Bristol-Myers Squibb and Ono Pharmaceutical settle patent dispute with Merck Inc over Keytruda (pembrolizumab)

Bristol-Myers Squibb and Ono Pharmaceutical have announced the companies have signed a global patent license agreement with Merck & Co., Inc. to settle all patent-infringement litigation related to Merck’s PD-1 antibody Keytruda (pembrolizumab). The agreement will result in the dismissal with prejudice of all patent litigation between the companies pertaining to Keytruda. Bristol-Myers Squibb and Ono, who discovered and developed the PD-1 antibody Opdivo (nivolumab), had asserted in litigation that Merck’s sale of Keytruda infringed the companies’ patents relating to the use of PD-1 antibodies to treat cancer in the U.S., Europe (United Kingdom, Netherlands, France, Germany, Ireland, Spain and Switzerland), Australia, and Japan. As part of the agreement, Merck will make an initial payment of $625 million to Bristol-Myers Squibb and Ono. Merck is also obligated to pay ongoing royalties on global sales of Keytruda of 6.5% from January 1, 2017 through December 31, 2023, and 2.5% from January 1, 2024 through December 31, 2026. Under the agreement, the companies have also granted certain rights to each other under their respective patent portfolios pertaining to PD-1.