In one of the first district court opinions applying the Federal Circuit’s recent GSK decision on induced infringement in the context of label carve-outs, Judge Richard Andrews in the District of Delaware held that plaintiff...more
1/26/2022
/ Amarin ,
Generic Drugs ,
GlaxoSmithKline ,
Induced Infringement ,
JMOL ,
Life Sciences ,
Marketing ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Product Labels
How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for? By way of background, a sponsor can obtain orphan drug...more
On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding...more
8/20/2021
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
Biotechnology ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
GlaxoSmithKline ,
Induced Infringement ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Product Labels ,
Teva Pharmaceuticals
On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). The Executive Order was billed by the White House as “historic” and comparable to Teddy...more
7/28/2021
/ Antitrust Provisions ,
Biden Administration ,
Biologics ,
Biosimilars ,
Competition ,
Executive Orders ,
Generic Drugs ,
Life Sciences ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Agenda ,
Regulatory Reform