News & Analysis as of

Pay-For-Delay Patents Abbreviated New Drug Application (ANDA)

McDonnell Boehnen Hulbert & Berghoff LLP

Takeda Pharmaceuticals U.S.A., Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020)

ANDA litigation, pursuant to the Hatch-Waxman Act, has become more complicated over the years since enactment of the statute in 1984, with more patents being asserted and more parties participating over the opportunity to...more

McDermott Will & Emery

ANDA Update - March 2017 Volume 3, Number 1

McDermott Will & Emery on

Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more

Perkins Coie

Recent Court Cases Interpreting “Reverse Payments” Post-Actavis

Perkins Coie on

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

BakerHostetler

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

BakerHostetler on

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

McDermott Will & Emery

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

McDermott Will & Emery on

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

Foley & Lardner LLP

Supreme Court Applies Antitrust Scrutiny to ANDA Reverse Payment Settlement Agreements

Foley & Lardner LLP on

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

Troutman Pepper

Drug Company Patent Settlements Subject To Rule Of Reason Antitrust Scrutiny

Troutman Pepper on

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

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