September 8, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Bristol-Myers Squibb Company , the New York, NY-based pharmaceutical company, and Ono Pharmaceutical Company, Ltd. , the Osaka, Japan-based pharma company, have filed a law suit against Merck & Co., (MRK), the White House Station, NJ-based pharmaceutical company, that states Merck’s Keytruda infringes on a patent the former companies possess for treating melanoma with a PD-1 compound.
Keytruda, which has the generic name pembrolizumab, was approved last week by the FDA. The same day as the approval announcement, BMS and Ono filed their suit, which states that Keytruda, the first PD-1 inhibitor approved in the US, violates a patent (No. 8,728,474) assigned to Ono and licensed by BMS in May. The patent, entitled “Immunopotentiative composition,” covers the treatment of cancer “via immunopotentiation caused by inhibition of immunosuppressive signal induced by PD-1, PD-L1, or PD-L2.”
While Keytruda holds the status of the first PD-1 inhibitor approved in the US, BMS and Ono have had their PD-1 inhibitor, Opdivo, the generic name of which is nivolumab, approved in Japan, where the drug went on sale last week. BMS will apply for approval of Opdivo for the treatment of melanoma in the US by September 30.
At stake is an estimated $30 billion-market for a new class of cancer drugs. Referred to as immunotherapy drugs, they amp up the body’s own immune system to fight cancer. Immunotherapy drugs have produced exciting results in clinical trials, particularly against melanoma—which both Keytruda and Opdivo target.
PD-1 inhibitors are “therapeutic antibodies that block the programmed cell death protein-1 (PD-1) immune checkpoint pathway,” according to an article by Donald Harvey of Emory University, published in the peer-reviewed journal Nature. This blockade “promote[s] immune responses against cancer.” Because PD-1 inhibitors harness the body’s defense system to fight cancer, the side effects are less severe than existing therapies, such as radiation or chemotherapy, which kill cancer cells as well as healthy cells.
BMS and Ono’s complaint states, “The plaintiffs put this scientific breakthrough into practice by developing an anti- D-1 antibody called nivolumab, the first anti-PD-1 antibody approved anywhere in the world for cancer treatment….Merck is threatening to exploit that invention with a later-developed anti-PD-1 antibody.” The complaint further states that marketing Keytruda is “deliberate, willful, and in reckless disregard of valid patent claims.”
Merck, which stated in an August filing to the U.S. Securities and Exchange Commission that the Ono patent was invalid, said in a statement that it would move forward with marketing Keytruda and that it is “confident… that it will not be prevented from doing so by the Ono/BMS patents.”
