AstraZeneca to Pay Pfizer $107.5M in Tagrisso Patent Dispute

Pfizer, through its subsidiary Wyeth, has been awarded $107.5 million in damages from AstraZeneca following a ruling by a Delaware federal jury. The jury determined that AstraZeneca's cancer drug Tagrisso (osimertinib) infringed on patents held by Wyeth.

The unanimous jury verdict found that AstraZeneca violated three claims of Wyeth’s ‘312 patent and one claim of the ‘162 patent. These infringements applied to both the second-line and first-line adjuvant use of Tagrisso. However, the jury did not find AstraZeneca’s patent infringement to be willful.

Regarding the validity of Wyeth’s patent claims, the jury unanimously decided that AstraZeneca had not provided “clear and convincing evidence” that the patents were invalid. Consequently, all of AstraZeneca's challenges to the validity of Wyeth’s patents, which included arguments about lack of enablement, written description, anticipation, and obviousness, were dismissed.

Wyeth, which Pfizer acquired in 2009, initiated the lawsuit against AstraZeneca in 2021. The lawsuit centered around two key patents that Wyeth claimed Tagrisso was infringing upon. The first patent, known as the ‘314 patent, pertains to methods for treating non-small cell lung cancer (NSCLC) patients who are resistant to gefitinib and/or erlotinib with an EGFR blocker that covalently binds to the protein’s cysteine 773 residue.

Additionally, AstraZeneca was found to have breached Wyeth’s ‘162 patent, which involves using irreversible inhibitors for treating NSCLC patients resistant to gefitinib or erlotinib, particularly those with the T790M mutation on the EGFR protein.

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

Initially, the lawsuit also included Puma Biotechnology, a California-based company and the exclusive licensee of the patents, as a plaintiff. However, in March 2024, AstraZeneca successfully argued in a Delaware court to remove Puma Biotechnology from the case.

Tagrisso, first approved by the FDA in November 2015, is a targeted cancer therapy for NSCLC patients with the T790M EGFR mutation. The drug functions by targeting and inhibiting specific mutant forms of the EGFR protein, which disrupts the growth and proliferation of cancer cells.

Since its initial regulatory approval, Tagrisso has become one of AstraZeneca’s most valuable products. In the first quarter of 2024, Tagrisso was the company's top-performing cancer drug, generating nearly $1.6 billion with a 15% growth. Across AstraZeneca’s entire pharmaceutical portfolio, Tagrisso was second only to the diabetes medication Farxiga (dapagliflozin) in sales performance. In 2023, Tagrisso generated close to $5.8 billion in revenue.

The jury’s decision signifies a significant victory for Pfizer and Wyeth, underscoring the importance of patent protections in the pharmaceutical industry. The case highlights the ongoing battles over intellectual property rights within the sector, as companies strive to protect their innovations and market share.