AstraZeneca to Pay Pfizer $107.5M in Damages in Tagrisso Patent Tussle

Pictured: Sign above the entrance of a U.S. courth

Pictured: Sign above the entrance of a U.S. courth

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Pfizer’s Wyeth unit notched a legal victory over AstraZeneca on Friday as a federal jury found the British-Swedish company violated two key patents in developing and marketing its lung cancer drug Tagrisso.

Pictured: Sign above the entrance of a U.S. courthouse/iStock, Mariakray

Pfizer, through its Wyeth unit, is entitled to receive $107.5 million in damages from AstraZeneca after a Delaware federal jury on Friday found that the British-Swedish pharma’s cancer drug Tagrisso (osimertinib) violated patent protections.

Voting unanimously, the jury found that AstraZeneca infringed on three claims of Wyeth’s so-called ‘312 patent and one claim of the ‘162 patent. These violations held for both the second-line and first-line adjuvant use of Tagrisso. At the same time, the jury found no evidence that AstraZeneca’s infringement of Wyeth’s patents was willful.

Regarding the validity of Wyeth’s claims, the jurors also voted unanimously that AstraZeneca had not presented “clear and convincing evidence” that the patents were invalid. The jury rejected all of AstraZeneca’s validity challenges to Wyeth’s patents, including lack of enablement, written description, anticipation and obviousness.

Wyeth, which Pfizer acquired in 2009, sued AstraZeneca in 2021 claiming that Tagrisso infringes on two key patents. The first, dubbed the ‘314 patent, covers methods for treating non-small cell lung cancer (NSCLC) patients resistant to gefitinib and/or erlotinib with an EGFR blocker that covalently binds to the protein’s cysteine 773 residue.

AstraZeneca also was found to have violated Wyeth’s ‘162 patent, which protects using these irreversible inhibitors to treat gefitinib- or erlotinib-resistant NSCLC patients with the specific T790M mutation on the EGFR protein.

The two technologies are used by Wyeth and Puma Biotechnology’s Nerlynx (neratinib), a kinase inhibitor that—like Tagrisso—irreversibly binds to EGFR. Nerlynx is indicated for HER2-positive breast cancer.

The original lawsuit also lists California-based biotech Puma—the exclusive licensee of the patents in question—as a plaintiff, but AstraZeneca in March 2024 successfully convinced a Delaware court to boot the biotech off the case.

First approved by the FDA in November 2015 for the treatment of NSCLC patients carrying the T790M EGFR mutation, Tagrisso is a targeted cancer therapy that works by targeting and inhibiting specific mutant forms of the EGFR protein. This mechanism of action disrupts the cancer cells’ growth and proliferation.

Since winning its first regulatory approval, Tagrisso has become one of AstraZeneca’s strongest assets. In the first quarter of 2024, Tagrisso was the company’s best-selling cancer growing 15% to bring in nearly $1.6 billion. Across all of AstraZeneca’s pharmaceutical assets, Tagrisso was outperformed only by the diabetes treatment Farxiga (dapagliflozin). In 2023, Tagrisso brought in nearly $5.8 billion.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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