US court dismisses Amgen biologic patent suit

A Delaware court has dismissed a patent infringement claim brought by Amgen against a biosimilar maker.

On Monday, March 26, District Judge Leonard Stark of the US District Court for the District of Delaware dismissed the claim against Coherus Biosciences.

Amgen had filed the patent lawsuit in May last year, alleging that Coherus had infringed US patent number 8,273,707, which covers a process for purifying proteins.

The clash centred on Amgen’s drug Neulasta (pegfilgrastim). It’s approved by the Food and Drug Administration (FDA) to decrease the incidence of infection in patients receiving myelosuppressive chemotherapy.

Amgen claimed that it had gone through the ‘patent dance’ under the Biologics Price Competition and Innovation Act (BPCIA), which provides a shortened regulatory pathway for biosimilar drugs, with Coherus.

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

According to the claim, Coherus submitted its biologic application in August last year and, within 20 days of receiving notification from the FDA that the drug had been accepted for review, Coherus exchanged the information under the BPCIA.

“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, adding that Coherus had committed an act of infringement when it submitted its application.

But, earlier this week, the Delaware court granted Coherus’s motion to dismiss the claim.

The reasons behind the dismissal were sealed, although the court adopted an earlier report which recommended that the case be dismissed for failure to state a claim.

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