Sanofi v Amgen Inc

Case [2023] FCA 264

FEDERAL COURT OF AUSTRALIA

Sanofi v Amgen Inc. [2023] FCA 264

File number: NSD 876 of 2022
Judgment of: NICHOLAS J
Date of judgment: 24 March 2023
Catchwords:

PATENTS – whether order for discovery of documents should be made in appeal pursuant to s 60(4) of the Patents Act 1990 (Cth) – whether appellant should be granted leave to rely on experimental proof pursuant to r 34.50(2)(b) of the Federal Court Rules 2011 (Cth) in said appeal

Held: discovery refused – leave under r 34.50(2)(b) granted on terms for some experiments and refused for others

Legislation:

Evidence Act 1995 (Cth) s 55

Federal Court of Australia Act 1976 (Cth) ss 37M-37P

Federal Court Rules 2011 (Cth) rr 20.11, 20.14, 20.15, 34.50

Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) s 60(4)

Patents Act 1990 (Cth) ss 60, 160

Cases cited:

AstraZeneca AB v Apotex Pty Ltd (2014) 226 FCR 324

Bristol Myers Squibb Co v F H Faulding & Co Ltd (2000) 97 FCR 527

D’Arcy v Myriad Genetics Inc (2015) 258 CLR 334

F Hoffman-La Roche v Chiron Corporation (2000) 47 IPR 516

Genetics Institute Inc v Kirin-Amgen Inc (1999) 92 FCR 106

Kimberly Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1

Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2014) 217 CLR 274

Rinehart v Rinehart(No 2) [2015] FCA 339

Division: General Division
Registry: New South Wales
National Practice Area: Intellectual Property
Sub-area: Patents and associated Statutes
Number of paragraphs: 66
Date of hearing: 17 March 2023
Counsel for the Appellant: Mr D Shavin KC
Solicitor for the Appellant: Jones Day
Counsel for the Respondent: Mr C Dimitriadis SC with Mr T Cordiner KC
Solicitor for the Respondent: Wrays Lawyers Pty Ltd

ORDERS

NSD 876 of 2022
BETWEEN:

SANOFI

Appellant
AND:

AMGEN INC.

Respondent

ORDER MADE BY:

NICHOLAS J

DATE OF ORDER:

24 MARCH 2023

THE COURT ORDERS THAT:

1.The appellant be granted leave pursuant to r 34.50(2)(b) of the Federal Court Rules 2011 (Cth) to rely on the experiments referred to in para 9(1) of Mr Muratore’s affidavit dated 1 March 2023 conducted by Professor van der Merwe, as reported in his declaration, on the condition that:

(a)the appellant provide to the respondent copies of all documents constituting or recording any instructions provided to Professor van der Merwe in relation to the experiments; and

(b)any evidence in chief to be given by Professor van der Merwe in relation to his experiments be by affidavit in admissible form and which complies with any relevant Rule of Court or Practice Note concerning the giving of expert evidence.

2.The appellant be granted leave pursuant to r 34.50(2)(b) of the Federal Court Rules 2011 (Cth) to rely on the experiments referred to in para 14 of Mr Muratore’s affidavit dated 1 March 2023 conducted by Dr Frenzel, as reported in his declaration dated 6 July 2019, on the condition that:

(a)the appellant provide to the respondent copies of the raw…

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Details
AGLC
Sanofi v Amgen Inc [2023] FCA 264
Case
[2023] FCA 264
Decision Date

CaseChat Overview and Summary

Sanofi sought leave to rely on experimental proof from Professor Anton van der Merwe and Dr Andrew Frenzel in its appeal to the Federal Court of Australia. The dispute revolves around the relevance and admissibility of experimental evidence conducted by these experts in proceedings outside of Australia, which was not properly disclosed as required by the Federal Court Rules 2011 (Cth). The primary legal issues were whether the court should grant an order for the discovery of documents in the appeal, and if the appellant should be allowed to rely on experimental proof without adhering to the procedural requirements of Rule 34.50 of the Federal Court Rules 2011 (Cth).

The court found that the relevance of the experiments to the issues in the appeal needed to be clearly demonstrated by Sanofi. It held that experimental evidence could lead to protracted debates and complications, and thus, it was incumbent on Sanofi to show the relevance of the experiments. The court granted leave for Sanofi to rely on the experiments under Rule 34.50(2)(b) of the Federal Court Rules 2011 (Cth) on certain conditions, including the provision of specific documents and protocols to the respondent and adherence to expert evidence rules. The court refused the discovery order, as the experiments were not relevant to the appeal, and the necessary procedural steps had not been followed.

The court ordered that Sanofi be granted leave to rely on the experiments conducted by Professor van der Merwe and Dr Frenzel, subject to conditions such as the provision of relevant documents and compliance with expert evidence rules. The interlocutory application was otherwise dismissed, and the proceedings were scheduled for hearing. The respondent was required to file and serve any reply evidence by a specified date. The orders were made to ensure the proceedings were conducted efficiently and that the evidence presented was relevant and admissible.

