News & Analysis as of

The FTC gets activist post-Actavis

In 2013, the FTC left its mark on the pharmaceutical industry when the Supreme Court ruled in FTC v. Actavis that settlement agreements for patent infringement suits between branded and generic drug companies are not immune...more

Lupin Appeals Fine Imposed by European Commission in “Pay-For-Delay” Crackdown

In July of this year, the European Commission imposed fines on French pharmaceutical company Servier and five generic drug makers, including Lupin Ltd., totaling €427.7 million. The fines were the result of a five-year...more

First Post-Actavis Jury Verdict Goes to Defendants on Causation Question

After six weeks of trial and two days of deliberation, the jury has returned its verdict in favor of the defendants in In re: Nexium. This trial began as a challenge to the allegedly anticompetitive effects of the settlements...more

In re: Nexium: Ranbaxy’s Motion for a Mistrial to Be Argued Today

Today, the Nexium district court will hear arguments on the Ranbaxy defendants’ motion for a mistrial. As we have previously reported, In re: Nexium is the first pay-for-delay case to go to trial since the Supreme Court’s...more

What’s Next for In re: Nexium: Defendants’ Motions for Directed Verdicts Likely to Turn on Sufficiency of Expert Testimony

As we previously reported, the In re: Nexium trial is the first pay-for-delay trial in the wake of the Supreme Court’s Federal Trade Commission v. Actavis decision. But if the Nexium defendants have it their way, plaintiffs’...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

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

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 Rules That Pay-For-Delay Settlements Subject To Antitrust Challenges

Antitrust challenges to so-called “pay-for-delay” settlements in drug patent suits are allowed under the U.S. Supreme Court’s recent decision in Federal Trade Commission v. Actavis, Inc....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

Federal Trade Commission v. Actavis, Inc. et al. – Supreme Court Holds Reverse Payment Settlement Agreements to be Analyzed under...

On June 17, 2013, the Supreme Court of the United States ruled 5-3 in favor of the Federal Trade Commission and issued its long-awaited decision in Federal Trade Commission v. Actavis, Inc. et al. 570 U.S. __ (2013), Slip Op....more

“Reverse Payment” Settlements Subject to Greater Antitrust Scrutiny: Implications of Supreme Court FTC v. Actavis Ruling

By rejecting the “scope of the patent” test and holding that reverse payment patent settlements “can sometimes violate the antitrust laws,” the Supreme Court of the United States subjects such settlements to greater antitrust...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

Drug Company Patent Settlements Subject To Rule Of Reason Antitrust Scrutiny

This week, the Supreme Court announced that “reverse payment” settlements of patent litigation between branded and generic pharmaceutical companies are, when challenged in a subsequent antitrust case, to be judged under the...more

FTC v. Actavis: "Reverse Payments"—Not Presumptively Lawful, Not Presumptively Unlawful, But Subject to a Rule-of-Reason Analysis

On June 17, 2013, after years of litigation in the lower courts, the United States Supreme Court issued its long-awaited decision in FTC v. Actavis. The 5-3 decision, however, did not have a clear winner, and the case was...more

Supreme Court Issues Significant Patent Antitrust Decision Rejecting The “Scope Of The Patent” Rule

In the most significant patent antitrust decision in decades, Federal Trade Commission v. Actavis, Inc., No. 12-416, 2013 WL 2922122 (June 17, 2013), the Supreme Court has held, by a 5-3 vote with Justice Alito recused, that...more

Supreme Court Holds that “Reverse Payment” Patent Settlements are Subject to Potential Antitrust Condemnation, but only After...

SUMMARY OF DECISION - In FTC v. Actavis, Inc., 570 U.S. ____ (Slip Op. June 17, 2013), the Supreme Court addressed for the first time the underlying antitrust merits of the Federal Trade Commission’s long-running...more

U.S. Supreme Court Rules That “Reverse Payment” Settlements in ANDA Litigation Are Not Presumptively Unlawful But Must Be Assessed...

The Supreme Court ruled 5-3 on June 17, 2013 in favor of the Federal Trade Commission in FTC v. Actavis. Writing for the majority that included Justices Kennedy, Ginsburg, Sotomayor and Kagan, Justice Breyer’s opinion...more

Supreme Court Game-Changer: Rule of Reason Applies to ANDA Reverse Payment Settlements

In Federal Trade Commission v. Actavis, Inc., No. 12-416, 2013 U.S. LEXIS 4545 (U.S. June 17, 2013), the U.S. Supreme Court reversed the Eleventh Circuit decision in FTC v. Watson Pharmaceuticals, Inc., 677 F.3d 1298 (2012),...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

FTC v. Actavis Decision Offers Guidance to Drug Manufacturers

June 18, 2013 – The Supreme Court handed down a 5-3 decision yesterday in FTC v. Actavis, Inc., holding pay-for-delay agreements are subject to antitrust review, but are not presumptively unlawful. The decision was authored...more

April 2013: Life Sciences Litigation Update: Will the Supreme Court Resolve Circuit Split on Settlement of ANDA Disputes?

On March 25, 2013, the U.S. Supreme Court heard oral argument in Federal Trade Commission v. Actavis, Inc. (Docket No. 12-416). The Actavis case centers around the debate over the type of antitrust analysis that should apply...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

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