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BMS takes PD-1 rivalry with Merck to the law courts

Claims Keytruda infringes antibody patents it holds with Ono Pharmaceutical

Bristol-Myers Squibb (BMS)The rivalry between Bristol-Myers Squibb and Merck & Co in the development of the PD-1 inhibitor drug class has escalated into a legal wrangle.

Just as Merck last week claimed the distinction of getting the first PD-1 inhibitor approved in the US with FDA approval for its Keytruda (pembrolizumab) drug in melanoma, BMS and partner Ono Pharmaceutical filed a lawsuit claiming the drug infringes patents covering the use of antibodies which bind to the drug target.

BMS and Ono were first to market in Japan with their Opdivo (nivolumab) PD-1 inhibitor - also approved for melanoma in the first instance - while Merck seems to be on track to win the race in Europe. In the US, nivolumab is not likely to be approved until early- to mid-2015, giving Merck a valuable head start in the market.

At stake is a market for PD-1 inhibitors that could swell to be worth tens of billions of dollars in the coming years, according to analysts, as the drugs' mechanism of making tumour cells vulnerable to attack by the patient's own immune system could be broadly applicable across multiple tumour types.

BMS and Ono claim in their September 4 filing that Keytruda infringes on a patent (No. 8,728,474) - assigned to Ono and licensed by BMS - that was awarded in the US in May and is entitled 'Immunopotentiative composition'.

The patent covers the use of antibodies to treat cancer or infection "via immunopotentiation caused by inhibition of immunosuppressive signal induced by PD-1, PD-L1, or PD-L2," with broad wording that implies other companies developing PD-1 inhibitors - a list which includes Roche and AstraZeneca - may have to be wary of similar infringement actions.

"The plaintiffs put this scientific breakthrough into practice by developing an anti- PD-1 antibody called nivolumab, the first anti-PD-1 antibody approved anywhere in the world for cancer treatment," says the complaint, which was filed in the US District Court, for the district of Delaware.

"Merck is threatening to exploit that invention with a later-developed anti-PD-1 antibody," it continues, saying that the imminent launch of Keytruda is "deliberate, wilful, and in reckless disregard of valid patent claims."

For its part, Merck insists that the action is without merit and will not stop it moving ahead with a launch of Keytruda in the US and other markets around the world.

"Merck is confident … that it will not be prevented from doing so by the Ono/BMS patents," it said in a statement.

Article by
Phil Taylor

8th September 2014

From: Regulatory



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