November 29, 2011
Earlier this month, the U.S. District Court for New Jersey held that Orchid’s third counterclaim to compel Hoffmann-La Roche to change the patent use codes for two of the Orange Book-listed patents for the osteoporosis drug Boniva® failed to state a claim for relief under 21 U.S.C. 355(j)(C)(ii) and dismissed it with prejudice in Hoffmann-La Roche Inc. v. Orchid Chemicals & Pharmaceuticals Ltd. The court did so without waiting for the upcoming ruling from the U.S. Supreme Court in Caraco Pharmaceutical Laboratories v. Novo Nordisk A/S.
According to the court’s order, the motion to dismiss “may be decided easily” since Orchid’s “sole argument in opposition is that a case is pending before the Supreme Court which might change existing law.” The court concluded that Orchid’s sole argument was “a concession that [its] third counterclaim [was] not valid.”
Meanwhile, the Supreme Court scheduled oral argument in Caraco Pharmaceutical Laboratories v. Novo Nordisk A/S for December 5, 2011. As earlier reported, the crux of the Caraco case is whether a generic drug manufacturer can counterclaim to compel correction or deletion of a Patent Use Code (PUC) for an Orange Book-listed patent when the patent holder allegedly submits an incorrect PUC that misstates the scope of the patent. The Caraco case is expected to resolve an important issue in Hatch-Waxman litigation and may have an effect on healthcare costs, according to some industry observers.
Whether Orchid’s third counterclaim will be resurrected once the Supreme Court issues its decision in the Caraco case remains to be seen.
If you have questions regarding this latest development, please contact Fitch Even partner Kendrew H. Colton, the author of this alert.