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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:
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In the keenly awaited judgment in
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Federal Court of Australia has heard an appeal from a Patent Office opposition decision forming part of the global patent litigation concerningAmgen 's PCSK9 antibody patents. In contrast to outcomes inthe United States andEurope , the Australian Patent Office upheld the patent applications including against claims of lack of fair basis, sufficiency and best method (Sanofi vAmgen ). It remains to be seen how the Court will approach these issues. - The
Federal Court of Australia has delivered judgment inAustralia's landmark CRISPR patent dispute, finding that none of the claims inToolGen 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 inMay 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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The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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