Blog Big Molecule Watch June 08, 2021

Sanofi Files Opposition to Amgen’s Petition for Federal Circuit to Reconsider Decision Invalidating Praluent Patents

As we previously reported, in April 2021, Amgen petitioned for the full Federal Circuit to reconsider the decision of a three-judge panel that two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165 patent”) and 8,859,741 (the “’741 patent”), covering its cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab), were invalid for failing to comply with the enablement requirement.  In its petition, Amgen argued that the Federal Circuit panel improperly established a new standard for enablement of “genus claims with functional limitations” and that the Federal Circuit’s treatment of enablement as a legal issue, rather than an issue of fact, is inconsistent with Supreme Court precedent.

On May 28, 2021, Sanofi filed its opposition to Amgen’s petition.  Sanofi argues that the panel decision “panel did not actually articulate any new test” for enablement, but rather “simply applied [the Federal Circuit’s] recent decisions addressing functional genus claims” to conclude that “Amgen’s functional claims… require ‘undue experimentation’… and are thus not enabled.”  Sanofi also argued that Amgen’s contention that “the panel’s decision will wreak havoc on innovation” is a “exaggerated argument” that the Federal Circuit had previously “heard and rejected.”  Sanofi further argued that the panel decision is consistent with Supreme Court decisions that treat “enablement, as an invalidity defense…[as] a question of law with underlying factual determinations.”

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