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Supreme Court affirms Federal Circuit Court decision in Amgen v Sanofi patent enablement case

May 18, 2023

The US Supreme Court handed down its decision in Amgen v Sanofi, relating to the enablement requirement.  Amgen filed the Supreme Court petition in response to a Federal Court decision which invalidated genus claims in two Amgen patents relating to Repatha® (evolocumab) which it asserted against Sanofi/Regeneron regarding Praluent® (alirocumab).  A unanimous Supreme Court affirmed the Federal Circuit’s ruling that the Amgen patent claims were not enabled.

On 3 November 2022, the Supreme Court granted Amgen’s petition for certiorari in relation to ‘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—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort’”.

The patents in suit relate to engineered antibodies that reduce levels of low-density lipoprotein (LDL) cholesterol.  In 2011, both Amgen and Sanofi obtained patents covering the antibody used in their respective drugs.  The dispute concerned two additional patents Amgen obtained in 2014 claiming  “the entire genus” of antibodies that “bind to specific amino acid residues on PCSK9” and “block PCSK9 from binding to [LDL receptors].”

The Supreme Court emphasised that to satisfy the enablement requirement, it may be sufficient to provide “an example if the specification also discloses ‘some general quality . . . running through’ the class that gives it ‘a peculiar fitness for the particular purpose’”.

The Court held that Amgen’s patents only describe 26 antibodies but claim “a vast number of additional antibodies,” and opined that Amgen “offers persons skilled in the art little more than advice to engage in “trial and error” to make every embodiment within a broad claim.