Pfizer unit wins $107.5M verdict in cancer drug patent case against AstraZeneca

A Delaware federal jury has ordered AstraZeneca to fork over $107.5 million to Pfizer for infringing two of the latter company's patents with its marketing of blockbuster oncology med Tagrisso.

In the case, Pfizer subsidiary Wyeth and Puma Biotechnology first sued AstraZeneca in 2021. 

A decade prior to that, in 2011, Puma licensed what became its metastatic HER2-positive breast cancer drug Nerlynx from Pfizer for an undisclosed sum, taking on sole responsibility for the drug's global development and commercialization. Pfizer originally got its hands on the compound after snatching up Wyeth for $68 billion back in 2009.

The companies’ 2021 lawsuit accused AZ of violating two Wyeth patents that each cover a “method for treating gefitinib-resistant cancer.”

AstraZeneca's non-small cell lung cancer (NSCLC) med Tagrisso scored FDA approval in 2015, a decade after “provisional applications” were filed for the two patents, according to the lawsuit. Tagrisso's product label “encourages acts” of direct infringement, Puma and Wyeth argued, further claiming that AZ was aware of the patent protections.

Earlier this year, the court removed Puma Biotechnology as a plaintiff in the case. Even still, Puma "maintains contractual rights to recover monetary damages in the AstraZeneca litigation," the company said in a May 17 SEC filing. Puma's share price was up about 17% to $4.80 on Monday morning.

When Puma and Wyeth first sued, Tagrisso was AZ’s top-selling drug. More recently, it has been passed by chronic kidney disease med Farxiga by a narrow margin.

Still, with $5.8 billion in 2023 sales, royalty damages were likely to be lucrative. A Delaware federal jury last week put the owed sum at $107.5 million after finding that the British drugmaker did induce patent violations. The jury wasn’t swayed by AZ’s arguments that the patents are invalid, the verdict notes.

The Tagrisso maker is “disappointed” by the verdict, a company spokesperson said in an emailed statement, pointing out that a bench trial on “additional defenses” raised by AZ is slated for next month. A final judgment should be entered following the bench trial.

“We are confident in our IP position in relation to Tagrisso and we will vigorously defend our rights,” the AZ representative added. “AstraZeneca is committed to ensuring that patients who would benefit from treatment with Tagrisso in its approved indications will continue to have access to this product.”

Pfizer did not immediately reply to Fierce Pharma’s request for comment.

Meanwhile, AstraZeneca has successfully fended off Tagrisso generics with three of its own patent infringement suits. The latest settlement was in 2022, blocking Alembic Pharmaceuticals from making a Tagrisso copycat until the branded med’s intellectual property protection expires in the next decade “[e]xcept as specifically authorized,” a filing stipulated.