Caraco v. Novo Nordisk (Prandin®): Federal Circuit Reversed in Patent Use Code Case
- Sterne, Kessler, Goldstein & Fox
On April 17, 2012, the U.S. Supreme Court issued a unanimous decision delivered by Justice Kagan in Caraco Pharmaceutical Laboratories Ltd. v. Novo Nordisk A/S, reversing the Federal Circuit and holding that a generic manufacturer (Caraco) may force correction of an Orange Book use code that inaccurately describes a brand company's (Novo's) patent as covering a particular method of using the drug in question under 21 U.S.C. §355(j)(5)(C)(ii)(I) ("the counterclaim provision"). To read the full summary, download the attached PDF.