Second Circuit Affirms “Pay for Delay” Dismissal: On May 13, 2024, the Second Circuit affirmed dismissal of antitrust claims brought by wholesalers, retailers, and employee benefit funds that alleged they overpaid for the...more
5/31/2024
/ Antitrust Provisions ,
Dismissals ,
Fair Value Standard ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Investment Funds ,
Life Sciences ,
Monopolization ,
Orange Book ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Retailers ,
Settlement ,
Wholesale
This week, the FTC continued its intense regulatory focus on pharmaceutical patents listed in the FDA’s Orange Book. As reported in earlier editions of The Interplay, the FTC issued a policy statement in September 2023,...more
5/7/2024
/ Anti-Competitive ,
Antitrust Provisions ,
Class Action ,
Class Certification ,
Competition ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Orange Book ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Settlement Agreements ,
Sherman Act ,
Warning Letters
Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more
4/2/2024
/ AbbVie ,
Antitrust Litigation ,
AstraZeneca ,
Boehringer ,
Class Action ,
CVS ,
Delisting ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
GlaxoSmithKline ,
Hospitals ,
Medical Devices ,
Monopolization ,
Mylan Pharmaceuticals ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Rebates ,
Sherman Act ,
Teva Pharmaceuticals
On December 8, 2021, a federal district court granted a preliminary injunction temporarily enjoining enforcement of the California state law Preserving Access to Affordable Drugs, which attempts to sanction reverse-payment...more
12/14/2021
/ Article III ,
Constitutional Challenges ,
Dormant Commerce Clause ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Prescription Drugs ,
Settlement Agreements ,
Settlement Negotiations ,
State Attorneys General
A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more
1/9/2020
/ Actavis Inc. ,
Anti-Competitive ,
Appeals ,
Biosimilars ,
Burden-Shifting ,
Constitutional Challenges ,
Dormant Commerce Clause ,
Due Process ,
Eighth Amendment ,
Federal Trade Commission (FTC) ,
FTC v Actavis ,
Generic Drugs ,
Hatch-Waxman ,
New Legislation ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Preemption ,
Prescription Drugs ,
Reverse Payment Settlement Agreements ,
Rule-of-Reason Analysis