Amgen Inc. v. Sanofi

Amgen owns two patents that describe cholesterol-lowering drugs that share a common written description. In 2014, Amgen filed suit against Sanofi alleging infringement of multiple patents, including the two at issue in this case. Among the jury’s conclusions in that case was that the patents were not invalid for lack of written description and enablement. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that a “skilled artisan” can reasonably conclude that the inventor had possession of the claimed invention. To satisfy the enablement requirement, a patent specification must contain sufficient information that a “skilled artisan” would be enabled to make and use the claimed invention. The U.S. Court for the Federal Circuit reversed and remanded, finding the jury instructions regarding enablement were erroneous. On remand, the court ruled in favor of Sanofi on the issue of lack of enablement and for Amgen on the issue of lack of written description. Amgen appealed, and the Federal Circuit affirmed the district court’s determination that the asserted claims were invalid for lack of enablement.