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2025 WIPO IP Judges Forum Informal Case Summary-Federal Court of Australia [2024]: Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd (No 4), [2024] FCA 678

This is an informal case summary prepared for the purposes of facilitating exchange during the 2025 WIPO IP Judges Forum.

 

Session 4: Evidence

 

Federal Court of Australia [2024]: Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd (No 4), [2024] FCA 678

 

Date of judgment: June 18, 2024

Issuing authority: Federal Court of Australia

Level of the issuing authority: First Instance

Type of procedure: Judicial (Civil)

Subject matter: Patents (Inventions)

Plaintiff: Pfizer Ireland Pharmaceuticals

Defendant: Samsung Bioepis AU Pty Ltd (No. 4)

Keywords: Patents, Discovery, Whether “fishing”, Excessive prior art permutations under the Patents Act, Relevance of inventor’s notes to inventive step, Best method under the Patents Act

 

Basic facts: This was an application for non-standard discovery by categories in patent infringement and revocation proceedings. Two categories were sought, the first seeking production of all research and development documents within a specific time frame, and the second seeking production of documents related to inutility of the patent.

 

Held: Justice Burley, Federal Court of Australia, declined to order discovery of the research and development documents in category one.  A previous decision stated that inventor’s notes and the like may be accepted as relevant on the question of inventive step, but of secondary significance only – and that this does not pass the test of “directly relevant to the issues raised by the pleadings or in the affidavits”. Where the evidence has not (yet) raised inventive step by reason of the inventor’s inventive steps but on the state of common general knowledge and prior art documents, the relevance of the inventor’s own path “is truly secondary”.

 

Other factors considered by Justice Burley were the additional work in producing documents and in producing, answering, and considering evidence based on them, which adds to the costs. Justice Burley noted that if the patentee relied on evidence from the inventors, the evaluation of whether to grant full discovery would be different.

 

On the other hand, documents were ordered to be produced which were relevant to a failure to disclose the best method. The example in the patent, by itself, was conceded not to disclose the best method, and the patentee relied on information understood by the person skilled in the art from the whole of the specification.

 

Relevant holdings in relation to evidence: The inventor’s notebooks were not ordered in the absence of evidence from the inventor.

                                                                                      

Relevant legislation: Federal Court of Australia Act 1976 (Cth) s 37M; Patents Act 1990 (Cth) ss 7(2), 7(3), 40(1)(a), 40(2); Federal Court Rules 2011 (Cth) rr 20.14, 20.15 and Schedule 1