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SUPERNUS PHARMACEUTICALS,
Plaintiffs,
V.
INC.
Defendants.
COMPLAINT
Plaintiffs Shire LLC
Supernus Pharmaceuticals,
("Shire" ), Shire
Development
LLC
("Shire
Development" ), and
attorneys, for their Complaint against Defendants Apotex Corp. and Apotex, Inc. (collectively
1.
of the
United States, Title 35, United States Code, involving United States Patent Nos. 6,287,599 ("the
'599 patent") and 6,811,794 ("the '794 patent") (attached as Exhibits A and B respectively
hereto) (collectively "the patents-in-suit").
THE PARTIES
2.
Shire is a corporation organized and existing under the laws
of the State of
41042.
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3.
Shire Development
of the
19087.
Supernus is a corporation organized and existing under the laws
4.
of the State of
of business
20850.
5.
under the laws
Upon information
of Canada,
6.
pharmaceutical
Upon information
generic
of Florida.
7.
Upon information
with a place
of
Apotex, Inc. Upon information and belief, Apotex Corp. acts at the direction of, under the
control of, and for the direct benefit
of Apotex, Inc.
by
Apotex, Inc.
9.
Upon information
of
Apotex, Inc., including for Abbreviated New Drug Application ("ANDA") No. 205430 ("the
Apotex ANDA"). Apotex's ANDA states that Apotex Corp. is the "authorized US agent" for
communications
with respect to Apotex's ANDA.
10.
Upon information
to accept service of
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11.
Upon information
distributor and sells and offers for sale Apotex, Inc.'s drug product throughout
including the state
of Florida.
JURISDICTION AND VENUE
12.
This Court has jurisdiction over the subject matter of this action pursuant to 28
of Florida.
15.
Upon information
and belief, Apotex, Inc. is the applicant for Apotex's ANDA, and Drug Administration
U.S. Food
("FDA") under
505(j) of the
Federal Food, Drug, and Cosmetic Act ("FDCA") (codified at 21 U.S.C. $ 355(j)), seeking
approval to manufacture,
Hydrochloride
Hyperactivity
Extended-Release
of Attention Deficit
16.
17.
Upon information
registered agent named CT Corporation located at 1200 South Pine Island Road, Plantation,
Florida 33324.
18.
Upon information
of the state of
Florida. For example, upon information and belief, Apotex Corp. is registered to do business in
the State
of Florida
(a/k/a
19.
preparation
Upon information
and submission
for the
of Apotex's ANDA,
commercial manufacture,
of
20.
Upon information
presence within this judicial district and/or substantial events giving rise to acts
of infringement of
that have occurred and/or will occur within this judicial district including its preparation
and/or contribution
or offer to sell Apotex's Proposed Products in the United States including the state of Florida.
21.
manufacturing,
Upon information
distributing,
and/or selling generic drug products for sale and use throughout
the
of Florida,
22.
Upon information
products distributed
of Florida.
submitted to the jurisdiction
23.
Upon information
and has previously
of this Court
availed itself
of this
Additionally,
Apotex, Inc. and Apotex Corp. are plaintiffs in a civil action currently pending in
of the
Southern District
of Florida
themselves
v. Mylan
Pharmaceuticals,
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of Guanfacine Hydrochloride
of Intuniv.
Intuniv
of
Disorder.
dosage forms with
26.
minimized
pH dependent dissolution profiles" and was duly and legally issued on September
11,
2001.
27.
with minimized
dosage forms
November 2, 2004.
28.
Pursuant to 21
in FDA's
publication entitled "Approved Drug Products with Therapeutic Equivalence Evaluations" (commonly known as the "Orange Book") as covering Intuniv.
29.
Upon information
and belief, Apotex filed its ANDA with the FDA under $ 505(j)
4 mg ("Apotex's Proposed Products" ) before the expiration of the '599 and '794 patents.
30.
notice
Upon information
the
to include a
of certification for
C.F.R. 505(j)(2)(B)(ii) of the FDCA regarding Apotex's Product ("Apotex's Notice Letter" ).
This letter was received by Shire on October 8, 2013.
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FIRST COUNT
(Infringement
by Apotex)
31.
32.
minimized
11,
("Shire
upon assignment
from Shire Labs. Supernus granted Shire an exclusive license under the '599 patent with respect
to, inter alia, drug products containing the active ingredient guanfacine or salts thereof.
