Pharmaceutical Patent Infringement and IP Protection
In a 9-0 decision, the U.S. Supreme Court on April 17, 2012, allowed Caraco Pharmaceutical Laboratories Ltd. to employ the counterclaim provision of the Hatch-Waxman Act to challenge as overbroad Novo Nordisk’s use code for a patent covering the diabetes drug Prandin®. The FDA uses the “use codes” provided by branded drug manufacturers to determine whether a generic company’s proposed use of a drug would infringe a method-of-use patent held by the manufacturer of the branded drug. The breadth of the use code can make the difference between approval and denial of a generic company’s application. Thus, the expansion of the counterclaim provision to challenge use codes is significant and impacts the dynamic in Hatch-Waxman Act litigations.
This webcast will address the key factors that led to Caraco and the recent Appellate decisions, address the impact that these decisions will have on patent litigation and prosecution going forward, provide practical strategies for pharmaceutical companies to anticipate and address, and also highlight likely actions by Congress and the Federal Food and Drug Administration.
Sapna W. Palla, Counsel, Kaye Scholer LLP
Benjamin Hsing, Partner, Kaye Scholer LLP
June 7, 2012