Statute
BPCIA
102 published works
Big Molecule Watch
HyClone Seeks to Quash Amgen’s Subpoena Issued in Amgen/Accord Denosumab BPCIA Litigation
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…
Big Molecule Watch
Regeneron, Mylan, and Biocon Settle in Aflibercept BPCIA Litigation
On April 22, 2025, the U.S. District Court for the Northern District of West Virginia entered a Stipulation and Order Vacating Permanent Injunction and Dismissing All Claims and Counterclaims with…
Big Molecule Watch
Amgen and Fresenius Settle Denosumab BPCIA Case
On March 7, 2025, the District Court for the District of New Jersey entered a Stipulation and Order of Dismissal Without Prejudice in view of a settlement agreement between Amgen…
Big Molecule Watch
HyClone Seeks to Quash Amgen’s Subpoena Issued in Denosumab BPCIA Litigation Against Fresenius
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…
Big Molecule Watch
Year in Review: Top Legal Developments of 2024
By Timothy Beavers|Kevin DeJong|Alexandra Lu|Joshua Weinger
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments…
Big Molecule Watch
Are Reference Product Sponsors Asserting More Patents in BPCIA Litigation?
On October 24, 2014, Amgen initiated the first litigation under the Biologics Price Competition and Innovation Act (“BPCIA”), asserting infringement of two patents. Over the last two calendar years, Amgen,…
Big Molecule Watch
Update on Pending Denosumab BPCIA Litigations
There are four pending BPCIA litigations brought by Amgen against biosimilar companies seeking to market denosumab biosimilars. Two of the four cases are pending in the District Court for the…
Big Molecule Watch
Amgen Files BPCIA Complaint Against Fresenius Kabi Regarding Denosumab
By Sam Herron
On October 4, 2024, Amgen filed a BPCIA complaint in the District Court for the Northern District of Illinois Eastern Division against Fresenius Kabi related to Fresenius Kabi’s proposed biosimilar…
Big Molecule Watch
Regeneron Files BPCIA Complaint Against Sandoz Regarding Aflibercept Biosimilar
By Kevin DeJong
On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz’s ENVEEZU (aflibercept-abzv). This is the…
Big Molecule Watch
Eculizumab BPCIA Litigation Update: Court Denies Alexion’s Motion for an Injunction Pending Appeal
By Sam Herron
As we previously reported, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) sued Samsung Bioepis Co. Ltd. (“Samsung”) in January 2024 in the U.S. District Court for…