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On November 4, 2022, the Supreme Court granted cert in Amgen Inc. v. Sanofi, a patent infringement case that involves the application of the statutory enablement requirement of Section 112 of the patent laws to what is referred to as a "genus claim" as it applies in the context of pharmaceutical applications. The two patents in dispute relate to antibody drugs that reduce low-density lipoprotein (“LDL”) cholesterol.

The Court heard oral arguments in the case on March 27. Specifically at issue is "whether enablement is governed by the statutory requirement that the specifications teach those skilled in the art to 'make and use' the claimed invention, or whether it must instead enable those skilled in the art 'to reach the full scope of claimed embodiments' without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial 'time and effort.'"

Robert Rando, an intellectual property attorney who filed an amicus brief in the case, joined us to break down the arguments.

 

Featuring:

Robert J. Rando, Partner, Greenspoon Marder LLP

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As always, the Federalist Society takes no position on particular legal or public policy issues; all expressions of opinion are those of the speaker.