On May 14, 2025, HyClone Laboratories, LLC (“HyClone”) filed a Motion to Quash in the U.S. District Court for the District of Utah, seeking to quash Amgen Inc.’s (“Amgen”) subpoena to HyClone issued in Amgen’s denosumab BPCIA case against Accord.
Amgen’s subpoena to HyClone seeks information regarding the full formulations of HyClone’s cell culture media products, the HyClone™ Cell Boost™ 7a Supplement (“CB7A”) and HyClone™ Cell Boost™ 7b Supplement (“CB7B”) (together, “CB7A/B”). In its Motion to Quash, HyClone argues that Amgen’s requests are “overly broad, extraordinarily burdensome, and/or prejudicial,” and that Amgen cannot establish that the full formulations are necessary to Amgen’s patent claims, which only require specific components at specific concentrations.
As we have previously reported, earlier this year, HyClone sought to quash a similar subpoena issued by Amgen issued in the denosumab BPCIA litigation against Fresenius. In that case, Amgen withdrew its subpoena and requested that HyClone withdraw its Motion to Quash. Amgen noted that the parties in the underlying matter, Amgen v. Fresenius, 1:25-cv-01080 (D.N.J.), had filed a stipulation and proposed order dismissing the case, and the Court dismissed the case without prejudice. In view of the settlement, HyClone withdrew its Motion to Quash, and the civil case regarding the subpoena was terminated.
In its recent Motion, HyClone argues that “Amgen is engaged in a second fishing expedition in connection with its patent infringement case against Accord.” Further, HyClone argues that if the Court were to order disclosure of the full CB7A/B formulations, the Court should require an initial “source code”-type inspection, with additional protective measures for any paper production(s) relating to specific components that Amgen’s outside lawyers or experts have identified as relevant to its claims.
Stay tuned to Big Molecule Watch as we continue to monitor key developments in BPCIA litigations and the biosimilars market.