Amgen Files Lawsuit Against Sandoz Over Patent Infringement

Amgen is suing generics maker Sandoz, claiming that Sandoz’s attempts to market a biosimilar for the blockbuster bone marrow drug Neulasta infringes on two of its patents for the drug.

According to the three-count suit filed in U.S. District Court for the Northern District of California, Sandoz submitted an aBLA to the FDA for its biosimilar pegfilgrastim before two patents on Neulasta expired in October, thereby violating the Biologics Price Competition and Innovation Act.

The first patent concerns a method for purifying proteins also used in manufacturing biological products, while the other covers production and development of the biological product. If Sandoz is permitted to market the drug, Amgen contends it will further violate the patents.