AstraZeneca to Pay Wyeth $107.5M in Tagrisso Patent Case

In a critical legal decision, a federal jury in Delaware has determined that AstraZeneca is required to pay $107.5 million in damages to Pfizer's Wyeth division. This ruling comes as a result of AstraZeneca infringing on two pivotal patents associated with its widely-used cancer medication, Tagrisso. The legal proceedings trace back to 2021, when Wyeth alleged that AstraZeneca had violated its '314' and '162' patents. These patents pertain to the application of irreversible EGFR inhibitors for treating patients with non-small cell lung cancer (NSCLC) who have developed resistance to earlier generation EGFR tyrosine kinase inhibitors such as gefitinib and erlotinib.

The jury concluded, without dissent, that AstraZeneca had indeed infringed on three claims of the '314 patent and one claim of the '162 patent with its Tagrisso drug, which is sanctioned for both second-line and first-line adjuvant use in NSCLC. However, the jury did not find AstraZeneca's infringement to be willful.

Since its introduction to the market with FDA approval in 2015, Tagrisso has been a critical product for AstraZeneca, amassing nearly $5.8 billion in revenue in 2023 alone. The drug functions by targeting specific mutations in the EGFR protein, thereby interrupting cancer cell growth and proliferation. Due to its substantial commercial success, Tagrisso has become AstraZeneca's leading cancer treatment, surpassed only by the diabetes drug Farxiga.

The ruling poses a significant financial challenge for AstraZeneca, putting a key revenue stream at risk. The company is expected to appeal the decision, firm in its stance that the patents held by Wyeth are invalid. This case highlights the intense competition and high stakes of intellectual property rights within the pharmaceutical sector.

As AstraZeneca faces this setback, it will need to strategize on how to secure Tagrisso's market position and address the wider ramifications of the jury's verdict. The implications of this case extend beyond AstraZeneca and Wyeth, potentially impacting the broader field of biopharmaceutical innovation and patent protection.