Orders

Orders of the court

1. The appellant be granted leave pursuant to r 34.50(2)(b) of the Federal Court Rules 2011 (Cth) to rely on the experiments referred to in para 9(1) of Mr Muratore’s affidavit dated 1 March 2023 conducted by Professor van der Merwe, as reported in his declaration, on the condition that:

(a) the appellant provide to the respondent copies of all documents constituting or recording any instructions provided to Professor van der Merwe in relation to the experiments; and

(b) any evidence in chief to be given by Professor van der Merwe in relation to his experiments be by affidavit in admissible form and which complies with any relevant Rule of Court or Practice Note concerning the giving of expert evidence.

2. The appellant be granted leave pursuant to r 34.50(2)(b) of the Federal Court Rules 2011 (Cth) to rely on the experiments referred to in para 14 of Mr Muratore’s affidavit dated 1 March 2023 conducted by Dr Frenzel, as reported in his declaration dated 6 July 2019, on the condition that:

(a) the appellant provide to the respondent copies of the raw data from the experiments;

(b) the appellant provide to the respondent copies of any experimental protocol prepared by Dr Frenzel and used by him for the purpose of conducting the experiments;

(c) the appellant provide to the respondent copies of all documents constituting or recording any instructions provided to Dr Frenzel in relation to the experiments; and

(d) any evidence in chief to be given by Dr Frenzel in relation to his experiments be by affidavit in admissible form and which complies with any relevant Rule of Court or Practice Note concerning the giving of expert evidence.

3. The interlocutory application be otherwise dismissed.

4. The proceeding be listed for hearing:

(a) for the taking of evidence commencing at 10.15am on 6 November 2023 for 10 days; and

(b) for submissions commencing at 10.15am on 11 December 2023 for 3 days.

5. The respondent file and serve any evidence in reply by 4.00pm, 29 September 2023.

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

Background

Background to the litigation

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Evidence

Evidence Before The Court

Rule 34.50 of the FCR provides:34.50 Experimental proof as evidence(1)If a party (the proponent) proposes to tender, as evidence in a proceeding, experimental proof of a fact, the proponent must apply for orders in relation to the experimental proof, including orders about any of the following:(a)the service on other parties of particulars of the experiment and of each fact that the proponent asserts is, will or may be proved by the experiment;(b)any persons who must be permitted to attend the conduct of the experiment;(c)the time when, and the place where, the experiment must be conducted;(d)the means by which the conduct and results of the experiment must be recorded;(e)the time by which any other party (the opponent) must notify the proponent of any grounds on which the opponent will contend that the experiment does not prove a fact that the proponent asserts is, will or may be proved by the experiment.(2)Evidence of the conduct and results of the experiment is admissible in the proceeding, only:(a)if the proponent has complied with subrule (1) and any orders given under that subrule; or(b) with the leave of the Court.(3)If an order mentioned in paragraph (1)(e) has been made, and the opponent has not complied with the order in relation to a ground, the opponent may rely on the ground only with the leave of the Court.Professor Anton van der Merwe’s experiments Sanofi seeks leave under r 34.50(2)(b) of the FCR to rely on experiments conducted by Professor Anton van der Merwe which are relied on by Sanofi in proceedings in Israel and experiments conducted by Dr Andrew Frenzel which are relied on by Sanofi in EPO proceedings. It is common ground that r 34.50(1) of the FCR was not complied with. The relevant experiments were conducted by experts retained by Sanofi or Regeneron for the purpose of proceedings in other jurisdictions and prior to the commencement of this proceeding. Experimental evidence can give rise to expensive and time consuming debates between expert witnesses and has the potential to create a “trial within a trial” as to the appropriateness of the methodology used, the conditions of the material and the facility used to conduct the experiment, the accuracy of any observations or measurements made, and the interpretation of the results. It is incumbent on Sanofi to show that the experiments in respect of which it seeks leave are relevant to an issue in the proceeding in the sense that they could rationally affect (directly or indirectly) the assessment of the probability of the existence of a fact in issue in the proceeding: see s 55 of the Evidence Act 1995 (Cth). It would not be consistent with the overarching purpose to grant Sanofi leave to rely on experiments in the circumstances unless Sanofi can establish the relevance of those experiments to those matters which it says they will be relied on to prove. Sanofi seeks leave to rely on Professor van der Merwe’s experiments and declaration as proof that Eli Lilly’s antibody LY 3015014 produced by Absolute Antibody and another antibody known as REGN2625 produced by Regeneron (together, “the test antibodies”) were tested for their ability to compete with Amgen’s reference antibody 21B12 and that the order in which the antibodies were added to the assay can impact the outcome of the competition assay. Further, Sanofi also seek to rely on Professor van der Merwe’s experiments as proof that competition observed was due to steric hindrance rather than the test antibodies binding to the same residues on PCSK9 to which the reference antibody 21B12 binds.

Decision

Reasons for decision

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Ratio Decidendi

Legal Principle Established

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