Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S 566 U.S. ___, 132 S. Ct. 1670 (Apr. 17, 2012)
The Hatch-Waxman Act
Congress designed the Hatch-Waxman Act (codified at 21 U.S.C. § 355(b), (j), (l) and 35 U.S.C. §§ 156, 271, and 282) to inspire medical innovation by giving medical-device and pharmaceutical patent owners a more fruitful patent term while providing follow-on manufacturers to more quickly market their products once medical patents expire. Unlike other products, advanced medical devices and drugs must be FDA approved. These products can’t be marketed until proven sufficiently safe and effective through tests and clinical trials. FDA approval is expensive and time consuming. But it’s more than a matter of time and money. Medical innovators—especially drug developers—face the significant risk that a potential product will not live up to its promise.
Continue Reading Supreme Court confirms that generic drug manufacturers can challenge brand-name use-code descriptions in patent litigation