Judge Recommends Dismissal of Suit Over Coherus' Proposed Pegfilgrastim

A Delaware Magistrate Judge has recommended that Amgen’s lawsuit against biosimilar developer Coherus be dismissed. Big Molecule Watch reports that Magistrate Judge Christopher J. Burke made a sealed recommendation that Coherus be granted its motion to dismiss the entire suit, and Coherus expects the District Court to decide in the first quarter of 2018 whether to adopt the recommendation.

Amgen’s original complaint, arising from the Biologics Price Competition and Innovation Act (BPCIA), asserted that Coherus would infringe on 1 or more claims of its US Patent Number 8,273,707 (the so-called ‘707 patent), which relates to a process for purifying a protein by mixing a protein preparation with a solution, if the FDA approved Coherus’ pegfilgratim biosimilar, CHS-1701. Amgen, the maker of the reference pegfilgrastim, Neulasta, claimed that “Coherus is piggybacking on the fruits of Amgen’s trailblazing efforts” in developing the biosimilar product.

In June 2017, Coherus filed its motion to dismiss the BPCIA litigation, saying that Amgen had failed to state a claim on which relief could be granted by the court. After Coherus received a complete response letter from the FDA for CHS-1701 just weeks after filing its motion (and subsequently terminated approximately 30% of its workforce in an attempt to streamline operations and save costs), the company in July moved for a stay of discovery in the case pending the motion to dismiss. The biosimilar developer cited the need to preserve its financial resources in light of the regulatory setback. Amgen, according to Coherus, could “use its vast resources to bankrupt Coherus with unnecessary litigations expenses before Coherus can launch [CHS-1701].”

Coherus has also been defending itself against Amgen in a California state court; in March, the reference pegfilgrastim maker filed a complaint that Coherus had engaged in a “massive conspiracy” to steal trade secrets concerning pegfilgrastim. The lawsuit alleged that Coherus induced Amgen employees to breach confidentiality agreements and to transmit proprietary knowledge to Coherus on stolen USB drives. Coherus rejected the allegations as baseless.

Coherus reports that its development of CHS-1701 is on track for resubmission of its Biologics License Application to the FDA by early 2018. Meanwhile, the biosimilar developer continues phase 3 clinical development of adalimumab (Humira) and etanercept (Enbrel) for the US market, and has begun preclinical activities related to its ranibizumab (Lucentis) biosimilar.