Our Patent Case Summaries provide a weekly summary of the precedential patent-related opinions issued by the Court of Appeals for the Federal Circuit and the opinions designated precedential or informative by the Patent Trial and Appeal Board.
Wyeth LLC v. AstraZeneca Pharmaceuticals LP, et al.
No. 2024-2325 (Fed. Cir. (D. Del.) July 9, 2026). Opinion by Lourie, joined by Linn and Hughes.
Wyeth sued AstraZeneca for induced infringement of two patents related to methods of treating gefitinib and/or erlotinib resistant non-small cell lung cancer (g/e-resistant NSCLC) by administering an irreversible epidermal growth factor receptor inhibitor. The claims at issue require “administering daily to the patient” a “unit dosage” of such an inhibitor.
The district court construed “unit dosage” according to an express definition in the specification that referred to a quantity of active material “calculated to produce the desired therapeutic effect.” The case then proceeded to trial where a jury found the claims not invalid, found that AstraZeneca induced infringement, and awarded Wyeth $107,500,000 in damages. AstraZeneca filed a post-trial motion for judgment as a matter of law (JMOL) arguing that the claims are invalid because the specification does not enable skilled artisans to determine a therapeutically effective unit dosage without undue experimentation. The district court agreed and granted JMOL of invalidity for lack of enablement. Wyeth appealed.
The Federal Circuit affirmed. As to claim construction, the court rejected Wyeth’s argument that the district court improperly imported FDA-type clinical safety and efficacy requirements into the claims. The Federal Circuit explained that the claimed “unit dosage” must be “administered daily” to a patient, and “unit dosage” requires producing the desired therapeutic effect. Thus, the claims “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 also explained that “the specification reinforces that plain reading of the claims.”
Turning to enablement, the Federal Circuit held that the specification failed to enable the full scope of the claimed unit dosage. According to the court, “the specification must provide guidance to allow a skilled artisan to determine a daily unit dosage calculated to produce a therapeutic effect in a patient across the full scope of claimed compounds without undue experimentation.” But here, “the specification leaves the determination of the claimed ‘unit dosage’ entirely to the knowledge of the skilled artisan.” It discloses no working examples of the needed unit dosage, and the disclosed ranges for certain compounds were merely “general” and “projected, with no explanation of how they were derived or how skilled artisans would select among them.
The court also relied on unrebutted trial testimony, including testimony from Wyeth’s own experts, establishing that the disclosed dosage ranges for at least two of the three exemplary compounds exceed the maximum tolerated dose in humans.
Thus, the Federal Circuit affirmed the district court’s grant of JMOL of invalidity of the asserted claims for lack of enablement.
Intellectual Pixels Ltd. v. Sony Interactive Entertainment LLC
No. 2024-2174 (Fed. Cir. (PTAB) July 10, 2026). Opinion by Dyk, joined by Stoll and Stark.
Intellectual Pixels Limited (IPL) owns a patent that discloses methods for generating digital images. The challenged claims require two pertinent limitations, “generating at least one updated image” and “compressing the at least one updated image.”
Sony initiated an IPR proceeding challenging the patent claims as obvious over “Wiltshire” in combination with other prior art references. The Patent Trial and Appeal Board issued a final written decision concluding that Sony had not shown that the challenged claims were unpatentable. The Board concluded that Wiltshire did not disclose the generating limitation and thus did not reach the question of whether Wiltshire disclosed the compressing limitation.
In a prior appeal, the Federal Circuit vacated and remanded, concluding that substantial evidence did not support the Board’s finding that Wiltshire did not disclose the generating limitation. On remand, the Board recognized that Wiltshire disclosed the generating limitation and also concluded that it disclosed the compressing limitation. The Board thus issued a second final written decision holding the challenged claims unpatentable as obvious. IPL appealed.
In the appeal, IPL argued that the Board’s second final written decision exceeded the Federal Circuit’s mandate and that the decision was, in any event, unsupported by substantial evidence. The Federal Circuit disagreed and affirmed.
To begin, the court explained that “the mandate rule provides that issues actually decided on appeal are foreclosed from further consideration,” and the scope of the mandate “is limited to issues actually decided, either explicitly or by necessary implication in the previous litigation.” Applied here, the Federal Circuit ruled that the Board’s remand determination as to the generating limitation “was compelled by our mandate, not foreclosed by it” as IPL had argued. As to the compressing limitation, the Federal Circuit explained that the issue was never reached in the Board’s first final written decision, and so it “was not appealable or decided by us, and thus was not within the scope of our mandate.” Accordingly, “the Board did not err by revisiting the compressing limitation issue on remand.”
Lastly, IPL argued in the alternative that the Board’s findings in the second final written decision are not supported by substantial evidence. The Federal Circuit found that argument unpersuasive and thus affirmed.