Duchesnay Et. Al. v. Actavis Laboratories FL Et. Al.
Duchesnay Et. Al. v. Actavis Laboratories FL Et. Al.
.
37. The 695 patent was duly and legally issued by the United States Patent and
Trademark Office (PTO) on January 22, 2002. Duchesnay Inc. is the owner by assignment of
the 695 patent and has the right to sue for infringement thereof. Duchesnay Inc. lists the 695
patent in the Approved Drug Products With Therapeutic Equivalence Evaluations (Orange
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Book) for NDA No. 021876. A true and correct copy of the 695 patent is attached as Exhibit
A.
38. Duchesnay USA Inc. holds a license under the 695 patent. Duchesnay USA Inc.
distributes Diclegis
tablets.
50. Under 35 U.S.C. 271(e)(2)(A), the submission to the FDA of ANDA No.
205811 seeking approval for the commercial manufacture, use, or sale of Actaviss Generic
Product before the expiration date of the 695 patent, constitutes infringement, either literally or
under the doctrine of equivalents.
51. The filing of the ANDA by Defendants through Actavis Laboratories FL, Inc.
constituted direct infringement under 35 U.S.C. 271(e).
52. Under 35 U.S.C. 271(b) and 271(e)(2)(A), defendants Actavis, Inc. and
Actavis Pharma, Inc. induced the infringement of the 695 patent by actively and knowingly
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causing to be submitted, and/or assisting with, participating in, contributing to, and/or directing
the submission of ANDA No. 205811 to the FDA knowing that the submission of ANDA No.
205811 would constitute direct infringement of the 695 patent. Defendants Actavis, Inc. and
Actavis Pharma, Inc.s knowing and purposeful activities causing to be submitted, and/or
assisting with, participating in, contributing to, and/or directing the filing of ANDA No. 205811,
knowing that its submission would constitute direct infringement, constitutes induced
infringement of the 695 patent.
53. Upon FDA approval of ANDA No. 205811, Actavis will infringe one or more
claims of the 695 patent, either literally or under the doctrine of equivalents under 271(a) by
making, using, offering to sell, selling, and/or importing Actaviss Generic Product, and by
actively inducing infringement by others under 271(b) and /or contributing to infringement
under 271(c), unless this Court orders that the effective date of any FDA approval of ANDA
No. 205811 shall be no earlier than the expiration of the 695 patent and any additional periods
of exclusivity.
54. On information and belief, Actavis knows and intends that physicians will
prescribe and parties will take Actaviss Generic Product for which approval is sought in ANDA
No. 205811, and therefore will infringe at least one claim in the 695 patent.
55. On information and belief, Actavis had knowledge of the 695 patent and, by its
promotional activities and proposed package insert for Actaviss Generic Product, knows or
should know that it will aid and abet anothers direct infringement of at least one of the claims of
the 695 patent, either literally or under the doctrine of equivalents.
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56. On information and belief, Actavis is aware and/or has knowledge that healthcare
professionals and/or patients will use Actaviss Generic Product according to the instructions in
the proposed package insert in a way that directly infringes the 695 patent.
57. The offering to sell, sale, making, and/or importation of Actaviss Generic
Product would actively induce infringement of at least one of the claims of the 695 patent, either
literally or under the doctrine of equivalents. Actavis has knowledge and is aware of Duchesnay
Inc.s 695 patent, as evidenced by Actavis Laboratories FL, Inc.s May 30, 2014 Notice Letter.
58. On information and belief, if ANDA No. 205811 is approved, Actavis intends to
and will offer to sell, sell, and/or import in the United States Actaviss Generic Product.
59. Actavis has had and continues to have knowledge that Actaviss Generic Product
is especially adapted for a use that infringes the 695 patent.
60. On information and belief, Actavis has had and continues to have knowledge that
there is no substantial non-infringing use for Actaviss Generic Product.
61. Duchesnay will be irreparably harmed if Actavis is not enjoined from infringing
or actively inducing infringement of at least one claim of the 695 patent. Pursuant to 35 U.S.C.
283, Duchesnay is entitled to a permanent injunction against further infringement. Duchesnay
does not have an adequate remedy at law.
COUNT II FOR DECLARATORY JUDGMENT AS TO THE 695 PATENT
62. Paragraphs 1-61 are incorporated herein by reference.
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63. On information and belief, Actavis, through Actavis Laboratories FL, Inc., filed
or caused to be filed with the FDA ANDA No. 205811 under 21 U.S.C. 355(j) to obtain
approval for the commercial manufacture, use, and sale of Actaviss Generic Product in the
United States before the expiration of the 695 patent.
64. On information and belief, Actavis is actively seeking approval to sell Actaviss
Generic Product for the same indications and the same dosage as the Diclegis
product sold by
Duchesnay.
65. On information and belief, Actavis has made preparations to make, market, offer
for sale, sell, and/or import Actaviss Generic Product labeled for the same indications and the
same dosage as the Diclegis
product.
