With Dan Bagatell, Bryan Beel, Ph.D., Shannon Bloodworth
In Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, the Supreme Court has unanimously held that generic drug manufacturers may invoke the counterclaim provision of the Hatch-Waxman Act, 21 U.S.C. § 355(j)(5)(C)(ii)(I), to force branded drug manufacturers to correct overbroad descriptions of their method-of-use patents in the Food and Drug Administration's "Orange Book."