Federal Circuit Affirms JMOL Overturning $107.5 Million Jury Award: Patents Do Not Enable Unit Dosages For Treatment Of A Patient
08/04/2026
In Wyeth LLC v. AstraZeneca Pharmaceuticals LP, No. 2024-2325 (Fed. Cir. July 9, 2026), the Federal Circuit affirmed the District of Delaware’s grant of judgment as a matter of law that asserted patent claims directed to methods of treating gefitinib- or erlotinib-resistant non-small cell lung cancer (NSCLC) were invalid for lack of enablement under 35 U.S.C. § 112(a). The Court affirmed the district court’s determination on JMOL that the patent specifications did not enable a person of ordinary skill in the art to determine, without undue experimentation, therapeutically effective daily dosages across the full scope of the claims. At trial, a jury had found the asserted claims of the patents not invalid and infringed, and awarded $107.5 million in damages. However, enablement is a question of law based on underlying facts, and is therefore amenable to resolution on JMOL.