U.S. Federal Court Approves Bristol Myers Squibb & AstraZeneca Joint Stipulations to Dismiss Patent Infringement Lawsuits

U.S. Federal Court Approves Bristol Myers Squibb & AstraZeneca Joint Stipulations to Dismiss Patent Infringement Lawsuits

The U.S. Federal Court in Delaware by its presiding Judge Matthew F. Kennelly has approved Bristol Myers Squibb (BMS) and AstraZeneca joint stipulations to dismiss three separate patent infringement lawsuits around their blockbuster cancer immunotherapies.

In the suits, BMS accused that the AstraZeneca drugs, Imfinzi and Imjudo, infringed patents on its own therapies, Opdivo and Yervoy, and wanted compensation for lost earnings.

Opdivo and Imfinzi are both PD-1 inhibitors and have generated billions of dollars in sales as cancer treatments for their respective companies. Yervoy and Imjudo are anti-CTLA-4 antibodies.

In 2011, Yervoy was first approved by the Food and Drug Administration (FDA) to treat melanoma, and has since been approved for kidney, lung, colorectal and other types of cancer. BMS sold over $2 billion worth of the drug in 2021, according to the company. Imjudo in combination with Imfinzi was approved for liver cancer in October last year.

BMS originally sued AstraZeneca over eight Opdivo patents in March 2022 and added another claim in the following April of that year. In its third lawsuit the company primarily focused on Yervoy and Imjudo, in January 2023.

The District of Delaware had issued a ‘scheduling order’, setting a trial for April 2024.

However, in its second-quarter earnings report, AstraZeneca said it had entered into a global settlement agreement with BMS and Ono Pharmaceutical ‘that resolves all patent disputes relating to Imfinzi and Imjudo between the companies’ totalling $510 million.

Before the AZ deal, BMS and Ono had previously settled another PD-1 patent lawsuit against Merck & Co. In 2017 settlement, Merck shelled out a $625 million payment and has been paying royalties based on sales from its mega-blockbuster PD-1 inhibitor Keytruda for its patent lawsuit.

In a statement to Fierce Pharma, an AstraZeneca spokesperson confirmed that the company has taken a provision of $510 million to resolve all patent disputes with BMS and its partner Ono Pharmaceutical over PD-L1 inhibitor Imfinzi and CTLA-4 antibody Imjudo. The British pharma has baked the one-time charge into its second-quarter financials.