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Supreme Court of the United States › Generic Drugs

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

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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

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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

Manatt, Phelps & Phillips, LLP

Supreme Court Will Hear Medication Abortion Case; Three States Ask to Intervene in District Court

Manatt, Phelps & Phillips, LLP on

The Big Picture - On December 13, 2023, the Supreme Court announced its intention to review the August 16 ruling by the Fifth Circuit in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration, et al....more

Axinn, Veltrop & Harkrider LLP

Clarity May Be Around the Corner for Antitrust Scrutiny of Reverse Payment Settlements

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In the ten years since the Supreme Court ruled in Federal Trade Commission v. Actavis that reverse payment settlements—or settlements where a patent holder pays an accused patent infringer cash or other consideration to end...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

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

ArentFox Schiff

Investigations Newsletter: Supreme Court to Hear US Government in FCA Scienter Oral Argument

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Supreme Court to Hear US Government in FCA Scienter Oral Argument - On March 20, 2023, the US Supreme Court agreed to allow the federal government to participate in oral argument in the Supreme Court’s review of the...more

McDonnell Boehnen Hulbert & Berghoff LLP

FTC Prevails in Reverse Payment Case

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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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2020 #2

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Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., Appeal No. 2019-2402 (Fed. Cir. Nov. 5, 2020) - In our Case of the Week, the Federal Circuit addressed a lingering question about venue following the...more

White and Williams LLP

Are We Nearing the End of the ACA?: Return to California v. Texas

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This alert is Part 1 of a three-part series where White and Williams will examine the United States Supreme Court case, California v. Texas. Part 1, below, examines the case in full and how the decision in the case will...more

Faegre Drinker Biddle & Reath LLP

Circuit Does Not Quite Clarify the Supreme Court’s Not-Quite-Clarification of “Clear Evidence” in Albrecht

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The U.S. Supreme Court’s 2019 decision in Merck Sharp & Dohme, Inc. v. Albrecht, 139 S.Ct. 1668 (2019), discussed... addressed impossibility preemption in label change lawsuits. In Albrecht, the Supreme Court purported to...more

Butler Snow LLP

No Way Around It: The Need for Federal "Permission and Assistance" Can Preempt a State Tort Duty

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In the simplest case for federal preemption, federal law prohibits conduct that a state tort duty would require, such as a change in the design of an approved medical device to cure an alleged defect. Because federal law is...more

White & Case LLP

Supreme Court Says America Invents Act Did Not Alter On-Sale Bar

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Squib of Holding and Key Implication: The United States Supreme Court, in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., held on January 22, 2019 that "a commercial sale to a third party who is required to keep...more

Esquire Deposition Solutions, LLC

U.S. IPR Patent Review Process Legality Has Been Upheld

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Houston-based oilfield services company Oil States International, Inc. challenged the legality of inter partes review (IPR), a patent review process that allows the Patent Trial and Appeal Board (PTAB) to hold hearings with...more

A&O Shearman

Reverse Payment Patent Settlements in the Pharmaceutical Industry: A Year in Review

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This past year has seen renewed challenges to reverse payment settlement agreements in the pharmaceutical industry. Since the Supreme Court’s Actavis decision in mid-2013, potentially anti-competitive agreements are...more

Mintz - Health Care Viewpoints

SCOTUS Ruling Gives a Boost to Biosimilars; FDA Continues to Advance Products Through AdComs

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On a sweltering hot D.C. morning, those of us anxiously awaiting the Supreme Court’s opinion in its first case involving biosimilar biological products finally exhaled. The June 12, 2017 opinion followed the parties’ oral...more

The Volkov Law Group

Super Moon Harkens Low Tide for Hatch-Waxman Patent Disputes

The Volkov Law Group on

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

Knobbe Martens

Supreme Court Will Not Review Pay-For-Delay Case over GSK’s Lamictal

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On November 7, 2016, the U.S. Supreme Court declined to review an appeal from a Third Circuit decision finding that a settlement between GlaxoSmithKline (GSK) and Teva Pharmaceutical Industries Ltd. (Teva) involving 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

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...

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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

Perkins Coie

Recent Court Cases Interpreting “Reverse Payments” Post-Actavis

Perkins Coie on

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

Morrison & Foerster LLP - Class Dismissed

Still Waiting—FDA Delays Rulemaking

Morrison & Foerster LLP - Class Dismissed on

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - May 2016

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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

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