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

Yates J – 27 September 2023

Amgen is the applicant for a number of patent applications relating to its cholesterol lowering antibody technology.  Sanofi unsuccessfully opposed the grant of those applications before the patent office.  Sanofi appealed that dismissal to the Federal Court.  In the run up to the Federal Court hearing (set down for November and December of this year before Justice Nicholas) Sanofi attempted to shrink the body of evidence being relied on by Amgen. 

Amgen had given notice that it sought to rely on several declarations made by three experts in the patent opposition proceedings and then filed supplementary affidavits from those same witnesses.  Sanofi objected to that course and filed an interlocutory application seeking to exclude certain of that evidence on the grounds that it was “substantially duplicative” in two ways.  First, Sanofi complained that there was overlap between the expertise and evidence given by the experts, relying on the observations made in Novartis AG v Pharmacor Pty Ltd [2022] FCAFC 58 where the Full Court excluded evidence from expert witnesses with overlapping expertise – see our note on this here.  Second, Sanofi complained that, for each witness, there was substantial duplication between the declarations from the office and their respective affidavits, and this was embarrassing as it gave rise to uncertainty as to the evidence on which Amgen relied.  Justice Yates rejected Sanofi’s application in its entirety, finding that the decision in Novartis was not applicable and that its complaint about any “uncertainty” caused by the form of the relevant affidavits did not justify the relief sought.

A key feature of Yates J’s reasoning was that Amgen’s approach had been foreshadowed in the orders made at the first case management conference.  In essence, at that hearing, both parties advanced orders that permitted them to rely on declarations from the patent office proceeding and Amgen informed the Court that it intended to call evidence from all of the same witnesses it had relied on in the patent office.  Justice Nicholas made orders to the effect that the parties had leave to:

• tender the declarations filed in the opposition proceedings, subject to any objections to that evidence; and
• file and serve any affidavit made by any witness who had made a declaration referred to in (i), which included “any supplementary evidence not included in the witness’ declaration”.

In accordance with those orders, Amgen gave notice that it intended to rely on several declarations from three expert witnesses and filed further affidavits from those witnesses.  Amgen said that those affidavits were intended to: (a) supplement the evidence given by the deponents (including by clarifying certain statements); (b) respond to statements made by Sanofi’s experts; and (c) address anticipated objections to the admissibility of some statements made in those witnesses’ declarations.

Sanofi said that it could not have known at the time of the first case management hearing that Amgen intended to rely on all of the declarations together with further “summarising” affidavits.  In support of its application, Sanofi argued that Amgen had not complied with the orders and that:

• Amgen’s expert evidence was “substantially duplicative”, relying on observations made in Sanofi asserted that permitting Amgen to rely on all of the evidence would 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” and that this “raises serious questions as to the fair, efficient and effective conduct of the appeal”; and
• the expert affidavits were embarrassing because the deponents’ approach of summarising statements made in their declarations resulted in duplication or recasting of 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”.

Justice Yates was unpersuaded.  His Honour said that the problems Sanofi raised “(if they be problems)” existed at the time of the first case management hearing (and the orders made after that hearing).  Sanofi had made no complaint about the number of expert witnesses or duplication of evidence that would arise “even though those matters must have been obvious to the applicant at that time”, and the circumstances had not changed since that time “except for the applicant’s apparent change of mind”.  Justice Yates observed that 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”.  Ultimately, his Honour found that Nicholas J’s decision to grant leave in the terms he did at the first case management hearing “set the pattern for the filing of evidence in this appeal”.  

Directly in response to Sanofi’s arguments as to the “superior advantage” that Amgen would gain in the expert conclaves and concurrent evidence, his Honour made the following instructive comment: “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).”  Justice Yates went on state that the Full Court’s decision in Novartis dealt with circumstances that were not analogous and that the Full Court decision provides no useful support for the orders that Sanofi sought.  By this, his Honour appears to have made clear that Novartis does not support the argument that unbalanced hot tubs are problematic per se.   

Justice Yates also rejected Sanofi’s argument that Amgen had not complied with the orders in filing affidavits which duplicated some of the declaratory evidence from the patent office.  His Honour held that those orders specifically envisaged that a declarant could supplement what was said in their declaration and the orders did not confine the nature or extent of the supplementation.  His Honour observed that, where leave to rely on a declaration in opposition proceedings is permitted with additional supplementary affidavit evidence, it is inevitable that some summarising and duplication will be involved and that differences in language will emerge between what was said in the declaration and what is said in the affidavit.  However, his Honour considered that this was not a proper matter of complaint because it was an incident of the course the parties chose to adopt.  Moreover, his Honour pointed out that any resulting issues could be dealt with in responsive evidence and/or in the expert conclave and, that it remains open to Sanofi to object to the evidence in the ordinary course, including under the powers provided under ss 135 and 136 of the Evidence Act 1995 (Cth).

These findings lead one to question whether, had Sanofi raised the issue of witness duplication (a la Novartis) at the first case management conference, it would have had better prospects of restricting Amgen’s evidence.  This decision emphasises the importance of considering issues of perceived disadvantage resulting from the filing of potentially duplicative evidence at the time evidence orders are made.