On April 17, 2012, the Supreme Court resolved an important, long-standing question under the Hatch-Waxman Act. While the Act provides that an ANDA applicant sued for patent infringement may bring a counterclaim seeking an order requiring the brand manufacturer to “correct or delete the patent information [it] submitted... on the ground that the patent does not claim… an approved method of the drug,” 21 U.S.C. § 355(j)(5)(C)(ii)(I), the Federal Circuit had never breathed life into this section. In the unanimous Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk, A/S decision, the Supreme Court held that an ANDA applicant may employ this provision to force correction of a use code that inaccurately describes the brand manufacturer’s patent as covering a particular method of using the drug in question.

The Underlying Dispute and Proceedings Below

The Supreme Court’s decision arose from the Prandin® (repaglinide) ANDA litigation between Novo Nordisk, A/S (“Novo”), the NDA holder, and Caraco Pharmaceutical Laboratories, Ltd. (“Caraco”), the first generic to file an ANDA. FDA had approved Prandin® to treat diabetes with: (i) repaglinide alone; (ii) repaglinide in combination with metformin; and (iii) repaglinide in combination with thiazolidinediones such as pioglitazone (TZDs). Novo’s patent for the repaglinide compound itself expired in 2009 (the “’035 patent”), leaving Novo with a method-of-use patent claiming a “method for treating [diabetes by] administering… repaglinide in combination with metformin” (the “’358 patent”), which expires in 2018. No patents have issued for the use of repaglinide alone or in combination with TZDs.