Case 1:16-cv-00766-UNA Document 1 Filed 09/01/16 Page 1 of 8 PageID #: 1

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF DELAWARE
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NEOS THERAPEUTICS, INC. and NEOS

THERAPEUTICS, LP,
Plaintiffs,
v.
ACTAVIS LABORATORIES FL, INC.,
ACTAVIS PHARMA, INC., and TEVA
PHARMACEUTICALS USA, INC.,
Defendants.

COMPLAINT
Plaintiffs Neos Therapeutics, Inc. and Neos Therapeutics, LP (collectively, Plaintiffs),
for their Complaint against Defendants Actavis Laboratories FL, Inc., Actavis Pharma, Inc., and
Teva Pharmaceuticals USA, Inc. (collectively, Defendants), hereby allege as follows.
PARTIES
1.

Plaintiff Neos Therapeutics, Inc. is a corporation organized and existing under the

laws of the State of Delaware with a principal place of business at 2940 North Highway 360,
Suite 400, Grand Prairie, Texas 75050.
2.

Plaintiff Neos Therapeutics, LP is a limited partnership organized and existing

under the laws of the State of Texas with a principal place of business at 2940 North Highway
360, Suite 400, Grand Prairie, Texas 75050.
3.

Upon information and belief, Defendant Actavis Laboratories FL, Inc. (Actavis

FL) is a Florida corporation with a principal place of business at 4955 Orange Drive, Davie,
Florida 33314.

Upon information and belief, Actavis FL develops, manufactures, and/or

distributes numerous generic drugs for sale and use throughout the United States, including in

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this judicial district (District) and including as a subsidiary and agent of Teva Pharmaceuticals
USA, Inc.
4.

Upon information and belief, Defendant Actavis Pharma, Inc. (Actavis Pharma)

is a Delaware corporation having a principal place of business at Morris Corporate Center III,
400 Interspace Parkway, Parsippany, New Jersey 07054. Upon information and belief, Actavis
Pharma distributes numerous generic drugs, including those manufactured by Actavis FL and/or
for which Actavis FL is the named applicant of the approved ANDA, for sale and use throughout
the United States, including in this District and including as a subsidiary and agent of Teva
Pharmaceuticals USA, Inc.
5.

Upon information and belief, Defendant Teva Pharmaceuticals USA, Inc.

(Teva) is a Delaware corporation having a principal place of business at 1090 Horsham Road,
North Wales, Pennsylvania 19454. Upon information and belief, Teva develops, manufactures,
and/or distributes numerous generic drugs for sale and use throughout the United States,
including in this District and including through its subsidiaries and agents, Actavis FL and
Actavis Pharma.
NATURE OF THE ACTION
6.

This is a civil action for the infringement of the following U.S. patents by

Defendants: U.S. Patent Nos. 8,709,491 (the 491 patent); 8,840,924 (the 924 patent);
9,017,731 (the 731 patent); and 9,265,737 (the 737 patent). This action is based upon the
Patent Laws of the United States, 35 U.S.C. 1 et seq.
JURISDICTION AND VENUE
7.

This Court has subject matter jurisdiction over this civil action pursuant to 28

U.S.C. 1331 and 1338(a).

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8.

This Court has personal jurisdiction over each of the Defendants for purposes of

this civil action.

9.

This Court has personal jurisdiction over Defendant Actavis FL for purposes of

this civil action by virtue of, inter alia, its systematic and continuous contacts with Delaware and
the fact that, upon information and belief, Actavis FL intends to sell the proposed generic
products at issue in this litigation in this District upon receiving approval from the United States
Food and Drug Administration (FDA).

Upon information and belief, Actavis FL has

previously consented to litigating in this forum, as shown by, inter alia, its conduct in multiple
prior litigations in this District. In particular, Actavis FL consented to and/or did not contest
personal jurisdiction in this District in at least: (1) Civil Action No. 15-687 (D.I. 26); (2) Civil
Action No. 15-413 (D.I. 6); (3) Civil Action No. 15-393 (D.I. 9); (4) Civil Action No. 15-164
(D.I. 10); (5) Civil Action No. 14-1118 (D.I. 14); (6) Civil Action No. 14-912 (D.I. 9); (7) Civil
Action No. 14-882 (D.I. 14); (8) Civil Action No. 14-776 (D.I. 16); (9) Civil Action No. 14-200
(D.I. 22 & D.I. 48).
10.

