Denise Loring, Katherine Helm examine issues surrounding second-generation drug patents

The manufacturers of brand-name prescription drugs view so-called "second-generation patents" as necessary protection for the substantial investment in improving and obtaining FDA approval of improved drugs. In the view of manufacturers of generic drugs, however, second-generation patents represent an attempt to extend the period of patent exclusivity for brand-name drugs and maintain high profits. In a recent article published in the New York Law Journal, Denise Loring and Katherine Helm of the Fish & Neave IP Group of Ropes & Gray examine the issues and conclude that litigation under the Hatch-Waxman Act, which governs second-generation drug patents, will continue to increase. To read the article, please click "Download PDF".