On July 24, the Department of Justice (DOJ) and Federal Trade Commission (FTC) held the second of three listening sessions focused on competition in the pharmaceutical marketplace as part of the agency's implementation of the...more
7/29/2025
/ Antitrust Provisions ,
Biologics ,
Biosimilars ,
Competition ,
Department of Justice (DOJ) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Healthcare ,
Life Sciences ,
Orange Book ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Warning Letters
On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more
7/2/2025
/ Antitrust Provisions ,
Biosimilars ,
Competition ,
Department of Justice (DOJ) ,
Drug Distribution ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare ,
Intellectual Property Protection ,
Life Sciences ,
Patents ,
Patient Access ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Reform
West Virginia Attorney General (AG) Patrick Morrisey announced a total $17 million settlement agreement with pharmaceutical companies, Pfizer and Ranbaxy after more than a decade of litigation regarding the companies’ alleged...more
1/23/2025
/ Antitrust Violations ,
Competition ,
Drug Pricing ,
Generic Drugs ,
Healthcare ,
Multidistrict Litigation ,
Pay-For-Delay ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Settlement ,
State Attorneys General ,
Unfair Competition ,
Unfair or Deceptive Trade Practices
"Right to Try" legislation, which enables terminally ill patients or patients with a "life threatening disease or condition" to seek access to investigative drugs with little to no oversight from the FDA, has been enacted in...more
4/13/2018
/ Biopharmaceutical ,
Clinical Trials ,
Expanded Access Programs (EAPs) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Life Sciences ,
Patient Access ,
Pharmaceutical Industry ,
Preemption ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Oversight ,
Right to Try ,
Terminal Illness Treatments
To prevail in a product-hopping case, a plaintiff must be prepared to establish both monopoly power and anticompetitive effects.
On September 28, a unanimous panel of the U.S. Court of Appeals for the Third Circuit...more
10/6/2016
/ Anti-Competitive ,
Appeals ,
Generic Drugs ,
Hatch-Waxman ,
Mylan Pharmaceuticals ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Hopping ,
Sherman Act ,
Summary Judgment ,
Warner Chilcott
On December 22, 2014, the Federal Trade Commission (FTC or the Commission) released an overview of pharmaceutical patent settlements filed with the Commission in Fiscal Year 2013 (October 1, 2012–September 30, 2013). The FTC...more
A United States district court judge sitting in the District of New Jersey has held that only patent litigation settlements involving monetary payments from branded to generic pharmaceutical manufacturers are subject to the...more