On July 9, the federal circuit issued a decision in Wyeth LLC v. AstraZeneca Pharmaceuticals LP, affirming a district court's grant of judgment as a matter of law ("JMOL") invalidating Wyeth's asserted claims in U.S. Patents 10,603,314 and 10,596,162 for lack of enablement under 35 U.S.C. § 112(a). The case arose from Wyeth's infringement suit against AstraZeneca over Tagrisso(R) (osimertinib), an irreversible EGFR inhibitor used to treat gefitinib/erlotinib-resistant non-small cell lung cancer. A jury had initially found the patents not invalid and awarded Wyeth $107.5 million in damages, but the district court overturned that verdict post-trial.
The asserted claims recited a method of treating resistant lung cancer by administering a daily "unit dosage" of an irreversible EGFR inhibitor that covalently binds to specific cysteine residues. The specification defined "unit dosage" as a "physically discrete unit... containing a predetermined quantity of active material calculated to
