Search results for Hatch-Waxman

Key Provisions of the Remedy Act and Their Impact on Hatch‑Waxman Litigation

In the United States, both patent law and U.S. Food and Drug Administration (FDA) regulations govern the commercial availability of drug products and any potential periods of marke...

Supreme Court Hears Skinny Label Arguments in Hikma v Amarin, Signaling Impact on Hatch-Waxman Carve-Out Strategy

The Supreme Court heard oral argument on April 29, 2026, in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889), the closely watched skinny-label case for which the...

Hikma Tells Justices Cox Ruling Boosts 'Skinny Label' Case

Hikma Pharmaceuticals USA Inc. told the U.S. Supreme Court on Monday that the justices' recent decision clearing an internet company in a copyright case bolsters the drugmaker's ch...

Supreme Court Hears Oral Argument in Hikma Pharmaceuticals USA, Inc.

Today, the U.S. Supreme Court heard oral argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, a case that could reshape the landscape of pharmaceutical pa...

Court Denies Early Dismissal in Patent Suit Over Generic Cataract Surgery Drug

The filer of an abbreviated new drug application (ANDA) looking to win early dismissal of Hatch-Waxman patent claims faces a steep climb — and a recent decision from the District o...

Court Denies Early Dismissal in Patent Suit Over Generic Cataract Surgery Drug

The filer of an abbreviated new drug application (ANDA) looking to win early dismissal of Hatch-Waxman patent claims faces a steep climb — and a recent decision from the District o...

Pfizer, Dexcel Take Two Patents Off Table For Bench Trial

Drugmaker Pfizer and an Israeli competitor that is seeking to create a generic version of a Pfizer heart medication said Tuesday they have reached an agreement to remove two assert...

Supreme Court Hears Oral Argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc.: Induced Infringement and “Sk...

Yesterday, the U.S. Supreme Court heard oral argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, a case that could reshape the landscape of pharmaceutica...

New ANDA Cases - First Quarter 2026

This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act....By: Robins K...

Doctor’s Orders: The Search for a Workable Pleading Standard in Hikma v. Amarin

Pharmaceutical patent litigators are no strangers to the delicate dance between the Hatch-Waxman Act and 35 U.S.C. § 271(b). On one side of this statutory tightrope lies the Hatch-...

Supreme Court hears ‘skinny labeling’ drug patent infringement case

On April 29, the U.S. Supreme Court held oral arguments in the Hikma v. Amarin “skinny labeling” case, which considers the pleading standard for claims of “active inducement” of pa...

The Skinny on Skinny Labels: The Active Inducement Problem That Patent Practitioners Should Know

On January 16, 2026, the United States Supreme Court agreed to hear Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889), a case that will directly shape the future o...

ANDA Litigation Settlements - First Quarter 2026

This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hat...

FDA’s Fiscal Year 2027 Budget is Chock-Full of Legislative Proposals – Especially on Hatch-Waxman and the BPCIA

By Kurt R. Karst —

Justices Voice Concern that Upholding CAFC’s Hikma ‘Skinny Label’ Ruling Will Harm Generics Industry

The U.S. Supreme Court heard oral arguments today in Hikma v. Amarin, a closely-watched case that in part asks the Justices to weigh in on whether a drugmaker calling its product a...

A Bitter pH-ill to Swallow: Federal Circuit Affirms Mylan’s Win Over Actelion’s Epoprostenol Drug Patents

Last week in Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., the Federal Circuit delivered generic drug maker Mylan Pharmaceuticals Inc. with a notable victory when it...

Hikma, Cipla Cut Deals In Pfizer Heart Drug Patent Case

Hikma Pharmaceuticals PLC and Cipla Ltd. have reached settlements with Pfizer Inc. in a case over the two defendants' efforts to create generic versions of the heart medication Vyn...

Hikma v. Amarin at the Supreme Court: The Parties’ Opening Briefs

In recent years, the Federal Circuit has, with varying levels of agreement, considered what behavior by generic drugmakers constitutes inducement of infringement regarding so-calle...

Hikma v. Amarin at the Supreme Court: The Parties’ Opening Briefs – Part II

In recent years, the Federal Circuit has, with varying levels of agreement, considered what behavior by generic drugmakers constitutes inducement of infringement regarding so-calle...

How Does Orange Book Delisting Affect Ongoing Hatch-Waxman Litigation?

In the wake of the Federal Circuit’s 2024 Orange Book delisting decision in Teva v. Amneal, Hatch-Waxman practitioners have been left to grapple with several unanswered questions....

How Does Orange Book Delisting Affect Ongoing Hatch-Waxman Litigation?

In the wake of the Federal Circuit’s 2024 Orange Book delisting decision in Teva v. Amneal, Hatch-Waxman practitioners have been left to grapple with several unanswered questions....

<![CDATA[Strengthening the Generic Drugs Supply Chain]]>

US Supreme Court weighs case that could hinder cheaper drug manufacturing

By Zara Norman/Medill News Service WASHINGTON — John Bailey said he’s saved tens of thousands of dollars over the last decade by relying on a generic prescription to lower his chol...

Hot Takes: What the Oral Arguments in Hikma/ Amarin Revealed

The Supreme Court heard oral arguments yesterday in Hikma Pharmaceuticals USA v. Amarin Pharma, Inc., a case with broad implications for the generic industry’s practice of “skinny...