Analysis shows patent use codes in USA have doubled since August 2003

With all of the hubbub over Patent Use Codes (PUCs) since the US Court of Appeals for the Federal Circuit issued its April 2010 decision in Novo Nordisk A/S v Caraco Pharmaceutical Laboratories, addressing whether the patent delisting counterclaim provisions at FDC Act section 505(j)(5)(C)(ii)(I), as added by the Medicare Modernization Act,  may be used to correct or delete an Orange Book-listed PUC, law firm Hyman, Phelps & McNamara says it thought it would be interesting to analyze the growth of PUCs. The comments are posted on HP&M's FDA Law Blog.

In Novo Nordisk, the Federal Circuit, in a two to one, decision, reversed and vacated a 2009 judgment and order and injunction requiring Novo Nordisk to change an Orange Book-listed PUC for a patent on its drug product, Prandin (repaglinide) Tablets. The Court ruled that 'the Hatch-Waxman Act authorizes a counterclaim only if the listed patent does not claim any approved methods of using the listed drug,' and that 'the terms of the counterclaim provision do not authorize an order compelling the patent holder to change its use code narrative.'

Caraco has filed a petition for panel rehearing and rehearing en banc. Several amicus briefs have been filed in the case in support of Caraco's rehearing petition, including briefs from GPhA, Mylan, Teva, Apotex and the Consumers Federation of America. Meanwhile, others have alleged that the PRANDIN use code change is anticompetitive and violates Section 2 of the Sherman Act because it stalls generic competition.