Friday, April 19 2024   \  Published by Spruson & Ferguson.

The 2023 Pharmaceutical Patent Review

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. Read more

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