Bristol Myers Squibb (BMS) and AstraZeneca have quickly resolved patent infringement lawsuits related to their cancer immunotherapies. The companies reached a resolution after a federal judge in Delaware approved their joint stipulations to dismiss three separate lawsuits. BMS accused AstraZeneca of infringing on patents covering its PD-1 inhibitor Opdivo and CTLA-4 agent Yervoy.
To settle the disputes, AstraZeneca agreed to pay a provision of $510 million, which has been included as a one-time charge in its second-quarter financials. This settlement comes after BMS and Ono Pharmaceutical (BMS’s partner) had previously settled another PD-1 patent lawsuit against Merck & Co, resulting in a $625 million payment from Merck and ongoing royalty payments based on sales of Merck’s PD-1 inhibitor Keytruda.
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The settlement between BMS and AstraZeneca saves both companies time and attention, even though BMS’s windfall might have been larger if the case had proceeded further due to the blockbuster sales of AstraZeneca’s PD-1 cancer drug Imfinzi.
Over the last decade, the PD-1/L1 class has had a significant impact on cancer treatment, with Opdivo bringing in $8.2 billion in total sales for BMS in 2022 and Imfinzi generating $2.8 billion in sales for AstraZeneca the same year. Both companies consider their PD-1/L1 drugs as essential components of their oncology portfolios.
On the other hand, the CTLA-4 class has been less successful, with Yervoy generating $2.1 billion in 2022 and Imjudo receiving its first FDA approval in October, following previous failures.
AstraZeneca settled the lawsuits at a time when Imfinzi and Imjudo are experiencing another stage of growth due to new approvals in liver cancer and biliary tract cancer. In the second quarter, the combined sales of Imfinzi and Imjudo surpassed $1 billion for the first time, showing a 58% growth compared to the same period the previous year at constant currencies.
In comparison, Opdivo’s sales in the second quarter rose 5% to $2.1 billion but fell 7% below analysts’ expectations. Yervoy, with a $585 million haul, exceeded Wall Street’s consensus estimate by 5%.
Overall, the settlement allows both Bristol Myers Squibb and AstraZeneca to focus on further developing and marketing their cancer immunotherapies without the distraction and uncertainty of ongoing patent litigation.
