Wyeth LLC v. AstraZeneca Pharmaceuticals LP, Appeal No. 2024-2325 (Fed. Cir. July 9, 2026)

In our Case of the Week, the Federal Circuit affirmed a district court ruling reversing a $107.5 million jury verdict against AstraZeneca in a case involving methods of treating drug-resistant lung cancer using “irreversible EGFR inhibitors.”  Wyeth’s patents required administering “daily to the patient” a “unit dosage” of a covered inhibitor, with the specification disclosing only three exemplary compounds supported solely by in vitro data, and no working examples of a dosage actually administered to patients.

Patentee Wyeth sued AstraZeneca in September 2021 based on AstraZeneca’s sale of its drug Tagrisso, and a jury ultimately awarded Wyeth $107.5 million.  AstraZeneca moved for JMOL, arguing the claims were invalid for lack of enablement because identifying a workable unit dosage was highly unpredictable and the disclosed ranges were too broad to guide a skilled artisan.  The district court granted JMOL, explaining that Wyeth’s specifications disclosed no working dosage examples, and that some disclosed doses would be toxic or even lethal based upon testimony from Wyeth’s own experts and the inventors.  The court held the claims invalid under 35 U.S.C. § 112(a) as offering only “a starting point” requiring undue experimentation.

On appeal, the Federal Circuit affirmed JMOL of invalidity for lack of enablement as to both patents.  The Federal Circuit explained that although the claims do not impose FDA-type safety standards, Wyeth’s argument ignored the requirement that the “unit dosage”—which was construed be “calculated to produce [a] desired therapeutic effect”—be “administer[ed] daily” to a human “patient.”  Giving that language, the claims required daily administration of a dosage producing a therapeutic effect in an actual patient, not merely in vitro EGFR inhibition.  The district court’s post-verdict discussion of toxicity was a permissible “elaboration” of that construction, not an improper new one.

Accordingly, the reviewing panel affirmed the lower court’s subsequent enablement determination.  Because “the more one claims, the more one must enable,” the specification needed to teach a skilled artisan how to determine a daily unit dosage across the full scope of claimed compounds without undue experimentation.  Instead, Wyeth left dosage determination entirely to the skilled artisan’s knowledge.  Wyeth disclosed no working examples translating in vitro data into human dosing, and in vitro data alone cannot support an in vivo limitation.  Critically, applying the disclosed ranges to two of the three named compounds produced doses that were toxic and exceeded the maximum tolerated dose in humans, as conceded by Wyeth’s own experts and the inventors.  This evidence of inoperative embodiments, combined with the specification’s own acknowledgment that dosing “depend[s] on the judgment of the practitioner and [is] peculiar to each individual,” showed the dosing task was complex and unguided, warranting greater disclosure than was provided.

The court further rejected Wyeth’s argument that the district court imposed an extraneous “non-lethality” requirement, explaining that toxicity evidence was relevant not as a claim limitation but because it showed the specification gave “little guidance as to which disclosed dosages, if any, are suitable for daily administration to a patient.”  Without teaching how to distinguish operative from inoperative embodiments, the specification left that task to trial-and-error experimentation, which is precisely what the enablement doctrine forbids.  Unlike ordinary dose-range claims that leave safety and efficacy to FDA review, these claims were limited to dosage forms administered to actual patients yet disclosed no operative dosage for any claimed compound, requiring undue experimentation to practice.

The opinion can be found here.

By Jason Evans

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Intellectual Pixels Ltd. v. Sony Interactive Entm’t LLC, Appeal No. 2024-2174 (Fed. Cir. July 10, 2026)

On appeal from an inter partes review finding all challenged claims of U.S. Patent No. 10,681,109 unpatentable, the Federal Circuit affirmed, rejecting an argument that the Patent Trial and Appeal Board violated the Court’s mandate from a prior appeal.  The ’109 patent claimed priority to 2001 and was directed to using a remote server to handle image processing for a local client device, wherein the remote server “generat[ed] at least one updated image” in response to input from the client device, then “compress[ed] the [] updated image” before transmitting it to the client.  The prior art at issue on appeal, a patent to Wiltshire, disclosed a system whereby a video game “such as Doom, Pong, Packman [sic], [or] Myst” was run on a remote server but played through a local terminal.

In its initial decision, the Board had found Wiltshire did not teach the “generating” limitation (most video games at the time used various pre-existing images), and did not reach the “compressing” limitation but noted Wiltshire is “completely silent as to the content or origin of [a] ‘compressed video MPEG stream’” referred to therein.  In the first appeal, the Federal Circuit reversed the “generating” finding because Wiltshire expressly referred to running Doom, and the parties agreed that the changing player perspectives in that early first-person game required “generating [an] updated image.”  On remand, the Board found that Wiltshire with other prior art also taught the “compressing” limitation, since Wilshire disclosed a “compressed video MPEG stream” transmitted to the client device.  In the instant appeal, the patentee argued this contradicted the Board’s “completely silent as to the content or origin” finding, and—because that finding was before the Court and not set aside in the prior appeal—violated the Court’s prior mandate.  The Federal Circuit rejected this argument, explaining that issues “undecided on the merits by the trial court because they were moot, and thus on appeal unripe” are generally open on remand.  Here, “[s]ince the Board’s decision as to obviousness was based on the generating limitation, any findings of fact as to the compressing limitation were not subject to appeal, were not decided by us, and were not part of our mandate.  It is well established that Article III courts review judgments, not opinions,” and “[i]ssues that do not form the basis of the judgment are outside the scope of an appeal.”  Accordingly, the Court found the Board’s decision to be consistent with its prior mandate, and also affirmed the Board’s obviousness decision as supported by substantial evidence.

The opinion can be found here.

By Jason Wrubleski

This article summarizes aspects of the law and does not constitute legal advice. For legal advice with regard to your situation, you should contact an attorney.