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BPCIA
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Biosimilars Law Bulletin
BPCIA Litigation Update: Amgen v. Sandoz in the District of New Jersey
By Paul Macri
As one BPCIA case came to a close in May[1], another got underway. On May 1, 2023, Amgen filed a complaint in the District of New Jersey, accusing Sandoz of…
Biosimilars Law Bulletin
Janssen and Amgen Settle Stelara BPCIA Case
By An Nguyen
On Tuesday, May 23, 2023, Janssen and Amgen settled their case regarding Amgen’s proposed biosimilar to Stelara in Delaware district court.[1] Stelara, also known as ustekinumab, is an anti-IL-12/IL-23 antibody…
Big Molecule Watch
Janssen and Amgen Settle STELARA (Ustekinumab) BPCIA Litigation
By Keith Zullow
We previously reported on Janssen’s complaint alleging that Amgen’s filing of an aBLA for ustekinumab, a biosimilar of STELARA, infringes Janssen patents, and about Janssen seeking a preliminary injunction to…
Big Molecule Watch
Biogen Seeks Preliminary Injunction in Natilizumab BPCIA Litigation – Hearing Scheduled for May 17
In October 2022, we reported that Biogen was seeking a preliminary injunction in its BPCIA case brought in the District of Delaware against Sandoz relating to Sandoz’s proposed multiple sclerosis…
Big Molecule Watch
Regeneron v. Mylan – Update on Aflibercept BPCIA Litigation
As we previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023,…
Big Molecule Watch
Update on Arbutus mRNA Vaccine Patent Litigations
By Elaine Blais
Last week, Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus) filed a complaint for patent infringement in the District of New Jersey against Pfizer, Inc. and BioNTech SE. Arbutus/Genevant…
Big Molecule Watch
Janssen Seeks a Preliminary Injunction in BPCIA Ustekinumab Case Against Amgen
On March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale,…
Big Molecule Watch
Genentech and Tanvex Reach Settlement in Principle in Trastuzumab BPCIA Litigation
By Sam Herron
On January 6, 2023, Genentech and Tanvex reached a settlement in principle to resolve all claims with respect to Genentech’s BCPIA complaint. As we previously reported, Genentech filed a complaint…
Big Molecule Watch
BPCIA Aflibercept Litigation: Regeneron Files 12(c) Motion to Dismiss Mylan’s Counterclaim for Inequitable Conduct
On Friday, December 16, 2022, Regeneron moved to dismiss Mylan’s inequitable conduct defense and counterclaim against two of the six patents asserted in the parties’ BPCIA suit concerning Mylan’s proposed…
Big Molecule Watch
Biogen Seeks a Preliminary Injunction in Natalizumab BPCIA Case Against Sandoz
Biogen seeks a preliminary injunction in its BPCIA case against Sandoz related to Sandoz’s proposed biosimilar of TYSABRI (natalizumab). On October 20, 2022, the Court issued a sealed order on…