AstraZeneca Wins Tagrisso Patent Appeal
The U.S. Court of Appeals for the Federal Circuit in Washington affirmed a lower‑court ruling that two patents asserted by Pfizer’s subsidiary Wyeth against AstraZeneca were invalid. The appellate court’s decision, issued on Thursday, upheld the judgment that the patents lacked a valid written description and could not be reproduced by an ordinary scientist without undue experimentation.
Pfizer acquired Wyeth in 2009 and filed the lawsuit in 2021, alleging that AstraZeneca’s lung‑cancer drug Tagrisso infringed patents covering the breast‑cancer therapy Nerlynx, which is produced by Puma Biotechnology under a license from Pfizer. The dispute centered on whether Tagrisso’s molecular composition fell within the scope of Wyeth’s patents.
Tagrisso generated more than $7.2 billion in global revenue for AstraZeneca in the most recent fiscal year, highlighting the drug’s significant contribution to the company’s earnings.
In a related 2024 proceeding, a Delaware jury had awarded Wyeth $107.5 million in damages against AstraZeneca. However, U.S. District Judge Matthew Kennelly, sitting by designation in Delaware, overturned that verdict later in 2024 after concluding that the patents were deficient in their written descriptions. The Federal Circuit’s affirmation of Judge Kennelly’s ruling on the same grounds solidifies the invalidation of the patents.