Reverse Payment Settlement Agreements Generic Drugs

News & Analysis as of

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

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

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

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

Following Actavis, California Supreme Court Crafts “Structured Rule of Reason” Test for Evaluating Pay-for-Delay Settlements

Last Thursday the Supreme Court of California decided In re Cipro Cases I & II, No. S198616 (Cal. May 7, 2015), holding that reverse payment, or “pay-for-delay,” settlements can be challenged as unreasonable restraints on...more

Plausibly Alleging Non-monetary Settlements as Reverse Payments After Actavis

In In re Lipitor Antitrust Litigation, No. 12 Civ. 2389 (D.N.J.), U.S. District Judge Peter G. Sheridan has confirmed his prior ruling that under the Supreme Court’s decisions in Twombly, Iqbal, and FTC v. Actavis, Inc., 133...more

In re: Nexium Plaintiffs Seek New Trial

As reported previously, the first post-Actavis jury verdict in a “reverse payment” antitrust case handed a win to the defendants. Now, plaintiffs in In re: Nexium (Esomeprazole) Antitrust Litigation have moved for a new...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

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

Antitrust Bulletin - Vol. 5, No. 1

In this Issue: - New Developments - U.S. Supreme Court Will Decide Whether Patent Agreements That Postpone the Sale of Generic Drugs Violate Antitrust Laws - Direct Purchasers Have Standing to Bring Antitrust...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

Supreme Court, in FTC v. Actavis, rejects the “scope of the patent” test, holding that antitrust law’s “rule of reason” analysis...

Patent rights and antitrust law contain inherently antagonistic policies: While antitrust law is aimed at preventing monopolies and promoting competition, patent law explicitly rewards inventors with a time-limited right to...more

FTC v. Actavis, Inc. Q&A: Implications for Pharmaceutical Companies

On June 17, 2013, in FTC v. Actavis, Inc., the U.S. Supreme Court ruled that plaintiffs may bring antitrust suits against so-called “reverse payment” or “pay-for-delay” settlements, under which pioneer and generic...more

Supreme Court Subjects Reverse Payment Settlements to Antitrust Review

In a recent opinion with powerful implications for drug manufacturers, the U.S. Supreme Court decided in FTC v. Actavis that reverse payment settlement agreements can violate the antitrust laws despite the antitrust immunity...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

High Court Finds Antitrust Scrutiny Applies to Pay-for-Delay Settlements

On June 17, 2013, the U.S. Supreme Court determined that the Federal Trade Commission’s (FTC) antitrust challenge to a reverse payment settlement agreement between drug manufacturers, otherwise known as a “pay-for-delay”...more

Supreme Court Holds That Reverse Payment Patent Settlements Are Subject to Antitrust Scrutiny

For over a decade, the antitrust enforcers at the Federal Trade Commission have challenged the type of patent settlement where a brand-name drug manufacturer pays a prospective generic manufacturer to settle patent...more

Supreme Court Holds Reverse Payment Settlements Are Subject to Rule-of-Reason Scrutiny in Landmark Ruling

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 Act...more

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