In its July 5, 2016 decision in Amgen v. Apotex, the Federal Circuit interpreted the Biologics Price Competition and Innovation Act (BPCIA) for the second time. The Court reiterated that the BPCIA requires a biosimilar...more
7/7/2016
/ Amgen ,
Apotex ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions
The Federal Circuit, sitting en banc in Akamai Technologies, Inc. v. Limelight Networks, Inc., this week adopted a new standard governing divided infringement under 35 U.S.C. § 271(a). The new standard is likely to enhance...more
8/18/2015
/ 35 U.S.C. § 271(e)(1) ,
Covered Business Method Patents ,
Direct Infringement ,
Divided Infringement ,
En Banc Review ,
Induced Infringement ,
Joint Tortfeasors ,
Limelight v Akamai ,
Patent Infringement ,
Patents ,
Reversal
On July 21, the Federal Circuit interpreted the patent litigation procedures and requirements of the Biologics Price Competition and Innovation Act (BPCIA), including whether a company submitting an abbreviated BLA (“k...more
7/24/2015
/ Biosimilars ,
BPCIA ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Opt-Outs ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Preliminary Injunctions ,
Prescription Drugs
On Monday, in Nautilus Inc. v. Biosig Instruments, the United States Supreme Court unanimously set aside the Federal Circuit’s indefiniteness standard, potentially easing the way for defendants to invalidate ambiguous patent...more