News & Analysis as of

Supreme Court of the United States Generic Drugs Patent Litigation

The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary... more +
The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary with only a limited number of cases granted review each term.  The Court is comprised of one chief justice and eight associate justices, who are nominated by the President and confirmed by the Senate to hold lifetime positions. less -
Proskauer - Minding Your Business

The Broad Impact of Edwards v. Meril on the Safe Harbor Provision

The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more

McDermott Will & Emery

Pay for Delay Is Sometimes Okay

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The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a...more

Axinn, Veltrop & Harkrider LLP

Large and Unjustified: Second Circuit Clarifies Pleading Requirements in Reverse Payments Cases

On May 13—and more than ten years after Federal Trade Commission v. Actavis, the leading U.S. Supreme Court case on reverse payment settlements—the Second Circuit for the first time weighed in on whether (and how) antitrust...more

Foley Hoag LLP

The Fate of the Skinny Label: Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC

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On May 15, 2023, the Supreme Court denied certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC et al., a case some argued had enormous implications for so-called “skinny labeling” practices amongst generic drug...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

McDonnell Boehnen Hulbert & Berghoff LLP

FTC Prevails in Reverse Payment Case

The Federal Trade Commission (FTC) spent the better part of a decade attacking the practice of innovator drug companies settling ANDA litigation by providing payments to generic applicants challenging the validity of Orange...more

The Volkov Law Group

Super Moon Harkens Low Tide for Hatch-Waxman Patent Disputes

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This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...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

Fenwick & West Life Sciences Group

Will the Supreme Court Review Whether FDA-Mandated Bioequivalence Testing to Maintain Approval Falls Within the § 271(e)(1) Safe...

The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...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

Patterson Belknap Webb & Tyler LLP

Turing, Daraprim, and Refusals to Deal with Generic Manufacturers

Drug company Turing Pharmaceuticals made headlines recently when it reportedly raised the price of Daraprim, used commonly by AIDS patients to fight life-threatening infections, from $13.50 to $750 per tablet. Amidst...more

McDermott Will & Emery

Third Circuit Extends Actavis to Reverse Settlement Agreements Involving Non-Cash Consideration - King Drug Company of Florence,...

Addressing for the first time whether reverse settlement agreements involving non-cash consideration merit antitrust scrutiny, the U.S. Court of Appeals for the Third Circuit reversed the district court, applying the...more

K&L Gates LLP

Third Circuit Says Actavis Not Limited to Cash

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In the first decision by a federal appeals court interpreting the U.S. Supreme Court’s landmark ruling in FTC v. Actavis, the Third Circuit recently held in King Drug Co. of Florence v. SmithKline Beecham Corp. that so-called...more

Robins Kaplan LLP

Shire Development, LLC v. Watson Pharms., Inc.

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Case Name: Shire Development, LLC v. Watson Pharms., Inc., 787 F.3d 1359 (Fed. Cir. June 3, 2015) (Circuit Judges Prost, Chen, and Hughes presiding; Opinion by Hughes, J.) (Appeal from S.D. Fla., Middlebrooks, J.) - Drug...more

Robins Kaplan LLP

Teva Pharms. USA, Inc., v. Sandoz, Inc.

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Case Name: Teva Pharms. USA, Inc., v. Sandoz, Inc., Fed. Cir. Nos. 2012-1567, -1568, -1569, -1570, 2015 U.S. App. LEXIS 10229 (Fed. Cir. June 18, 2015) (Circuit Judges Moore, Mayer, and Wallach presiding; Opinion by Moore,...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

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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