Free Stipulation - District Court of Delaware - Delaware

Case 1:04-cv-00884-SLR

Document 56

Filed 08/19/2005

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ------------------------------------------------------x FERRING B.V., : : Plaintiff, : : v. : : TEVA PHARMACEUTICALS USA, INC. : and TEVA PHARMACEUTICAL : INDUSTRIES LIMITED, : : Defendants. : ------------------------------------------------------x

Civil Action No. 04-884-SLR

STIPULATION AND ORDER The parties, by their counsel, stipulate and agree subject to Order of this Court as follows: WHEREAS, plaintiff Ferring has filed a patent infringement lawsuit, C.A. 04-884-SLR ("the Action"), in the United States District Court for the District of Delaware against defendants Teva, alleging that Teva infringed U.S. Patent No. 5,047,398 ("`398 patent") by filing Abbreviated New Drug Application No. 77-122 ("ANDA") and seeking marketing approval for 0.1 mg and 0.2 mg desmopressin acetate tablets ("ANDA Product") prior to the expiration of the `398 patent; and WHEREAS, Teva has filed a counterclaim in the Action seeking a declaratory judgment that the `398 patent is invalid, not infringed and unenforceable; and WHEREAS, Teva seeks final FDA approval to market and sell the ANDA Product manufactured as disclosed in its ANDA; and WHEREAS final approval can not be granted by FDA since, as a result of the Action, an automatic 30-month stay of approval of the ANDA is currently in effect; and

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WHEREAS, Appeal No. 05-1284 is currently pending in the Court of Appeals for the Federal Circuit in the matter captioned Ferring B.V. and Aventis Pharmaceuticals, Inc. v. Barr Laboratories, Inc. ("Appeal"): 1. Ferring agrees that the 30 month stay of final approval of Teva's ANDA Product

shall be terminated. The parties shall cause this stipulation to be filed with the Delaware District Court and, upon entry, the Order appended as Exhibit A hereto, will be submitted to the FDA by Teva. 2. Upon submission to the FDA of the Order appended as Exhibit A hereto pursuant

to Paragraph 1 above, Teva will withdraw its Motion to Lift the Stay of Proceedings now pending in this Action. Teva agrees that it will submit the Order appended as Exhibit A to the FDA within four business days of entry of said Order by the Court. The stay of proceedings currently in force shall remain in effect until the resolution of Appeal No. 05-1284 pursuant to the Order entered by the Court on April 27, 2005. 3. Nothing in this Stipulation shall be construed as a waiver of any right of Ferring

to seek and obtain damages from Teva accruing from its market entry (if any) prior to the expiration of the `398 patent, or to seek any and all appropriate relief from the Court, including enjoining Teva from further infringing the `398 patent during the pendency of the Action, upon resolution of Appeal No. 05-1284 in Ferring's favor. 4. Nothing in this Stipulation shall be construed as a waiver of any right of Teva to

seek and obtain damages from Ferring (if any) based on a claim of antitrust or unfair competition. 5. Nothing in this Stipulation shall be construed as a license of any kind under or to

any Ferring patent or other form of intellectual property including but not limited to United

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States Patent Nos. 5,047,398, 5,500,413, 5,647,850 and 5,763,407. If this case goes forward to a trial on the merits, neither the existence nor terms of this Stipulation and Order shall be usable for any evidentiary purpose on the issues of patent validity, enforceability or patent infringement. 6. Teva shall provide written notice of market entry of its ANDA Product to Ferring,

copy to its counsel at Morgan, Lewis & Bockius LLP, by certified mail. 7. Ferring shall provide notice and a copy of the Appeal Decision to Teva's counsel,

Sutherland, Asbill & Brennan, LLP within one business day of the entry of the Appeal Decision. 8. Teva may, with the express written approval of Ferring, transfer all of its interest

in this Stipulation to any party to whom Teva transfers all of its rights and interests in its ANDA, provided that any party to whom such transfer is made shall first enter into and execute an undertaking, in form and substance acceptable to Ferring, to be bound to this Stipulation as if an original party hereto and agreeing to perform all duties and obligations of Teva hereunder. CONSENTED TO:

/s/ Francis DiGiovanni Francis DiGiovanni (#3189) Connolly Bove Lodge & Hutz LLP The Nemours Building 1007 North Orange Street P.O. Box 2207 Wilmington, DE 19899 Telephone: (302) 658-9141 [email protected] Attorneys for Ferring B.V.

/s/ Josy W. Ingersoll Josy W. Ingersoll (#1088) Young Conaway Stargatt & Taylor LLP The Brandywine Building 1000 West Street, 17th Floor Wilmington, DE 19899-0391 Telephone: (302) 571-6600 [email protected] Attorneys for Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Limited

SO ORDERED

Dated: Wilmington, Delaware August __, 2005

___________________________________ United States District Judge

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