News & Analysis as of

Pay-For-Delay Pharmaceutical Industry Abbreviated New Drug Application (ANDA)

McDermott Will & Emery

ANDA Update - March 2017 Volume 3, Number 1

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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

Manatt, Phelps & Phillips, LLP

Health Update - January 2017

Top Five Healthcare Antitrust Trends to Watch in 2017 - Antitrust enforcement and litigation had a big year in 2016. In this article, we look back at the most significant cases for the healthcare industry over the last...more

Latham & Watkins LLP

Supreme Court Denies Cert in Lamictal Pay-For-Delay Litigation

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Third Circuit has previously ruled that non-cash payments to settle patent litigation may violate antitrust laws. On November 7, 2016, the Supreme Court of the United States declined to hear the petition of...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

Manatt, Phelps & Phillips, LLP

FTC Maintains Aggressive Stance Against Pay-for-Delay Deals

A recent complaint filed by the Federal Trade Commission (FTC) indicates that the agency is continuing its aggressive pursuit of agreements between drug manufacturers that delay the entry of generic pharmaceuticals into the...more

Proskauer Rose LLP

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

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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

McDonnell Boehnen Hulbert & Berghoff LLP

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

Foley & Lardner LLP

FTC’s $1.2 Billion Disgorgement Settlement With Cephalon: Heightened Scrutiny of Hatch-Waxman Settlements

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On May 28, 2015, the Federal Trade Commission (FTC) announced the settlement of its 2008 lawsuit against Cephalon, Inc. (now owned by Teva Pharmaceutical Industries, Ltd.), which alleged that Cephalon had made “reverse...more

Foley & Lardner LLP

California Supreme Court Scrutinizes Reverse Payment ANDA Settlements

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In In Re Cipro Cases I & II, the California Supreme Court laid out a four-part rule of reason analysis for evaluating ANDA settlements that involve a reverse payment to the generic challenger (also referred to as “pay for...more

Foley & Lardner LLP

Supreme Court Applies Antitrust Scrutiny to ANDA Reverse Payment Settlement Agreements

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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

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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

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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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