April 29, 2013
SHIRE LLC, and SUPERNUS PHARMACEUTICALS, INC., Plaintiffs,
IMPAX LABORATORIES, INC., WATSON PHARMACEUTICALS, INC., WATSON LABORATORIES, INC.-FLORIDA, WATSON PHARMA, INC., and ANDA, INC., Defendants. AND RELATED COUNTERCLAIMS
Joseph R. Robinson (Pro Hac Vice), Heather Morehouse Ettinger (Pro Hac Vice), TROUTMAN SANDERS LLP, New York, NY, Matthew D. Murphey (194111), TROUTMAN SANDERS LLP, Irvine, CA, Attorneys for Plaintiffs and Counter-Defendants, SHIRE LLC and SUPERNUS PHARMACEUTICALS, INC.
Scott R. Raber (SBN 194924), RIMON, P.C., San Francisco, California, John L. North (Pro Hac Vice), Jeffrey J. Toney (Pro Hac Vice), Laura Fahey Fritts (Pro Hac Vice), Jonathan D. Olinger (Pro Hac Vice), KASOWITZ, BENSON, TORRES & FRIEDMAN LLP, Atlanta, Georgia, Norman E.B. Minnear (Pro Hac Vice), KASOWITZ, BENSON, TORRES & FRIEDMAN LLP, New York, New York, Attorneys for Defendants and Counter-Plaintiffs, WATSON PHARMACEUTICALS, INC., WATSON, LABORATORIES, INC.-FLORIDA, WATSON PHARMA, INC., and ANDA, INC.
KASOWITZ, BENSON, TORRES & FRIEDMAN LLP, Laura Fahey Fritts, Attorneys for Defendants and Counter-Plaintiffs WATSON PHARMACEUTICALS, INC., WATSON LABORATORIES, INC.-FLORIDA, WATSON PHARMA, INC., and ANDA, INC.
JUDGMENT AND ORDER OF PERMANENT INJUNCTION
RICHARD SEEBORG, District Judge.
This action for patent infringement having been brought by Plaintiffs Shire LLC ("Shire") and Supernus Pharmaceuticals, Inc. ("Supernus" and collectively with Shire, the "Plaintiffs") against Defendants Watson Pharmaceuticals, Inc., Watson Laboratories, Inc.-Florida, Watson Pharma, Inc., and Anda, Inc. (collectively, "Defendants") for infringement of United States Patent Nos. 6, 287, 599 and 6, 811, 794 ("the '599 Patent" and "the '794 Patent" respectively, and collectively the "Shire Patents") and U.S. Patent No. 5, 854, 290 ("the '290 Patent");
Defendants and Plaintiffs have entered into a Settlement Agreement (the "Settlement Agreement") and Shire and Defendants have entered into a License Agreement (the "License Agreement"), under which Shire has granted Defendants a license to the Shire Patents (the "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");
Defendants filed or caused to be filed Abbreviated New Drug Application ("ANDA") No. 202110 (the "Watson 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 Watson ANDA (the "Watson Product");
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.
IT IS HEREBY ORDERED, ADJUDGED AND DECREED:
1. This Court has jurisdiction over the parties and subject matter of this action.
2. Defendants admit that the Shire Patents are valid and enforceable with respect to the Watson Product.
3. All affirmative defenses, claims and counterclaims, which have been or could have been raised by Defendants in this action with respect to the '290 Patent and the Shire Patents are dismissed with prejudice.
4. Except in the event the Shire Patents are asserted against Defendants with respect to a product other than the Watson Product in any other or future cause of action or litigation, Defendants shall not dispute that the Shire Patents are valid and enforceable.
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.
6. Defendants are hereby also enjoined and estopped during the term of the Shire Patents from making any challenge as to the infringement by the Watson Product of the Shire Patents.
7. Neither this Judgment and Order nor the entry of this Judgment and Order may be asserted by Plaintiffs against Defendants, and shall have no preclusive effect whatsoever, with respect to any product other than the Watson Product.
8. The foregoing injunctions against Defendants 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.
9. This Judgment and Order is binding upon and constitutes claim preclusion and issue preclusion with respect to validity and enforceability of the Shire Patents (except in the event the Shire Patents are asserted against Defendants with respect to a product other than the Watson Product), and infringement by the Watson 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 Defendants with respect to a product other than the Watson Product).
10. Subject to paragraph 7 above, Defendants hereby agree 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 the Watson Product of any of the Shire Patents.
11. Except as authorized and licensed by Shire, Defendants, its officers, agents, servants, employees, affiliates, successors and all persons in active concert or participation with Defendants, 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 Watson Product.
12. Nothing herein prohibits or is intended to prohibit Defendants from maintaining a "Paragraph IV Certification" pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (including as amended or replaced) or pursuant to 21 C.F.R. § 314.94(a)(12) (including as amended or replaced) with respect to the Shire Patents or the 290 Patent.
13. Nothing herein restricts or is intended to restrict the U.S. Food and Drug Administration from approving the Watson ANDA.
14. The parties waive all right to appeal from this Judgment and Order.
15. This Court shall retain jurisdiction of this action and over the parties for purposes of enforcement of the provisions of this Judgment and Order.
16. Each party is to bear its own costs and attorneys' fees.
IT IS SO ORDERED.