Patent Use Codes: Will Supreme Court Curb Carve-outs Or Spawn Suits?
The high court hears oral arguments in a case that could limit the ability of generics to carve out still-patented uses from their labeling to get prompt ANDA approval. Brand manufacturers argue that allowing such challenges will invite a flood of lawsuits. Caraco v. Novo revolves around a patent use code for the diabetes drug Prandin.
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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.
The Federal Circuit ruled that AstraZeneca cannot claim infringement of unpatented uses of rosuvastatin; the court affirmed the validity of section viii labeling carve-outs.
In oral arguments in Caraco v. Novo Nordisk, justices also ask whether Caraco could have sued FDA for accepting Novo’s Prandin patent use code instead of filing a counterclaim against Novo to force it to change the code.