Opinions — Thursday, July 9, 2026

The Federal Circuit affirmed the district court's grant of judgment as a matter of law that asserted claims 1, 3, and 9 of U.S. Patent 10,603,314 and claim 1 of U.S. Patent 10,596,162—owned by Wyeth and directed to methods of treating gefitinib/erlotinib-resistant non-small cell lung cancer using irreversible EGFR inhibitors—are invalid for lack of enablement under 35 U.S.C. § 112(a). Following a jury verdict finding the claims not invalid and awarding Wyeth $107.5 million for AstraZeneca's induced infringement through its drug Tagrisso, the district court granted AstraZeneca's renewed JMOL motion, concluding that no reasonable jury could have found the claims enabled. The Federal Circuit held that the claims require daily administration to a patient of a "unit dosage" containing "a predetermined quantity of active material calculated to produce the desired therapeutic effect," and that the specification failed to enable a skilled artisan to practice this method without undue experimentation. The court rejected Wyeth's argument that the district court improperly imported FDA-style clinical safety requirements, holding instead that the claim language itself—particularly "administering daily to the patient"—inherently contemplates a repeatable dosing regimen in humans, not merely any concentration that kills cancer cells in vitro. The specification disclosed no working examples of unit dosages administered to patients, and unrebutted trial evidence showed that disclosed dosage ranges would be toxic or exceed maximum tolerated doses.

The decision clarifies that method-of-treatment claims requiring daily administration to patients must be enabled for actual human use at therapeutically effective and tolerable doses, not merely enabled for achieving a biological effect in cell culture. This distinction operates independently of FDA approval standards but still requires the specification to provide sufficient guidance for determining dosages that can be repeatedly administered to patients without causing toxicity that would prevent the claimed daily regimen. The court emphasized that elaborating on claim construction post-verdict to clarify what was inherent in the original construction is permissible under Cordis Corp. v. Boston Scientific Corp. The decision signals particular scrutiny of pharmaceutical method claims that recite patient administration where the specification provides only broad dosage ranges and in vitro data without bridging to in vivo tolerability, especially where patent applicants' own post-filing publications acknowledge that effective concentrations in vitro exceed what can be safely administered to humans.

The Federal Circuit affirmed the PTAB's decision in an ex parte reexamination finding claim 1 of Magnolia Medical Technologies' U.S. Patent 10,039,483 anticipated by the Brannon prior art reference. The '483 patent covers a blood sequestration device designed to reduce microbial contamination by separating an initial volume of blood from the sample used for testing. Magnolia challenged the Board's finding that Brannon disclosed both the "fluid reservoir" limitation (requiring a reservoir configured to receive an initial volume of blood) and the "bypass" limitation (requiring subsequent blood to bypass the reservoir and sequestered initial volume).

The court's application of anticipation doctrine turned on claim construction and the proper application of antecedent basis principles. Magnolia argued that the "initial volume of blood" must be present at the moment of venipuncture and that Brannon's fluid chamber—which must be air-free to avoid embolism risks—could not meet this requirement. The court rejected this temporal limitation as unsupported by the claim language, finding nothing requiring the limitation be satisfied at venipuncture specifically. On the bypass limitation, the court applied the antecedent basis rule to hold that because the claim required only "an initial volume" (not "the entire initial volume") to be sequestered, Brannon's disclosure that some initial blood reaches the test sample did not defeat anticipation.