Key Takeaway: Federal Circuit invalidates patent claims directed to a method for treating non-small cell lung cancer through administration of “a unit dosage” of an irreversible epidermal growth factor receptor inhibitor because the patent specification fails to enable treatment via the unit dosage.
In Wyeth LLC v. AstraZeneca Pharmaceuticals LP., Case No. 24-2325 (Fed. Cir. Jul. 9, 2026), the Federal Circuit affirmed the district court’s decision to grant judgment as a matter of law (“JMOL”), holding that the claims reciting a method for treating non-small cell lung cancer (“NSCLC”) are invalid for lack of enablement.
The asserted patent claims recite a method for treating gefitinib and/or erlotinib resistant NSCLC in a patient. The method comprises administering to the patient a pharmaceutical composition comprised of a daily “unit dosage” of an irreversible epidermal growth factor receptor (“EGFR”) inhibitor that covalently binds to specific amino acids at a specific location of EGFR. The irreversible EGFR inhibitor can be any compound which binds to cysteine 773 of EGFR, while the “unit dosage” is “physically discrete units suitable as unitary dosages 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.” According to the specification, calculating the unit dosage depends on numerous factors, including 1) the patient to be treated, 2) the capacity of the patient’s system to utilize the active ingredient, 3) the degree of therapeutic effect desired, 4) the compound employed, 5) the mode of administration, and 6) the severity of the condition being treated. The patent specification further states that while a skilled artisan would be aware of the effective dose, generally, the effective dose will be between 0.5 to about 1000 mg/kg of body weight, and the total daily dosage is projected to be from about 1 to 1000 mg, preferably from about 2 to 500 mg.
At trial, a jury concluded that the asserted claims were not invalid and that the defendant induced infringement. Post-trial, the defendant renewed its motion for JMOL, arguing that the patents claim but do not enable treatment via a unit dosage. Although the specification identified ranges for the unit dosage, defendant contended that the ranges were too broad and provided insufficient guidance for an artisan to determine a dose. The district court agreed with defendant and granted JMOL, invalidating the patents for lack of enablement and concluding that no reasonable jury could have found that the patents enabled a skilled artisan to administer the claimed “unit dosage” without undue experimentation because 1) the specification did not disclose working examples of unit dosages administered to a patient and 2) defendant presented evidence that some disclosed dosage levels would be toxic, including doses required to achieve a therapeutic effect in patients. The district court also noted that the patent lacked guidance for reliably screening compounds to determine their therapeutic dose ranges. The plaintiff appealed, alleging the district court erred in two distinct ways: 1) the court’s claim construction of “unit dosage” improperly imputed clinical safety and efficacy requirements into the claims, and 2) the court’s grant of JMOL of lack of enablement fails on the evidence.
On appeal, the Federal Circuit affirmed the district court’s decision granting JMOL and invalidating the patent. Regarding Plaintiff’s claim construction argument, the Federal Circuit stated that because the claims require administration of the unit dose to a patient, the unit dosage must be tailored for practical administration to a human patient, and not merely capable of producing an anti-cancer effect in vitro.
Regarding enablement, the Federal Circuit stated that to enable the claims “the specification must provide guidance to allow a skilled artisan to determine a daily unit dosage calculated to provide a therapeutic effect in a patient across the full scope of claimed compounds without undue experimentation.” The specification at issue did not provide the necessary guidance. Instead, the patent specification failed to provide any working examples of a unit dosage calculated to achieve therapeutic effect and suitable for administration in humans. The specification identified three compounds as preferred embodiments, determined by in vitro experimentation, but did not explain how to extrapolate in vivo dosing from these in vitro experiments. And, although the specification provided dosage ranges, the Federal Circuit determined these ranges were general, and that the specification provided no guidance over how to select a compound or how to calculate the unit dosage. Further, both parties’ experts agreed that the ranges disclosed in the patent far exceeded the amount that could be administered to a patient for at least one of the preferred embodiments. Lastly, the specification itself highlighted the numerous factors that affect determination of a unit dosage.
The Federal Circuit’s decision to uphold JMOL highlights the importance of ensuring that method claims for the treatment of a patient are properly enabled. To avoid enablement issues in methods of treatment patents, the patent specification should disclose treatment ranges that are suitable for use in a patient (i.e., effective and non-toxic), and should not merely disclose the ranges used during in vitro experiments. Alternatively, the specification should disclose how to determine a non-toxic and effective dose, rather than assuming a skilled artisan would know how to make the appropriate determination without undue experimentation. Lastly, although claiming a sizable dosage range may seem preferable to ensure a more expansive patent scope, hopeful patentees should be cautious about claiming ranges that substantially exceed a suitable therapeutic amount in methods of treatment claims.
Editor: Brenden S. Gingrich, Ph.D.
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