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Implications of 'Amgen v. Sanofi' On the State of Enablement Law
On Feb. 11, 2021, the Federal Circuit affirmed the district court's judgment as a matter of law (JMOL) that Amgen's asserted claims to genera of antibodies were invalid for lack of enablement. Amgen Inc. v. Sanofi, No. 2020-1074, 2021 WL 501114 (Fed. Cir. Feb. 11, 2021). The panel consisting of Chief Judge Prost and Judges Lourie and Hughes unanimously affirmed the District of Delaware's holding that undue experimentation would be required to practice the full scope of the claims-at-issue. Id.
Although this decision was highly fact-dependent, turning on the scope of particular antibody claims and the level of detail in the attendant specifications, its implications potentially stretch beyond the biotech space to the state of enablement law more generally. In particular and as further explained below, the decision appears to take steps to harmonize the prior cases that appropriately were guided by the Wands factors with the cases discussing the "full scope" of enablement that have engendered some confusion in the law.
Background of the Decision
Amgen Inc., Amgen Manufacturing, Ltd., and Amgen USA, Inc. (collectively, Amgen) appealed from a decision of Judge Andrews of the District Court for the District of Delaware granting JMOL of lack of enablement of claims 19 and 29 of U.S. Patent 8,829,165 (the '165 patent) and claim 7 of U.S. Patent 8,859,741 (the '741 patent). Amgen Inc. v. Sanofi, 2021 WL 501114, at 3. The '165 patent and the '741 patent claim antibodies that bind to one or more of fifteen amino acid residues of the proprotein convertase subtilisin/kexin type 9 (PCSK9) protein and block PCSK9 from binding to low-density lipoprotein (LDL) receptors. Id. This, in turn, allows LDL receptors to continue regulating the amount of circulating LDL cholesterol linked to heart disease. The court found that the claimed antibodies were defined by their function: binding to specific amino acid residues on the PCSK9 protein and blocking the PCSK9/LDL receptor interaction. Id. The specification was said to disclose amino acid sequences for 26 antibodies that fall within the claims, including the antibody evolocumab, marketed by Amgen as Repatha®. Id.
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