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Knobbe Martens

Federal Circuit Review | August 2024

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Specify the Steps of Information Manipulation or Lose under § 101 - In Mobile Acuity Ltd. v. Blippar Ltd. Appeal No. 22-2216, the Federal Circuit held that patent claims that merely recite result-orientated, functional...more

Axinn, Veltrop & Harkrider LLP

FDA After Chevron

Under the Supreme Court's Chevron doctrine, courts will defer to a federal agency's interpretation of an ambiguous statute unless that interpretation is unreasonable. Chevron U.S.A. Inc. v. Natural Resources Defense Council,...more

Haug Partners LLP

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

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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

Hogan Lovells

SCOTUS won’t hear Teva v. GSK: Where does that leave us on FDA labeling carve-outs?

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The Supreme Court of the United States has denied certiorari in the Teva v. GSK “skinny labeling” case, leaving intact the Federal Circuit’s August 2021 decision, which we summarized online here. In the article below, we...more

Foley & Lardner LLP

Supreme Court Won’t Hear Skinny Label Case

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The Supreme Court decided not to grant certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, which has come to be known as the “skinny label” case. That means the Federal Circuit’s August 2021 decision (which was a...more

Foley Hoag LLP

Previewing Generic’s Skinny Label: Supreme Court to Rule on Teva’s Certiorari Petition

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The Supreme Court is expected to consider Teva’s pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the...more

Robins Kaplan LLP

Hatch-Waxman Venue Update: Will SCOTUS Limit Where Brands Can Sue Generics?

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Generic and branded pharma companies alike are waiting with baited breath to see if the U.S. Supreme Court will take up the issue of personal jurisdiction in Hatch-Waxman patent cases this term. After a broad ruling from the...more

Perkins Coie

Recent Court Cases Interpreting “Reverse Payments” Post-Actavis

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Patent settlement agreements were traditionally deemed outside the purview of antitrust scrutiny unless the patent holder’s conduct fell outside the legitimate scope of the patent’s exclusionary power. This all changed when...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - May 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

McDermott Will & Emery

ANDA Update - October 2015

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Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Saul Ewing LLP

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

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Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

Proskauer Rose LLP

First Federal Appellate Court Holds a NonCash Reverse Payment Subject to Antitrust Scrutiny: Is the Third Circuit's Decision in...

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Recently, the Third Circuit issued the first federal appellate decision interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc.[1], potentially greatly expanding the scope of settling parties in reverse...more

K&L Gates LLP

Supreme Court Takes a Pass on Generic Drug Labeling Appeal

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In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more

Robins Kaplan LLP

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

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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

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Denies Certiorari in Momenta Case

The Supreme Court on Monday declined to grant certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, a case involving a split in authority that has arisen among Federal Circuit judges regarding the scope of the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Oral Argument in FTC v. Actavis

The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...more

McDonnell Boehnen Hulbert & Berghoff LLP

Case Brief: Federal Trade Commission v. Watson Pharmaceuticals

[Ed. The Supreme Court heard oral argument today in Federal Trade Commission v. Watson Pharmaceuticals. While Patent Docs will provide analysis regarding the oral argument in a subsequent post, we provide the following...more

Foley & Lardner LLP

Supreme Court to Hear AndroGel Reverse Payment Case

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The Supreme Court granted certiorari in Federal Trade Commission v. Watson Pharmaceuticals, Inc., to address whether and when “reverse payment” agreements made to settle ANDA litigation violate antitrust laws....more

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