Supreme Court Allows Generics To Challenge Orange Book Use Codes In Hatch-Waxman Litigation

Introduction

Today, the United States Supreme Court held that a generic drug manufacturer who is sued for infringement of a method-of-use patent pursuant to the Hatch-Waxman Act may assert a counterclaim alleging that the use code listed in the Orange Book inaccurately characterizes the uses claimed in the listed patent and requesting that the branded drug manufacturer correct the use code characterization accordingly. See Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, No. 10-884 (U.S. 2012) (Slip Op.). This expanded counterclaim is likely to become a recurring issue in Hatch-Waxman litigation regarding branded drugs with multiple approved methods of use.

Background and Litigation Below

Under the Hatch-Waxman Act, a generic manufacturer seeking FDA approval for a generic version of a branded drug must certify for each unexpired patent listed in the Orange Book for the branded drug that the generic will not seek approval prior to the expiration of the patent ("Paragraph III certification") or that the patent is invalid or will not be infringed by the manufacture, use or sale of the generic product ("Paragraph IV Certification").1 Additionally, when the branded drug is indicated for several different uses, a generic can "carve out" uses from its proposed labeling that are covered by method patents,2 and may file a "section viii statement" alleging that it does not seek approval for the uses that are covered by the Orange Book patents.3 While FDA may approve an ANDA containing a section viii statement to a listed method of use patent, it will refuse to do so if indications within the generic's proposed labeling overlap with the "use code" listed in the Orange Book.4

Novo Nordisk's branded product Prandin® (repaglinide) was approved by FDA for the treatment of diabetes as a monotherapy, as well as in combination with metformin, and in a separate combination with thiazolidinediones. See Slip Op. at 7. Novo brought a patent infringement suit against Caraco based upon its ANDA submission for a generic version of Prandin® prior to the expiration of Novo's patents, including a patent covering the use of repaglinide in combination with metformin to treat diabetes. See id. at 7-8. Caraco filed a Paragraph IV certification on the metformin combination use patent, but later submitted a "section viii" statement to carve out the metformin combination indication from its proposed labeling. See id. Novo, however, subsequently changed the use...