News & Analysis as of

Hatch-Waxman Antitrust Violations

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

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

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

The Volkov Law Group on

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

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

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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