September 16, 2016, marked the fourth anniversary of the effective date for the invalidity proceedings before the Patent Trial and Appeal Board (PTAB or Board) created by the America Invents Act (AIA). These new AIA...more
Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar -
The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more
6/7/2016
/ aBLA ,
Amended Regulation ,
America Invents Act ,
Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Community Trademark ,
Declaratory Judgments ,
EU ,
Filing Fees ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Inventions ,
Notice Requirements ,
On-Sale Bar ,
Patent Dance ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Popular ,
Preliminary Injunctions ,
Prior Art ,
Public Use ,
Renewal Fees ,
Sandoz ,
Sandoz v Amgen ,
Trademark Registration ,
Uniform Commercial Code (UCC) ,
USPTO
In March 2015, the FDA approved the first biosimilar application, which was for a follow-on biologic drug of Amgen’s reference product NEUPOGEN® (filgrastim). Yet, before the applicant, Sandoz, could launch its biosimilar...more
6/3/2016
/ aBLA ,
Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen