gavel-pills-istock-525883642-vnphotolab-
AVNphotolab / iStockphoto.com
12 June 2017Americas

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.”

More news: SCOTUS allows early notice from biosimilar makers Disagreement on SCOTUS Amgen v Sandoz ruling QXMédical seeks declaration of non-infringement Eli Lilly pays $55m for diabetes treatments PTAB awards victory to Bass in Diprivan IPR Foley & Lardner hires new partner in New York

Did you enjoy reading this story?  Sign up to our free newsletters and get stories like this sent straight to your inbox.


More on this story

Americas
30 July 2019   California-based Amgen is barred from succeeding on its patent infringement claim against Coherus Biosciences, according to the US Court of Appeals for the Federal Circuit.
Big Pharma
4 February 2021   Coherus Biosciences has signed a deal with Chinese biopharmaceutical company Shanghai Junshi Biosciences for the development and commercialisation rights to toripalimab, Junshi’s PD-1 inhibitor, in the US and Canada.

More on this story

Americas
30 July 2019   California-based Amgen is barred from succeeding on its patent infringement claim against Coherus Biosciences, according to the US Court of Appeals for the Federal Circuit.
Big Pharma
4 February 2021   Coherus Biosciences has signed a deal with Chinese biopharmaceutical company Shanghai Junshi Biosciences for the development and commercialisation rights to toripalimab, Junshi’s PD-1 inhibitor, in the US and Canada.