Supreme Court’s Caraco ruling signals need for FDA fix
18 April 2012
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Eileen McDermott, New York
The US Supreme Court has once again reversed the Federal Circuit in a case some hope may result in the Food and Drug Administration clarifying its guidelines on use codes filed with new drug applications
In a unanimous opinion, the Court said that generic manufacturer Caraco Pharmaceutical Laboratories may bring a counterclaim seeking to correct brand manufacturer Novo Nordisk’s use code with the Food and Drug Administration for a patent on the diabetes drug Prandin (generic repaglinide).
In May 2009, Novo Nordisk amended the language in its use code for US patent number 6,677,358 to include uses Caraco’s generic drug would cover, thereby barring Caraco from launching the drug.
Caraco filed a counterclaim...
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