faces the difficulties to which it has referred in a way that would justify granting the relief it now seeks.

39    In cases where leave to rely on a declaration in opposition proceedings is permitted in an appeal, with additional evidence from the declarant by way of affidavit, scope always exists for differences in language to emerge between what was said in the declaration and what is said in the affidavit. That, however, cannot be a matter of complaint. Here, it appears to be no more than an incident of the course that the parties have chosen to adopt in preparing their evidence. Further, some “summarising” will inevitably be involved, as will some duplication.

40    The applicant has amply demonstrated that, in the present case, it can identify the existence of possible differences between what a witness has said in a declaration and what the same witness has said in an affidavit. The applicant is well able to raise with its own expert witnesses whether there is, in substance, a “disconformity” and, if so, whether that matter is worthy of being addressed by responding evidence. “Disconformities” are also capable of being addressed by the experts themselves in conclave.

41    Even where a difference is not simply a matter of expression but a matter of departure from what has previously been said, Order 5 permits that course to be adopted. It is now up to the applicant to make its own decisions as to how it deals with such matters.

42    While I accept that the affidavits given by the respondent’s witnesses involve “summarising”, I accept the respondent’s submission that this might be justified (I say no more) as providing context in which additional evidence is to be advanced or as providing the necessary introduction for revised evidence that seeks to overcome previous deficiencies that might found an objection on admissibility grounds. There may well be other reasons why “summarising” might be permitted. If, however, the applicant considers that particular “summarising” gives rise, itself, to an objection on admissibility grounds, then the applicant can make its objection at the appropriate time. It is also open to a trial judge to utilise the powers under ss 135 and 136 of the Evidence Act 1995 (Cth) in an appropriate case. The point of present importance is that “summarising” of the kind identified by the applicant is not a failure to comply with the procedural orders that have been made.

Conclusion and disposition

43    The applicant has not made out any ground that justifies the granting of the relief it seeks. The interlocutory application should be dismissed with costs.

Associate:

Dated:    27 September 2023