Amgen sets sights on Coherus over biologic drug

Amgen has set its sights on Coherus Biosciences, a biosimilar maker, for allegedly infringing a patent concerning a process for purifying proteins.

The biopharmaceutical company filed its lawsuit at the US District Court for the District of Delaware on Wednesday, May 10, alleging that Coherus had infringed US patent number 8,273,707.

The dispute centres on Amgen’s drug Neulasta (pegfilgrastim), which is approved by the Food and Drug Administration (FDA) to decrease the incidence of infection in patients receiving myelosuppressive chemotherapy.

According to the claim, the parties had gone through the ‘patent dance’ under the Biologics Price Competition and Innovation Act (BPCIA), which provides a shortened regulatory pathway for biosimilar drugs.

The ‘patent dance’ allows parties to address any patent claims while an applied-for drug is being approved by the FDA.

In August last year, Coherus submitted its biologic application to the FDA, the claim said.

Within 20 days of receiving notification from the agency that the drug had been accepted for review, Coherus exchanged the information required under the BPCIA with Amgen.

“This information exchange culminated in the parties’ agreement in April 2017 that the ‘707 patent should be included in an immediate infringement action to be filed by Amgen,” said the suit.

Amgen argued that Coherus had committed an act of infringement when it submitted its application to the FDA.

Unless enjoined by the court, Coherus will infringe the patent by producing the biologic, said Amgen.

The biopharmaceutical company is seeking a ruling that Coherus has infringed and will infringed the patent, as well as damages, injunctive relief and a jury trial.

A spokesperson for Amgen said: "As a developer of both innovative biologics and biosimilars, Amgen supports a science-based, patient-centric, regulatory framework for biosimilars. Amgen believes that the application, review and approval of biosimilars should proceed in compliance with all the provisions of the BPCIA, including the patent provisions."

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