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Apotex Inc. v. Alcon Research, Ltd.

United States District Court, S.D. Indiana, Indianapolis Division

February 27, 2017

APOTEX INC., Plaintiff,
v.
ALCON RESEARCH, LTD., et al., Defendants. BARR LABORATORIES, INC., Intervenor-Defendant.

          ENTRY ON MOTION TO DISMISS

          Hon. William T. Lawrence, Judge

         This cause is before the Court on the motion of Intervenor-Defendant Barr Laboratories, Inc., (“Barr”) seeking to dismiss this case for lack of subject matter jurisdiction (Dkt. No. 38). The motion is fully briefed, and the Court, being duly advised, GRANTS the motion for the reasons set forth below.

         I. BACKGROUND

         This case arises out of the desire of Plaintiff Apotex, Inc., (“Apotex”) to market a generic version of the drug olopatadine, which is currently marketed by the Defendants (collectively referred to herein as “Alcon”) under the name Pataday. The parties agree on the following relevant background facts:

Alcon holds the approved NDA for Pataday® (olopatadine). It has listed two patents in the Orange Book: U.S. Patent No. 6, 995, 186 (the “'186 patent”), scheduled to expire on May 12, 2024, and U.S. Patent No. 7, 402, 609 (the “'609 patent”), scheduled to expire on December 19, 2022.
On September 8, 2008, Barr filed the first ANDA to make a generic version of Pataday®. Its ANDA contained a Paragraph IV certification to the '186 and '609 patents. As the first ANDA filer, Barr earned 180-day generic drug exclusivity.
Barr's ANDA received final approval from the FDA on July 15, 2015. Apotex is a subsequent ANDA filer, meaning it filed its ANDA after Barr filed its ANDA.
Apotex's olopatadine ANDA has received “tentative approval” from the FDA, but the FDA may not approve Apotex's ANDA until Barr's 180-day exclusivity period expires.
In 2009, Alcon sued Barr in this [district], alleging that the generic olopatadine product described in Barr's ANDA would infringe the '186 and '609 patents. Alcon Research Ltd. v. Barr Labs., Inc., No. 1:09-cv-00026-RLY-TAB (S.D. Ind.). After more than four years of litigation, Alcon and Barr settled the case. The court entered a Stipulation of Dismissal on May 9, 2013.
Alcon also sued Apotex in 2009, again in this [district]. Alcon Research Ltd. v. Apotex Inc., No. 1:09-cv-00102-RLY-TAB (S.D. Ind.) (the “Apotex Patent Action”). As in the Barr lawsuit, Alcon alleged that the generic olopatadine product described in Apotex's ANDA would infringe the '186 and '609 patents.

Dkt. No. 39 at 12-13 (citations omitted) (quoted in Dkt. No. 40 at 2-3).

         In July 2013, after four years of litigation, Alcon and Apotex settled the Apotex Patent Action and it was dismissed without prejudice. The settlement agreement provided Apotex a license to the '186 and '609 patents. However, despite the license, Apotex could not-and still cannot-launch its generic product because of Barr's right to a 180-day exclusivity period.

         Pursuant to the Hatch-Waxman Act, the 180-day period will not be triggered until Barr begins marketing its generic product. However, Barr will forfeit its exclusivity period if it fails to begin marketing its generic product within 75 days of:

(AA) In an infringement action brought against [Apotex] with respect to the patent[s] or in a declaratory judgment action brought by [Apotex] with respect to the patent[s], 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.
[or]
(BB) In an infringement action or a declaratory judgment action described in subitem (AA), a court signs a settlement order or consent decree that enters a final judgment that includes a finding that the ...

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