Reverse Payment Settlement Agreements Federal Trade Commission

News & Analysis as of

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

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’s Latest “Pay for Delay” Action Focuses on Noncash “Payments” and New “Product Hopping” Theory of Harm

The Federal Trade Commission (FTC) filed an antitrust complaint this week against Endo Pharmaceuticals and several generic companies, alleging that these companies entered into anticompetitive “reverse payment” settlements of...more

The Use of Expert Opinions in ‘Reverse-Payment’ Settlement Cases Under Actavis - King Drug Company of Florence, Inc., et al. v....

Applying its previous rulings in related litigation and interpreting FTC v. Actavis, 570 U.S. 756 (2013), the U.S. District Court for the Eastern District of Pennsylvania was tasked with determining whether to preclude expert...more

FTC Issues Report on ANDA Settlement Agreements

In January, the Federal Trade Commission issued a report on the terms of settlement agreements between branded and generic drug companies in ANDA litigation under the Hatch-Waxman Act, according to the provisions of the...more

FTC Amicus Brief Confirms Need for Independent Proof of Causation in Private Reverse-Payment Antitrust Cases

In the ongoing battles over the antitrust treatment of pharmaceutical patent settlements, the Federal Trade Commission and private industry have not agreed on much. But a recent FTC amicus brief appears to signal a high level...more

More on Patent Settlements Including Litigation at the European Courts

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

FTC Asserts That Its Failure to Object to a “Reverse Payment” Settlement Should Not Be Interpreted as Approval

On November 17, 2015, the FTC submitted an amicus brief to the Third Circuit Court of Appeals in In re Effexor XR Antitrust Litigation, where the district court had dismissed the plaintiffs’ claims of antitrust violations...more

IP Matters, Fall 2015

Textile Copyright Cases Ripe for ADR - While normally focused on music and media matters, copyright lawyers in California have grown busy with something else: fabrics. Hundreds of textile copyright suits involving fabric...more

ANDA Update - October 2015

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

Turing, Daraprim, and Refusals to Deal with Generic Manufacturers

Drug company Turing Pharmaceuticals made headlines recently when it reportedly raised the price of Daraprim, used commonly by AIDS patients to fight life-threatening infections, from $13.50 to $750 per tablet. Amidst...more

Antitrust Implication of Recent FTC Patent Related Agreement

In recent years, the Federal Trade Commission (FTC) has refocused its efforts on the interplay between the patent system and antitrust law, particularly in the pharmaceutical industry. While most of this focus has manifested...more

Third Circuit Extends Actavis to Reverse Settlement Agreements Involving Non-Cash Consideration - King Drug Company of Florence,...

Addressing for the first time whether reverse settlement agreements involving non-cash consideration merit antitrust scrutiny, the U.S. Court of Appeals for the Third Circuit reversed the district court, applying the...more

First Federal Appellate Court Holds a NonCash Reverse Payment Subject to Antitrust Scrutiny: Is the Third Circuit's Decision in...

Recently, the Third Circuit issued the first federal appellate decision interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc.[1], potentially greatly expanding the scope of settling parties in reverse...more

King Drug Co. of Florence, Inc. v. SmithKline Beecham Corp. (3rd Cir. 2015)

Ever since the Supreme Court's decision in FTC v. Actavis in 2013, courts (predominantly district courts) have grappled with the scope of the decision. It was evident that the presence of a large cash payment from the...more

Cephalon and Teva's $1.2 Billion Consent Order with the FTC: Is it Really a Harbinger of Things to Come?

On June 17, 2015, the U.S. District Court for the Eastern District of Pennsylvania approved a consent order (the “Consent Order”) between the Federal Trade Commission and defendants Cephalon, Inc. and its parent, Teva...more

California Supreme Court Decision in Cipro Highlights the Lack of Predictability in Antitrust Jurisprudence and Counseling

On May 7, 2015, the Supreme Court of California issued an opinion in In re Cipro Cases I & II, a case centered on pay-to-delay settlements between drug makers and generic manufacturers. The Court found the existence of an...more

Teva Agrees to Pay $1.2 Billion in FTC’s Pay-For-Delay Suit Against Cephalon

Recently, the FTC announced that it reached a settlement in its pay-for-delay lawsuit, FTC v. Cephalon Inc. in the U.S. District Court for the Eastern District of Pennsylvania, with Teva Pharmaceuticals Industries, Ltd.,...more

Antitrust Enforcers Discuss Recent Highlights, Ongoing Cases, Enforcement Priorities and General Trends at the 2015 ABA Section of...

The American Bar Association (ABA) Section of Antitrust Law Spring Meeting concluded earlier this month with the traditional “Enforcers’ Roundtable,” an interview with leading competition authorities about recent highlights,...more

Reverse Payments, Actavis, and the Lower Courts at Sea, Part 2: The Brewing Conflict Over Non-Cash Settlements

Our first post in this series was titled “What Is a Reverse Payment?” As the recent cases discussed in today’s post show, the courts are struggling with a fundamental component of that question: What, for that matter, is a...more

FTC v. Actavis, Inc. (In re Androgel Antitrust Litigation (II) (N.D. Ga.)

In FTC v. Actavis, Inc., 133 S. Ct. 2223 (2013), the Supreme Court reversed and remanded to the district court to apply a rule of reason analysis to defendants’ reverse payment settlement. On remand, defendants Solvay and...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 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

The Current Intersection of Antitrust and Managed Care

This article provides a summary of key healthcare antitrust developments in 2013, highlighted by two important Supreme Court decisions: - In FTC v. Phoebe Putney Health System, Inc.,133 S.Ct. 1003 (2013), the Court...more

Top Stories of 2013: #4 to #6

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...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

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