In borrowing a page from the '80s band "Men Without Hats," on June 12, 2017, the U.S. Supreme Court brought greater certainty for both biosimilar applicants and originator companies. In Sandoz Inc. v. Amgen Inc., the Supreme...more
7/19/2017
/ Amgen ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Relief ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Remedies ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims
Biosimilars Around the World -
Last month’s Supreme Court ruling in Sandoz v. Amgen brought greater certainty to both biosimilar applicants and originators in the United States. The July 2017 issue of Sterne Kessler’s...more
In Sandoz Inc. v. Amgen Inc., the Supreme Court brought greater certainty to two key issues relating to the “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA). First, the Court held that where a...more
6/13/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims ,
Unfair Competition
The Court of Appeals for the Federal Circuit yesterday heard oral arguments on the applicability and interpretation of two key provisions of the Biologics Price Competition and Innovation Act (BPCIA). Briefly, oral argument...more
6/5/2015
/ Amgen ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Exclusive Remedy ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Oral Argument ,
Sandoz ,
Sandoz v Amgen ,
Statutory Interpretation
The Federal Circuit yesterday granted Amgen’s motion for a preliminary injunction to keep Sandoz’s biosimilar form of Neupogen off the market until the Court renders its decision on the merits of the appeal. The parties had...more
On April 14, 2015 the Biotechnology Industry Organization (BIO) filed an amicus curiae brief with the Court of Appeals for the Federal Circuit1 in support of remand or reversal of the Amgen v. Sandoz lower court’s ruling that...more
On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more
3/23/2015
/ Amgen ,
Biologics ,
BPCIA ,
Commercial Marketing ,
Conversion ,
Dismissals ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
Unfair Competition