The Federal Circuit has spoken. In a per curiam opinion, it denied Valeant’s petition for rehearing by the panel and rehearing en banc. A case watched closely by the biotechnology and pharmaceutical industries, the Federal...more
Last week, Mylan filed a brief in opposition to Valeant’s petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402. In November, a Federal Circuit panel held that venue in Hatch-Waxman...more
Earlier this month, Valeant Pharmaceuticals North America LLC (“Valeant”) filed a petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, arguing that the Federal Circuit panel’s...more
On November 5, 2020, in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where...more
In Amgen’s long-running dispute with biosimilar-maker Sandoz over biosimilar versions of Amgen’s filgrastim (Neupogen®) and pegfilgrastim (Neulasta®) biologics, the Federal Circuit earlier this year affirmed summary judgment...more
In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more
9/26/2017
/ 35 U.S.C. § 271(e)(1) ,
Amgen ,
Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
Damages ,
Food and Drug Administration (FDA) ,
Hospira ,
Intellectual Property Litigation ,
Life Sciences ,
Patent Expiration ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Safe Harbors
When a small pharmaceutical company discovers a new medicine, it’s not uncommon for the company – which may not itself have the resources or infrastructure to get that medicine to patients – to seek a distribution partner...more
5/17/2017
/ Biologics ,
Build America Investment Initiative ,
Food and Drug Administration (FDA) ,
On-Sale Bar ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Teva Pharmaceuticals ,
USPTO
In Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015), a Federal Circuit panel held that Sequenom Inc.’s prenatal diagnosis patent claims patent ineligible subject matter under the two-step test of Mayo...more
9/10/2015
/ BIA ,
Biotechnology ,
DNA ,
En Banc Review ,
European Patent Office ,
Kappos ,
Mayo v. Prometheus ,
Myriad ,
Myriad-Mayo ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Preemption ,
Prometheus ,
SCOTUS ,
Sequenom ,
Trade Secrets ,
WARF
The courts must “say what the law is,” even when that law, as Judge Lourie described the BPCIA, is “a riddle wrapped in a mystery inside an enigma.” Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23,...more
7/22/2015
/ aBLA ,
Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Conversion ,
Dismissals ,
Food and Drug Administration (FDA) ,
Licensing Rules ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
Unfair Competition