Key Takeaways -
Regulatory Relief for U.S. Manufacturing: The EO streamlines FDA and EPA processes to encourage domestic pharmaceutical production....more
Synopsis:
In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera,...more
Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more
7/9/2024
/ Biosimilars ,
Biotechnology ,
FDA Approval ,
Generic Drugs ,
Hatch-Waxman ,
Life Sciences ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Product Labels
In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in...more
3/26/2024
/ Antitrust Provisions ,
Biologics ,
Department of Justice (DOJ) ,
Federal Rule 12(b)(6) ,
Federal Trade Commission (FTC) ,
Inventions ,
Inventors ,
Life Sciences ,
Motion to Dismiss ,
Novartis ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Regeneron ,
Sherman Act ,
Walker Process Claims