Teva Sues FDA Over Failure to Substantively Respond to COPAXONE Citizen Petition

By Kurt R. Karst –      

In a Complaint (and Motion for Temporary Restraining Order and Expedited Preliminary Injunction) lodged in the U.S. District Court for the District of Columbia, Teva Pharmaceutical Industries Ltd. and Teva Neuroscience, Inc. (collectively “Teva”) allege that FDA’s May 2, 2014 denial “without comment” of a December 2013 Citizen Petition (Docket No. FDA-2013-P-1641) concerning COPAXONE (glatiramer acetate injection) violates the FDC Act and the Administrative Procedure Act (“APA”).  The lawsuit comes just weeks before each patent listed in the Orange Book for the 20MG/ML strength of COPAXONE will expire (on May 24, 2014), and at which time FDA could make ANDA approval decisions. 

Teva’s December 2013 Citizen Petition is one of several such petitions the company has filed over the past few years, including Docket Nos. FDA-2008-P-0529, FDA-2009-P-0555, FDA-2010-P-0642, FDA-2012-P-0555, FDA-2013-P-0025.  In each instance (except for one petition that was apparently withdrawn – FDA-2013-P-1128), FDA has denied the petition without comment.  Teva’s December 2013 petition requests that FDA refrain from approving any ANDA referencing COPAXONE “unless and until” such an ANDA provides:

1. Information demonstrating that the proposed generic product contains the identical active ingredient as Copaxone®, not merely an active ingredient that is similar (or even highly similar) to Copaxone®’s;

2. Results of non-clinical and clinical investigations demonstrating that the immunogenicity risks associated with the proposed generic product are no greater than the risks associated with Copaxone®, including a demonstration that the risks of alternating or switching between use of the proposed product and Copaxone® are not greater than the risks of using Copaxone® without such alternation or switching; and

3. Results of comparative clinical investigations in RRMS patients using relevant safety and effectiveness endpoints demonstrating that the proposed generic drug is bioequivalent to Copaxone®.

According to Teva:

Despite Congress’s clear command, FDA has never provided a meaningful response addressing the merits of the core issues Teva has raised.  Instead, it repeatedly has denied Teva’s petitions “without comment” on the merits of Teva’s request to have FDA establish clinical trial requirements for ANDAs referencing Copaxone®, repeatedly asserting that “it would be premature and inappropriate” to “comment on the approvability of any ANDA or NDA for any glatiramer acetate injection drug product . . . before the Agency has had an opportunity . . . to fully consider specific data and information in such an application.”  

That “clear command” from Congress, says Teva, comes from FDC Act § 505(q), which was added to the statute in 2007 and governs FDA’s response timeframe (originally 180 days and now 150 days) to certain citizen petitions.  “The May 2, 2014 Response violates the plain text, structure, and history of the FDCA and fundamentally undermines the statutory scheme,” argues Teva.  For more on 505(q) petitions see our previous post here.

Teva is seeking declaratory and injunctive relief.  Among other things, Teva wants a declaration that FDA’s May 2, 2014 petition response violates the APA, a declaration “that FDA may not approve or otherwise permit the introduction into interstate commerce of any ANDA product referencing Copaxone® that does not comply with the conditions requested in Teva’s December 5, 2013 citizen petition,” and the court to enjoin FDA from approving any ANDA for generic COPAXONE that does not comply with its December 2013 petition to FDA.

UPDATE:

May 9, 2014: The following Minute Order was entered:

MINUTE ORDER denying plaintiffs' motion for a temporary restraining order. For the reasons stated on the record during the hearing held this day, plaintiffs' motion for a temporary restraining order is DENIED. Defendants' opposition to plaintiffs' motion for a preliminary injunction, along with an outline of the administrative record, is due Monday, May 12, 2014 at 5:00 p.m. A motions hearing on plaintiffs' motion for a preliminary injunction is set before the Honorable Ellen Segal Huvelle on Wednesday, May 14, 2014, at 2:00 p.m. in Courtroom 23A. Signed by Judge Beryl A. Howell on May 9, 2014.