Shire LLC, Supernus Pharmaceuticals, Incl et al v. IMPAX Laboratories, Inc. et al

Filing 241

JUDGMENT AND ORDER OF PERMANENT INJUNCTION. Signed by Judge Richard Seeborg on 4/29/13. (cl, COURT STAFF) (Filed on 4/29/2013)

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Joseph R. Robinson (Pro Hac Vice)
[e-mail]
Heather Morehouse Ettinger (Pro Hac Vice)
[e-mail]
TROUTMAN SANDERS LLP
The Chrysler Building / 405 Lexington Avenue
New York, NY 10174
Telephone:
[phone]
Facsimile:
[phone]
Matthew D. Murphey (194111)
[e-mail]
TROUTMAN SANDERS LLP
5 Park Plaza, Suite 1400
Irvine, CA 92614-2545
Telephone:
[phone]
Facsimile:
[phone]
Attorneys for Plaintiffs and Counter-Defendants
SHIRE LLC and SUPERNUS PHARMACEUTICALS, INC.
Scott R. Raber (SBN 194924)
[e-mail]
RIMON, P.C.
1 Embarcadero Center, Suite 400
San Francisco, California 94111
Telephone: [phone]
Facsimile: 800.930.7271
John L. North (Pro Hac Vice)
[e-mail]
Jeffrey J. Toney (Pro Hac Vice)
[e-mail]
Laura Fahey Fritts (Pro Hac Vice)
[e-mail]
Jonathan D. Olinger (Pro Hac Vice)
[e-mail]
KASOWITZ, BENSON, TORRES & FRIEDMAN LLP
1349 West Peachtree Street, N.W., Suite 1500
Atlanta, Georgia 30309
Telephone: [phone]
Facsimile: 404.260.6081
Norman E.B. Minnear (Pro Hac Vice)
[e-mail]
KASOWITZ, BENSON, TORRES & FRIEDMAN LLP
1633 Broadway
New York, New York 10019
Telephone: [phone]
Facsimile: 212.500.3563
Attorneys for Defendants and Counter-Plaintiffs
WATSON PHARMACEUTICALS, INC., WATSON
LABORATORIES, INC.-FLORIDA, WATSON PHARMA,
INC., and ANDA, INC.

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T RO U TM A N S A ND E R S LLP
5 PARK PLAZA, STE. 1400
IRVINE, CA 92614

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JUDGMENT & ORDER OF PERM INJUNCTION
Case No. 10-CV-05467-RS

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UNITED STATES DISTRICT COURT

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NORTHERN DISTRICT OF CALIFORNIA

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SAN FRANCISCO DIVISION

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SHIRE LLC, and SUPERNUS
PHARMACEUTICALS, INC.,

Case No. 10-CV-05467-RS

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JUDGMENT AND ORDER OF
PERMANENT INJUNCTION

Plaintiffs,
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v.
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IMPAX LABORATORIES, INC., WATSON
PHARMACEUTICALS, INC., WATSON
LABORATORIES, INC.–FLORIDA,
WATSON PHARMA, INC., and ANDA, INC.,

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Defendants.

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AND RELATED COUNTERCLAIMS.
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This action for patent infringement having been brought by Plaintiffs Shire LLC (“Shire”)

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and Supernus Pharmaceuticals, Inc. (“Supernus” and collectively with Shire, the “Plaintiffs”)

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against Defendants Watson Pharmaceuticals, Inc., Watson Laboratories, Inc.–Florida, Watson

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Pharma, Inc., and Anda, Inc. (collectively, “Defendants”) for infringement of United States Patent

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Nos. 6,287,599 and 6,811,794 (“the ’599 Patent” and “the ’794 Patent” respectively, and

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collectively the “Shire Patents”) and U.S. Patent No. 5,854,290 (“the ’290 Patent”);

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Defendants and Plaintiffs have entered into a Settlement Agreement (the “Settlement

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Agreement”) and Shire and Defendants have entered into a License Agreement (the “License

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Agreement”), under which Shire has granted Defendants a license to the Shire Patents (the

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“License”), pursuant to the terms and conditions in the Settlement Agreement and License

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Agreement;

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Shire currently markets in the United States pursuant to New Drug Application No. 22-

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037 an extended-release tablet containing guanfacine hydrochloride for the treatment of attention

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deficit hyperactivity disorder, all strengths of which Shire currently sells under the trade name

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Intuniv (the “Intuniv Product”);

T RO U TM A N S A ND E R S LLP
5 PARK PLAZA, STE. 1400
IRVINE, CA 92614

20456889v2

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JUDGMENT & ORDER OF PERM INJUNCTION
Case No. 10-CV-05467-RS

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Defendants filed or caused to be filed Abbreviated New Drug Application (“ANDA”) No.

