Amgen v Sanofi: Big Pharma awaits SCOTUS decision

15-12-2022

Timothy Sendek

Amgen v Sanofi: Big Pharma awaits SCOTUS decision

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As patent attorneys look ahead to 2023's key rulings, Timothy Sendek of Akerman offers insights on the pending enablement case at the Supreme Court.

The Supreme Court recently granted a petition for a writ of certiorari in a case concerning an issue of significant importance in the pharmaceutical and chemical technology industry. 

The November 4, 2022 grant in the case of Amgen v Sanofi addresses the following question:

Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—ie, to cumulatively identify and make all or nearly all embodiments of the invention without substantial “time and effort”.


Amgen, Sanofi, Akerman, big pharma, SCOTUS, genus claims, certiorari, chemical technology, drugs, patents, antibodies, Federal Circuit

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