On February 4, 2025, HyClone Laboratories, LLC (“HyClone”), a cell culture media supplier, filed a Motion to Quash a subpoena issued by Amgen, Inc. (“Amgen”). The underlying subpoena was issued in Amgen’s ongoing denosumab BPCIA litigation against Fresenius Kabi USA, LLC and its affiliates (“Fresenius”) in the District Court for the Northern District of Illinois, to which HyClone is a nonparty. Amgen’s subpoena seeks information surrounding the formulation of HyClone’s cell culture media product, the HyClone™ Cell Boost™ 7a Supplement (“CB7A”).
In its Motion to Quash, HyClone argues that Amgen has not shown the relevance of the full CB7A formulation, and that Amgen’s requests are overbroad and vague. Further, HyClone argues that Amgen’s requests are unduly burdensome because they seek HyClone’s trade secret information. HyClone argues that, if the Court were to order disclosure of the full CB7A formulation, the Court should require an initial “source code”-type inspection, and that any paper production(s) relating to any specific components be subject to a supplemental protective order that would impose additional restrictions, including (1) that the information be produced only on three copies of copy-proof paper per side; and (2) the information is restricted to outside counsel’s eyes only and three experts per side.
Stay tuned to Big Molecule Watch as we continue to monitor key developments in ongoing denosumab litigations and the biosimilars market.