FDA Lawyers Blog

by Brian Malkin and Christopher Gosselin

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then required Cobrek to either file a suitability petition to determine whether the ampule Hectoral® injection had been withdrawn for reasons of safety or efficacy or reformulate to match the new Hectoral® injection formulation and provide Genzyme with a Paragraph IV notice letter for the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.

by Andrew S. Wasson

Sanofi-Aventis ("Sanofi") and partner Debiopharm were foiled by the United States District Court for the District of Columbia in their attempt to force FDA to rescind approvals for generic oxaliplatin products. While the District Court of New Jersey entered a judgment that the generic applicants did not infringe one of the Orange Book patents (U.S. Patent No. 5,338,874), the Federal Circuit later vacated and remanded the district court ruling. In the meantime, based on the district court ruling of non-infringement, FDA approved several generic oxaliplatin applications.

Sanofi sued FDA, arguing that FDA inappropriately applied the provision of the Hatch-Waxman Act to lifting of the "30-month stay." The Hatch-Waxman Act prevents FDA from approving a generic application that challenges a patent listed in the Orange Book until thirty months elapses from the date that notice is provided by the generic challenger of its challenge (the "30-month stay"). 21 U.S.C. § 355(j)(5)(B)(iii). The 30-month stay may be lifted if "the district court decides that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity)." 21 U.S.C. § 355(j)(5)(B)(iii)(I). Here, Sanofi and Debiopharm argued that even though the district court entered a judgment that the patent was not infringed, the 30-month stay should be put back into place because the Federal Circuit vacated the district court opinion.

The United States District Court for the District of Columbia disagreed with Sanofi and Debiopharm. Analyzing the issue under the rubric of the Administrative Procedures Act and Chrevron deference, the court found that FDA's decision to approve generic applicants was neither arbitrary, capricious, nor an abuse of discretion. In particular, the court noted that the provision for the 30-month stay stands in stark contrast to other provisions in the Hatch-Waxman Act which specifically reference an appellate action. The court therefore concluded that the, "plain language of the statute dictates that the thirty-month stay terminate upon the entry of judgment by a district court that a patent is invalid or not infringed, regardless of any subsequent appeal, and that the FDA was bound to follow this directive."