On November 7, 2023, the Federal Trade Commission (FTC) sent notice letters1 to 10 brand drug manufacturers of drug-device combination products, including drugs delivered by asthma inhalers, epinephrine autoinjectors, and...more
On June 30, 2023, a jury in the Northern District of California found Gilead and Teva not liable in a trial accusing the companies of engaging in an illegal reverse payment to delay generic versions of two HIV drugs, Truvada...more
7/6/2023
/ Anti-Competitive ,
Antitrust Litigation ,
Antitrust Violations ,
Generic Drugs ,
HIV ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Reverse Payments
The Seventh Circuit recently confirmed that Actavis is the appropriate framework to assess biosimilar patent settlements, despite the differences in the regulatory structure—the first appellate court ruling on this issue. In...more
On April 13, 2021, the U.S. Court of Appeals for the Fifth Circuit issued an opinion in Impax Laboratories, Inc v. Federal Trade Commission, affirming the Federal Trade Commission's (FTC) unanimous decision that Endo...more
Drug Approval and Patent Listing Process -
Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more
India's competition authority, the Competition Commission of India (CCI), has begun scrutinizing and investigating pharmaceutical patent settlement agreements between brand and generic firms for potential anticompetitive...more