On October 19, FDA granted a citizen petition filed on behalf of Genzyme Corporation ("Genzyme") requesting FDA to confirm that a second 30-month stay would issue following a subsequent Paragraph IV notice sent for a reformulated generic version of Hectoral® injection (doxercalciferol). FDA recently granted the petition, despite language in a 2004 FDA guidance stating that the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ("the MMA") "generally precludes multiple 30-month stays for those applications to which it applies."
In October 2007, Pentech Pharmaceuticals, Inc. (subsequently purchased by Cobrek; hereafter "Cobrek") submitted an application for a generic version of Hectoral® injection (ampules) containing a Paragraph IV certification for all of the Orange Book-listed patents. Within 45 days of receiving Cobrek's Paragraph IV notice letter, Genzyme asserted one of the patents against Cobrek, triggering a 30-month stay. Prior to approving Cobrek's application, Genzyme received approval for a new formulation of Hectorol® injection in stoppered vials. When FDA approved the supplement, Genzyme withdrew the ampule product from the market and submitted new patent information. Cobrek responded by amending its application to reflect the new patent information, but Genzyme did not sue on the new patent information.
FDA then required Cobrek to either file a suitability petition to determine whether the ampule Hectoral® injection had been withdrawn for reasons of safety or efficacy or reformulate to match the new Hectoral® injection formulation and provide Genzyme with a Paragraph IV notice letter for the new formulation. Cobrek chose-perhaps mistakenly-the latter route. Upon receiving Cobrek's notice letter, Genzyme sued Cobrek for infringement of the originally-asserted patent and the patent listed for the new stoppered vial formulation.