Under Section 262(l)(8)(A) of the BPCIA, a biosimilar maker must provide notice to the reference product sponsor 180 days before the date of first commercial marketing of the biosimilar. ...more
Today, Judge Gregory Sleet of the U.S. District Court of Delaware orally dismissed Genentech’s lawsuit against Amgen alleging violations of the BPCIA. Judge Sleet did not issue a written opinion, but his order states that...more
3/2/2017
/ Amgen ,
BPCIA ,
Commercial Marketing ,
Discovery Disputes ,
Dismissals ,
Exclusive Remedy ,
Genentech ,
Generic Drugs ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Written Notice
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
Last week, the Solicitor General submitted its brief in Amgen v. Sandoz, arguing that the Supreme Court should review and decide in Sandoz’s favor both questions presented by the parties’ cross-petitions for certiorari. Two...more
12/14/2016
/ Amgen v Apotex ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Cross Motions ,
Denial of Certiorari ,
Notice Requirements ,
Patent Dance ,
Petition for Writ of Certiorari ,
Sandoz v Amgen ,
SCOTUS ,
Solicitor General
With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more
10/26/2016
/ AbbVie ,
Amgen ,
Amgen v Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Celltrion ,
Commercial Marketing ,
Generic Drugs ,
Hospira ,
Motion for Summary Judgment ,
Notice Requirements ,
Obviousness ,
Patent Dance ,
Patent Infringement ,
Patent Invalidity ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Sandoz v Amgen
Among the first generation of biosimilar litigation under the Biologics Price Competition and Innovation Act (BPCIA) is a dispute between Amgen and Apotex over Apotex’s proposed biosimilar versions of Amgen’s Neupogen...more
Amgen and Hospira have fired off dueling letters to the court in their litigation over Amgen’s Epogen biosimilar, debating whether the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009...more
7/13/2016
/ Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hospira ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Private Right of Action
Yesterday, the Federal Circuit decided Amgen v. Apotex, No. 2016-1308 (Fed. Cir. July 5, 2016), its second decision interpreting the U.S. biosimilar statute, the Biologics Price Competition and Innovation of Act of 2009...more
7/6/2016
/ Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz v Amgen
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
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