FDA is Sued Over Generic CARBATROL; Lawsuit Challenges FDA Decisions on Pre-MMA 180-Day Exclusivity

May 30, 2011

By Kurt R. Karst –      

Last Friday, Nostrum Pharmaceuticals, LLC (“Nostrum”) lodged a Complaint against FDA in the U.S. District Court for the District of New Jersey seeking declaratory and injunctive relief arising from the Agency’s decisions on pre-Medicare Modernization Act (“MMA”) 180-day exclusivity with respect to Nostrum’s ANDA No. 76-697 for a generic version of CARBATROL (carbamazepine) Extended-release Capsules, 300 mg, which FDA approved on May 20, 2011.  On that same day, FDA approved two other strengths under Nostrum’s ANDA – 100 mg and 200 mg – after the Agency determined that another applicant, CorePharma, forfeited post-MMA 180-day exclusivity eligibility.  Those strengths are not at issue in the lawsuit.  At issue is FDA’s application of the so-called “holding-on-the merits” standard with respect to one Orange Book-listed patent on which Nostrum qualified for 180-day exclusivity (U.S. Patent No. 5,912,013 (“the '013 Patent”)), and FDA's interpretation that 180-day exclusivity terminates with the July 5, 2011 expiration of another patent on which Nostrum qualified for 180-day exclusivity (U.S. Patent No. 5,326,570 (“the ‘570 patent”)).  Lerner, David, Littenberg, Krumholz & Mentlik, LLP and Hyman, Phelps & McNamara, P.C. represent Nostrum in the lawsuit.

CARBATROL is listed in the Orange Book with two patents – the '013 Patent, which expires on June 15, 2016, and the ‘570 Patent, which expires on July 5, 2011.  Nostrum was the first company to submit an ANDA containing a Paragraph IV certification to each patent, thereby qualifying the company for 180-day exclusivity based on each patent.   Under the pre-MMA statute, 180-day exclusivity is patent-by-patent and is triggered by the earlier of: (1) the first commercial marketing of the drug by a first filer; or (2) “the date of a decision of a court in [a patent infringement action] holding the patent which is the subject of the certification to be invalid or not infringed.” 

With respect to the court decision trigger to pre-MMA 180-day exclusivity, FDA stated in an April 11, 2006 letter to ANDA applicants that the Agency:

interprets the language of the court decision trigger provision . . . to require a court decision with an actual “holding” on the merits that the patent is invalid, not infringed, or unenforceable.  The holding must be evidenced by language on the face of the court’s decision showing that the determination of invalidity, noninfringement, or unenforceability has been made by the court. 

FDA’s May 20, 2011 Letter Decision concerning 180-day exclusivity for Carbamazepine Extended-release Capsules says that Nostrum’s exclusivity with respect to the ‘013 patent was triggered by a June 14, 2009 ruling in Shire Labs, Inc. v. CorePharma, LLC, C.A. 06-2266 (D.N.J.), in which the court entered a final judgment of its previous order granting CorePharma's motion for summary judgment of non-infringement of the '013 patent.  According to FDA, this “holding is adequate as a basis to trigger the running of exclusivity as to the '013 patent,” and thus “Nostrum's exclusivity with respect to the '013 patent has expired.”

Nostrum says in its May 27, 2011 Complaint that the June 2009 order “did not qualify as the type of order that can trigger the start of Plaintiff's 180 day marketing exclusivity period with respect to the '013 Patent,” and that “FDA's determination denying Plaintiff its entitlement to 180 day exclusivity based on the '013 Patent is an arbitrary, capricious and unlawful decision that this Court should set aside.”  Instead, says Nostrum, the court should rule that Nostrum “is entitled to 180 day marketing exclusivity based on Plaintiff's paragraph IV certification to the '013 Patent because the referenced 2009 court decision did not, and could not, trigger the running of Plaintiff's exclusivity period for the '013 Patent.”

With respect to exclusivity stemming from the ‘570 patent, FDA ruled that Nostrum is eligible for 180-day exclusivity, which was triggered on May 20, 2011 when Nostrum began commercial marketing.  The ‘570 patent, however, expires on July 5, 2011.  Nostrum says in its Complaint that:

Based on FDA's past decisions and on its publicly announced policy, FDA, upon expiration of the '570 Patent on July 5, 2011, will likely unlawfully approve pending ANDAs for Carbamazepine Extended release Capsules 300 mg in violation of 21 U.S.C. § 355(j).  FDA's approval of other ANDAs for extended release 300 mg Carbamazepine will deny Plaintiff, by more than four months, its right to exclusively market its 300 mg Carbamazepine drug product for the entire 180 day exclusivity period to which Plaintiff is entitled, causing Plaintiff to suffer irreparable harm.

Nostrum seeks declaratory judgments with respect to 180-day exclusivity for both the ‘013 and ‘570 patents, as well as a preliminary and permanent injunction prohibiting FDA from approving another ANDAs for Carbamazepine Extended release Capsules, 300 mg, “until the expiration of Plaintiff's full 180 days of marketing exclusivity based on either the '013 Patent or the '570 Patent.”