Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a...more
4/12/2016
/ Amgen ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Injunctive Relief ,
Notice Requirements ,
Patent Litigation ,
Petition for Writ of Certiorari ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
Although Sandoz’ application for FDA approval to market a biosimilar version of ENBREL® (etanercept) has yet to be approved, Amgen has brought suit under the Patent Act and Biologics Price Competition and Innovation Act...more
3/4/2016
/ Amgen ,
Biosimilars ,
BPCIA ,
Inter Partes Review (IPR) Proceeding ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
On February 16, 2016, Sandoz, Inc. filed a petition for writ of certiorari to the Supreme Court, asking the Court to overturn the Federal Circuit decision that interpreted the “patent dance” provisions of the Biologics Price...more
2/19/2016
/ Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
Injunctive Relief ,
Patent Dance ,
Patent Litigation ,
Petition for Writ of Certiorari ,
Pre-Market Notification ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product cleared a significant regulatory hurdle on February 9, 2016, when the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee voted 21-3...more
The USPTO Patent Trial and Appeal Board (PTAB) denied institution of two Inter Partes Review challenges brought by Amgen, Inc. against two Humira patents covering stable formulations of anti-human Tumor Necrosis Factor alpha...more
Judge Cohn of the U.S. District Court for the Southern District of Florida has issued another decision interpreting the complicated provisions of the Biologics Price Competition and Innovation Action (BPCIA), ruling that the...more
The Federal Circuit denied the petitions for rehearing en banc filed in Amgen Inc. v. Sandoz Inc., which was the court’s first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA). Perhaps the...more
10/20/2015
/ Amgen ,
Amicus Briefs ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Petition For Rehearing ,
Sandoz ,
Sandoz v Amgen
Amgen has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Apotex, Inc. infringes two of its patents. Although several complaints have...more
8/31/2015
/ Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz v Amgen
In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that...more
7/23/2015
/ Amgen ,
Biosimilars ,
BPCIA ,
Generic Drugs ,
Marketing Exclusivity Periods ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz ,
Sandoz v Amgen
In Amgen v. Sandoz, a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that appears to favor biosimilar applicants...more
7/22/2015
/ Biosimilars ,
BPCIA ,
Generic Drugs ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Sandoz v Amgen ,
Sponsors
The Federal Circuit is set to hear oral arguments in Amgen v. Sandoz on June 3, but in the meantime has granted Amgen’s motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market until...more
Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. The appeal is on an expedited briefing schedule at the Federal...more
Judge Seeborg of the U.S. District Court for the Northern District of California issued an order in Amgen, Inc. v. Sandoz, Inc., ruling that the patent dispute resolution procedures of the Biologics Price Competition and...more
While Sandoz has grabbed the biosimilar headlines for being the first company to have a product approved under the Biologics Price Competition and Innovation Act (its product Zarxio™ (filgrastim-sndz) is a biosimilar of...more
In Sandoz Inc. v. Amgen Inc., the Federal Circuit upheld the district court decision dismissing Sandoz’s declaratory judgment action for lack of jurisdiction. Although this may be the first Federal Circuit decision relating...more