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Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation | Venable LLP

Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation | Venable LLP
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CAFC Tightens Enablement Standard for Functional Claiming of Antibodies | Proskauer - Minding Your Business

In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35 U.S.C. § 112. This decision establishes that it is more difficult to satisfy the enablement requirement for antibody claims that use functional language to describe the antibody. (The court granted Amgen’s motion to extend the deadline for filing a petition for panel rehearing and/or rehearing en banc until April 14, 2021. See id., Order (March 8, 2021).) Antibody drugs represent a significant and expanding segment of pharmaceutical products, and pharmaceutical companies have waged high-stakes legal battles over antibody patents in an effort to retain control in the field of their therapeutic innovation.

Functional Claiming of Antibodies Enablement Standard Tightened

Monday, March 15, 2021 In the recent case of  Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35 U.S.C. § 112. This decision establishes that it is more difficult to satisfy the enablement requirement for antibody claims that use functional language to describe the antibody. (The court granted Amgen’s motion to extend the deadline for filing a petition for panel rehearing and/or rehearing en banc until April 14, 2021.  See id., Order (March 8, 2021).) Antibody drugs represent a significant and expanding segment of pharmaceutical products, and pharmaceutical companies have waged high-stakes legal battles over antibody patents in an effort to retain control in the field of their therapeutic innovation.

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