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On April 17, 2012, the Supreme Court announced its decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk. This case involves drug manufacturer “use codes,” which are patent descriptions that brand name drug manufacturers submit to the Food and Drug Administration for use in determining whether a given generic drug, if approved for marketing, will infringe a patent held by a brand name manufacturer. The question in this case is whether a generic drug company can, in the course of a patent infringement suit brought by a brand name drug company, file a counterclaim challenging the accuracy of a particular use code.
In an opinion delivered by Justice Kagan, the Court unanimously held that a generic drug manufacturer may indeed challenge the use code in this manner. Justice Sotomayor filed a concurring opinion.
To discuss the case, we have Gregory Dolin, who is Associate Professor and Co-Director of the Center for Medicine and Law at the University of Baltimore School of Law.