News & Analysis as of

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

Federal Judge Puts Narcolepsy Drug Horizontal Conspiracy Claims to Bed

On Monday, June 23, 2014, a Federal Judge in the Eastern District of Pennsylvania granted summary judgment for five pharmaceutical companies on horizontal conspiracy claims brought by Apotex Inc. and direct purchaser and end...more

District Court Upholds FTC Hart-Scott-Rodino Rules for Pharmaceutical Patent Transfers

A federal court has upheld the validity of the FTC’s recent rules for reporting certain transfers of exclusive patent rights in the pharmaceutical industry under the Hart-Scott-Rodino Antitrust Improvements (“HSR”) Act. We...more

Court Endorses FTC Authority To Require Special Reporting for Pharmaceutical Licenses

A federal court has endorsed the Federal Trade Commission’s authority to adopt regulations under the Hart-Scott-Rodino (HSR) Act that target specific industries. In Pharmaceutical Research and Manufacturers of America v....more

FTC’s Reporting Rule for Pharmaceutical Patent Transfers Upheld

On May 30, 2014, the U.S. District Court for the District of Columbia ruled in favor of the Federal Trade Commission (FTC) in a dispute with the Pharmaceutical Research and Manufacturers of America (PhRMA) regarding the...more

District Court Upholds HSR Rulemaking on Pharmaceutical Patent Licensing Transactions

The transfer of certain patent rights in the pharmaceutical industry will remain subject to the premerger notification rules under the Hart-Scott-Rodino Act (HSR Act) after a federal judge rejected a challenge brought by the...more

Jumping Into The Actavis Briar Patch — Insight Into How Courts May Structure Reverse Payment Antitrust Proceedings And The...

In This Issue: - INTRODUCTION - WHAT ARE REVERSE PAYMENT SETTLEMENT AGREEMENTS? ..The Basic Framework of Hatch-Waxman Litigation ..The Federal Trade Commission’s View of Reverse Payment Settlements and Its...more

FTC Asks Court to Reverse Payment Decision

On May 2, 2014, the Federal Trade Commission (FTC) filed an amicus brief with the U.S. Court of Appeals for the Third Circuit requesting that the court reverse the district court’s decision in Lamictal Direct Purchaser...more

Is 4-3 the New 3-2? FTC Continues to Target Pharmaceutical Mergers

The Federal Trade Commission (“FTC” or “Commission”) has often stated that merger analysis requires more than a simplistic determination that high market concentration leads to anticompetitive effects. Still, the antitrust...more

FTC Continues Aggressive Posture On Reverse Payment Settlement Agreements With Reference To Disgorgement

In two recent statements, the FTC reaffirmed its intention aggressively to pursue reverse-payment patent settlement agreements in the pharmaceutical industry. ...more

Advertising Law

FDA “Dislikes” Drug Company’s Facebook Page - Switzerland-based IBSA Institut Biochimique SA recently got a thumbs-down from the Food and Drug Administration over a Facebook ad for its hypothyroidism drug, Tirosint,...more

Notifications and Names: FTC Workshop Explores Effect of State Legislation and Naming Conventions on Follow-On Biologic...

Biologic medicines represent some of the most significant—both clinically and financially— pharmaceutical products in the United States today. Biologics have had remarkable success in the treatment of patients with many...more

FTC Targets Reporting of Licensing of Pharmaceutical Patents With Special Rules for Premerger Notification: What You Need to Know

On November 15, 2013, the Federal Trade Commission (“FTC”) adopted special rules for determining whether “exclusive” licenses of pharmaceutical patents are required to be reported to the FTC and the Antitrust Division of the...more

HSR Act Allows Pharmaceutical Licensing Transactions To Be Subject to Unique Reporting Requirements, FTC Tells Court

The Federal Trade Commission (FTC) has asked a federal court to find that the agency has authority under the Hart-Scott-Rodino Act (HSR Act) to promulgate reporting requirements that apply solely to transfers of patent rights...more

FDA, IP, and FTC Developments in the Run-up to the First U.S. Biosimilar Approval

As we near the fourth anniversary of the enactment of the Biologics Price Competition and Innovation Act, which established the first abbreviated approval route for follow-on biologics in the United States, multiple federal...more

Pharmaceutical Association Calls Out FTC in Filing Seeking to Enjoin New Rule Targeting the Industry

Last November, the Federal Trade Commission (“FTC”) with the “concurrence” of the Antitrust Division of the Justice Department, and over the strenuous objection of Pharmaceutical Research and Manufacturers of America...more

FTC Workshop Seeks to Spark Biosimilars Competition

Demand for biologics is growing fast, but even after Congress passed authorizing legislation in 2010, the pace of generic entry appears to have stalled. Seeking to spur increased generic competition, the FTC held an all-day...more

Clash Of Titans over Biosimilars at FTC Workshop

On Tuesday, February 4, the Federal Trade Commission (FTC) conducted an all-day public workshop at its headquarters in Washington, D.C. on competition issues involving biologics and biosimilars. During highly informative...more

Federal Court Finds Actavis Applies Only To Settlements Involving Monetary Payments

A United States district court judge sitting in the District of New Jersey has held that only patent litigation settlements involving monetary payments from branded to generic pharmaceutical manufacturers are subject to the...more

"Antitrust and Competition: Nonmerger Enforcement Activity Heats Up on Both Sides of the Atlantic"

U.S. and European antitrust agencies had similar enforcement priorities last year, a trend we expect to continue in 2014. Nonmerger enforcement will continue to focus on intellectual property, financial services and...more

"Antitrust and Competition: Surveying Global M&A Enforcement Trends"

US: Agencies Continue Aggressive Enforcement - Despite changes in leadership at the U.S. Department of Justice’s (DOJ) Antitrust Division and the Federal Trade Commission (FTC) (collectively, the Agencies) in 2013, the...more

Reverse payment deals under the microscope in the EU

Lessons from the latest Commission decision on agreements affecting generic entry: - The European Commission’s crack down on so-called “reverse payment” agreements continues. - In the EU these agreements may...more

FTC Expands Scope of Hart-Scott-Rodino Reporting Rules for Pharmaceutical Patent Rights Transfers

The Federal Trade Commission has broadened the rules dictating when pharmaceutical companies must report a transfer of exclusive patent rights to the U.S. Department of Justice and FTC for antitrust review and approval. Under...more

Clearance: Proskauer's Quarterly Antitrust Update - Fall 2013

In Federal Trade Commission v. Actavis, Inc., the Supreme Court, in a 5-3 decision written by Justice Breyer, reversed the Eleventh Circuit's dismissal of an FTC complaint under Section 5 of the Federal Trade Commission...more

New FTC Rules for Exclusive Pharmaceutical Patent Licenses

The Federal Trade Commission (FTC) has issued final rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) relating to the transfer of exclusive patent rights in the pharmaceutical industry. These new...more

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