U.S. Supreme Court Restores Generic Pharma's Ability To Challenge Orange Book Use Code Information

The U.S. Supreme Court's unanimous ruling on April 17, 2012, in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S was a resounding win for both Caraco and the generic pharmaceutical industry as a whole. Specifically, the Court held that a generic manufacturer may employ the counterclaim provision of 21 U.S.C. § 355(j)(5)(C)(ii)(I)—part of the Medicare Modernization Act of 2003 amendments to the Hatch-Waxman Act—to force correction of an Orange Book use code that inaccurately describes the brand's patent as covering a particular method of using the drug. Allowing generic manufacturers to counter-claim for correction of overly broad use codes provides a faster, more efficient means for bringing non-infringing generic products to market, while hopefully curtailing abuses of use codes by brand pharmaceutical companies seeking to delay generic competition.

The drug at issue in this case is PRANDIN® (repaglinide), which is used for the treatment of type 2 diabetes (non-insulin dependent diabetes mellitus). There are three FDA-approved indications for PRANDIN®: (1) treatment with repaglinide alone; (2) treatment with repaglinide in combination with metformin and (3) treatment with repaglinide in combination with thiazolidinediones (TZDs). When Caraco filed its abbreviated new drug application (ANDA) in 2005 seeking approval to market generic repaglinide, the Orange Book listing for PRANDIN® included two patents: U.S. Patent No. RE37,035 ("the '035 patent") and U.S. Patent No. 6,677,358 ("the '358 patent"). The '035 patent, which claimed the compound repaglinide, expired in 2009, leaving only the '358 patent, which claims only the second FDA-approved use: repaglinide-metformin combination therapy. At the time Caraco filed its ANDA, Novo's included a use code for the '358 patent stating "[u]se of repaglinide in combination with metformin to lower blood glucose." Novo holds no unexpired patents claiming the use of repaglinide alone or in combination with TZDs.

Caraco's ANDA contained a paragraph III certification for the '035 patent and a paragraph IV certification for the '358 method-of-use patent, asserting that it was invalid, unenforceable and/or not infringed. In response to the paragraph IV certification, Novo filed suit against Caraco in the U.S. District Court for the Eastern District of Michigan. Upon review of Caraco's ANDA, the FDA advised Caraco that if it was not seeking to market repaglinide with metformin, it could submit a section viii statement seeking approval for only the two unpatented approved uses. Caraco took the FDA's cue and submitted an amended ANDA with a section viii statement, with proposed labeling...