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Agreements

Date: 2017-01-20

Type of information: Licensing agreement

Compound: Keytruda® (pembrolizumab - MK-3475)

Company: BMS (USA - NY) Merck&Co (USA - NJ) Ono Pharmaceutical (Japan)

Therapeutic area: Cancer - Oncology

Type agreement:

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Disease:

Details:

 * On January 20, 2017, Merck&Co announced it agreed to enter into a settlement and license agreement with BMS and Ono Pharmaceutical Co., Ltd., resolving the worldwide patent infringement litigation related to the use of an anti-PD-1 antibody for the treatment of cancer, such as Keytruda® (pembrolizumab). The agreement will result in the dismissal with prejudice of all patent litigation between the companies pertaining to Keytruda. BMS and Ono, who discovered and developed the PD-1 antibody Opdivo® (nivolumab), had asserted in litigation that Merck&Co’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.

Under the settlement and license agreement, Merck&Co will make a one-time payment of $625 million to BMS and provide royalties on the worldwide sales of Keytruda® for a non-exclusive license to market Keytruda® in any market in which it is approved. For global net sales of Keytruda®, the company will pay BMS royalties as follows: 6.5 percent of net sales occurring from Jan. 1, 2017 through and including Dec. 31, 2023; and
2.5 percent of net sales occurring Jan. 1, 2024 through and including Dec. 31, 2026.
The parties also agreed to dismiss all claims in the relevant legal proceedings. 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 BMS and Ono in a 75/25 percent allocation, respectively.

 

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