We review the requirements to use experiments in Federal Court patent proceedings having regard to the recent decision in Sanofi v Amgen.
The Federal Court of Australia recognises that it is not uncommon for parties engaged in multi-jurisdictional patent litigation to seek to rely upon experiments conducted for the purpose of corresponding overseas proceedings. In Sanofi v Amgen Inc  FCA 264 (Sanofi v Amgen), the Court has provided guidance on some of the factors taken into consideration by the Court when exercising its discretion to grant leave to rely upon such experiments.
Pharmaceutical and biopharmaceutical patent litigation is often a multi-jurisdictional affair. Rather than replicate experiments for each proceeding, a party may seek to rely upon one set of experiments (and even the experimenter’s affidavit or declaration) in multiple jurisdictions. In proceedings in the Federal Court of Australia, however, leave of the Court is required for a party to rely on evidence of experiments already conducted, including for overseas litigation.
Legislation and practice
A party may not tender experimental proof as evidence in the Federal Court of Australia without leave of the Court, unless it has applied for orders for the experiment to be conducted, including in the presence of the opposing party’s representatives: rule 34.50(2)(b) of the Federal Court Rules 2011 (Cth) (FCR). The purpose of the rule is to ensure that an opposing party has an adequate opportunity to challenge the validity of an experiment, and avoid wasteful duplication by the opposing party of an experiment that can be seen to be valid.
While the FCR does not refer to experiments or experimental evidence conducted in other jurisdictions, the Federal Court’s Intellectual Property Practice Note (IP-1) directs that a party seeking to rely on experiments already conducted in corresponding proceedings in other jurisdictions should inform the court of the fact to avoid unnecessary duplication.
The onus is on the party seeking leave to show that the experiments are relevant to an issue in the proceeding (s 55 of the Evidence Act 1995 (Cth)).
The Court’s power to grant leave is unfettered. Relevant factors the Court will consider include:
- whether the persons who conducted the experiment are available for cross-examination;
- the extent to which the party conducting the experiment has prevented the other party from viewing the experiment;
- whether repetition will involve undue expense and inconvenience;
- the time at which the application for leave is made; and
- any prejudice to the other party.
The Sanofi v Amgen decision Sanofi v Amgen is an appeal to the Federal Court from a decision of a delegate of the Commissioner of Patents which rejected Sanofi’s opposition and directed that Amgen’s five patent applications in respect of antigen binding proteins to proprotein convertase subtilisin kexin type 9 (PCSK9) proceed to grant.
In its appeal, Sanofi sought leave to rely on experiments conducted earlier, on behalf of Sanofi for the purpose of proceedings in other jurisdictions, by:
- Professor Anton van der Merwe in respect of competition binding assays between an Eli Lily antibody and Amgen’s reference antibody, which are relied on by Sanofi in ongoing proceedings in Israel; and
- Dr Andrew Frenzel in respect of:
- competition binding assays between various antibodies and two of Amgen’s reference antibodies (Competition Assay); and
- experiments conducted on antibodies which were obtained by screening of an antibody-phage library (Phage Library Assay),
which are relied on by Sanofi in ongoing European Patent Office proceedings.
In granting Sanofi leave to rely on Professor van der Merwe’s experiments, Nicholas J considered the experiments to be directly relevant to Sanofi’s case based on lack of clarity and lack of definition. His Honour did not, however, allow Sanofi to rely on Professor van der Merwe’s experiments as evidence that the Eli Lilly antibody was within any of the relevant claims.
In regard to Dr Frenzel’s experiments, Nicholas J granted leave to Sanofi to rely on the Competition Assay experiments subject to Sanofi providing to Amgen copies of the raw data from the experiments, any experimental protocol prepared by Dr Frenzel and used by him for the purpose of conducting the experiments, and all documents constituting or recording any instructions provided to Dr Frenzel in relation to the experiments. His Honour considered the Competition Assay experiments would be relevant at least to the ground of lack of clarity.
His Honour was not, however, persuaded that the Phage Library Assay experiments could be of any assistance in the determination of the grounds of invalidity asserted by Sanofi. Moreover, having considered the parties’ evidence in the European Patent Office proceedings, his Honour noted there was a significant debate between the parties’ respective experts as to what conclusions may be drawn from the Phage Library Assay experiments. In particular, Amgen’s expert was critical of both the experimental protocol and data analysis by Dr Frenzel, and did not consider the antibody libraries used by Dr Frenzel to have been publicly available before the priority date.
His Honour considered that if Sanofi were granted leave to rely on the Phage Library Assay experiments it would likely give rise to a substantial and undue waste of time and costs that is better avoided by requiring the relevant experiments to be carried out in accordance with an agreed or court-ordered protocol.
Sanofi v Amgen is a reminder of the Federal Court’s attitude towards experimental evidence from corresponding proceedings in other jurisdictions. Although time and money may be saved by seeking leave to rely on experiments already conducted for overseas proceedings, a party should ensure that the experimental evidence is relevant to the grounds in dispute and should be prepared to provide to the other party raw data of the experiments, experimental protocols and documents pertaining to instructions provided to the expert conducting the experiments.
If there is a prospect of a serious debate about the experimental protocol, the steps taken in the earlier experiment and/or the validity of conclusions drawn from it, the Court will likely require a new experiment to be conducted under the requirements of the Federal Court Rules.
Read more from the Prescription - May 2023