United States District Court, S.D. Indiana, Indianapolis Division
ENTRY ON MOTION TO DISMISS
William T. Lawrence, Judge
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.
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
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).
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
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.
(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 ...