Forty years ago, Congress passed the Hatch-Waxman Act, which streamlined the generic drug approval process and revamped how patent infringement claims would be litigated against those prospective generic drug applicants. At...more
12/19/2024
/ Abbreviated New Drug Application (ANDA) ,
Competition ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Policy Statement
Federal Circuit Allows Teva Patents to Remain in Orange Book. -
The Federal Circuit recently granted Teva Pharmaceutical’s motion for a stay of removal of its patents from the Orange Book in its ongoing dispute with...more
8/1/2024
/ Antitrust Litigation ,
Class Action ,
Consumer Protection Laws ,
Distributed Ledger Technology (DLT) ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Health Insurance ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pharmacy Benefit Manager (PBM) ,
Sherman Act ,
Teva Pharmaceuticals ,
The Clayton Act
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
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
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
Today, as part of the Trump Administration's stated goal to lower drug prices, the Food and Drug Administration (FDA) published a list of pharmaceutical companies that have allegedly refused to sell samples of their drugs to...more
On Sept. 28, 2016, in Mylan Pharmaceuticals Inc. v. Warner Chilcott Public Limited Co. (Doryx), the Third Circuit affirmed the lower court’s grant of summary judgment rejecting antitrust claims brought against Warner Chilcott...more