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Patent Use Codes: Will Supreme Court Curb Carve-outs Or Spawn Suits?

Executive Summary

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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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.

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