Latest Case This Week: Amgen Inc. v. Sanofi, Aventisub LLC (Fed. Cir.)

Why the Biden Administration Was Right Earlier This Week to Change Course in the Obamacare Challenge Pending Before the Court

VIKRAM DAVID AMAR

Illinois Law Dean Vikram David Amar comments on an unusual move by the U.S. Solicitor General’s office, sending a letter to the U.S. Supreme Court amending the position of the federal government in a case currently pending before the Court challenging the Affordable Care Act. Dean Amar explains why the arrival of a new administration should generally not trigger such position reversals, but he argues that the unusual circumstances—specifically the “exceptional implausibility” of the government’s prior filings—may justify the government’s action in this instance.

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Amgen Inc. v. Sanofi, Aventisub LLC

Court: US Court of Appeals for the Federal Circuit

Docket: 20-1074

Opinion Date: February 11, 2021

Judge: Alan David Lourie

Areas of Law: Drugs & Biotech, Intellectual Property, Patents

Elevated LDL cholesterol is linked to heart disease. LDL receptors remove LDL cholesterol from the bloodstream; the PCSK9 enzyme regulates LDL receptor degradation. Amgen’s 165 and 741 patents describe antibodies that purportedly bind to the PCSK9 protein and lower LDL levels by blocking PCSK9 from binding to LDL receptors. Amgen sued Sanofi, alleging infringement of multiple patents, including the 165 and 741 patents. Amgen and Sanofi stipulated to infringement of selected claims and tried issues of validity to a jury. The court granted judgment as a matter of law (JMOL) of nonobviousness and of no willful infringement. Following remand, a jury again found that Sanofi failed to prove that the asserted claims were invalid for lack of written description and enablement. The district court granted Sanofi’s Motion for JMOL for lack of enablement and denied the motion for lack of written description. The Federal Circuit affirmed. Undue experimentation would be required to practice the full scope of these claims, which encompasses millions of candidates claimed with respect to multiple specific functions. It would be necessary to first generate and then screen each candidate antibody to determine whether it meets the double-function claim limitations.