aibioFederal Circuit affirms invalidity of Puma-licensed patents in Tagrisso suit against AstraZeneca
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The Federal Circuit affirmed on July 9, 2026 that the asserted patent claims are invalid. Wyeth, the Pfizer subsidiary and co-plaintiff, had won a $107.5 million jury award against AstraZeneca Pharmaceuticals LP and AstraZeneca AB.
Key facts
- Company
- Puma Biotechnology Inc (NASDAQ: PBYI)
- News type
- Legal
- Primary source
- Puma Biotechnology 10-Q for the quarter ended June 30, 2026 (SEC EDGAR)
Puma Biotechnology, Inc. (Nasdaq: PBYI) said in its 10-Q filed Aug 6, 2026 that the U.S. Court of Appeals for the Federal Circuit affirmed on July 9, 2026 a Delaware federal court judgment holding invalid the patent claims in its infringement suit over AstraZeneca's cancer drug Tagrisso. A jury had found for Wyeth, the Pfizer subsidiary that is a co-plaintiff, and awarded it $107.5 million before the trial judge ruled the claims invalid.
The case is Puma Biotechnology, Inc. et al. v. AstraZeneca Pharmaceuticals LP et al., 1:21CV01338, filed Sept. 22, 2021 in the U.S. District Court for the District of Delaware. The defendants are AstraZeneca Pharmaceuticals, LP and AstraZeneca AB. AstraZeneca PLC was also sued but was dismissed by stipulation in December 2021. The 10-Q names no individual defendants.
The case
Puma's complaint alleges that AstraZeneca's commercial manufacture, use, offer for sale, sale, distribution and importation of Tagrisso (osimertinib) for gefitinib and/or erlotinib resistant non-small cell lung cancer infringes U.S. Patent Nos. 10,603,314 and 10,596,162. Puma is the exclusive licensee of both patents under its agreement with Pfizer, and Wyeth is a co-plaintiff. The plaintiffs sought a judgment of infringement and monetary damages in an amount to be proven at trial.
AstraZeneca AB and AstraZeneca Pharmaceuticals LP answered on Nov. 5, 2021 with counterclaims challenging the patents as not infringed and/or invalid and accusing the plaintiffs of unclean hands and patent misuse. Puma filed its answer denying those claims on Dec. 17, 2021.
Defendants
AstraZeneca Pharmaceuticals, LP and AstraZeneca AB are the remaining defendants and counterclaim plaintiffs. AstraZeneca PLC was dismissed on a stipulation that the court ordered on Dec. 13, 2021. Pfizer, which was named as a counterclaim defendant, was dismissed from the counterclaims the same way.
Where it stands
The case was reassigned to visiting Judge Matthew Kennelly of the Northern District of Illinois. The court issued its claim construction decision on March 29, 2023. It dismissed Puma as a plaintiff on constitutional standing grounds, and on April 29, 2024 it dismissed AstraZeneca's counterclaims against Puma, which removed Puma from the case. Wyeth stayed in as plaintiff.
At a jury trial on May 13 to 17, 2024, the jury found that use of Tagrisso under each of its three FDA-approved indications infringes the asserted claims, that AstraZeneca induces that infringement, and that the patents are not invalid. It awarded Wyeth damages for past infringement through Dec. 31, 2023. On Aug. 6, 2024, after a bench trial, Judge Kennelly ruled for Wyeth on AstraZeneca's equitable defenses. On Aug. 14, 2024 he granted AstraZeneca's motion for judgment as a matter of law in part, holding both patents invalid under 35 U.S.C. § 112 for lacking enablement and adequate written description as to a particular claim limitation.
Wyeth appealed on Sept. 12, 2024. Oral argument was held on May 7, 2026, and the Federal Circuit affirmed on July 9, 2026, holding the claims invalid. The 10-Q says Puma can request further review from the full Federal Circuit and the Supreme Court. Puma says it "respectfully disagrees" with the invalidity ruling on the particular claim limitation.
Why it matters to shareholders
Under its worldwide exclusive license with Pfizer, as amended, Puma says it keeps contractual rights to recover monetary damages in the AstraZeneca litigation, and that those rights were unaffected by the court's March 18, 2024 and April 29, 2024 orders. The 10-Q does not say how the Federal Circuit ruling affects those rights, and it gives no amount Puma expects to receive.
The filing does show one cost item. Selling, general and administrative expenses for the quarter included a $0.9 million reversal of a previously recorded legal accrual related to the AstraZeneca litigation.
Puma also discloses a separate legal malpractice suit against its former lawyers and patent proceedings in China and Europe over its NERLYNX (neratinib) tablet. Those matters are separate from the Tagrisso case.