This Court has personal jurisdiction over Defendant Actavis Pharma by virtue of,

inter alia, the fact that it is a Delaware corporation.

11.

This Court has personal jurisdiction over Defendant Teva by virtue of, inter alia,

the fact that it is a Delaware corporation.

12.

Venue is proper in this District as to all Defendants pursuant to 28 U.S.C. 1391

and 1400(b).
THE PATENTS
13.

On April 29, 2014, the 491 patent, titled Composition Comprising A Mixture Of

Dextro- and Levo-Amphetamines Complexed With Ion-Exchange Resin Particles To Form Drug

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Resin Particles, was duly and legally issued by the United States Patent and Trademark Office
(USPTO). Since the issuance of the 491 patent, Plaintiff Neos Therapeutics, LP has been, and
continues to be, the 491 patents sole owner. A copy of the 491 patent is attached hereto as
Exhibit A.
14.

On September 23, 2014, the 924 patent, titled Compositions And Methods Of

Making Rapidly Dissolving Ionically Masked Formulations, was duly and legally issued by the
USPTO. Since the issuance of the 924 patent, Plaintiff Neos Therapeutics, LP has been, and
continues to be, the 924 patents sole owner. A copy of the 924 patent is attached hereto as
Exhibit B.
15.

On April 28, 2015, the 731 patent, titled Composition Comprising A Mixture Of

Dextro- and Levo-Amphetamines Complexed With Ion-Exchange Resin Particles To Form Drug
Resin Particles, was duly and legally issued by the USPTO. Since the issuance of the 731
patent, Plaintiff Neos Therapeutics, LP has been, and continues to be, the 731 patents sole
owner. A copy of the 731 patent is attached hereto as Exhibit C.
16.

On February 23, 2016, the 737 patent, titled Pharmaceutical Composition

Comprising Amphetamines Complexed With Ion-Exchange Resin Particles, was duly and
legally issued by the USPTO. Since the issuance of the 737 patent, Plaintiff Neos Therapeutics,
LP has been, and continues to be, the 737 patents sole owner. A copy of the 737 patent is
attached hereto as Exhibit D.
17.

Plaintiff Neos Therapeutics, Inc. holds New Drug Application (NDA) 204326

for ADZENYS XR-ODT brand amphetamine extended-release orally disintegrating tablets.

18.

ADZENYS XR-ODT is the result of years of effort and innovation and is FDA

approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6

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years and older. Among other distinctions, ADZENYS XR-ODT is the first and only FDAapproved extended-release orally disintegrating tablet for the treatment of ADHD. ADZENYS
XR-ODT is also the first and only FDA-approved drug product that employs ion-exchange
resin particles in an extended-release orally disintegrating tablet.

ADZENYS XR-ODT

addresses a long-felt, unmet need for a safe and effective once-a-day tablet for treating ADHD
that rapidly disintegrates in the mouth and can be administered without water.
19.

The 491 patent, the 924 patent, the 731 patent, and the 737 patent are all listed

for ADZENYS XR-ODT in the FDA publication Approved Drug Products with Therapeutic
Equivalence Evaluations (the Orange Book).
ACTS GIVING RISE TO THIS ACTION
20.

Upon information and belief, on or before July 22, 2016, Defendants submitted

ANDA No. 209253 to the FDA under 505 of the Federal Food, Drug and Cosmetic Act (21
U.S.C. 355(j)). ANDA No. 209253 seeks FDA approval for the commercial manufacture, use,
and sale of amphetamine extended-release orally disintegrating tablets containing 3.1 mg, 6.3
mg, 9.4 mg, 12.5 mg, 15.7 mg and 18.8 mg of amphetamine base as the active ingredient (the
Generic Products). ANDA No. 209253 specifically seeks FDA approval to market the Generic
Products prior to the expiration of the 491 patent, the 924 patent, the 731 patent, and the 737
patent.
21.

Pursuant to 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act,

ANDA No. 209253 alleges that the claims of the 491 patent, the 924 patent, the 731 patent,
and the 737 patent are invalid and/or will not be infringed by the manufacture, use, or sale of the
Generic Products. Plaintiff Neos Therapeutics, Inc. received written notification of ANDA No.

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209253 and its 505(j)(2)(A)(vii)(IV) allegations with respect to the 491 patent, the 924
patent, the 731 patent, and the 737 patent on or about July 25, 2016.
22.

