11 July 2016Americas

MSD says Keytruda drug does not infringe Genentech patent

Merck Sharp & Dohme (MSD) has filed a lawsuit against Genentech asking the US District Court for the Central District of California to re-evaluate a patent belonging to Genentech.

MSD claims that Genentech’s US patent number 7,923,221, covering biotechnology used to produce cancer drugs, is invalid and that MSD’s Keytruda (pembrolizumab) and/or bezlotoxumabcancer drugs do not infringe the patent.

The lawsuit was filed on July 7.

The US Food and Drug Administration (FDA) has approved Keytruda, a skin and lung cancer drug, to be marketed and sold in the US.

MSD is further seeking approval from the FDA to market and sell bezlotoxumab in the US, a treatment for prevention of clostridium difficile infection recurrence, an intestinal tract infection.

The FDA has granted priority review for bezlotoxumab and is set to take action on July 23.

MSD said if it marketed and sold Keytruda before the patent belonging to Genentech was ruled on, Merck would be in a position where it could be threatened with a lawsuit by its rival.

It was stated in the complaint: “Without declaratory relief, the threat of suit poses a substantial risk of injury to plaintiff [MSD] as well as the patients, physicians and nurses using Keytruda (pembrolizumab) and/or planning to use bezlotoxumab.”

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