AstraZeneca Wins Appeal in Pfizer Patent Dispute Over Lung Cancer Drug Tagrisso

A U.S. appeals court has affirmed a lower court's decision in favor of AstraZeneca, invalidating two patents held by Pfizer's Wyeth subsidiary in a dispute over the blockbuster lung cancer drug Tagrisso. The ruling on Thursday protects a key revenue source for the UK-based pharmaceutical giant from a significant infringement claim.

Court Upholds Patent Invalidation

The U.S. Court of Appeals for the Federal Circuit in Washington agreed with a previous ruling that the two patents Wyeth accused AstraZeneca of violating were invalid. The court found that the patents lacked a valid written description of their inventions.

This decision upholds a 2024 verdict from U.S. District Judge Matthew Kennelly. He determined that the patents would not allow a scientist of ordinary skill to recreate the inventions without requiring "excessive experimentation," a key standard for patent validity. That ruling had overturned an earlier jury award.

Financial Implications

The legal victory is crucial for AstraZeneca, as Tagrisso is one of its most commercially successful products. The drug is a cornerstone of the company's oncology portfolio and a significant driver of its growth.

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Key figures in the dispute include:

• $7.2 billion: Tagrisso's global revenue for AstraZeneca last year, according to company filings.
• $107.5 million: The amount a Delaware jury had awarded to Wyeth in 2024 before the verdict was overturned by a judge.

Case Background

The lawsuit was initiated in 2021 by Wyeth, a subsidiary acquired by Pfizer in 2009. The suit claimed that Tagrisso infringed on patents related to Nerlynx, a breast cancer treatment that Puma Biotechnology produces under license from Pfizer.

After the initial jury verdict favored Wyeth, the case was reversed by Judge Kennelly later that year. Thursday's appellate court decision affirms that reversal, bringing a new level of legal finality to the dispute in AstraZeneca's favor.