The Solicitor General filed a brief as amicus curiae urging the Supreme Court should grant Caraco's petition for writ of certiorari to review Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd. (Fed. Cir. 2010). The Solicitor General's brief came in response to the Supreme Court's request for the U.S. government's views on the matter. The Solicitor General's brief asserted that the Federal Circuit erred in its April 2010 decision and that the Supreme Court's review was warranted.
We have blogged on this case a number of times, from a number of angles. In broad strokes, Caraco submitted a section viii statement subject matter related to the combined administration of repaglinide and metformin in an ANDA to market a generic version of Novo Nordisk's Prandin® product. Indeed, Novo Nordisk had listed a patent in the Orange Book reciting such a combination. Originally, Novo Nordisk had submitted a use code narrative to FDA for this method of use patent which described the combined administration of these two active agents. FDA approved Caraco's section viii. When Novo Nordisk submitted a broader use code narrative, however, FDA determined that Caraco could not properly submit a Section viii statement, because the use code narrative now overlapped with Caraco's proposed uses. Caraco filed a counterclaim under 21 U.S.C. § 355(j)(5)(C)(ii), requesting that the court order Novo Nordisk to revert the use code narrative to its original scope. While the District Court granted this request, the Federal Circuit reversed.
Critically, FDA has taken the position that its role vis-à-vis patents is merely "ministerial." In other words, FDA will not pass on whether the use code narrative properly describes the scope of an Orange Book patent. Nor will FDA pass on whether a generic labeling does not propose to market the drug for a protected patent use. Rather, FDA will merely compare the use code narrative submitted by the NDA holder on its face to the generic labeling. FDA will allow the use of a Section viii statement if no overlap exists between the narrative and generic's proposed labeling. While we have argued elsewhere that FDA should revisit its ministerial role for the sake of administrative efficiency, it is interesting to note that FDA's ministerial role plays a major part in the Solicitor General's argument.