-
Federal Circuit Affirms JMOL Overturning $107.5 Million Jury Award: Patents Do Not Enable Unit Dosages For Treatment Of A Patient
08/04/2026In 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.
The asserted patent claims were directed to methods of treating certain drug-resistant cancers by administering an irreversible epidermal growth factor receptor (EGFR) inhibitor in a daily “unit dosage.” The district court construed “unit dosage,” based on the specification’s definition, as “physically discrete units suitable as unitary dosage for the subject, each unit containing a predetermined quantity of active material calculated to produce the desired therapeutic effect in association with the required diluents; i.e., carrier, or vehicle.” The patent specification identified three compounds as preferred embodiments and reported in vitro results involving those compounds. The specification also disclosed broad, “general” and “projected” dosage ranges, but did not provide working examples of a unit dosage calculated to produce a therapeutic effect and suitable for daily administration to a human patient.
On JMOL, the district court rejected plaintiff’s argument that the claims merely required “a method for killing cancer cells,” but instead required that “the ‘unit dosage’ ‘produce[s] the desired therapeutic effect’ in a patient.” In finding the asserted claims invalid for lack of enablement, the district court concluded that the patent specifications only provided a starting point for future research to determine a dose with therapeutic effect, noting that the broad dosing ranges in the patent included toxic levels and provided no method for determining the therapeutic dosing ranges.
On appeal, plaintiff argued that the district court had allegedly imported clinical safety and efficacy requirements into the claims and had impermissibly modified the construction of “unit dosage” after the verdict. The Federal Circuit rejected those arguments. The Federal Circuit agreed that the claims did not require compliance with Food and Drug Administration standards or proof of any specified level of clinical safety or efficacy. It nevertheless agreed with the district court that the requirements to administer a “unit dosage” daily to a human “patient” had operative meaning and that the district court’s construction was correct.
Turning to enablement, the Federal Circuit focused on whether the specifications taught a skilled artisan how to translate the disclosed compounds’ in vitro activity into therapeutically effective daily dosing for human patients. The specifications identified that the appropriate dose would depend on numerous variables regarding the patient, the compound, and the treatment. They also provided general dosage ranges, without explanation of how they were derived. The ranges were viewed as a starting point for further research rather than sufficient guidance to determine effective doses across the full scope of the asserted claims.
The Federal Circuit also noted that, at trial, unrebutted evidence concerning the disclosed dosage ranges indicated that applying those ranges to at least two of the three identified compounds would produce doses exceeding the maximum tolerated dose in humans. That evidence supported the conclusion that that the specifications did not teach how to identify an operative daily unit dosage without undue experimentation.
In the opinion’s conclusion, the Federal Circuit recognized that patents may claim methods of treatment with ranges of doses, without clinical data, and without the testing that would be required by the FDA to establish safety. But, in this case, the Federal Circuit noted: “The problem with these patents is that, perhaps because of close prior art, their claims are limited to dosage forms to be administered to patients, yet they disclosed only a broad range of doses some of which were shown to be toxic, and they disclosed no actual dosages for any compound within the scope of the claims, thereby leaving it to a practitioner of the claims to perform undue experimentation.”
IP Litigation