Amgen Files Patent Infringement Lawsuit Over Accord’s Sensipar Generic

Amgen is suing Accord Healthcare and its parent company Intas Pharmaceuticals for alleged infringement of a patent by their generic version of Amgen’s Sensipar (cinacalcet).

In a complaint filed in the District of Delaware, Amgen said it received a May 21 letter from Accord saying it had submitted an ANDA for the generic. The lawsuit seeks a judgment that the Sensipar patent used in Accord’s ANDA is not “invalid, uninfringed and/or unenforceable,” which the letter from Accord contended.

Amgen claims the defendants’ ANDA products, once approved by the FDA, will either directly infringe upon or contribute to the infringement of at least one patent claim and that the company will be “substantially and irreparably harmed.”