Apotex Seeks to Trigger 180-Day Exclusivity for Generic LEXAPRO Tablets

By Kurt R. Karst –      

In a Complaint for Declaratory Judgment filed in the U.S. District Court for the Eastern District of Michigan (Southern Division) last week by Apotex Inc., the company is trying to trigger 180-day exclusivity for generic LEXAPRO Tablets.  Apotex heavily relies on the U.S. Court of Appeals for the Federal Circuit’s October 2010 decision in Teva Pharms. USA, Inc. v. Eisai Co., 620 F.3d 1341 (Fed. Cir. 2010), for establishing jurisdiction.

LEXAPRO Tablets is currently listed in FDA’s Orange Book with three patents:  U.S. Patent Nos. 6,916,941 ("the '941 patent") and 7,420,069 ("the '069 patent"), both of which expire on August 12, 2022, but are subject to pediatric exclusivity that expires on February 12, 2023, and RE34712 (“the ‘712 patent”), which expires on September 14, 2011, but is subject to pediatric exclusivity that expires on March 14, 2012.  FDA’s Paragraph IV Certification List does not identify the first date on which an ANDA containing a Paragraph IV certification was submitted to FDA, because the ANDA was submitted to FDA before the Agency began listing such a date in March 2004.  Nevertheless, we understand that at least one ANDA containing a Paragraph IV certification to the ‘712 patent was submitted to FDA prior to December 8, 2003, when the Medicare Modernization Act (“MMA”) was enacted.  As such, 180-day exclusivity is governed by the pre-MMA version of the FDC Act, where exclusivity is patent-by-patent.

Apotex submitted ANDA No. 78-777 to FDA in 2007 containing a Paragraph IV certification to the ‘941 patent, and later amended the ANDA to contain a Paragraph IV certification to the ‘069 patent.  (There is no indication that Apotex submitted a Paragraph IV certification to the ‘712 patent, and we assume such certification is a Paragraph III.)  Apotex believes that the company is a subsequent Paragraph IV applicant with respect to the ‘941 and ‘069 patent, and is therefore blocked by another company’s 180-day exclusivity on each patent.  Neither the NDA holder nor patent owner sued Apotex for infringement of the ‘941 or ‘069 patents within the statutory 45-day period (or thereafter), leaving Apotex unable to obtain a court decision through the normal channels to trigger the first applicant’s 180-day exclusivity.  Instead, Apotex, through its January 2011 Complaint, seeks to use the MMA’s declaratory judgment provisions to obtain a court decision to trigger 180-day exclusivity

The MMA amended the FDC Act to affirmatively permit a generic applicant with an application containing a Paragraph IV certification to bring an action for declaratory judgment of patent invalidity or noninfringement (referred to in the law as a “civil action to obtain patent certainty”), provided: (1) the NDA holder or patent owner has allowed the 45-day period in which to file a suit for patent infringement to expire without bringing an action for patent infringement or invalidity; and (2) if the generic applicant’s notice to the NDA holder or patent owner relates to patent noninfringement, the notice includes an offer of confidential access to the generic applicant’s application for purposes of determining whether the NDA holder or patent owner should bring an action for patent infringement.  (Apotex apparently met both requirements.)  The MMA also amended the patent statute to provide that “courts of the United States shall, to the extent consistent with the Constitution, have subject matter jurisdiction in any action brought  . . . under [28 U.S.C. § 2201] for a declaratory judgment” of invalidity or noninfringement.

In the last few of years, the Federal Circuit has addressed the proper jurisdictional scope of the “case or controversy” requirement under Article III of the U.S. Constitution for a court to have jurisdiction in ANDA Hatch-Waxman declaratory judgment actions where a patent covering the Reference Listed Drug is listed in the Orange Book.  Most recently, in Teva Pharms. USA, Inc. v. Eisai Co., the Federal Circuit ruled that “[w]hen an Orange Book listing creates an ‘independent barrier’ to entering the marketplace that cannot be overcome without a court judgment that the listed patent is invalid or not infringed – as for Paragraph IV filers – the company manufacturing the generic drug has been deprived of an economic opportunity to compete.  A declaratory judgment redresses this alleged injury because it eliminates the potential for the corresponding listed patent to exclude the generic drug from the market.” (Internal citations omitted.)

Given the Federal Circuit’s recent ruling, Apotex argues:

By listing the ‘941 patent and the ‘069 patent in the Orange Book and not suing Apotex on those patents, Defendants have created patent and legal uncertainty that impairs Apotex’s right to market a non-infringing generic product without the risk of catastrophic infringement damages.  By virtue of Defendants’ actions, Apotex is also suffering an “FDA-approval-blocking-injury” or “the harm of being unable to launch . . . generic products covered by the [Apotex] ANDA” because of another applicant’s so-called 180-day exclusivity.  This patent and legal uncertainty and impairment of Apotex’s rights are, alone or in combination, sufficiently concrete and cognizable injuries-in-fact that are fairly traceable to the Defendants and that can be redressed only by a declaratory judgment from this Court.

Apotex’s recent Complaint concerning generic LEXAPRO is not the only case in which the company is arguing that the Federal Circuit’s ruling in Teva Pharms. USA, Inc. v. Eisai Co. creates declaratory judgment jurisdiction to obtain a court decision to trigger a first-filer’s 180-day exclusivity.  In Pfizer Inc. v. Apotex Inc., Case No. 1:08-07231, which is pending in the U.S. District Court for the Northern District of Illinois (Eastern Division), Apotex is seeking a declaratory judgment to create a court decision to trigger 180-day exclusivity for generic LIPITOR (arotvastatin calcium) Tablets, which is reportedly held by Ranbaxy.  Both of the pending Apotex cases, which were brought following what appears to be an increasing trend with some companies in deciding not to sue within the statutory 45-day period (and obtain a 30-month stay on ANDA approval) but rather following a wait-and-see approach, should add some helpful interpretation on the scope and effect of the Federal Circuit’s October 2010 decision.