Assertions of obviousness based on prior art references in combination with “routine optimization” by one skilled in the art are common in the chemical and biological fields. The Federal Circuit recently addressed this issue...more
10/10/2018
/ Appeals ,
Biologics ,
Burden-Shifting ,
Chemicals ,
Inter Partes Review (IPR) Proceeding ,
Nonobvious ,
Obviousness ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patents ,
Prior Art ,
Reversal ,
Substantial Evidence Standard
MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC -
(Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley) -
This case arose out of an ANDA litigation between Millennium and a number of generic-drug companies who sought FDA...more
On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more
2/4/2017
/ Amgen ,
Appeals ,
Biologics ,
Biosimilars ,
BPCIA ,
Certiorari ,
Commercial Marketing ,
Cross Motions ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
License Applications ,
Life Sciences ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Remedies ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS