Patent Use Codes: FDA Might Have Administrative Remedies, Solicitor General Says
In calling for the Supreme Court to take up a case involving the alteration of a patent use code to block generic competition, the Acting Solicitor General suggested steps FDA could take to address the problem.
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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.
The Supreme Court will address whether an ANDA sponsor can challenge a brand name company's alteration of a drug's patent use code to block generic competition.
Patent Code Changes: Dangerous Precedent Or Unique Circumstance? Supreme Court Seeks Government's Views
Generic companies contend that the Caraco v. Novo Nordisk case could enable brand firms to game the system and delay generic approvals; Novo says the case may never happen again.