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US Supreme Court decision in Amgen v Sanofi case


Photo by Fine Photographics on Unsplash

On 18 May 2023, the US Supreme Court handed down a landmark decision in the famous dispute between Amgen and Sanofi, highlighting the crucial issue of sufficiency of description.

As a reminder, in 2011, both pharmaceutical companies obtained patents covering antibodies employed in their respective PCSK9-inhibiting drugs, and Amgen then sued Sanofi for patent infringement.

In response, Sanofi filed a counterclaim to invalidate the patents cited against it arguing that the antibodies claimed were insufficiently disclosed.

In this dispute, a question was then submitted to the Supreme Court to determine whether the description of Amgen's patents claiming an entire antibody genus contained enough technical information to enable a person skilled in the art to make and use the invention for the entire genus covered by the claims, and thus fulfilled 35 U.S.C. 112 requirements. In this case, the description included 26 specific examples vs. millions of antibodies claimed.

The judges unanimously decided that these patents should not have been granted on the grounds that their descriptions were not sufficiently detailed to enable a person skilled in the art to make and use all the antibodies of the genus. The judges took the opportunity to reiterate that the description of a patent must enable a person skilled in the art to make and use the broadly claimed invention and that the quantity of experimentation needed to be performed by one skilled in the art must be "reasonable". In other words, the judges recalled that the criterion of sufficiency of description is proportional to the scope of protection of the invention defined by the claims. The broader the scope of protection, the more the invention shall be described in the description in order to meet the criterion of sufficiency of description.

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