- On the same day that Keytruda was approved by the FDA, Bristol-Myers Squibb filed a suit in the District Court in Delaware saying that Merck had violated the 474 patent that it was awarded on May 20.
- BMS has its own PD-1 inhibitor cancer drug, nivolumab, which is already approved in Japan and marketed as Opdivo. The company has not yet filed with the FDA, but anticipates U.S. approval by Q2 2015.
- BMS has a deep history in this space. It created the first FDA-approved immunotherapy drug for melanoma, Yervoy (ipilimumab).
The already-contentious race for US approval of the first PD-1 inhibitor to treat melanoma just got even nastier. Although Keytruda was approved ahead of nivolumab, BMS and its marketing partner Ono are claiming that a critical process that contributes to Keytruda’s efficacy is patented by the US Patent & Trademark Office.
Specifically, BMS and Ono have patented the use of antibodies to bind to PD-1 in order to block the PD-1 checkpoint pathway. In this way, the anti-PD-1 antibodies allow a patient’s immune system to resume its ability to recognize, attack, and destroy cancer cells.
For its part, Merck is confident that it will be able to defend its position and move into various markets with Keytruda, because the company says that BMS’s patent is "without merit." Regardless, both companies have very ambitious clinical trial programs underway and are working to rapidly advance immunotherapy.