On October 11, 2024, Edwards filed a petition for a writ of certiorari with the U.S. Supreme Court. The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe harbor, an infringing act is “solely...more
As we previously discussed, on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device patents in the Food and Drug...more
7/17/2024
/ Antitrust Provisions ,
Class Action ,
Consumer Protection Laws ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Orange Book ,
Patent Infringement ,
Patents ,
Unfair Competition ,
Warning Letters
As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more
3/18/2024
/ Antitrust Violations ,
Biotechnology ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Unfair Competition ,
Warning Letters
On June 2, 2023, drug manufacturer Shire US Inc. and related entity Shire LLC (collectively, “Shire”) asked the Supreme Court to review an Eleventh Circuit ruling involving the interplay between state tort law and FDA...more
On March 29, 2023, the Solicitor General of the United States asked the Supreme Court to review a Federal Circuit judgment in a Hatch-Waxman case between Teva and GSK. In its decision below, the Federal Circuit held that Teva...more