Apotex Seeks Exclusivity-Triggering Court Decision in Declaratory Judgment Action Over Generic BENICAR Patent

By Kurt R. Karst –

In a recent Complaint for Declaratory Judgment filed in the U.S. District Court for the Northern District of Illinois (Eastern Division), Apotex Inc. (“Apotex”) is attempting to trigger 180-day exclusivity for generic versions of the hypertension drug BENICAR (olmesartan medoxomil) Tablets, 5 mg 20 mg, and 40 mg, under the failure-to-market 180-day exclusivity forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I). The complaint is the latest in a string of thus far unsuccessful attempts by Apotex to obtain an exclusivity-triggering court decision, including exclusivity for generic versions of LEXAPRO (escitalopram) Tablets and LIPITOR (atorvastatin calcium) Tablets (see here).

BENICAR Tablets, which is approved under NDA No. 021286, is listed in the Orange Book with information on two patents: (1) U.S. Patent No. 5,616,599 (“the ‘599 patent”), which is identified as a drug product, drug substance, and method-of-use patent and the pediatric exclusivity for which expires on October 25, 2016; and (2) U.S. Patent No. 6,878,703 (“the ‘703 patent”), which is identified as a method-of-use patent the pediatric exclusivity for which expires on May 19, 2022.  On July 11, 2006, all claims of the ‘703 patent were disclaimed, and, according to Apotex, the patent expired on April 12, 2009 for failure to pay maintenance fees.  In the February 2010 Orange Book Cumulative Supplement (page A-4), a “delist requested” flag was added to the ‘703 patent entry.  FDA did not remove the ‘703 patent from the Orange Book given the existence of a Paragraph IV certification to the patent.  According to FDA’s List of Paragraph IV Patent Certifications, the first ANDA submitted to FDA containing a Paragraph certification to as to either the ‘599 patent or ‘703 patent was April 25, 2006.

According to Apotex, Mylan Laboratories Ltd. (“Mylan”) (formerly Matrix) was the first company to submit an ANDA for generic BENICAR Tablets containing a Paragraph IV certification, and Mylan’s ANDA contained Paragraph IV certifications with respect to both the ‘599 and ‘703 patents.  Patent infringement litigation was initiated against Mylan with respect to the ‘599 patent but not the ‘703 patent.  Mylan failed in its challenge of the ‘599 patent, and in September 2010, the U.S. Court of Appeals for the Federal Circuit affirmed the validy of the patent.  Mylan’s subsequent appeal to the U.S. Supreme Court also failed (see here).  Thus, Mylan’s Paragraph IV certification to the ‘599 patent converted to a Paragraph III certification, preventing ANDA approval until October 25, 2016 when pediatric exclusivity applicable to the patent expires.  FDA tentatively approved Mylan’s ANDA No. 078276 on March 5, 2008.  On September 16, 2009, FDA tentatively approved a second ANDA – Sandoz’s ANDA No. 090237.  FDA has not yet tentatively approved Apotex’s ANDA No. 204089, which was submitted years after the Mylan ANDA, and contains a Paragraph IV certification to the ‘703 patent.  Patent infringement litigation was not initiated against Apotex with respect to the ‘703 patent.

Under the 180-day exclusivity failure-to-market forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I), there must be two events – or “bookends” – to calculate a “later of” event between items (aa) and (bb).  The first bookend date under item (aa) is the earlier of the date that is:

(AA) 75 days after the date on which the approval of the application of the first applicant is made effective under subparagraph (B)(iii); or

(BB) 30 months after the date of submission of the application of the first applicant

That event has already happened here given the April 25, 2006 date on the List of Paragraph IV Patent Certifications. The other bookend – the (bb) part of the equation – provides that the (bb) date is “the date that is 75 days after the date as of which, as to each of the patents with respect to which the first applicant submitted and lawfully maintained a [Paragraph IV] certification qualifying the first applicant for the 180-day exclusivity period,” one of three events occurs:

(AA) In an infringement action brought against that applicant with respect to the patent or in a declaratory judgment action brought by that applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed.

(BB) In an infringement action or a declaratory judgment action described in [FDC Act § 505(j)(5)(D)(i)(I)(bb)(AA)], a court signs a settlement order or consent decree that enters a final judgment that includes a finding that the patent is invalid or not infringed.

(CC) The patent information submitted under [FDC Act § 505(b) or (c)] is withdrawn by the holder of the application approved under subsection (b).

The (AA) and (BB) court decision events under item (bb) can be triggered in patent infringement litigation by “the first applicant or any other applicant (which other applicant has received tentative approval).”  Based on the D.C. Circuit’s March 2, 2010 decision in Teva Pharms USA, Inc. v. Sebelius, a mere patent delisting request is not enough to trigger a forfeiture event under the failure-to-market forfeiture, and in particular under subitem (CC).  Moreover, FDA, in the context of the Teva decision, ruled in a Letter Decision that the Court’s reasoning “appears to preclude a forfeiture of exclusivity on the basis of a patent expiration where the expiration is in the control of the NDA holder,” such as patent expiration for failure topay maintenance fees. 

Given these decisions, a subsequent ANDA sponsor, like Apotex, has limited options to trigger the forfeiture of a first applicant’s 180-day exclusivity eligibility.  Apotex’s Complaint seeks a declaration of non-infringement and a declaration that FDA may approve Apotex’s ANDA No. 204089:

whenever that application is otherwise in condition for approval, without awaiting any further order, judgment, or decree of this Court; that the judgment entered in this case is a judgment reflecting a decision that the patent in suit is not infringed pursuant to 21 U.S.C. § 355 (j)(5)(B)(iii)(I)(aa); and that the thirty-month period referred to in 21 U.S.C. § 355(j)(5)(B)(iii) and any other marketing exclusivity periods to which Plaintiffs might otherwise be entitled (including any pediatric exclusivity) with respect to the ’703 patent are shortened to expire upon the date of entry of judgment in this case . . . .

Given that FDA has not yet tentatively approved Apotex’s ANDA No. 204089, this case, like other declaratory judgment actions before it, raises several questions . . . . and not just about the “case or controversy” requirement under Article III of the U.S. Constitution for a court to have jurisdiction in an ANDA Hatch-Waxman declaratory judgment action.  This case once again raises the question of how FDA might interpret the “which other applicant has received tentative approval” parenthetical at FDC Act § 505(j)(5)(D)(i)(I)(bb).  If a subsequent applicant first obtains a final court decision in its favor and then tentative approval, when does the 75-day period begin?  Is the tentative approval retroactive to the date of the final court decision, or would FDA interpret the statute such that the 75-day period begins on the date on which the subsequent applicant completed the statutory criteria?  Or, might FDA interpret the statute such that the 75-day period does not even begin under such a scenario because a subsequent applicant must have tentative approval at the time there is a final court decision?