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
The recently reversed jury verdict and billion-dollar judgment in favor of Juno Therapeutics on the grounds that the asserted claims did not satisfy the written description requirement of 35 U.S.C. § 112. See Juno...more
11/18/2021
/ Intellectual Property Protection ,
Inventions ,
Life Sciences ,
Patent Applications ,
Patent Litigation ,
Patent Prosecution ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO ,
Written Descriptions
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 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
The presidential administration may have changed, but the legislative branch remains focused on issues relating to patient access to drugs. One of these efforts includes P.L. 117-8, the Advancing Education on Biosimilars Act...more