Shire LLC et al v. Sandoz Inc.

Filing 39

Judgment and Order of Permanent Injuction (For more information, see Lead Case at Case No. 11-cv-01110-RBJ-KMT). Civil Case Terminated. By Judge R. Brooke Jackson on 04/18/13. (alvsl)

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IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLORADO
Civil Action No.: 1:11-cv-01110-RBJ-KMT
SHIRE LLC,
SUPERNUS PHARMACEUTICALS, INC.,
SHIRE DEVELOPMENT INC.,
SHIRE INTERNATIONAL LICENSING
B.V.,
AMY F.T. ARNSTEN, PH.D.,
PASKO RAKIC, M.D., and
ROBERT D. HUNT, M.D.,
Plaintiffs,
v.
SANDOZ INC.,
Defendant.

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JUDGMENT AND ORDER OF PERMANENT INJUNCTION
This action for patent infringement having been brought by Plaintiffs Shire LLC,
Shire International Licensing B.V., Shire Development LLC (d/b/a Shire Development Inc.)
(“Shire”), Amy F.T. Arnsten, Ph.D. (“Dr. Arnsten”), Pasko Rakic, M.D. (“Dr. Rakic”), and
Robert D. Hunt, M.D. (“Dr. Hunt”), and Supernus Pharmaceuticals, Inc. (“Supernus” and
collectively with Shire, Dr. Arnsten, Dr. Rakic, and Dr. Hunt, the “Plaintiffs”) against Defendant
Sandoz Inc. (“Sandoz”) for infringement of United States Patent Nos. 6,287,599 and 6,811,794
(the “Shire Patents”) and United States Patent No. 5,854,290 (“the ’290 Patent”);
Sandoz and Plaintiffs have entered into a Settlement Agreement (the “Settlement
Agreement”) and Shire LLC and Sandoz have entered into a License Agreement (the “License
Agreement”), under which Shire has granted Sandoz a license to the Shire Patents (the

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“License”), pursuant to the terms and conditions in the Settlement Agreement and License
Agreement;
Shire currently markets in the United States pursuant to New Drug Application
No. 22-037 an extended-release tablet containing guanfacine hydrochloride for the treatment of
attention deficit hyperactivity disorder, all strengths of which Shire currently sells under the trade
name Intuniv (the “Intuniv Product”);
Sandoz filed or caused to be filed Abbreviated New Drug Application (“ANDA”)
No. 202568 (the “Sandoz ANDA”) containing a “paragraph IV certification” with respect to the
Shire Patents and seeking FDA approval to sell, offer for sale, use and/or import into the United
States a product under or described in the Sandoz ANDA (the “Sandoz Product”);
Sandoz acknowledges that all the claims in the Shire Patents are valid and
enforceable with respect to Sandoz Product, and any other pharmaceutical product, which is
submitted to the United States Federal Drug Administration for regulatory approval pursuant to
an Abbreviated New Drug Application as a Therapeutic Equivalent (as defined in the current
edition of the “Approved Drug Products with Therapeutic Equivalence Evaluations”) to the
Intuniv Product (a “Generic Equivalent Intuniv Product”);
The Parties have agreed to terminate the pending litigation by the entry of this
Judgment and Order; and
Plaintiffs and Sandoz now consent to this Judgment and Order.
IT IS HEREBY ORDERED, ADJUDGED AND DECREED:
1.

This Court has jurisdiction over the parties and subject matter of this action.

2.

Sandoz admits that the Shire Patents are valid and enforceable with respect to the

Sandoz Product and any Generic Equivalent Intuniv Product.

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3.

All affirmative defenses, claims and counterclaims, which have been or could

have been raised by Sandoz in this action with respect to the Shire Patents are dismissed with
prejudice.
4.

All affirmative defenses, claims and counterclaims, which have been or could

have been raised by Sandoz or the Plaintiffs in this action with respect to the ‘290 Patent are
dismissed with prejudice.
5.

Except in the event the Shire Patents are asserted against Sandoz with respect to a

product other than the Sandoz Product or any Generic Equivalent Intuniv Product in any other or
future cause of action or litigation, Sandoz shall not dispute that the Shire Patents are valid and
enforceable.
6.

Sandoz admits that the sale, use or import of the Sandoz Product would constitute

infringement of the Shire Patents in the absence of the License.
7.

Sandoz is hereby also enjoined and estopped during the term of the Shire Patents

from making any challenge as to the infringement of the Sandoz Product of the Shire Patents.
8.

Neither this Judgment and Order nor the entry of this Judgment and Order may be

asserted by Plaintiffs against Sandoz, and shall have no preclusive effect whatsoever, with
respect to any product other than the Sandoz Product or any Generic Equivalent Intuniv Product.
9.

The foregoing injunctions against Sandoz shall take effect immediately upon

entry of this Judgment and Order by the Court, and shall continue generally until the expiration
of the Shire Patents.
10.

This Judgment and Order is binding upon and constitutes claim preclusion and

issue preclusion with respect to validity and enforceability of the Shire Patents as against the
Sandoz Product and shall have no preclusive effect whatsoever with respect to any product other

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than the Sandoz Product or any Generic Equivalent Intuniv Product, and infringement by the
Sandoz Product of the Shire Patents between the parties in this action or in any other action
between the parties (except in the event the Shire Patents are asserted against Sandoz with
respect to a product other than the Sandoz Product or any Generic Equivalent Intuniv Product).
11.

Subject to paragraph 8 above, Sandoz hereby agrees not to aid, abet, assist, enable

or participate with any third party in a challenge to the validity or enforceability of the Shire
Patents or challenge the infringement by a Generic Equivalent Intuniv Product of any of the
Shire Patents.
12.

Except as authorized and licensed by Shire, Sandoz, its officers, agents,

servants, employees, affiliates, successors and all persons in active concert or participation with
Sandoz, are permanently enjoined from using, promoting, offering for sale, importing, selling,
shipping, distributing or manufacturing in or to the United States and/or inducing others to use,
promote, offer for sale, import, sell, ship, distribute or manufacture in the United States the
Sandoz Product or any Generic Equivalent Intuniv Product.
13.

The parties waive all right to appeal from this Judgment and Order.

14.

This Court shall retain jurisdiction of this action and over the parties for purposes

of enforcement of the provisions of this Judgment and Order.
15.

Each party is to bear its own costs and attorneys' fees.

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DATED this 18th day of April, 2013.

BY THE COURT:

___________________________________
R. Brooke Jackson
United States District Judge

Respectfully submitted this 16th day of April, 2013.

Attorneys for Plaintiffs

Attorneys for Defendant

_____s/Thomas C. Bell
DAVIS GRAHAM & STUBBS LLP

____s/Brad W. Breslau
____s/Brad W. Breslau
COZEN O’CONNOR

Thomas C. Bell
1550 Seventeenth St.
Suite 500
Denver, Colorado 80202
Telephone: [phone]
Facsimile: [phone]
Email: [e-mail]

Brad W. Breslau
Cozen O’Connor
707 17th Street, St. 3100
Denver, CO 80202
Telephone: [phone]
Facsimile: [phone]
Email: [e-mail]

Of Counsel:
Edgar H. Haug
Jason A. Lief
Frommer Lawrence & Haug LLP
745 Fifth Avenue
New York, New York 10151
Telephone: [phone]
Facsimile: [phone]
Email: [e-mail]
Email: [e-mail]

Of Counsel:
W. Blake Coblentz
Cozen O’Connor
16271 I Street, NW, St. 1100
Washington, DC 20006
Telephone: [phone]
Facsimile: [phone]
Email: [e-mail]