Patent Use Codes For Brands Can Be Challenged By Generics, Supreme Court Rules
This article was originally published in The Pink Sheet Daily
Executive Summary
The high court says the Hatch-Waxman Act did not intend for one patented use of a drug to prevent the marketing of a generic for unpatented uses; Justice Sotomayor criticizes FDA for not providing clearer direction to brand manufacturers about what to include in their use codes.