Amgen takes more patent action over Sandoz biosimilar
Amgen has sued Sandoz for allegedly infringing two patents related to cancer drug Neulasta (pegfilgratim), following Sandoz’s plans to sell a biosimilar version of the drug.
The complaint, made to the US District Court for Northern District of California on May 12, alleges infringement of US patent numbers 9,940,878 and 5,824,784. The ‘878 patent covers a method of purifying proteins, while the ‘784 patent covers a biological product composition.
Sandoz was alleged to have infringed the patents when it applied for US Food and Drug Administration approval to engage in the commercial manufacture, use and sale of a biosimilar version of the drug.
Amgen said that the parties began the Biologics Price Competition and Innovation Act’s patent exchange information process, known as the “patent dance”. It was then that Amgen believed that the ’878 and ‘784 patents will be infringed by Sandoz’s biosimilar drug.
Amgen claims that although the ‘784 patent expired in October 2015, the ‘878 patent is valid until October 2031.
The company also sued Sandoz in a separate case for allegedly refusing to engage in conversations about the patents. That case, which concerns the Zarxio (filgrastim-sndz) drug made by Sandoz, could still be heard by the US Supreme Court.
Amgen generated $3.9 billion in US sales from Neulasta in 2015, and remains confident that it will “continue to generate substantial sales and cash flow for years to come even after competitors enter the market”.
