Over the clamorous arguments of the generic pharmaceutical industry, on July 29, the Federal Circuit refused to review en banc its April 2010 decision in Novdisk A/S v. Caraco Pharm. Labs. Ltd., where it nixed a district court injunction compelling Novo Nordisk to modify a patent use code narrative relating to the drug Prandin® (repaglinide). Judges Gajarsa and Dyk entered spirited dissents, potentially setting the stage for legislative remedy or Supreme Court review.
Caraco, its parent company Sun Pharmaceutical Industries, and six other amicus curiae from the generics industry, requested that the Federal Circuit rehear the case en banc. Caraco and Sun argued that the original decision misconstrued the language of the Hatch-Waxman Act and failed to read the statutory language in the context of the full provision itself and with other provisions of the Act, such as subsection viii. Continuing the thread of Judge Dyk's dissent in the original opinion, the request also argued that the ruling failed to give the appropriate deference to FDA in its interpretation of "patent information."
Despite these arguments, the Federal Circuit refused to rehear the case, with Judges Gajarsa and Dyk dissenting. Writing the dissent, Judge Gajarsa stated that the April opinion "eviscerates Section viii" and that "[w]ith the majority's blessing, pioneering drug manufacturers now have every incentive to follow Novo's lead and draft exceedingly broad use codes thereby insulating themselves from generic competition and rendering Section viii a dead letter." Judge Gajarsa stated that it was an "untenable and absurd result" that even though the Orange Book patent would admittedly not cover Caraco's proposed carved-out labeling, Caraco would be effectively blocked from marketing until that patent's expiration in 2018. In addition, Judge Gajarsa argued that the opinion "effectively invalidates" he FDA's effort to define patent information broadly.