A U.S. appeals court on Thursday sided with AstraZeneca in a patent dispute brought by Pfizer's Wyeth unit over the lung cancer medication Tagrisso.
The U.S. Court of Appeals for the Federal Circuit in Washington agreed with a lower-court conclusion that two patents Wyeth had accused AstraZeneca of infringing were invalid.
Pfizer, which acquired Wyeth in 2009, filed its lawsuit against AstraZeneca in 2021. The complaint alleged that Tagrisso infringed on patents tied to the breast cancer drug Nerlynx, which Puma Biotechnology manufactures under license from Pfizer.
AstraZeneca reported that Tagrisso generated more than $7.2 billion in global revenue last year, according to company filings.
In 2024 a jury in Delaware awarded Wyeth $107.5 million against AstraZeneca. That verdict was later set aside in 2024 by U.S. District Judge Matthew Kennelly, who was sitting by designation in Delaware. Judge Kennelly determined the patents lacked valid written descriptions of their inventions and concluded they would not permit an ordinary scientist to recreate the inventions without excessive experimentation.
On Thursday the Federal Circuit affirmed Kennelly's ruling, reaching the same determination regarding the sufficiency of the patents' written descriptions.
Context and implications
The appeals court decision upholds the lower court's legal finding that the challenged patents did not meet the written-description requirement. That legal ground was central to the judge's decision to overturn the jury award earlier in 2024, and the Federal Circuit's agreement preserves that outcome.
The dispute centers on patent validity and its application to a high-revenue oncology therapy. The litigation involved multiple parties and legal steps: Pfizer's acquisition of Wyeth in 2009, Pfizer's 2021 suit against AstraZeneca, a 2024 jury award to Wyeth, and the subsequent overturning and appellate affirmation based on written-description deficiencies.
The Federal Circuit's ruling maintains the vacatur of the jury award for the reasons articulated by Judge Kennelly, as affirmed on the same legal ground by the appeals court.