I. Introduction -
No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...more
10/11/2023
/ Abbreviated New Drug Application (ANDA) ,
Anti-Competitive ,
Antitrust Litigation ,
AstraZeneca ,
Causation ,
Food and Drug Administration (FDA) ,
FTC v Actavis ,
Generic Drugs ,
Hatch-Waxman ,
Motion to Dismiss ,
Orange Book ,
Pharmaceutical Industry ,
Popular ,
RanBaxy ,
Reverse Payment Settlement Agreements ,
SCOTUS ,
Settlement
For nearly a decade, the Supreme Court’s FTC v. Actavis decision has guided pharmaceutical litigators and advisors exploring the antitrust risks inherent in settling pharmaceutical patent lawsuits, especially when such...more
3/3/2022
/ Anti-Competitive ,
Biosimilars ,
Dormant Commerce Clause ,
Federal Trade Commission (FTC) ,
FTC v Actavis ,
Hatch-Waxman ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reverse Payment Settlement Agreements
The Federal Trade Commission (“FTC”) sued AbbVie and Besins Healthcare, co-owners of a patent that covered brand AndroGel, in 2017. The FTC claimed that the manufacturers had brought “sham” patent infringement litigation in...more
10/20/2021
/ Abbreviated New Drug Application (ANDA) ,
AbbVie ,
Antitrust Violations ,
Federal Trade Commission (FTC) ,
FTC Act ,
Hatch-Waxman ,
Monopolization ,
Noerr-Pennington Doctrine ,
Patent Infringement ,
Petition for Writ of Certiorari ,
Reverse Payment Settlement Agreements ,
Sham Litigation Exception ,
Teva Pharmaceuticals
On February 3, 2020, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement announcing their plans to collaborate in promoting competitive biological product markets and...more
2/10/2020
/ Antitrust Violations ,
Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Citizens Participation Acts ,
Competition ,
Drug Pricing ,
Expedited FDA Approval ,
False Statements ,
FDA Approval ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Joint Statements ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reverse Payment Settlement Agreements