The 2023 Pharmaceutical Patent Review

Welcome to Spruson & Ferguson’s wrap-up of the most notable developments in pharmaceutical patent law in Australia in 2023. The past year saw a number of important Federal Court decisions delivered, with the key question of ‘Commonwealth Government damages’ now on its way to the High Court.

We continue to see pharmaceutical patent cases making their way to trial, and legal issues which have seen recent attention, such as the validity of patent term extensions and the best method requirement, show no let up with a number of these cases currently before the Courts.

Amongst the highlights:

• In the keenly awaited judgment in Commonwealth of Australia v Sanofi, the Full Court of the Federal Court of Australia has upheld the trial judge’s decision that the Commonwealth is not entitled to damages arising from the grant of a 2007 interlocutory injunction preventing Apotex from launching generic clopidogrel products, on the basis of a patent which was later found invalid. The High Court has granted special leave, meaning that it will now proceed to consider an appeal. It is expected that the hearing will take place this year.
• The Federal Court of Australia has heard an appeal from a Patent Office opposition decision forming part of the global patent litigation concerning Amgen’s PCSK9 antibody patents. In contrast to outcomes in the United States and Europe, the Australian Patent Office upheld the patent applications including against claims of lack of fair basis, sufficiency and best method (Sanofi v Amgen). It remains to be seen how the Court will approach these issues.
• The Federal Court of Australia has delivered judgment in Australia’s landmark CRISPR patent dispute, finding that none of the claims in ToolGen Inc.’s patent application for platform CRISPR technologies are valid. ToolGen has subsequently applied to amend its claims and a hearing is scheduled to consider that application in May 2024 (Toolgen v Fisher).
• The Federal Court considered construction and inventive step issues in Sandoz v Bayer, providing important comments about the preparation of expert evidence in patent cases.
• We review recent developments in relation to patent term extensions. After a focus in recent years on the ‘first regulatory approval’ requirement, we expect there to be ongoing judicial consideration of the subject matter requirement that a PTE cover a ‘pharmaceutical substance per se’.
• We tackle the thorny issue of ‘best method’. Australia is one of the few major patent jurisdictions which has maintained in its patent law a discrete requirement that a patentee disclose the “best method” known to it of performing the invention. Rather than remain in the background or even fade away, best method challenges have assumed an increasingly prominent role in Australian patent disputes and can significantly affect the conduct and strategy of Federal Court litigation, in particular. Potential pharmaceutical patent litigants should be mindful of the substantive and procedural implications best method issues can have in the Australian iteration of global disputes.
• We provide an update on key pharmaceutical policy issues and an update on ongoing pharmaceutical patent litigation in the Courts.

As we continue into 2024, we hope this review provides a useful practical resource. Please do not hesitate to take the opportunity to contact our authors, all subject-matter experts in their respective fields, for advice on the issues raised by these important decisions.

The 2023 Pharmaceutical Patent Review

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