Defendants submission of ANDA No. 209253 to the FDA, including its

505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of at least Claims 1-9 of the 491

patent, Claims 1, 3-5, 7-8, 10-12, and 16-25 of the 924 patent, Claims 1-14 and 16-17 of the
731 patent, and Claims 1-14, 16-17, and 21 of the 737 patent under 35 U.S.C. 271(e)(2)(A).
Moreover, if Defendants commercially make, use, offer to sell, or sell within the United States,
or import into the United States, the Generic Products, or induce or contribute to any such
conduct, Defendants will further infringe these claims of the 491 patent, the 924 patent, the
731 patent, and the 737 patent under 35 U.S.C. 271(a), (b), and/or (c).
23.

Upon information and belief, each of Actavis FL, Actavis Pharma, and Teva has

participated in, contributed to, aided, abetted, and/or induced infringement of the 491 patent, the
924 patent, the 731 patent, and the 737 patent and/or will participate in, contribute to, aid,
abet, and/or induce infringement of the 491 patent, the 924 patent, the 731 patent, and the 737
patent once the Generic Products are commercially manufactured, used, offered for sale, or sold
in the United States, or imported into the United States. Each of Actavis FL, Actavis Pharma,
and Teva is jointly and severally liable for any and all infringement of the 491 patent, the 924
patent, the 731 patent, and the 737 patent.
24.

Upon information and belief, Defendants were aware of the 491 patent, the 924

patent, the 731 patent, and the 737 patent prior to filing ANDA No. 209253, including its
505(j)(2)(A)(vii)(IV) allegations with respect to those patents.
25.

Upon information and belief, if approved by the FDA, the label for the Generic

Products will induce others to directly infringe the 491 patent, the 924 patent, the 731 patent,

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and the 737 patent, and Defendants possess the specific intent to encourage others to engage in
such direct infringement.
26.

Upon information and belief, Defendants know that the Generic Products, if

approved by the FDA, would not be a staple article or commodity of commerce suitable for
substantial non-infringing use, but rather are especially made and/or adapted for use in the direct
infringement of the 491 patent, the 924 patent, the 731 patent, and the 737 patent, and
Defendants possess the specific intent that the Generic Products will contribute to the direct
infringement of those patents.
27.

Defendants actions render this an exceptional case under 35 U.S.C. 285.

28.

Plaintiffs will be irreparably harmed by Defendants infringing activities unless

those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at law.
PRAYER FOR RELIEF
WHEREFORE, Plaintiffs pray for judgment as follows:
A.

That Defendants have infringed the 491 patent, the 924 patent, the 731 patent,

and the 737 patent;

B.

That, pursuant to 35 U.S.C. 271(e)(4)(A), the effective date of any FDA

approval of ANDA No. 209253 shall not be earlier than the expiration date of the last to expire
of the 491 patent, the 924 patent, the 731 patent, and the 737 patent, including any extensions
or exclusivities;
C.

That Defendants, their officers, agents, servants, and employees, and those

persons in active concert or participation with any of them, are preliminarily and permanently
enjoined from commercially making, using, offering to sell, or selling in the United States, or
importing into the United States, the Generic Products, and any other product that infringes or

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induces or contributes to the infringement of the 491 patent, the 924 patent, the 731 patent,
and/or the 737 patent, prior to the expiration date of the last to expire of those patents, including
any extensions or exclusivities;
D.

That Plaintiffs be awarded monetary relief if Defendants commercially make, use,

offer to sell, or sell in the United States, or import into the United States, the Generic Products,
or any other product that infringes or induces or contributes to the infringement of the 491
patent, the 924 patent, the 731 patent, and/or the 737 patent, prior to the expiration of the last
to expire of those patents, including any extensions or exclusivities, and that such monetary relief
be awarded to Plaintiffs with prejudgment interest;
E.

That Plaintiffs be awarded the attorney fees, costs, and expenses that they incur

prosecuting this action under 35 U.S.C. 285; and

F.

That Plaintiffs be awarded such other and further relief as this Court deems just

and proper.
MORRIS, NICHOLS, ARSHT & TUNNELL LLP

/s/ Jack B. Blumenfeld

Jack B. Blumenfeld (#1014)
1201 North Market Street
P.O. Box 1347
Wilmington, DE 19899
(302) 658-9200
jblumenfeld@mnat.com

OF COUNSEL:
Peter J. Armenio, P.C.
Laura L. Fairneny
QUINN EMANUEL URQUHART & SULLIVAN, LLP
51 Madison Avenue
New York, NY 10010
(212) 849-7000

Attorneys for Plaintiffs

September 1, 2016