News & Analysis as of

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

FTC Workshop to Revisit Competition Issues Regarding Follow-On Biologics

Five years ago, the Federal Trade Commission (FTC) waded into the debate regarding the benefits and potential competition issues posed by the introduction of "follow-on biologics." Now, some three years after Congress...more

Pay-for-delay to Stay FTC’s Top Priority

In a recent interview, Federal Trade Commission (FTC) Bureau of Competition chairwoman Deborah Feinstein announced that targeting pay-for-delay arrangements by pharmaceutical companies would continue as a top priority for the...more

Antitrust agencies amend premerger notification rules to clarify reporting of certain acquisitions of exclusive patent rights in...

The US Federal Trade Commission, with the concurrence of the Antitrust Division of the US Department of Justice, has amended the premerger notification rules to clarify when a transfer of exclusive rights to a patent or part...more

FTC Announces Amendments to Hart-Scott-Rodino Rules Regarding Pharmaceutical Patent Licenses

The Federal Trade Commission (FTC) has announced revisions to the rules under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) that will apply to certain transactions involving the transfer of patent rights in...more

FTC Finalizes Amendments To HSR Rules Regarding Transfer Of Exclusive Patent Rights In The Pharmaceutical Industry

The Federal Trade Commission (FTC) has finalized certain amendments to the Hart-Scott-Rodino (HSR) premerger notification regulations clarifying the scope of reportable transactions involving transfers of patent rights in the...more

FTC Expands the Scope of Pharmaceutical Licensing Transactions That Will Be Subject to Premerger Review

The Federal Trade Commission (FTC) recently announced that it has finalized amendments to the premerger notification rules (HSR Rules) that provide a framework for determining when a transaction involving the transfer of...more

FTC Broadens Notification Requirements for Transfers of Pharmaceutical Patent Rights

The Federal Trade Commission (FTC) has revised the rule for determining when a transfer of exclusive rights to a patent in the pharmaceutical industry (including biologics and medicine manufacturing) results in a potentially...more

Finalized Amendments to Premerger Notification Rules Will Impact Pharma Companies

Pharmaceutical companies that use exclusive patent licenses to bring drugs and medicines to market must now notify the U.S. antitrust agencies of more of these types of licensing transactions and await approval before...more

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