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ARTICLE · 04 MAY 2025

Australia | Sanofi V Amgen Dispute Update

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Key lessons for other antibody patents approaching the end of their term.

AustraliaIntellectual Property
Michael Christie
Michael Christie
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Federal Court dismisses Sanofi's appeal and orders that Amgen's Repatha patent applications proceed to grant, offering key lessons for other antibody patents approaching the end of their term.

The global patent litigation concerning Amgen's PCSK9 antibody patents has highlighted the divergent approach taken by major jurisdictions in assessing the validity of functionally defined antibody claims. In the US, Amgen's patent claims were ruled invalid by the Federal Circuit for lack of enablement.1 In corresponding European opposition proceedings, the claims of Amgen's patent were found to be enabled, but were subsequently invalidated by the Board of Appeal for lacking an inventive step.2

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