Yesterday, the Federal Circuit provided much-anticipated guidance on the scope of the America Invents Act’s “on-sale” bar provision. Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., et al., Nos. 2016-1284, 2016-1787...more
5/3/2017
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
On-Sale Bar ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Teva Pharmaceuticals
The Federal Circuit’s recent decision in Amgen Inc. v. Apotex Inc., No. 16-1308, provides new guidance on the timeline of biosimilar approval and the impact to commercial marketing.
The ruling weighed in on a key...more
7/11/2016
/ Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
Generic Drugs ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Preliminary Injunctions
On April 13, 2015, the Inspector General (IG) of the Department of Health and Human Services announced in a letter to Senator Bernard Sanders (I. VT), that it would investigate recent price hikes for generic drugs. Generic...more