The Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) for the approval of biosimilar drugs. On...more
6/27/2017
/ Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz v Amgen ,
SCOTUS
BIO, Biologics, and Biosimilars -
The 2017 BIO International Convention began earlier this week, but there are still many sessions and forums still to come. Patent Docs has been highlighting a few sessions or other...more
On May 25, 2017, the FDA's Oncologic Drug Advisory Committee recommended approval of biologics license application ("BLA") 125545 submitted by Hospira Inc., a Pfizer company, for Retacrit, a proposed biosimilar to Amgen...more
In other Supreme Court news from Monday, June 20, 2016, the Court invited the Solicitor General to file briefs in the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals to express the views of the United...more
6/22/2016
/ Amicus Briefs ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Cross-Complaints ,
Declaratory Relief ,
FDA Approval ,
Injunctive Relief ,
IP License ,
Notice Requirements ,
Patents ,
Petition for Writ of Certiorari ,
Popular ,
Sandoz v Amgen ,
SCOTUS ,
Solicitor General
Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 in an effort to bring biosimilar drug products to market. The goal was for the BPCIA to mimic for biologic drugs the Hatch-Waxman statute...more
9/14/2015
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Biologics ,
Biosimilars ,
BPCIA ,
Disclosure Requirements ,
FDA Approval ,
Injunctive Relief ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Sandoz v Amgen
The Federal Circuit heard oral arguments in the Amgen v. Sandoz case on Wednesday, June 3, 2015. The three judges on the panel were Judge Newman, Judge Lourie, and Judge Chen. This case is on appeal from the U.S. District...more
The 2015 BIO International Convention begins in two weeks in Philadelphia. For the past few years, we have provided a series of previews with the goal of making the large amount of information and opportunities available at...more
Earlier this week, the Patent Trial and Appeal Board ("PTAB" or "Board") handed down what is thought to be the first set of inter partes review ("IPR") Final Written Decisions ("FWDs") in the biopharmaceutical industry. And...more
In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more