Biosimilar Applicants Must Provide Notice of Commercial Launch:
What You Need To Know -
Case Background -
In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more
7/7/2016
/ Amgen ,
Apotex ,
Appeals ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Licensing Rules ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions
Recently, the Patent Trial and Appeal Board issued its first set of final written decisions in three inter partes reviews relating to molecules in the large molecule biopharma space (IPR2013-00534, IPR2013-00535 and...more
FDA Publishes "Purple Book" to Catalog Biologics, Interchangeable and Biosimilar Products -
The US Food and Drug Administration (“FDA”) recently published its first “Lists of Licensed Biological Products with Reference...more
On Tuesday, July 23, Knobbe Martens hosted a live webinar event covering "Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework." Partners Eli Loots, Carol Pitzel Cruz, and Sheila Swaroop...more