Patent Use Codes For Brands Can Be Challenged By Generics, Supreme Court Rules
This article was originally published in The Pink Sheet Daily
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.
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PhRMA is concerned about the agency giving deference to generic sponsors in patent use code disputes, while GPhA wants a mechanism to challenge refuse-to-receive letters.
Industry has 90 days to comment on FDA’s current handling of generic challenges to brand protections.
Supreme Court precedent on use codes should have precluded approval of generic Precedex, firm asserts.