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Hatch-Waxman Federal Trade Commission (FTC) Today's Popular Updates

Fish & Richardson

Recent Decisions and FTC Challenges Dictate Caution When Listing Patents in the Orange Book

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In October 2023, Teva Pharmaceuticals filed a patent infringement lawsuit against Amneal Pharmaceuticals alleging that their generic version of Teva’s ProAir® HFA inhaler infringed upon the asserted claims of U.S. Patent Nos....more

Axinn, Veltrop & Harkrider LLP

Hatch-Waxman Overview

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more

WilmerHale

Unprecedented State Law on Pharmaceutical “Reverse Payments” Goes Into Effect

WilmerHale on

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

Jones Day

Antitrust Alert: New Law Requires Disclosure of Biologic Patent Settlement Agreements to Antitrust Authorities

Jones Day on

Last week, the Patient Right to Know Drug Prices Act ("Act") became law. The Act requires pharmaceutical companies to disclose to antitrust agencies agreements between biologic and biosimilar companies that relate to the...more

Cooley LLP

Alert: FTC Challenges "No-AG" Agreement as Illegal Reverse Payment

Cooley LLP on

On March 30 the US Federal Trade Commission filed suit in federal court alleging that settlements of patent litigation in the pharmaceutical industry in which a pioneer firm agrees not to market an "authorized generic"...more

BakerHostetler

FTC’s Latest “Pay for Delay” Action Focuses on Noncash “Payments” and New “Product Hopping” Theory of Harm

BakerHostetler on

The Federal Trade Commission (FTC) filed an antitrust complaint this week against Endo Pharmaceuticals and several generic companies, alleging that these companies entered into anticompetitive “reverse payment” settlements of...more

Robins Kaplan LLP

Jumping Into The Actavis Briar Patch — Insight Into How Courts May Structure Reverse Payment Antitrust Proceedings And The...

Robins Kaplan LLP on

In This Issue: - INTRODUCTION - WHAT ARE REVERSE PAYMENT SETTLEMENT AGREEMENTS? ..The Basic Framework of Hatch-Waxman Litigation ..The Federal Trade Commission’s View of Reverse Payment Settlements and Its...more

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