The Federal Circuit on Thursday issued an opinion in Amgen v. Sandoz holding that that the Biologics Price Competition and Innovation Act (BPCIA) preempts state-law claims that are based on a biosimilar applicant’s failure to...more
12/18/2017
/ Amgen ,
Biosimilars ,
BPCIA ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preemption ,
Sandoz ,
Sandoz v Amgen
On November 13, The Federal Circuit issued a decision affirming a district court judgment that Apotex did not infringe Amgen’s recombinant protein patent in its abbreviated Biologics License Applications referencing Amgen’s...more
11/22/2017
/ Amgen ,
Apotex ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
Expert Testimony ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
Amgen and Genentech have become embroiled in a novel procedural dispute relating to Mvasi, Amgen’s biosimilar of Genentech’s Avastin (bevacizumab). On October 6, in a complaint filed in the Central District of California,...more
On June 12, 2017, the Supreme Court decided Amgen v. Sandoz, the landmark case about the meaning of the Biologics Price Competition and Innovation Act (BPCIA). First, the Supreme Court held that no federal injunction is...more
6/14/2017
/ Amgen ,
Amgen v Sandoz ,
Biosimilars ,
BPCIA ,
Injunctions ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Sandoz ,
SCOTUS
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
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
Amgen v. Sandoz Biosimilar Litigation Update: Sandoz Follows the Patent Dance With Neulasta -
Prominent among the first generation of U.S. biosimilar litigations under the Biologics Price Competition and Innovation Act...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