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Antitrust Violations › Hatch-Waxman

Axinn, Veltrop & Harkrider LLP

FTC Peeling Back the Layers of the Orange Book

Axinn, Veltrop & Harkrider LLP on

The Federal Trade Commission (FTC) is continuing to pursue pharmaceutical manufacturers for allegedly improperly listing patents in the “Orange Book,” delaying the entry of generic drug competitors. On May 21, the FTC...more

Hogan Lovells

Republican FTC renews challenges to Orange Book patent listings

Hogan Lovells on

On May 21, 2025 the Federal Trade Commission (FTC) issued renewed warning letters to five companies regarding over 200 allegedly improperly-listed patents in the Food and Drug Administration (FDA)’s Orange Book. Announcing...more

Haug Partners LLP

Xryem: Pharmaceutical Settlement Acceleration Clause Found Anticompetitive Due To Risk Of “Profit Crushing Competition”

Haug Partners LLP on

On August 13, 2021, in a decision that largely flew under antitrust and patent practitioners’ radars, U.S. District Judge Lucy H. Koh mostly denied a motion to dismiss in the alleged “reverse payment” case, In Re Xyrem...more

Haug Partners LLP

The Sham Litigation Exception after AbbVie - Is the Subjective Element a Sham?

Haug Partners LLP on

The Federal Trade Commission (“FTC”) sued AbbVie and Besins Healthcare, co-owners of a patent that covered brand AndroGel, in 2017. The FTC claimed that the manufacturers had brought “sham” patent infringement litigation in...more

Morgan Lewis - As Prescribed

Proposed Antitrust Legislation Targets Pharmaceutical Industry, Would Grant FTC More Powers

Morgan Lewis - As Prescribed on

A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse...more

Cozen O'Connor

First Circuit Permits Antitrust Claims for Improperly Listing a Device Patent on the FDA’s Orange Book to Move Forward

Cozen O'Connor on

In a holding that could significantly broaden the antitrust inquiry in the context of the Hatch-Waxman regulatory scheme, on February 13, 2020, the U.S. Court of Appeals for the First Circuit issued an opinion that may have...more

White & Case LLP

California's New Reverse Payment Law Departs from Supreme Court Standard in FTC v. Actavis

White & Case LLP on

On October 7, 2019, California became the first state to enact legislation—Assembly Bill 824 ("AB 824")—rendering certain pharmaceutical patent litigation settlement agreements presumptively anticompetitive. This alert...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

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Berkheimer v. HP Inc., Appeal No. 2017-1437 (Fed. Cir. Feb. 8, 2018) - In Berkheimer v. HP Inc., the Federal Circuit reviewed the District Court’s summary judgment finding that certain claims of a patent were invalid as...more

Knobbe Martens

Ranbaxy and AstraZeneca Prevail in Nexium® Pay-For-Delay Case

Knobbe Martens on

On November 21, 2016, the U.S. Court of Appeals for the First Circuit upheld a 2014 jury verdict for AstraZeneca (AZ) and Ranbaxy regarding a 2012 payment of $700 million from AstraZeneca for Ranbaxy to abandon its challenge...more

The Volkov Law Group

Super Moon Harkens Low Tide for Hatch-Waxman Patent Disputes

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This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more

Patterson Belknap Webb & Tyler LLP

Two reverse-payment appeals to watch

Patterson Belknap Webb & Tyler LLP on

It has been over three years since the Supreme Court’s Actavis decision. Since then, numerous putative class actions alleging harm to competition as a result of “reverse-payment” settlements have flooded the courts. The...more

Patterson Belknap Webb & Tyler LLP

FTC Files Amicus Brief in First Circuit Seeking to Clarify Analysis in Post-Actavis Cases

Patterson Belknap Webb & Tyler LLP on

Direct and indirect purchasers of Nexium recently appealed District of Massachusetts Judge William Young’s denial of a request for a new trial in In re: Nexium to the First Circuit. As we previously reported, In re: Nexium...more

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