News & Analysis as of

Pay-For-Delay

McDermott Will & Emery

Pay for Delay Is Sometimes Okay

McDermott Will & Emery on

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

A&O Shearman

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

A&O Shearman on

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

A&O Shearman

ΑG opines that all of Servier’s pay-for-delay deals were restrictions of competition by object

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On 14 July 2022, Advocate General (AG) Kokott delivered her much awaited (non-binding) Opinions in Cases C-176/19 P, Commission v Servier and Others and C-201/19 P, Servier and Others v Commission. ...more

Haug Partners LLP

FTC’s Pharmaceutical Antitrust Suit Over Opioid License Agreement Between Endo and Impax Dismissed Because Patent Act Permits...

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On Wednesday, March 30, 2022, Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia, released a redacted opinion dismissing the Federal Trade Commission’s follow-on antitrust suit regarding Endo...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...

Robins Kaplan LLP on

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

White & Case LLP

HHS Report Reiterates Biden Administration Support for Wide-Ranging Action to Address Drug Prices

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On September 9, 2021, the Department of Health and Human Services ("HHS") released its widely anticipated "Comprehensive Plan for Addressing High Drug Prices." The HHS report supports far-reaching legislative and...more

Latham & Watkins LLP

Biden Executive Order and Policy Shifts Herald Era of Expanded Antitrust Enforcement - Japanese Version

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バイデン政権による競争法の執行強化により、過去の合併の見直しや、新たな報告義務の追 加、テクノロジー、ヘルスケア及び銀行分野など広い範囲の執行などの可能性が生じていま す。 ホワイトハウスは7月9日(金)、包括的な大統領令において独占禁止法上の優先項目を発表しました。 これはバイデン政権が特定した、過去40年間の独占禁止法運用の不備に対処するためのもので、7月12日...more

A&O Shearman

The UK Competition and Markets Authority imposes record fines for excessive pricing and anti-competitive “pay-for-delay”...

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The UK Competition and Markets Authority (CMA) has imposed over GBP260 million in fines on several drug makers for two breaches of competition law: (i) charging excessive and unfair prices, in breach of the Chapter II...more

Latham & Watkins LLP

Biden Executive Order and Policy Shifts Herald Era of Expanded Antitrust Enforcement

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Administration signals greater competition enforcement that could imperil past mergers, impose new reporting obligations, and broadly targets technology, healthcare, and banking sectors. The White House announced its...more

A&O Shearman

Beyond “pay-for-delay” – the EU-Commission’s investigation into patent filing practices and communication measures

A&O Shearman on

On 4 March 2021, the European Commission (Commission) opened a formal investigation into alleged anti-competitive conduct by the pharmaceutical company Teva. The Commission suspects Teva of having deployed a strategy with the...more

McDermott Will & Emery

‘Pay-for-Delay’ Agreements can be Restrictions of Competition by their very Nature

McDermott Will & Emery on

On 25 March 2021 the European Court of Justice (ECJ) dismissed all the appeals brought by Danish pharmaceutical company H. Lundbeck A/S (Lundbeck) and five generic manufacturers against the judgments of the General Court of...more

Hogan Lovells

Pay for delay and document retention - The ECJ‘s Lundbeck decision

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In the much-anticipated Lundbeck case (i.a. C-591/16 P), the European Court of Justice (“ECJ”) on 25th March 2021 confirmed the decision of the European Commission (“Commission”) to impose fines on Lundbeck and several...more

MoFo Life Sciences

Pay-For-Delay Has A Tough (Antitrust) Time At EU Top Court

MoFo Life Sciences on

In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the European Courts. In two recent rulings – “Lundbeck and...more

A&O Shearman

Patent settlements and competition law – guidance from Europe’s top court

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On 25 March 2021, the European Court of Justice (ECJ) ruled for the second time on a “pay-for-delay” settlement. These are settlements of a patent dispute that involve payments or other value transfers from the originator...more

Latham & Watkins LLP

Pay-for-delay: Review of the ECJ judgment in Lundbeck (Citalopram)

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The Court of Justice of the European Union (ECJ) has confirmed that pay-for-delay agreements with generic manufacturers ready to enter the market violate EU antitrust rules. ...more

A&O Shearman

European Commission completes current cycle of pay-for-delay probes with fines imposed on Teva and Cephalon

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On 26 November 2020, the European Commission (Commission) issued a decision fining pharmaceutical companies Teva and Cephalon EUR60.5 million for infringing Article 101 TFEU by agreeing to delay the entry of a cheaper generic...more

McDonnell Boehnen Hulbert & Berghoff LLP

Takeda Pharmaceuticals U.S.A., Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

ANDA litigation, pursuant to the Hatch-Waxman Act, has become more complicated over the years since enactment of the statute in 1984, with more patents being asserted and more parties participating over the opportunity to...more

Patterson Belknap Webb & Tyler LLP

No Antitrust Violations for Creating and Enforcing Humira Patent Thicket

Last month, Judge Manish Shah of the United States District Court of the Northern District of Illinois dismissed an antitrust complaint brought by indirect purchasers of AbbVie’s blockbuster rheumatoid arthritis drug,...more

Mintz - Intellectual Property Viewpoints

AbbVie’s Enforcement of its ‘Patent Thicket’ For Humira Under the BPCIA Does Not Provide Cognizable Basis for an Antitrust...

In a recent decision in In Re Humira (Adalimumab) Antitrust Litigation, No. 19-cv-1873, Judge Shah of the Northern District of Illinois dismissed a consolidated class action complaint filed by U.S. purchasers of AbbVie Inc.’s...more

Skadden, Arps, Slate, Meagher & Flom LLP

Investment in Possible Future Generic Marketing Excludes Legitimate Basis for Pharma Settlement, Suggests EU Advocate General

In her opinion issued on June 4, 2020, Advocate General (AG) Juliane Kokott recommended that the European Court of Justice (ECJ) dismiss in its entirety the appeal by Lundbeck A/S and Lundbeck Ltd against the General Court’s...more

Haug Partners LLP

FDA And FTC To Scrutinize Biologics Competition

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On February 3, 2020, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement announcing their plans to collaborate in promoting competitive biological product markets and...more

Hogan Lovells

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

Hogan Lovells on

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

WilmerHale on

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

White & Case LLP

California's New Reverse Payment Law Departs from Supreme Court Standard in FTC v. Actavis

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On October 7, 2019, California became the first state to enact legislation—Assembly Bill 824 ("AB 824")—rendering certain pharmaceutical patent litigation settlement agreements presumptively anticompetitive. This alert...more

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