Cancer giants BMS, AstraZeneca clash in new checkpoint inhibitor patent suit

After Bristol Myers Squibb took Merck & Co. and Roche to task for patent infringement with their big-selling immuno-oncology drugs, the drugmaker is now pressing its case against AstraZeneca.

In a newly filed lawsuit in Delaware, Bristol Myers says AZ is "exploiting" its research and patents by marketing a "later-developed anti-PD-L1 drug," than its own Opdivo, which scored FDA approval in 2014. Because the companies are "direct competitors," BMS says it's suffering "substantial damages, including lost profits" because of AZ's Imfinzi marketing.

It could be a high-dollar complaint: BMS won $625 million plus royalties from Merck in a similar lawsuit.

AZ launched Imfinzi after winning an FDA approval in 2017 to treat certain patients with locally advanced or metastatic bladder cancer.

BMS argues that it "invented methods for treating cancer and methods for enhancing immune responses by administering antibodies that bind to PD-L1." The company's Opdivo was the first anti-PD-1 antibody "approved anywhere in the world for cancer treatment" and the first drug in the class approved in the U.S. for lung cancer.

BMS contends AZ is stepping on eight patents issued by the U.S. Patent & Trademark Office between 2017 and 2019 relating to Opdivo and its checkpoint inhibitor research and demands compensation.

Both companies are major cancer players, with Bristol's Opdivo generating $7.5 billion worldwide last year and AstraZeneca's Imfinzi pulling down $2.4 billion.

The lawsuit comes after BMS sued cancer giants Merck and Roche on similar grounds. In the Merck case, the New Jersey drugmaker ended up paying $625 million plus royalties on its massively successful cancer drug Keytruda. BMS and its partner Ono Pharmaceutical split the proceeds 75/25.

And in a deal (PDF) unveiled in November 2020, Ono said Roche would make an undisclosed upfront payment plus pay single-digit royalties on its checkpoint inhibitor Tecentriq.