Merck agrees to resolve Keytruda patent infringement litigation

US-based Merck and associated affiliates have entered an agreement with Bristol-Myers Squibb and Ono Pharmaceutical, to resolve Keytruda (pembrolizumab) patent litigation.

The worldwide patent infringement litigation was related to the use of an anti-PD-1 antibody to treat cancer such as Keytruda.

Under the settlement and licence agreement, the company will pay $625m to Bristol-Myers Squibb.

Merck will also provide royalties on the worldwide sales of Keytruda for a non-exclusive licence to market it in any market where it is approved.

Merck chairman and CEO Kenneth Frazier said: "Today’s announcement eliminates uncertainty and enables us to continue to focus on Keytruda, our immuno-oncology medicine, which is already helping thousands of patients around the world and becoming a foundation for the treatment of cancer through our industry-leading clinical development programme."

For global net sales of Keytruda, Merck will pay royalties of 6.5% of net sales occurring from 1 January this year through to and including 31 December 2023 to Bristol-Myers Squibb.

The company will also pay 2.5% of net sales occurring from 1 January 2024 through to and including 31 December 2026.

Both companies have also agreed to dismiss all claims in the relevant legal proceedings.

Through its prescription medicines, vaccines, biologic therapies and animal health products, Merck works with customers and operates in more than 140 countries to deliver new health solutions.