The Supreme Court has finally granted cert. on a “pay-for-delay” case involving payments from a branded pharmaceutical company to a generic pharmaceutical company to delay the generic’s entry into the branded’s market. Pay-for-delay agreements come about in the context of the settlement of patents dispute arising from the generic’s ANDA application to the FDA under the Hatch-Waxman Act. Ironically, Hatch-Waxman was supposed to help control health care costs by providing an expediting approval process for generic drugs and thus expediting their entry into the market, speeding erosion of the branded’s price premium based on its patent exclusivity rights. These cases implicate health care law and public policy, patent law, antitrust law and the judicial preference and protection of settlements. For more background visit The Mogin Law Firm, P.C., www.moginlaw.com and see:
Daniel J. Mogin, Esq.