NEW YORK & OSAKA, Japan - Bristol-Myers Squibb Company and Ono Pharmaceutical Company, Ltd. 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). According to Bristol-Myers Squibb, 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 US, 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. The royalties will be shared between Bristol-Myers Squibb and Ono in a 75/25 percent allocation, respectively.
“Bristol-Myers Squibb and Ono’s agreement with Merck protects our scientific discoveries and validates the strong intellectual property rights we secured as the early innovators in the science of PD-1, a key mechanism in Immuno-Oncology that has proven to have transformational impact in cancer care,” says Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb. “Today’s agreement is also a good decision for patients as it supports the continuation of ongoing research and maintains access to anti-PD-1 therapies for cancer patients around the world.”
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 60 countries including the United States, Japan, and in the European Union.