News & Analysis as of

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

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

Third Circuit Says Actavis Not Limited to Cash

In the first decision by a federal appeals court interpreting the U.S. Supreme Court’s landmark ruling in FTC v. Actavis, the Third Circuit recently held in King Drug Co. of Florence v. SmithKline Beecham Corp. that so-called...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

After Actavis: Crafting Pharmaceutical Settlements that Avoid Antitrust Scrutiny

Last year’s Supreme Court decision in FTC v. Actavis cleared the way for more antitrust challenges to settlements between generic and branded pharmaceutical companies resolving Hatch-Waxman patent litigation. As a result,...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

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

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

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

Supreme Court Rules That “Pay for Delay” Generic Drug Patent Settlements Are Not Shielded From Antitrust Liability

The Supreme Court has held that the antitrust laws may forbid patent settlements that delay the market entry of generic drugs in return for large payments from manufacturers of competing branded drugs....more

Supreme Court Issues Actavis Decision On Reverse-Payment Settlements

The Supreme Court has issued its much-awaited decision in FTC v. Actavis on the antitrust analysis of reverse-payment settlements of Hatch-Waxman Act litigation....more

Reverse-Payment Patent Settlements Subject to Antitrust Analysis

The Supreme Court today decided FTC v. Actavis, Inc. and held, in a 5-3 decision authored by Justice Breyer, that so-called reverse-payment patent settlements are subject to full antitrust Rule of Reason analysis....more

Litigation Alert: Supreme Court Rules on “Reverse Payment” Settlements in Federal Trade Commission v. Actavis, Inc.

Today, the U.S. Supreme Court held in Federal Trade Commission v. Actavis, Inc. that so-called “reverse payment” settlement agreements should be analyzed under a rule-of-reason analysis under which the court assesses any...more

Supreme Court Chooses Middle Ground in Assessing Reverse Payment Settlements

The U.S. Supreme Court issued its much-anticipated opinion today in FTC v. Actavis, Inc., ruling that so-called “reverse payment” patent settlements between innovator and generic pharmaceutical manufacturers that are...more

Supreme Court Hears Arguments on "Pay for Delay" Agreements

On March 25, 2012, the Supreme Court heard oral argument on the legality of “reverse payment” or “pay for delay” agreements between brand-name and generic drug manufacturers....more

Par/Paddock Answers FTC Before Supreme Court

Par PharmaceuticalPar/Paddock, one of the generic drug company defendants in FTC v. Actavis Inc. et al. (the "reverse payment" ANDA settlement case now before the Supreme Court) filed its reponsive brief last week. In it,...more

Supreme Court Grants Cert in Watson Pay-For-Delay Case

On December 7, 2012, the Supreme Court granted certiorari in FTC v. Watson Pharmaceuticals. The Supreme Court is now poised to resolve the circuit split on the treatment of so-called “pay for delay” Hatch-Waxman Act patent...more

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