Less than three months after a Delaware federal jury ordered AstraZeneca to pay $107.5 million to Pfizer in a patent infringement case, a Delaware judge has nullified the award and invalidated the patents behind the lawsuit.
While denying AZ’s claims that it didn’t commit infringement and that Pfizer did not suffer damages, Judge Matthew Kennelly voided the Pfizer patents because it lacked clear written descriptions of its inventions and would not allow “persons of ordinary skill in the art” to duplicate them, according to court documents.
Pfizer did not respond to a request for comment.
The lawsuit surrounded AstraZeneca’s blockbuster lung cancer treatment Tagrisso, which was approved in 2015 and generated $5.8 billion in sales last year.
Pfizer claimed that AZ used intellectual property that was patented two decades ago by Pfizer subsidiary Wyeth for a HER2-positive breast cancer drug that was licensed to Puma Biotechnology in 2011. Pfizer picked up Wyeth in a $68 billion buyout in 2009.
In 2021, Pfizer and Puma filed the lawsuit against AZ claiming that Tagrisso’s label “encourages acts” of direct infringement. The companies also contended that AZ was aware of the patent protections.
Last year, Los Angeles-based Puma recorded sales of $203 million of the breast cancer drug, which is marketed as Nerlynx and was approved in 2017. It is the lone product in the company’s portfolio, and Puma has sole rights to its development and commercialization.
Earlier this year, the court removed Puma as a plaintiff from the case, even though it “maintains contractual rights to recover monetary damages in the AstraZeneca litigation,” according to a Securities and Exchange Commission filing in May, days before the jury sided with Pfizer.
Meanwhile, AZ 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, except if authorized.