68. On information and belief, Actavis has knowledge of the 695 patent and will
knowingly induce infringement of the 695 patent, if the FDA approves ANDA No. 205811
before the expiration of the 695 patent. On information and belief, if the FDA approves ANDA
No. 205811, Actavis Laboratories FL, Inc., in concert with Actavis, Inc. and Actavis Pharma,
Inc., will market, offer for sale, sell, and/or import Actaviss Generic Product in the United
States, which will constitute direct infringement of 35 U.S.C. 271(a) of the 695 patent. On
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information and belief, that marketing, offering for sale, and sale will occur with Actavis, Inc.
and Actavis Pharma, Inc.s specific intent and encouragement, and will be conduct that Actavis,
Inc. and Actavis Pharma, Inc. knows or should know will occur. On information and belief,
Actavis, Inc. and Actavis Pharma, Inc. will actively induce, encourage, aid, and abet that
conduct, with knowledge and specific intent that the conduct will be in contravention of
Duchesnays rights under the 695 patent.
69. If the FDA approves ANDA No. 205811, the market, offer for sale, and sale in
the United States of Actaviss Generic Product by Actavis before the expiration of the 695
patent will actively induce infringement by others under 35 U.S.C. 271(b) and/or contribute to
infringement under 271(c) by Actavis of one or more claims of the 695 patent, either literally
or under the doctrine of equivalents.
70. Duchesnay will be irreparably harmed if Actaviss threatened infringement of at
least one claim of the 695 patent is not enjoined. Duchesnay does not have an adequate remedy
at law. Thus, pursuant to 35 U.S.C. 283, Duchesnay is entitled to a permanent injunction
against such infringement.
71. As a result of the foregoing facts, there is a real, substantial, definite, concrete,
and continuing justiciable controversy between Duchesnay and Actavis as to liability for
infringement of the 695 patent. Actaviss actions have created in Duchesnay a reasonable
apprehension of irreparable harm and loss resulting from Actaviss threatened imminent actions.
72. Thus, under the totality of the circumstances, there is a substantial controversy
between Duchesnay and Actavis having sufficient immediacy and reality to establish declaratory
judgment jurisdiction relating to Actaviss threatened infringement of the 695 patent.
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PRAYER FOR RELIEF
WHEREFORE, Duchesnay respectfully requests that this Court enter judgment in its
favor as follows:
a) United States Patent No. 6,340,695 remains valid and is enforceable;
b) A judgment that Actavis, through Actavis Laboratories FL, Inc.s submission of
ANDA 205811 was an act of infringement and that Defendants making, using,
offering to sell, selling or importing Actaviss Generic Product prior to the
expiration of United States Patent No. 6,340,695 will infringe, actively induce
infringement and/or contribute to the infringement of United States Patent No.
6,340,695;
c) A judgment that defendants Actavis, Inc. and Actavis Pharma, Inc.s knowing and
purposeful activities causing to be submitted, and/or assisting with, participating
in, contributing to, and/or directing the filing of ANDA 205811 knowing that its
submission would constitute direct infringement and/or induced infringement of
United States Patent No. 6,340,695;
d) The effective date of any FDA approval of Actaviss Generic Product shall be no
earlier than the expiration date of United States Patent No. 6,340,695 and any
additional periods of exclusivity, in accordance with 35 U.S.C. 271(e)(4)(A);
e) Defendants, and all persons acting in concert with Defendants shall be enjoined
from commercially manufacturing, using, offering for sale, or selling Actaviss
Generic Product within the United States, or importing Actaviss Generic Product
into the United States, until the expiration of United States Patent No. 6,340,695,
in accordance with 35 U.S.C. 271(e)(4)(B) and 283;
f) This is an exceptional case and Duchesnay should be awarded its costs, expenses,
and disbursements in this action, including reasonable attorney fees, pursuant to
35 U.S.C. 285 and 271(e)(4);
g) Duchesnay is entitled to any further appropriate relief under 35 U.S.C.
271(e)(4); and
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h) Duchesnay is entitled to any further and additional relief that this Court deems
just and proper.
Respectfully submitted,
Dated: July 11, 2014 By: s/ John F. Brenner
PEPPER HAMILTON, LLP
John F. Brenner
Suite 400
301 Carnegie Center
Princeton, New Jersey, 08543-5276
(609) 951-4193
[email protected]
Attorneys for Plaintiffs Duchesnay Inc. and
Duchesnay USA Inc.
Of Counsel:
Charles E. Lipsey
FINNEGAN, HENDERSON, FARABOW
GARRETT & DUNNER, LLP
Two Freedom Square
11955 Freedom Drive
Reston, VA 20190-5675
(571) 203-2700
Barbara R. Rudolph
Barry W. Graham
Danielle A. Duszczyszyn
FINNEGAN, HENDERSON, FARABOW
GARRETT & DUNNER, LLP
901 New York Avenue, NW
Washington, DC 20001-4413
(202) 408-4000