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Pay-For-Delay Generic Drugs Prescription Drugs

A&O Shearman

European Commission sanctions first ever pharmaceuticals cartel and scores victory in pay-for-delay appeal

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The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more

Wilson Sonsini Goodrich & Rosati

Jury Finds Gilead and Teva Did Not Engage in an Anticompetitive Pay-for-Delay Scheme for HIV Drugs

On June 30, 2023, a jury in the Northern District of California found Gilead and Teva not liable in a trial accusing the companies of engaging in an illegal reverse payment to delay generic versions of two HIV drugs, Truvada...more

Robins Kaplan LLP

[Webinar] Health Care Antitrust Under President Biden 2.0 - Almost One Year In: What Have We Learned About The Democrats’ Approach...

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In March 2021, our experienced intellectual property, antitrust, and health care litigation lawyers shared some predictions on antitrust policy and enforcement in the health care sector. In “Health Care Antitrust under...more

Hogan Lovells

The Court of Justice of the European Union provides clarifications on the assessment under competition law of pay-for-delay deals...

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On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more

WilmerHale

Unprecedented State Law on Pharmaceutical “Reverse Payments” Goes Into Effect

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A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more

McGuireWoods Consulting

Pay for Delay Passes House of Representatives for First Time

As Congress focuses on how to drive down drug prices, there is bipartisan support for prohibiting reverse payment agreements, also known as “pay-for-delay” arrangements. These arrangements involve a brand-name pharmaceutical...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

Jones Day

European Commission Sets its Sights on Allegedly Excessive Drug Prices

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In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more

Carlton Fields

Third Circuit Creates Framework for Analyzing Numerosity

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The Third Circuit recently vacated class certification, granted by the Eastern District of Pennsylvania after nearly a decade of litigation, in an antitrust case alleging that a pharmaceutical company entered into agreements...more

Patterson Belknap Webb & Tyler LLP

District Court Narrowly Defines the Relevant Market in Post-Actavis Pay-For-Delay Suit

On August 8, the District of Connecticut issued a noteworthy ruling on how to approach defining the relevant market definition in a pay-for-delay suit. In In re Aggrenox Antitrust Litigation, 3:14-md-02516 (D. Conn.), three...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

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

Patterson Belknap Webb & Tyler LLP

Lupin Appeals Fine Imposed by European Commission in “Pay-For-Delay” Crackdown

In July of this year, the European Commission imposed fines on French pharmaceutical company Servier and five generic drug makers, including Lupin Ltd., totaling €427.7 million. The fines were the result of a five-year...more

McDermott Will & Emery

Pay-for-delay to Stay FTC’s Top Priority

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In a recent interview, Federal Trade Commission (FTC) Bureau of Competition chairwoman Deborah Feinstein announced that targeting pay-for-delay arrangements by pharmaceutical companies would continue as a top priority for the...more

Morgan Lewis

FTC v. Actavis, Inc. Q&A: Implications for Pharmaceutical Companies

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On June 17, 2013, in FTC v. Actavis, Inc., the U.S. Supreme Court ruled that plaintiffs may bring antitrust suits against so-called “reverse payment” or “pay-for-delay” settlements, under which pioneer and generic...more

Bracewell LLP

High Court Finds Antitrust Scrutiny Applies to Pay-for-Delay Settlements

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On June 17, 2013, the U.S. Supreme Court determined that the Federal Trade Commission’s (FTC) antitrust challenge to a reverse payment settlement agreement between drug manufacturers, otherwise known as a “pay-for-delay”...more

Mintz

Supreme Court Holds That Reverse Payment Patent Settlements Are Subject to Antitrust Scrutiny

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For over a decade, the antitrust enforcers at the Federal Trade Commission have challenged the type of patent settlement where a brand-name drug manufacturer pays a prospective generic manufacturer to settle patent...more

BakerHostetler

Federal Trade Commission v. Actavis, Inc. et al. – Supreme Court Holds Reverse Payment Settlement Agreements to be Analyzed under...

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On June 17, 2013, the Supreme Court of the United States ruled 5-3 in favor of the Federal Trade Commission and issued its long-awaited decision in Federal Trade Commission v. Actavis, Inc. et al. 570 U.S. __ (2013), Slip Op....more

McDermott Will & Emery

“Reverse Payment” Settlements Subject to Greater Antitrust Scrutiny: Implications of Supreme Court FTC v. Actavis Ruling

McDermott Will & Emery on

By rejecting the “scope of the patent” test and holding that reverse payment patent settlements “can sometimes violate the antitrust laws,” the Supreme Court of the United States subjects such settlements to greater antitrust...more

Foley & Lardner LLP

Supreme Court Applies Antitrust Scrutiny to ANDA Reverse Payment Settlement Agreements

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In Federal Trade Commission v. Actavis, Inc., the Supreme Court held that reverse payment (“pay-for-delay”) settlement agreements made in the context of settling Hatch-Waxman ANDA litigation should be evaluated for antitrust...more

Troutman Pepper

Drug Company Patent Settlements Subject To Rule Of Reason Antitrust Scrutiny

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This week, the Supreme Court announced that “reverse payment” settlements of patent litigation between branded and generic pharmaceutical companies are, when challenged in a subsequent antitrust case, to be judged under the...more

Wilson Sonsini Goodrich & Rosati

FTC v. Actavis: "Reverse Payments"—Not Presumptively Lawful, Not Presumptively Unlawful, But Subject to a Rule-of-Reason Analysis

On June 17, 2013, after years of litigation in the lower courts, the United States Supreme Court issued its long-awaited decision in FTC v. Actavis. The 5-3 decision, however, did not have a clear winner, and the case was...more

Perkins Coie

Supreme Court Issues Significant Patent Antitrust Decision Rejecting The “Scope Of The Patent” Rule

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In the most significant patent antitrust decision in decades, Federal Trade Commission v. Actavis, Inc., No. 12-416, 2013 WL 2922122 (June 17, 2013), the Supreme Court has held, by a 5-3 vote with Justice Alito recused, that...more

Morrison & Foerster LLP

Supreme Court Holds that “Reverse Payment” Patent Settlements are Subject to Potential Antitrust Condemnation, but only After...

SUMMARY OF DECISION - In FTC v. Actavis, Inc., 570 U.S. ____ (Slip Op. June 17, 2013), the Supreme Court addressed for the first time the underlying antitrust merits of the Federal Trade Commission’s long-running...more

McDonnell Boehnen Hulbert & Berghoff LLP

U.S. Supreme Court Rules That “Reverse Payment” Settlements in ANDA Litigation Are Not Presumptively Unlawful But Must Be Assessed...

The Supreme Court ruled 5-3 on June 17, 2013 in favor of the Federal Trade Commission in FTC v. Actavis. Writing for the majority that included Justices Kennedy, Ginsburg, Sotomayor and Kagan, Justice Breyer’s opinion...more

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