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Supreme Court’s Drug-Patent Antitrust Ruling Analyzed by Wiley Rein’s James Czaban, Brian Pandya and Christin Helms

July 1, 2013

The U.S. Supreme Court’s recent major ruling that certain drug-patent settlements are subject to antitrust scrutiny was analyzed by Wiley Rein attorneys in an article published in Bloomberg BNA’s Pharmaceutical Law and Industry Report, and several other Bloomberg BNA publications. The analysis of FTC v. Actavis was written by James N. Czaban, who chairs the firm’s Food & Drug Law Practice, Brian H. Pandya, a partner in the Intellectual Property and Litigation Practices, and Christin C. Helms, an associate in the Food & Drug Law Practice.

The case stemmed from the U.S. Federal Trade Commission’s (FTC) challenge to patent settlement agreements under the Hatch-Waxman Amendments in which a brand-name drug company pays a generic-drug maker to drop its patent challenge and keep its competing version off the market for a specified time period. Ruling in the FTC’s favor, the Supreme Court said on June 17 that these arrangements are subject to judicial antitrust scrutiny.

The Court’s decision “will be a major topic of discussion, concern and future litigation for years to come,” Mr. Czaban, Mr. Pandya and Ms. Helms said in their article, titled “Reverse Payments After FTC v. Actavis: Supreme Court Unsettles Hatch-Waxman Patent Settlements.”

“Companies operating under existing reverse payment agreements must prepare for the strong possibility that they will be subject to either an FTC enforcement action, a private class action lawsuit, or in many cases both,” the authors wrote.

The ruling also “raised multiple new questions while providing little in the way of concrete rules for the lower courts to use in what will likely be a blizzard of new antitrust cases,” according to the article.

The Bloomberg BNA article by Mr. Czaban, Mr. Pandya and Ms. Helms, with valuable assistance from Summer Associate Claire Frezza, can be read here.