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Big Molecule Watch
July 20, 2015

BMS receives patent for anti-PD-1 antibody treatment, sues Merck same day

On Tuesday, July 7, 2015, the USPTO granted U.S. Patent No. 9,073,994, directed to a method of treating metastatic melanoma using an anti-PD-1 antibody to Ono Pharmaceuticals, a partner of Bristol-Myers Squibb Co.  BMS makes Opdivo (nivolumab), an anti-PD-1 antibody, approved  to treat metastatic melanoma and non-small cell lung cancer.  Later that day, BMS and Ono filed suit in the District of Delaware against Merck & Co Inc., alleging that the use of Merck’s own anti-PD-1 antibody, Keytruda (pembrolizumab), infringes the ’994 patent.

Anti-PD-1 antibodies are promising cancer therapies that function by blocking the ability of certain cancer types to suppress T-cell activity in the tumor microenvironment.  Anti-PD-1 antibody therapies thus allow the patient’s own immune system to attack the tumor.  Opdivo received FDA approval for use in metastatic melanoma in December 2014, and non-small cell lung cancer in March 2015.  Keytruda was approved to treat metastatic melanoma in September 2014.

We will continue following this case and bring you updates as the litigation progresses.