News & Analysis as of August 10, 2025

Orange Book

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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +

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

Fish & Richardson on 3/4/2025

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

The Most Interesting Appellate Cases of 2024

Fish & Richardson on 2/11/2025

Appellate courts issued a variety of notable intellectual property (IP) cases in 2024, including cases touching on Orange Book listings, extraterritoriality, willful infringement, design patent obviousness, and public...more

Hatch-Waxman Overview

Axinn, Veltrop & Harkrider LLP on 6/14/2024

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

District of Delaware Finds Non-Orange Book-Listed Patents Subject to the Same Pleading Standard as Listed Patents in ANDA...

Fish & Richardson on 10/31/2023

As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more

10 Years after Actavis, the Cases that Follow Tell a Story

Haug Partners LLP on 10/11/2023

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

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