Coherus attempts to dismiss Amgen’s Neulasta suit
Coherus BioSciences has asked a court to dismiss patent infringement allegations brought against it by Amgen.
The biosimilar therapeutic developer told the US District Court for the District of Delaware on Thursday, June 8, that there was “no plausible interpretation under which Coherus would infringe the patent-in-suit”.
Amgen sued Coherus in May, alleging infringement of US patent number 8,273,707, covering its biologic Neulasta (pegfilgrastim), a drug given to patients undergoing chemotherapy.
The complaint was based on the Biologics Price Competition and Innovation Act (BPCIA) and attempted to block the entry of a biosimilar competitor to Neulasta.
Coherus said in its motion: “Coherus is entitled to dismissal because, as a matter of law, its accused manufacturing process does not infringe any claim of the ‘707 patent.”
The BPCIA provides a streamlined process for an applicant, such as Coherus, to obtain Food and Drug Administration approval to market a biosimilar of a reference product.
In August 2016, Coherus filed an abbreviated Biologic License Application (aBLA), seeking authorisation to market a biosimilar of Amgen’s Neulasta.
Coherus said that dismissal at this “early stage is entirely appropriate”.
The company added: “Regardless of whether it would be lawful for Coherus to market pegfilgrastim made with a non-aBLA process, the complaint provides no reason to think that such an eventuality is more than hypothetical.”
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