33.
Upon information
and/or distribution
34.
Upon information
IV
use,
certification to the '599 patent to obtain approval to engage in the commercial manufacture,
sale, offer for sale and/or importation
the expiration
of the
'599 patent.
35.
Upon information
manufacture,
sell, offer
36.
was aware
and 21
Upon information
and belief, as
of the
C.F.R. $ 314.95(c)(6).
37.
The submission and filing of Apotex's ANDA with a paragraph IV certification to
the
'599 patent for the purpose of obtaining approval to engage in the commercial manufacture,
an act
U.S.C. $ 271(e)(2)(A).
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38.
Upon information
for sale, and/or importation into the United States of Apotex's Proposed Products that are the
subject of Apotex's ANDA will infringe one or more claims of the '599 patent.
39.
was aware
Upon information
and belief, as
SECOND COUNT
(Infringement
of the '794
patent by Apotex)
40.
41.
minimized pH dependent
("Shire
assignment
from
Shire Labs, Supernus granted Shire an exclusive license under the '794 patent with respect to,
inter alia, drug products containing the active ingredient guanfacine or salts thereof.
42.
Upon information
and/or distribution
43.
Upon information
IV
use,
certification to the '794 patent to obtain approval to engage in the commercial manufacture,
sale, offer for sale and/or importation
'794 patent.
44.
Upon information
and belief, Apotex will commercially
manufacture,
sell, offer
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45.
was aware
and 21
Upon information
and belief, as
of the
C.F.R. $ 314.95(c)(6).
46.
The submission and filing
of Apotex's ANDA
with a paragraph
IV certification to
of obtaining
the expiration
an act
of infringement
U.S.C. $
271(e)(2)(A).
47.
Upon information
for sale, and/or importation into the United States of Apotex's Proposed Products that are the
subject of Apotex's ANDA will infringe one or more claims of the '794 patent.
48.
was aware
Upon information
and belief, as
of the '794
THIRD COUNT
(Induced and/or Contributory
Infringement
49.
50.
or more claims
Apotex Corp. is jointly and severally liable for Apotex, Inc.'s infringement
of one
51.
Apotex Corp. to infringe and/or contributed and/or will contribute to Apotex Corp.'s
infringement
of one or more
claims
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52.
Upon information
and belief, Apotex, Inc. has, continues to, and will actively
with knowledge
of the
rights
of Plaintiffs,
53.
Upon information
of
Apotex, Inc. Upon information and belief, Apotex Corp. serves as Apotex, Inc.'s United States
distributor and sells and offers for sale Apotex, Inc.'s drug product throughout
including Delaware.
Apotex's ANDA indicates that Apotex Corp. is the United States agent for
54.
Upon information
aided,
and/or filing
of
Apotex's ANDA.
55.
of the
'599 patent under 35 U.S.C. $ 271(b) and/or 35 U.S.C. $ 271(c) by virtue of commercial use,
sale, offer for sale and/or importation
56.
Upon information and belief, Apotex, Inc. and Apotex Corp. will induce and/or
by third parties
contribute to infringement
their inducement,
under 35
encouragement,
Proposed Products.
57.
Upon information
and belief, Apotex, Inc. has, continues to, and will actively
with knowledge
of the
rights
58,
Upon information
and belief, as
Inc. was aware of the existence of the '599 patent and acted without a reasonable basis for
believing that it would not be liable for inducing and/or contributing
infringement,
thus rendering this case "exceptional" under 35
to Apotex Corp.'s
U.S.C. $ 285.
9
WPBDOCS 8381636 2
59.
The acts
of infringement set
which neither has adequate remedy at law, unless Apotex Corp. is preliminarily
FOURTH COUNT
(Induced and/or Contributory
Infringement
60.
61.
Apotex Corp. is jointly and severally liable for Apotex, Inc.'s infringement
of one
of one or
62.
with knowledge
of the
rights
of Plaintiffs. of
63.
Upon information
Apotex, Inc. Upon information and belief, Apotex Corp. serves as Apotex, Inc.'s United States
distributor and sells and offers for sale Apotex, Inc.'s drug product throughout
including Delaware.
Apotex's ANDA indicates that Apotex Corp. is the United States agent for
64.
