At the end of 2017, inter partes review (IPR) proceedings for biosimilar products were on the rise. 2018 and the first half of 2019, however, have seen a dip in the number of new filings. And looking back at biosimilar IPRs...more
On January 13, 2017, the Supreme Court granted Sandoz’s petition for certiorari and Amgen’s cross-petition in Amgen v. Sandoz, case nos. 15-1039 and 15-1195. The two cases were consolidated, and an hour was allotted for oral...more
1/18/2017
/ Biologics ,
BPCIA ,
Certiorari ,
Commercial Marketing ,
Declaratory Judgments ,
License Applications ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz v Amgen ,
SCOTUS
In August 2015, FDA released a long-awaited draft guidance for the nonproprietary names of biologics and biosimilars. The draft guidance recommends that nonproprietary names for biologic products should consist of the “core”...more
Sandoz has filed a petition for a writ of certiorari in Amgen v. Sandoz, seeking Supreme Court review of the Federal Circuit’s ruling that it could not market Zarxio, its biosimilar version of Amgen’s cancer medicine...more
The U.S. biosimilars statute, the Biologics Price Competition and Innovation Act (“BPCIA”), was enacted in 2010 as part of the Affordable Care Act. Nearly six years later, the number of reported decisions addressing the...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