Reverse Payment Settlement Agreements Hatch-Waxman

News & Analysis as of

Two reverse-payment appeals to watch

It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The...more

Recent Court Cases Interpreting “Reverse Payments” Post-Actavis

Patent settlement agreements were traditionally deemed outside the purview of antitrust scrutiny unless the patent holder’s conduct fell outside the legitimate scope of the patent’s exclusionary power. This all changed when...more

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

FTC’s Amicus Brief in Wellbutrin XL Appeal Highlights Significance for Interpretation of Actavis

The FTC has recently weighed in again on the evolving interpretation of the Supreme Court’s 2013 opinion in FTC v. Actavis, 133 S. Ct. 2223 (2013). The agency submitted an amicus brief to the Third Circuit in the appeal of...more

The First Circuit Agrees that Non-Cash Reverse Payments Are Subject to Antitrust Scrutiny. Does the Loestrin Decision Point to...

Recently, the First Circuit became the second federal appellate court interpreting the Supreme Court's landmark decision in FTC v. Actavis, Inc. to hold that non-cash "reverse payments" between pioneer and generic...more

FTC Files Amicus Brief in First Circuit Seeking to Clarify Analysis in Post-Actavis Cases

Direct and indirect purchasers of Nexium recently appealed District of Massachusetts Judge William Young’s denial of a request for a new trial in In re: Nexium to the First Circuit. As we previously reported, In re: Nexium...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

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

Sowing Uncertainty: Navigating Patent Disputes and Antitrust Scrutiny Post King Drug

On June 26, 2015, the Third Circuit issued an opinion in King Drug Co. of Florence, Inc. v. Smithkline Beecham Corp., (Case No. 14-1243). King Drug. The opinion, which already has been extensively commented on and...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

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

Locke Lord QuickStudy: Filling in Some Actavis Gaps - California Supreme Court Adopts Structured Rule of Reason Test for Antitrust...

A sweeping new opinion from the California Supreme Court revives California Cartwright Act challenges to pay-for-delay pharmaceutical patent settlements. In re Cipro Cases I & II, (Case No. S198616, Slip Op. May 7, 2015). A...more

California Supreme Court Details Antitrust Analysis of "Reverse Payment" Patent Settlements

Last week, in In re Cipro Cases I & II, Case No. S198616, the Supreme Court of California adopted the United States Supreme Court's application of the Rule of Reason to the antitrust analysis of so-called "reverse payment"...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

Supreme Court corner - Q3 2013

RECENT DECISIONS - Federal Trade Commission v. Actavis - Decided: 6/17/2013 Patent Holding: (5-3) reverse payment settlement agreements should be reviewed based on a “rule of reason. In a split...more

Applying the Supreme Court’s Decision in Actavis: Consideration Value Comparisons by Courts Approving Reverse Payment Settlements

In FTC v. Actavis, the Supreme Court held that “reverse payment” pharma patent settlements within the scope of the patent may (or may not) violate the Sherman Act.1 The majority opinion in Actavis explained that Hatch-Waxman...more

Reverse Payment Agreements Under Hatch-Waxman

On March 25, 2013, the Supreme Court heard oral argument in Federal Trade Commission v. Actavis, Inc. No. 12-416. The question presented in the writ of certiorari concerned whether reverse payment agreements are per se...more

Reverse Payment Schemes Risk Antitrust Liability: U.S. Supreme Court Declines to Adopt Bright Line Test

A divided Supreme Court recently held in an opinion by Justice Breyer that “reverse payment” or “pay for delay” agreements between patent holders and potential competitors are not immune from scrutiny under antitrust laws....more

Supreme Court: Reverse Payment Settlements Subject to Antitrust Scrutiny

On June 17, 2013, the U.S. Supreme Court handed down a decision that addressed a “reverse payment” settlement agreement between a brand-name pharmaceutical company (plaintiff patent holder) and multiple generic drug companies...more

Supreme Court Applies Rule of Reason in Antitrust Challenges to Reverse-Payment Patent Settlements

One of the most controversial antitrust issues for the pharmaceutical industry during the last decade has been the treatment of patent settlements in which a patent-holding branded manufacturer made payments to its generic...more

FTC v. Actavis: What Does It Mean for Reverse-Payment Settlements?

On June 17, 2013, the United States Supreme Court announced a rule that blurs the lines between antitrust and patent law in the context of Hatch-Waxman litigation....more

U.S. Supreme Court Rejection of the “Scope of the Patent” Test in FTC v. Actavis Has Wide-Ranging Implications

Key Points: - Patent settlements must be analyzed under the rule of reason, requiring a full analysis of the net competitive effects - Payments to an alleged infringer may be permissible if justified by, for...more

Supreme Court Applies Antitrust Scrutiny to ANDA Reverse Payment Settlement Agreements

In Federal Trade Commission v. Actavis, Inc., the Supreme Court held that reverse payment (“pay-for-delay”) settlement agreements made in the context of settling Hatch-Waxman ANDA litigation should be evaluated for antitrust...more

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