Statute
BPCIA
102 published works
Big Molecule Watch
Amgen, Hikma, and Gedeon Settle Denosumab BPCIA Case
On November 24, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. and Amgen…
Big Molecule Watch
Amgen Files BPCIA Complaint Against Alkem Related to Denosumab Biosimilar
On November 14, 2025, Amgen, Inc. (“Amgen”) launched another BPCIA denosumab litigation when it filed a complaint in the U.S. District Court for the District of New Jersey against Alkem…
Big Molecule Watch
Register Today: Webinar Series: How the BPCIA Is Reshaping Biologics and Biosimilar Patenting Strategies
By Sarah Clarke
Join Michael Siekman, Allegra Padula, and Riley Wyberg as they open our webinar series with “The BPCIA Has Changed How Companies Should Be Protecting Innovative Biologics and Biosimilars—Has Your Company…
Big Molecule Watch
Amgen and Biocon Settle Denosumab BPCIA Case
On September 30, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”) and Biocon Biologics, Inc.,…
Big Molecule Watch
Amgen and Samsung Bioepis Settle Denosumab BPCIA Case
On September 5, 2025, the U.S. District Court for the District of New Jersey entered a Consent Order and Judgment resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”) and…
Big Molecule Watch
Amgen Fires Back with Counterclaims in Aflibercept BPCIA Litigation
By Kevin DeJong|Beth Ashbridge|Darlene Staines
As we previously reported, on June 17, 2025, Regeneron filed a complaint against Amgen under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU, infringes U.S. Patent No. 12,331,099 (“the ’099…
Big Molecule Watch
GENENTECH FILES FIRST PERTUZUMAB BPCIA COMPLAINT AGAINST SHANGHAI HENLIUS AND ORGANON
On August 14, 2025, Genentech, Inc. and Hoffman-La Roche Inc. (together, “Genentech”) filed a BPCIA complaint in the U.S. District Court of New Jersey against Shanghai Henlius Biotech, Inc. and Shanghai Henlius…
Big Molecule Watch
Amgen and Accord BioPharma Settle Denosumab BPCIA Case
On July 16, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen, Inc. (“Amgen”) and…
Big Molecule Watch
Amgen Files BPCIA Complaints Against Biocon, Shanghai Henlius/Organon and Hikma/Gideon Richter Regarding Denosumab Biosimilars
By Yoko Bian
In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC (“Amgen”) filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar. On June 25, 2025, Amgen…
Big Molecule Watch
Regeneron Files Another Complaint Against Amgen in Aflibercept BPCIA Litigation
On June 17, 2025, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed another complaint against Amgen Inc. (“Amgen”) under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU®, infringes U.S. Patent No. 12,331,099 (“the…