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Antitrust & Trade Regulation Health Intellectual Property

Read Antitrust & Trade Regulation updates, alerts, news, and legal analysis from leading lawyers and law firms:

Antitrust Division’s Spring Update 2017: Insights Regarding DOJ’s Enforcement and Policy

The Antitrust Division recently issued its 2017 annual spring update. The update emphasizes the Division’s recent litigation victories, particularly in the merger context. In his introductory remarks, Assistant Attorney...more

Nexium Case Extends Actavis Ruling

by McDermott Will & Emery on

Addressing a pay-for-delay and pharmaceutical-settlement antitrust jury trial for the first time since the 2012 Supreme Court of the United States decision in FTC v. Actavis (IP Update, Vol. 16, No. 7), the US Court of...more

Protecting Against Big Pharma's Tactics for Delaying Market Entry of Generics

by Tarter Krinsky & Drogin LLP on

Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some...more

President-Elect Trump Has Once-in-a-Century Opportunity to Substantially Revise the FTC’s Law Enforcement and Regulatory Agenda

by McDermott Will & Emery on

SUMMARY: Regulatory reform is the “cornerstone of the Trump administration,” and incoming President Donald Trump has a unique opportunity to quickly and substantially influence Federal Trade Commission (FTC) policy through...more

ANDA Update - Volume 2, Number 3

by McDermott Will & Emery on

On-Sale Bar Is No Bar for Selling Manufacturing Services to the Inventor - Addressing what constitutes an invalidating “sale” under § 102(b), the US Court of Appeals for the Federal Circuit sitting en banc affirmed the...more

FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment

On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept...more

EU Court Confirms European Commission’s Decision on Pay-for-Delay Agreements

by McDermott Will & Emery on

On 8 September 2016, the General Court of the European Union upheld the European Commission’s decision in which the antitrust regulator imposed fines of approximately EUR 150 million on Lundbeck and a number of generic...more

Update on Naming Biosimilars

In August 2015, FDA released a long-awaited draft guidance for the nonproprietary names of biologics and biosimilars. The draft guidance recommends that nonproprietary names for biologic products should consist of the “core”...more

Alert: FTC Challenges "No-AG" Agreement as Illegal Reverse Payment

by Cooley LLP on

On March 30 the US Federal Trade Commission filed suit in federal court alleging that settlements of patent litigation in the pharmaceutical industry in which a pioneer firm agrees not to market an "authorized generic"...more

FTC Launches First-Ever Attack on “No-AG Commitment” Pay-for-Delay Settlements

Today the FTC filed a complaint in the U.S. District Court for the Eastern District of Pennsylvania against Endo Pharmaceuticals for entering into “pay-for-delay” agreements with two different generic manufacturers that...more

European Competition Law Newsletter – August 2015

by McGuireWoods LLP on

Continuing an EU-wide trend, yet another trade association has been fined in the UK for cartel activities. This time it was a medical professionals’ association. The message is clear; trade associations of all types need to...more

Federal Appeals Court Upholds FTC HSR Rule on Pharma Patent Licenses

by Goodwin on

Background – the HSR Act: Under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the HSR Act), acquisitions of voting securities, assets and other commercial interests which exceed certain monetary thresholds...more

Is the Competition Bureau Targeting You? New IP Enforcement Guidelines

by Bennett Jones LLP on

On June 9, 2015, the Canadian Competition Bureau released updated draft Intellectual Property Enforcement Guidelines (IPEGs) for public comment. The comment period is open until August 10, 2015. It is the third publication of...more

REMS and Antitrust: Latest Litigation Lessons

by Robins Kaplan LLP on

Brand name pharmaceutical companies have long stood in the way of generic pharmaceuticals entering the market. To keep generics at bay, brands have used a variety tactics, including ultimately unlawful ones like fraudulently...more

Second Circuit Becomes First Court of Appeals to Address Pharmaceutical “Product Hopping” Under Antitrust Laws in Decision Barring...

by Shearman & Sterling LLP on

Few courts have addressed antitrust challenges to pharmaceutical “product hopping,” i.e., the practice of shifting customers from a drug nearing the end of its patent protection to a modified version that is covered by newer...more

Pfizer’s strategic response to the threat of generic competition upheld by the Federal Court

by DLA Piper on

On 25 February 2015, the Federal Court handed down its much-anticipated judgment in the matter of ACCC v Pfizer Australia Pty Ltd. In dismissing the Australian Competition and Consumer Commission’s (ACCC) allegations, Justice...more

Preliminary Injunction Order in Actavis Casts a Skeptical Eye Toward the “Hard Switch”

Last week, we briefly reported on the injunction granted by the U.S. District Court for the Southern District of New York in the New York Attorney General’s “product hopping” suit against Actavis and its subsidiary, Forest...more

Health Insurer Antitrust Claim Against Drug Company Remanded to State Court

by Dickinson Wright on

Over the last several years, several health insurers have brought antitrust claims against drug companies, contending that they were overcharged for drugs as a result of agreements reached by the drug companies in the...more

Dr. Reddy’s Laboratories Settles on Eve of Trial – Agrees to Cooperate with Plaintiffs

Much has happened since our last post on the Nexium “pay for delay” class action lawsuit. Jury selection began in the District of Massachusetts on Monday, October 20, 2014. The day prior, one of the generic drug makers, Dr....more

The Life Sciences Report - Spring 2014

In this issue: - A New Accelerator Takes Digital Health Start-Ups to the Next Level - The Return of the MedTech IPO Market - Is There a Deal in Your Future? A Guide to Navigating Antitrust Waters -...more

Advertising Law - Feb 13, 2014

FTC Drives Car-Related False Ad Suit to Settlement - The Federal Trade Commission recently settled charges with Nissan North America and its advertising agency over deceptive advertising for the Nissan Frontier pickup...more

IMS Study Shows Pro-Competitive Effects of Reverse Payment Settlement Agreements in ANDA Litigation

Earlier this month, the Generic Pharmaceutical Association (GPhA) held a press conference to announce the release of a study of the effects of reverse settlement payment agreements in ANDA litigation. ...more

Bloomberg Law: Actavis Court Requires Case-by-Case Analysis of Anticompetitive Effects of Reverse-Payment Settlements

by Jarod Bona on

This article analyzes the US Supreme Court's recent antitrust decision in FTC v. Actavis, which held that that courts should apply the rule of reason in analyzing reverse-payment settlements. ...more

Weekly eDiscovery Top Story Digest - June 26, 2013

by Rob Robinson on

Compiled by @ComplexD from online public domain resources, provided for your review/use is this week’s update of key industry news, views, and events highlighting key electronic discovery related stories, developments, and...more

Reverse-Payment Settlement Agreements Roundtable

by Howard Morse on

Reverse-payment settlements between brand name and generic drug companies have remained a staple hot-button issue in the antitrust community for more than a decade. In some antitrust circles, simply mentioning the term...more

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