On December 9, a federal district court in Florida issued a preliminary injunction prohibiting Apotex from selling a proposed biosimilar version of Amgen’s cancer drug Neulasta for 180 days after the biosimilar is approved. ...more
This fall marks the tenth anniversary of the effective date of the European Medicines Agency’s Guideline on Similar Biological Medicinal Products. As this blog noted previously, the EU’s biosimilar pathway both preceded the...more
Last month, a divided panel of the Federal Circuit issued a split decision in Amgen v. Sandoz (summary; opinion). Amgen (in which Patterson Belknap represented one of the amici supporting Amgen) is the court’s first decision...more
8/31/2015
/ Amgen ,
Appeals ,
Biologics ,
BPCIA ,
Commercial Marketing ,
Declaratory Relief ,
Mootness ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Preliminary Injunctions ,
Remedies ,
Sandoz ,
Sandoz v Amgen
In its January 2015 decision, Teva Pharms. USA, Inc. v. Sandoz, Inc., the Supreme Court held that the ultimate construction of a patent claim term is a question of law, subject to de novo appellate review, but that the...more
On June 3, the parties in Amgen v. Sandoz presented oral arguments to the Federal Circuit as part of their dispute over the Biologics Price Competition and Innovation Act (BPCIA). The appeal is focused on two questions:...more
6/13/2015
/ Amgen ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Injunctions ,
Oral Argument ,
Patent Dance ,
Sandoz v Amgen ,
TRO
Yesterday the Federal Circuit granted Amgen’s motion for an injunction pending appeal in Amgen v. Sandoz, the first appeal to squarely address the patent litigation provisions of the Biologics Price Competition and Innovation...more
After a series of preliminary skirmishes, the first full-fledged litigation under the Biologics Price Reduction and Innovation Act is Amgen’s lawsuit against Sandoz concerning Sandoz’s Zarxio, a biosimilar version of Amgen’s...more
On June 25, 2014, the United States Supreme Court decided ABC v. Aereo, one of the more important (and most closely watched) copyright cases of the digital era. The Court’s 6-3 decision that streaming-TV startup Aereo...more