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202110 (the “Watson ANDA”) containing a “paragraph IV certification” with respect to the Shire

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Patents and seeking FDA approval to sell, offer for sale, use and/or import into the United States

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a product under or described in the Watson ANDA (the “Watson Product”);

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Defendants acknowledge that all the claims in the Shire Patents are valid and enforceable
with respect to the Watson Product;
The Parties have agreed to terminate the pending litigation by the entry of this Judgment
and Order; and
Plaintiffs and Defendants now consent to this Judgment and Order.

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IT IS HEREBY ORDERED, ADJUDGED AND DECREED:

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1.

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

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2.

Defendants admit that the Shire Patents are valid and enforceable with respect to

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the Watson Product.
3.

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

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been raised by Defendants in this action with respect to the ’290 Patent and the Shire Patents are

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dismissed with prejudice.

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4.

Except in the event the Shire Patents are asserted against Defendants with respect

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to a product other than the Watson Product in any other or future cause of action or litigation,

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Defendants shall not dispute that the Shire Patents are valid and enforceable.

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5.

Defendants admit that the sale, use or import of the Watson Product would

constitute infringement of the Shire Patents in the absence of the License.
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Defendants are hereby also enjoined and estopped during the term of the Shire

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Patents from making any challenge as to the infringement by the Watson Product of the Shire

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Patents.

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7.

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

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asserted by Plaintiffs against Defendants, and shall have no preclusive effect whatsoever, with

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respect to any product other than the Watson Product.

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T RO U TM A N S A ND E R S LLP
5 PARK PLAZA, STE. 1400
IRVINE, CA 92614

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JUDGMENT & ORDER OF PERM INJUNCTION
Case No. 10-CV-05467-RS

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8.

The foregoing injunctions against Defendants shall take effect immediately upon

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entry of this Judgment and Order by the Court, and shall continue generally until the expiration of

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the Shire Patents.

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9.

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

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issue preclusion with respect to validity and enforceability of the Shire Patents (except in the

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event the Shire Patents are asserted against Defendants with respect to a product other than the

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Watson Product), and infringement by the Watson Product of the Shire Patents between the

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parties in this action or in any other action between the parties (except in the event the Shire

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Patents are asserted against Defendants with respect to a product other than the Watson Product).

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10.

Subject to paragraph 7 above, Defendants hereby agree not to aid, abet, assist,

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enable or participate with any third party in a challenge to the validity or enforceability of the

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Shire Patents or challenge the infringement by a the Watson Product of any of the Shire Patents.

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

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servants, employees, affiliates, successors and all persons in active concert or participation with

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Defendants, are permanently enjoined from using, promoting, offering for sale, importing, selling,

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shipping, distributing or manufacturing in or to the United States and/or inducing others to use,

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promote, offer for sale, import, sell, ship, distribute or manufacture in the United States the

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Watson Product.

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12.

Nothing herein prohibits or is intended to prohibit Defendants from maintaining a

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“Paragraph IV Certification” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (including as amended

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or replaced) or pursuant to 21 C.F.R. § 314.94(a)(12) (including as amended or replaced) with

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respect to the Shire Patents or the ‘290 Patent.

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13.

Nothing herein restricts or is intended to restrict the U.S. Food and Drug

Administration from approving the Watson ANDA.

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14.

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

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15.

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

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of enforcement of the provisions of this Judgment and Order.

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///

T RO U TM A N S A ND E R S LLP
5 PARK PLAZA, STE. 1400
IRVINE, CA 92614

20456889v2

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JUDGMENT & ORDER OF PERM INJUNCTION
Case No. 10-CV-05467-RS

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16.

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

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29th
April
IT IS SO ORDERED this ____________ day of ____________ 2013.

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_____________________________________
THE HONORABLE RICHARD SEEBORG
UNITED STATES DISTRICT JUDGE

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TROUTMAN SANDERS LLP

KASOWITZ, BENSON, TORRES &
FRIEDMAN LLP

By:

By:

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/s/ Heather Morehouse Ettinger
Heather Morehouse Ettinger

/s/ Laura Fahey Fritts
Laura Fahey Fritts

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Attorneys for Plaintiffs and CounterDefendants SHIRE LLC and SUPERNUS
PHARMACEUTICALS, INC.

Attorneys for Defendants and Counter-Plaintiffs
WATSON PHARMACEUTICALS, INC.,
WATSON LABORATORIES, INC.–FLORIDA,
WATSON PHARMA, INC., and ANDA, INC.

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SIGNATURE ATTESTATION
Pursuant to Civil L.R. 5-1, I hereby attest that concurrence in the filing of the foregoing

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document has been obtained from counsel for Defendants Watson Pharmaceuticals, Inc., Watson

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Laboratories, Inc.–Florida, Watson Pharma, Inc., and Anda, Inc. as indicated by a “conformed”

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signature (/s/).

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/s/ Heather Morehouse Ettinger
Heather Morehouse Ettinger

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T RO U TM A N S A ND E R S LLP
5 PARK PLAZA, STE. 1400
IRVINE, CA 92614

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JUDGMENT & ORDER OF PERM INJUNCTION
Case No. 10-CV-05467-RS