Bristol-Myers Squibb filed a lawsuit in US district court seeking unspecified damages from Merck & Co. for allegedly infringing a new immunotherapy patent. According to the litigation, filed in federal court for the District of Delaware, Bristol-Myers Squibb claims "Merck is threatening to exploit that invention" with a later-developed method of treatment, in violation of a patent issued on May 20.
The move comes as Merck won FDA approval for the melanoma drug Keytruda (pembrolizumab), the first anti-PD-1 immunotherapy to be cleared in the US. Merck said the lawsuit was without merit and that it was confident the company wouldn't be prevented from marketing Keytruda. The drugmaker expects to price the therapy at $12,500 a month, with analysts projecting sales of $1.8 billion for the drug by 2017.
Meanwhile, Bristol-Myers Squibb plans to submit its experimental PD-1 inhibitor nivolumab for FDA approval this quarter, with a decision by the agency anticipated by mid-2015. The therapy was recently launched in Japan in collaboration with partner Ono Pharmaceutical under the brand name Opdivo at an average annual cost of $143 000 per patient.
For related analysis, see ViewPoints: Japanese market provides mixed-sentiment reference points for price of forthcoming key drug launches and ViewPoints: Perlmutter's pipeline narrative continues to gain momentum at Merck & Co.
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