News & Analysis as of

Pay-For-Delay Pharmaceutical Patents

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

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

A&O Shearman on

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

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

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

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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

MoFo Life Sciences

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

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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

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

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

White & Case LLP on

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

Dechert LLP

The Servier Judgment: A Breath of Fresh Air for Pharmaceutical Companies?

Dechert LLP on

On 12 December 2018, the General Court (“Court”) partially annulled the European Commission’s decision of 9 July 2014 in the Servier case and consequently reduced Servier’s fine by more than 30%, from €330.99 million to...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

McDermott Will & Emery

Third Circuit Declines to Send Pay-for-Delay Litigation to Federal Circuit

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Addressing questions of federal jurisdiction, the US Court of Appeals for the Third Circuit ruled that it, and not the US Court of Appeals for the Federal Circuit, had jurisdiction over two consolidated appeals arising from...more

McDermott Will & Emery

ANDA Update - March 2017 Volume 3, Number 1

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Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more

Knobbe Martens

Ranbaxy and AstraZeneca Prevail in Nexium® Pay-For-Delay Case

Knobbe Martens on

On November 21, 2016, the U.S. Court of Appeals for the First Circuit upheld a 2014 jury verdict for AstraZeneca (AZ) and Ranbaxy regarding a 2012 payment of $700 million from AstraZeneca for Ranbaxy to abandon its challenge...more

Carlton Fields

Third Circuit Creates Framework for Analyzing Numerosity

Carlton Fields on

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

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

Manatt, Phelps & Phillips, LLP

FTC Maintains Aggressive Stance Against Pay-for-Delay Deals

A recent complaint filed by the Federal Trade Commission (FTC) indicates that the agency is continuing its aggressive pursuit of agreements between drug manufacturers that delay the entry of generic pharmaceuticals into the...more

McDermott Will & Emery

AbbVie Documents Not Protected by Privilege in FTC Sham Litigation Suit - Federal Trade Commission v. AbbVie, Inc., (E.D. Penn....

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The U.S. District Court for the Eastern District of Pennsylvania ordered AbbVie, Inc. and Besins Healthcare to produce unredacted documents to the Federal Trade Commission (FTC), because the documents were relevant to the...more

Patterson Belknap Webb & Tyler LLP

1st Circuit Joins 3rd Circuit: Non-Cash Reverse Payments Subject to Antitrust Scrutiny

Courts continue to evaluate the degree to which “reverse payments” are permitted post-Actavis. In the latest of these decisions, issued on February 22, 2016, the First Circuit held that non-cash payments may run afoul of the...more

Bryan Cave Leighton Paisner

Large ‘pay for delay’ fine imposed by CMA

On the 12th of February 2016, the UK Competition and Markets Authority (CMA) fined GlaxoSmithKline (GSK) and the successor companies to Alpharma Limited around £45m in total for breaches of Chapter I of the Competition Act...more

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