In March this year, Amgen sued Adello Biologics under the BPCIA in the District of New Jersey for infringement of seventeen patents, based on Adello’s submission of an aBLA for a biosimilar of Neupogen® (filgrastim). In October, Amgen filed an amended complaint, reducing the number of asserted patents to four, and naming Amneal Pharmaceuticals as an additional defendant. Amgen alleged in the amended complaint that, although Adello filed the aBLA with the FDA, “Adello entered into a license and commercialization agreement with Amneal on October 1, 2017, and under this agreement, Amneal is responsible for marketing, selling and pricing the Adello Filgrastim Product, while Adello is responsible for development, regulatory filings, obtaining FDA approval, and manufacturing the Adello Filgrastim Product.” Amgen further alleges that Adello is “acting in concert” with Amneal and “intends to commercially launch—commercially manufacture, use, sell, offer for sale, and/or import—the Adello Filgrastim Product upon receiving FDA approval, and prior to the expiration of each of the Asserted Patents.”
Yesterday, December 5, 2018, Amneal moved to dismiss Amgen’s amended complaint as to Amneal on the grounds that the complaint fails to state a claim for which relief can be granted against Amneal, and that the district court lacks subject matter jurisdiction over Amgen’s requests for declaratory relief. According to Amneal, Adello is the only biosimilar manufacturer and applicant in this case and, therefore, the only party accused by Amgen of committing acts of infringement under the BPCIA. Furthermore, Amneal asserts that no case or controversy of sufficient immediacy and reality exists to warrant the issuance of a declaratory judgment against Amneal, because the amended complaint does not allege that Amneal has done or is currently doing anything with respect to Adello’s filgrastim biosimilar candidate, aside from entering into a license and commercialization agreement last year. Alternatively, Amneal requests that the district court in its discretion decline to exercise declaratory judgment jurisdiction so as not to “upend the carefully crafted BPCIA statutory scheme.”
Stay tuned to Big Molecule Watch for further developments. Amgen and Adello are in the early stages of fact discovery, which is scheduled to conclude on August 16, 2019. Expert discovery is scheduled to close on January 20, 2020, but the district court has not yet set dates for trial or the final pretrial conference.