Big Molecule Watch
July 28, 2016

Amgen’s Neulasta Declaratory Judgment Action Dismissed in District of New Jersey

On July 22, 2016, the District Court for the District of New Jersey granted Sandoz’s motion to dismiss Amgen’s declaratory judgment action related to Sandoz’s biosimilar of Amgen’s Neulasta (pegfilgrastim).

As background,  Sandoz provided Amgen with required disclosures related to its pegfilgrastim biosimilar under § 262(l)(2) and (l)(3)(B) then sent Amgen a letter waiving receipt of Amgen’s detailed statement under (l)(3)(C) and declining to engage in the negotiations described in (l)(4) and (l)(5).  Sandoz also asserted that Amgen was required to file suit within 30 days of receipt of Sandoz’s letter to comply with (l)(6).  Amgen filed a complaint in the District of New Jersey in March seeking declaratory judgment related to the consequences of Sandoz’s alleged failure to comply with the BPCIA’s information exchange provisions.  After Amgen filed its complaint, Sandoz restarted the patent dance by sending a letter to Amgen requesting Amgen’s (l)(3)(C) statement.  Amgen complied, the parties completed the negotiations described in the BPCIA, and Amgen filed an infringement suit pursuant to (l)(6) in the Northern District of California on May 12, 2016.

Sandoz moved to dismiss the District of New Jersey action, asserting that Amgen’s Complaint failed to present a “justiciable case or controversy.” The court granted the motion, stating “any declaratory relief the Court grants on this issue would not impact Sandoz’s behavior in the dispute currently before this Court, because Sandoz already completed the (l)(4) step of the BPCIA with respect to its pegfilgrastim product, and the parties agreed to waive the (l)(5) step.  There is no concrete dispute left for the Court to decide as to the information exchange steps of the BPCIA, based on the facts presented here.”

Furthermore, the court determined that it would “violate the clear prohibition on the issuance of advisory opinions” to grant Amgen’s requests for declarations related “to (1) the consequences of Sandoz’s failure to comply with the information exchange provisions; and (2) which remedies should be available to an RPS in Amgen’s position.”

The court declined to rule on whether a case or controversy existed between the parties at the time that Amgen filed its complaint.

Stay tuned to Big Molecule Watch for more biosimilars litigation analysis.