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Anti-Competitive Generic Drugs

Haug Partners LLP

FTC Issues a Third Round of Warning Letters Over Improper Orange Book Listings

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On May 21, 2025, the Federal Trade Commission (FTC) renewed its efforts to challenge pharmaceutical manufacturers that have allegedly listed patents improperly in the Food and Drug Administration’s (FDA) publication of...more

Rivkin Radler LLP

Cigna Sues Bristol Myers Squibb Alleging Scheme to Block Generic Drug

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Cigna filed a lawsuit on June 24 in Manhattan federal court accusing Bristol Myers Squibb of unlawfully blocking generic versions of its blood cancer drug, Pomalyst, from entering the market. The suit also names Celgene, a...more

Latham & Watkins LLP

Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

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President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more

Cozen O'Connor

AbbVie and Besins Healthcare Settle Oregon Antitrust Allegations Over Testosterone Drug

Cozen O'Connor on

Oregon AG Dan Rayfield settled with AbbVie Inc. and Besins Healthcare, Inc. to resolve allegations that the pharmaceutical companies engaged in anti-competitive conduct relating to the sale of testosterone replacement gel in...more

Foley & Lardner LLP

Federal Circuit Says Proper Orange Book-Listed Patent Must Claim Active Ingredient

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In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...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

Jones Day

DOJ Obtains First Divestitures in a Criminal Antitrust Case

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The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more

The Volkov Law Group

DOJ Settles Criminal Antitrust Charges with Teva and Glenmark for $305 Million

The Volkov Law Group on

The Antitrust Division has been active – like any aggressive prosecution strategy, however, its results have been mixed.  Its record in criminal cases has taken serious hits – a stunning set of losses in the chicken...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

Jones Day

Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending

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Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more

The Volkov Law Group

Taro, Sandoz and Apotex Pay $447.2 Million to Settle False Claims Act Liability for Price-Fixing of Generic Drugs

The Volkov Law Group on

The healthcare industry faces cascading risks – one risk flows to another with compounding financial results.  Three generic drug companies just experienced this cascading liability. ...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 & Schulte

Fourth Circuit Breathes New Life into Monopolization Suit

The US Court of Appeals for the Fourth Circuit revived an antitrust suit alleging that a pharmaceutical manufacturer illegally maintained its monopoly for its innovator drug by precluding competition beyond the expiration...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

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

Cadwalader, Wickersham & Taft LLP

State Attorney General Insider – Winter 2020-2021, Issue No. 3: Notable Cases

Notable Cases - Here are a few of the major cases of interest within the state Attorneys General community that are receiving significant press coverage. ...more

White & Case LLP

Court of Justice ruling in Paroxetine

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The European Court of Justice's ruling in Paroxetine, handed down in record time just before Brexit, confirms the narrow interpretation of restrictions by object given in other recent cases. It also clarified certain issues...more

Goodwin

Roche Fined $14M for Undermining Biosimilar and Generic Competition in Romania

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On January 15, 2020, the Romanian Competition Council fined fined Roche Romania SRL €12.9 million ($14.2 million) following two investigations into what the Competition Counsel found to be Roche’s anti-competitive practices...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

Skadden, Arps, Slate, Meagher & Flom LLP

Third Circuit Holds FTC Must Show Defendants Are ‘About to Violate’ the Law for Injunctive Relief and Disgorgement

On February 25, 2019, in FTC v. Shire ViroPharma, Inc., the U.S. Court of Appeals for the Third Circuit confirmed that the Federal Trade Commission (FTC) cannot plead its way into federal court via Section 13(b) of the FTC...more

McDermott Will & Schulte

Cartel Snapshot - February 2019

Q4 Update: Overview of Cartel Investigations - Although 2018 saw guilty pleas and new indictments in several ongoing Department of Justice (DOJ) investigations, the year finished by continuing a downward trend in antitrust...more

Hogan Lovells

FTC backs FDA guidance intended to curtail citizen petition “shenanigans”

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On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. ...more

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