Merck Announces Settlement and License Agreement Resolving Keytruda Patent Litigation

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada), and certain of its affiliates, today announced it agreed to enter into a settlement and license agreement with Bristol-Myers Squibb Company 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).

Under the settlement and license agreement, the company will make a one-time payment of $625 million to Bristol-Myers Squibb 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 Bristol-Myers Squibb 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.

“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 program,” said Kenneth C. Frazier, chairman and chief executive officer, Merck.

The $625 million payment will be recorded in the company’s fourth-quarter and full-year 2016 results. This expense will be excluded from Merck’s non-GAAP results.

About Merck

For more than a century, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit and connect with us on Twitter, Facebook,YouTube and LinkedIn.

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