Statute
BPCIA
102 published works
Big Molecule Watch
Genentech and Samsung Bioepis Settle Bevacizumab Biosimilar Patent Dispute
As we previously reported, on June 28, 2020, Genentech, Inc. (“Genentech”) filed a complaint against Samsung Bioepis Co., Ltd. (“Samsung”) in the District of Delaware, alleging infringement of fourteen patents under the BPCIA based…
Big Molecule Watch
Biogen Files Sealed Complaint Against Sandoz and Polpharma Biologics Regarding Natalizumab
By Kevin DeJong
On September 9, 2022, Biogen filed a complaint in the District of Delaware against Sandoz and Polpharma Biologics. Biogen’s complaint is filed under seal. Based on the list of 28…
Big Molecule Watch
Regeneron Files First BPCIA Complaint Regarding Biosimilar Eylea against Mylan in West Virginia District Court
Regeneron filed a complaint yesterday against Mylan in the U.S. District Court for the Northern District of West Virginia, alleging infringement of twenty-four patents under the BPCIA based on Mylan’s submission…
Biosimilars Law Bulletin
Purple Book Update – Regeneron’s EYLEA (aflibercept)
Patents related to Regeneron’s EYLEA (aflibercept) were recently added to the Purple Book. Under the Biological Product Patent Transparency Act, signed into law December 27, 2020 and codified at 42…
Big Molecule Watch
New BPCIA Complaint: Genentech Files Suit Against Tanvex Regarding its Proposed Herceptin Biosimilar
By Kevin DeJong
Genentech filed a complaint yesterday against Tanvex in the U.S. District Court for the Southern District of California, alleging infringement of three patents under the BPCIA based on Tanvex’s submission…
Big Molecule Watch
Litigation and Regulatory Update for Alvotech’s Adalimumab Biosimilar
By Ilana Saltz|Zachariah Holmes
On September 20, 2021, the District Court for the Northern District of Illinois entered a scheduling order in AbbVie v. Alvotech, No. 21-2258, 21-2899 (N.D. Ill.). As we previously reported,…
Biosimilars Law Bulletin
Changes to the Purple Book: Progress in Transparency
The recently enacted “Purple Book Continuity Act of 2019” went into effect as of June 25, 2021. The FDA must proactively update the Purple Book information every 30 days with…
Big Molecule Watch
AbbVie Files Second Suit Against Alvotech For Patent Infringement Under the BPCIA
On May 28, AbbVie brought a second action in the Northern District of Illinois for patent infringement against Alvotech hf. under the BPCIA in connection with Alvotech’s proposed biosimilar version…
Big Molecule Watch
Alvotech Files Suit Against AbbVie to Invalidate Humira Patent Portfolio
On May 11, 2021, Alvotech USA and Alvotech hf (jointly, Alvotech) filed a complaint seeking declaratory judgement against AbbVie Inc. and AbbVie Biotechnology Ltd (jointly, AbbVie) in the Eastern District…
The IP Law Blog
Pfizer and BioNTech Claim Immunity from COVID-19 Vaccine Testing IP Claim
Pfizer and BioNTech recently asked the Southern District of California to dismiss a patent infringement claim from Allele Biotechnology related to Pfizer and BioNTech’s Covid-19 vaccine. Allele holds a patent…