WYETH LLC v. ASTRAZENECA PHARMACEUTICALS LP

WYETH LLC v. ASTRAZENECA PHARMACEUTICALS LP The Federal Circuit affirmed JMOL of invalidity for lack of enablement under § 112(a). The claims required daily administration of a therapeutically effective unit dosage to a patient, and the specifications did not teach how to determine such dosages across the claimed class without undue experimentation. For method-of-treatment dosing claims, broad projected dosage ranges and in vitro data may not enable patient dosing where the patent leaves compound-specific therapeutic dosing to skilled-artisan experimentation. Affirmed the district court's grant of JMOL of invalidity. The court rejected Wyeth's argument that the district court had imported FDA-style clinical safety or efficacy requirements; the construction instead gave effect to the claim requirement of daily administration of a defined “unit dosage” to a patient. The asserted patents defined “unit dosage” as a predetermined quantity calculated to produce the desired therapeutic effect, but disclosed no working patient-dosing examples. The specifications identified three example irreversible EGFR inhibitors and broad “general” or “projected” dose ranges, but did not explain how to translate in vitro activity into a daily therapeutic dose in humans. Trial evidence showed that disclosed ranges for at least two example compounds exceeded maximum tolerated human doses, reinforcing that the patents did not guide skilled artisans in distinguishing operative from inoperative dosing embodiments. Because the invalidity JMOL was affirmed, the Federal Circuit did not reach Wyeth's separate issue concerning pre-issuance damages and provisional rights under § 154(d). § 112(a) claim construction infringement damages precedential § 112(a) claim construction damages precedential § 112(a) claim construction