News & Analysis as of

Pay-For-Delay Patents 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

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

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

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

McDermott Will & Emery

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

McDermott Will & Emery on

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

McDermott Will & Emery on

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

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

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

McGuireWoods LLP

More on Patent Settlements Including Litigation at the European Courts

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Last week I posted on the European Commission’s (EC) latest report into patent settlement agreements between originator and generic companies in the European Union (EU). The EC says each time it produces these reports that...more

BakerHostetler

Status of Pay-for-Delay Cases Nearly Two Years After Actavis – “It ain’t over ’til it’s over.”

BakerHostetler on

Nearly two years ago the Supreme Court issued its opinion in FTC v. Actavis, 133 S. Ct. 2223 (2013), holding that a reverse payment made by a brand manufacturer to a generic manufacturer to resolve pending patent litigation...more

Patterson Belknap Webb & Tyler LLP

In re: Nexium Plaintiffs Seek a Permanent Injunction

As we reported earlier, the jury in In re: Nexium found that AstraZeneca had violated the antitrust laws by acting to keep generics off the market but that no generic would have been introduced earlier in the market even...more

Patterson Belknap Webb & Tyler LLP

In re: Nexium Plaintiffs Seek New Trial

As reported previously, the first post-Actavis jury verdict in a “reverse payment” antitrust case handed a win to the defendants. Now, plaintiffs in In re: Nexium (Esomeprazole) Antitrust Litigation have moved for a new...more

Patterson Belknap Webb & Tyler LLP

FTC Issues Report on ‘Pay-for-Delay’ Settlement Volume for FY 2013

The Federal Trade Commission staff recently issued a report detailing the number of “potential pay-for-delay settlements” that took place in fiscal year 2013. The FTC is a staunch opponent of so-called “pay-for-delay”—also...more

Brownstein Hyatt Farber Schreck

Development in Pharma Patent Settlement Lawsuit

In one of the first tests of the Supreme Court’s 2013 ruling in Federal Trade Commission v. Actavis, Inc. addressing the antitrust treatment of pharmaceutical patent settlements, a recent jury on Dec. 5, 2014, returned a...more

Patterson Belknap Webb & Tyler LLP

First Post-Actavis Jury Verdict Goes to Defendants on Causation Question

After six weeks of trial and two days of deliberation, the jury has returned its verdict in favor of the defendants in In re: Nexium. This trial began as a challenge to the allegedly anticompetitive effects of the settlements...more

Patterson Belknap Webb & Tyler LLP

In re: Nexium: Judge Young Denies Defendants’ Motions for a Directed Verdict

Last week, the Nexium district court ruled on defendants’ motions seeking judgment as a matter of law. As we previously reported in several earlier posts, In re: Nexium is the first pay-for-delay case to go to trial since...more

Wilson Sonsini Goodrich & Rosati

India Enters "Pay-for-Delay" Fray: CCI Investigating Pharmaceutical Patent Settlements

India's competition authority, the Competition Commission of India (CCI), has begun scrutinizing and investigating pharmaceutical patent settlement agreements between brand and generic firms for potential anticompetitive...more

McDermott Will & Emery

New IP Enforcement Policy in the EU

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Given that strategic importance of IP-sensitive industries for the EU economy, the European Commission (Commission) has introduced a new initiative with a view to strengthen the protection of EU-based IP rights by working...more

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