Upon information
aided,
and/or filing
of
Apotex's ANDA,
65.
of the
'794 patent under 35 U.S.C. $ 271(b) and/or 35 U.S.C. $ 271(c) by virtue of commercial use,
sale, offer for sale and/or importation
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66.
Upon information
and belief, Apotex, Inc. and Apotex Corp, will induce and/or
contribute to infringement
by third parties
of the '794
patent under 35
their inducement,
encouragement,
of Apotex's
Proposed Products.
67.
Upon information
and belief, Apotex, Inc. has, continues to, and will actively
with knowledge
of the
rights
68.
Upon information
and belief, as
Inc. was aware of the existence of the '794 patent and acted without a reasonable basis for
believing that it would not be liable for inducing and/or contributing
infringement,
thus rendering this case "exceptional" under 35
to Apotex Corp.'s
U.S.C. $ 285.
69.
The acts
which neither has adequate remedy at law, unless Apotex Corp. is preliminarily
(b) A judgment declaring that, pursuant to 35 U.S.C. $ 271(e)(2)(A), the submission and
filing
of Apotex's ANDA
with a paragraph
commercial manufacture,
use, sale, offer for sale and/or importation in the United States
of the
was an
the expiration
act of infringement;
11
WPBDOCS 8381636 2
(d) An order that, pursuant to 35 U.S.C. ) 271(e)(4)(A), the effective date of any approval
of the product
the
of Apotex's ANDA
enjoining Apotex, their officers, agents, servants, employees and attorneys, and those persons in
of the
of Apotex's
U.S.C. $ $ 271(e)(4)(C) and 284, if Apotex commercially manufactures, uses, sells, offers to sell
and/or imports any products that are the subject
'599 patent;
(g) A judgment declaring that, pursuant to 35 U.S.C. $ 271(b) and/or 35 U.S.C. $ 271(c),
Apotex, Inc. would induce and/or contribute to Apotex Corp.'s infringement
and that both defendants
of the '599
into the
United States
of Apotex's ANDA
prior to the
expiration
patent;
(i) A judgment declaring that the '794 patent is valid and enforceable;
12
WPBDOCS 8381636 2
(j) A judgment declaring that, pursuant to 35 U.S.C. $ 271(e)(2)(A), the submission and
filing
of Apotex's ANDA
with a paragraph
commercial manufacture,
of the
an
the expiration
act of infringement;
271(a), the commercial manufacture, use, sale, offer for sale and/or importation in the United
States of the products that are the subject of Apotex's ANDA prior to the expiration of the '794
patent will constitute an act
individually
and collectively;
(I) An order that, pursuant to 35 U.S.C. $ 271(e)(4)(A), the effective date of any approval
of the
of Apotex's ANDA
and permanently
enjoining Apotex, their officers, agents, servants, employees and attorneys, and those persons in
of the
of Apotex's ANDA
U.S.C. )$ 271(e)(4)(C) and 284, if Apotex commercially manufactures, uses, sells, offers to sell
and/or imports any products that are the subject
'794 patent;
(o) A judgment declaring that, pursuant to 35 U.S.C. $ 271(b) and/or 35 U.S.C. $ 271(c),
Apotex, Inc. would induce and/or contribute to Apotex Corp.'s infringement
and that both defendants
WPBDOCS 8381636 2
of the '794
13
into the
the
expiration
of the '794
patent;
(q) A judgment declaring that, pursuant to 35 U.S.C. $ 285, this is an exceptional case
and awarding
and costs;
(r) Such other and further relief as this Court may deem just and proper.
14
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Respectfully submitted,
Dated: November
21, 2013.
Daniel J. Barskv Eric C. Christu, Esq. (FBN 434647) echristu@shutts.corn Daniel J. Barsky, Esq. (FBN 0025713) dbarskv@shutts.corn
/s/
Of Counsel
FROMMER LAWRENCE Edgar H. Haug Jason A. Lief Erin A. Lawrence 745 Fifth Avenue New York, NY 10151 (212) 588-0800
k HAUG
LLP
SHUTTS k, BOWEN LLP 201 South Biscayne Boulevard Suite 1500 Miami, Florida 33131
(305) 358-6300
Attorneys for Plaintiffs Shire LLC, Shire Development LLC, and Supernus
Pharmaceuticals,
Inc.
15
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