Bristol Myers, AstraZeneca settle PD-1, CTLA-4 cancer immunotherapy patent suits for $510M

Bristol Myers Squibb and AstraZeneca have quickly resolved patent infringement lawsuits around their blockbuster cancer immunotherapies.

A federal judge in Delaware has approved the two companies’ joint stipulations to dismiss three separate lawsuits. In the suits, BMS accused AstraZeneca of encroaching on patents covering its PD-1 inhibitor Opdivo and CTLA-4 agent Yervoy.

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.

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

While Bristol’s windfall in the AZ case might have eventually been larger given the blockbuster sales from the British drugmaker’s PD-1 cancer drug Imfinzi, settling the cases early saves both BMS and AZ time and attention.

BMS sued AZ over eight Opdivo patents in March 2022 and then added another PD-1 patent infringement claim in a separate lawsuit filed this April. The New York pharma brought the lawsuit focusing on its Yervoy and AZ’s Imjudo in January, alleging that AZ stepped on two patents related to using an anti-CTLA-4 antibody or a combination of PD-L1 and CTLA-4 inhibitors to treat cancer.

Over the last decade, the entire PD-1/L1 class has made quite a splash in cancer treatment. In 2022, Opdivo brought BMS $8.2 billion in total sales, up from $7.5 billion the prior year. Imfinzi reeled in $2.8 billion in sales for AZ last year, compared with $2.4 billion in 2021. Both BMS and AZ view their PD-1/L1 drugs the cornerstones of their oncology portfolios.

The CTLA-4 class has been less successful. Yervoy generated $2.1 billion in 2022, and Imjudo only got its first FDA approval in October after a long history of failures.

AZ settled the lawsuits as Imfinzi and Imjudo embark on another stage of growth thanks to new approvals in liver cancer and biliary tract cancer.

In the second quarter, Imfinzi and Imjudo together surpassed $1 billion in sales in a quarter for the first time. Together, the pair grew sales 58% over the same period last year at constant currencies.

By comparison, Opdivo’s sales in the second quarter rose 5% to $2.1 billion, coming 7% below analysts’ expectations. Yervoy’s $585 million haul did exceed Wall Street’s consensus estimate by 5%.