In Wyeth v. Astrazeneca Pharmaceuticals LP, [2024-2325] (July 9, 2026), the Federal Circuit affirmed judgment as a matter of law of invalidity of the asserted claims of U.S. Patent Nos. 10,603,314 and 10,596,162 on methods of using irreversible inhibitors to treat “gefitinib and/or erlotinib resistant” non-small cell lung cancer.
After a five-day trial, a jury concluded that the asserted claims were not invalid and that AstraZeneca induced infringement of the asserted claims, awarding Wyeth $107,500,000 in damages. AstraZeneca renewed its motion for JMOL post-verdict and argued, in part, that no reasonable jury could have found the asserted patents not invalid. AstraZeneca argued that “the patents claim but do not enable treatment via a ‘unit dosage—i.e., a predetermined quantity of active material calculated to produce the desired therapeutic effect,’” and that the disclosed dosage ranges of 1 to 1,000 mg and 2 to 500 mg were too broad and provided insufficient guidance for a skilled artisan to determine a suitable dosage.
The district court emphasized that (1) the specification disclosed no working examples of unit dosages administered to patients, and (2) AstraZeneca presented unrebutted evidence that some disclosed dosage levels would be toxic, including doses required to achieve a therapeutic effect in patients. It also explained that the experimentation necessary to achieve a suitable unit dosage would not be routine because the asserted patents lacked guidance on how a skilled artisan could reliably screen compounds to determine their therapeutic dosage ranges.
On appeal, Wyeth contended that the district court improperly changed its construction of the term “unit dosage” post-verdict by adding additional clinical safety and efficacy requirements, and by using the flawed construction in granting JMOL. It argues that be-cause the claims do not include clinical-trial endpoints, a grant of JMOL based on the importation of unclaimed safety standards, or any consideration of “a safe unit dosage,” cannot be supported.
The Federal Circuit noted that while Wyeth is correct that the claims do not require FDA-type clinical safety or efficacy standards, but said Wyeth fails to appreciate and give meaning to other relevant claim terms—namely, that the claimed “unit dosage” must be “administer[ed] daily” to a human “patient.” The claims therefore plainly require the daily administration of a unit dosage to a patient to achieve a therapeutic effect in treating g/e-resistant NSCLC. The Federal Circuit said the specification reinforces the plain reading of the claims, explaining that calculating a therapeutically effective dosage “depends on the subject to be treated, capacity of the subject’s system to utilize the active ingredient, and degree of therapeutic effect desired.” The specification further recognizes that the “[p]recise amounts of active ingredient . . . depend on the judgment of the practitioner and are peculiar to each individual.”
The Federal Circuit said that district court’s “elaboration” on its construction of “unit dosage” post-verdict was permissible to “clarif[y] what was inherent in the construction.” Cordis Corp. v. Bos. Sci. Corp., 658 F.3d 1347, 1356 (Fed. Cir. 2011). The Federal Circuit t
We therefore find no error in the district court’s claim construction nor its elaboration of that construction on JMOL.
Turning to enablement, the specification must enable the full scope of the invention as defined by its claims. While some experimentation is permissible, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. while some experimentation is permissible, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In the context of the asserted claims, the specification must provide some basis for translating information about the disclosed compounds in vitro activity into the claimed daily dosing regimen “in a patient,” rather than leaving that determination entirely to a skilled artisan’s knowledge and experimentation.
Here, the specification leaves the determination of the claimed “unit dosage” entirely to the knowledge of the skilled artisan. (“The skilled artisan is aware of the effective dose for each patient.”). The Federal Circuit said that while the knowledge of one of ordinary skill may play an important role in enablement, it may not provide the only means to enable these specific claim limitations — that is what a specification of a patent must provide.
The Federal Circuit concluded that where, as here, the specification omits critical guidance needed to practice the claimed invention, requiring skilled artisans to fill those gaps through their own experimentation, undue experimentation is required.
The Federal Circuit concluded that 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.
