Three months after Cytiva subsidiary media supplier HyClone Laboratories filed a motion to quash a subpoena issued to it by Amgen in the context of denosumab BPCIA litigation between Amgen and Fresenius Kabi (subsequently settled), HyClone has filed a similar motion to quash an Amgen subpoena issued in the context of BPCIA patent infringement litigation commenced by Amgen against Accord and Intas. The motion was filed by HyClone on 14 May 2025 in the US District Court for the District of Utah. On 28 May 2025, Amgen filed a motion seeking to have the dispute regarding the subpoena transferred to the District of New Jersey.
HyClone is not a party to the underlying BPCIA litigation, which relates to Accord/Intas’ INTP23, biosimilar to Amgen’s Xgeva® and Prolia® (denosumab). Amgen commenced the BPCIA proceedings against Accord/Intas in November 2024. The proceedings were then centralised in February 2025 in the US District Court for the District of New Jersey with similar BPCIA proceedings Amgen brought against Samsung Bioepis (August 2024) and Fresenius Kabi (October 2024).
Amgen’s subpoena to HyClone requests 32 categories of information, including the full formulations of HyClone’s cell culture media supplements, marketed as HyClone™ Cell Boost™ 7a Supplement and HyClone™ Cell Boost™ 7b Supplement. Amgen alleges that this information is necessary because Accord/Intas infringe certain of its patents (eg. US 7,928,205, US 10,513,723 and US 11,254,963) based on concentrations and ingredients in the cell culture media used by Accord to manufacture its denosumab biosimilar.
HyClone argues that the subpoena should be quashed for a number of reasons, including that the information sought is irrelevant and the request is overly burdensome because it would require the disclosure of trade secrets.
Amgen has settled three of its US denosumab disputes over the last 12 months. A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, from 31 May 2025. Amgen settled its litigation against Celltrion in January 2025, permitting US launch of Celltrion’s denosumab biosimilar, CT-P41, from 1 June 2025. In March 2025, Amgen entered into a global settlement of its patent infringement litigation in relation to Fresenius Kabi’s denosumab biosimilar, allowing US launch of Fresenius’ biosimilar in mid-2025. Amgen’s BPCIA litigation against Accord/Intas and Samsung Bioepis regarding their denosumab biosimilars remains pending.