Free Order - District Court of Delaware - Delaware

I Case 1:04-cv—00884—SLR Document 57 Filed 08/24/2005 Paget of3
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
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FERRING B.V., :
Plaintifl, Civil Action No. 04-884-SLR
TEVA PHARMACEUTICALS USA, INC.
and TEVA PHARMACEUTICAL 1
INDUSTRIES LIMITED, :
Defendants.
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STIPULATION AND ORDER T
The parties, by their counsel, stipulate and agree subject to Order of this Court ds liollowsz
WHEREAS, plaintiff Ferring has filed a patent infringement lawsuit, C.A. 04-884-SLR i
("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 (“‘39S patent") by filing
Abbreviated New Drug Application No. 77-I22 ("ANDA") and seeking marketing approval for
0.I mg and 0.2 mg desmopressin acetate tablets (“ANDA Product") prior to the expiration ofthe
‘39S patent; and
NVHEREAS, Teva has tiled 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 Iinal approval can not be granted by FDA since, as a result ofthe Action, an
automatic 30-month stay ofapproval ofthe ANDA is currently in effect; and
1-nvnosaszm

Case 1:04-cv—00884—SLR Document 57 Filed 08/24/2005 Page 2 of 3
WHEREAS, Appeal No. 05-1284 is currently pending in the Court of Appeals for the
Federal Circuit in the matter captioned Ferririg B. VZ and A venlis P/zariiiacez::ic·aL>·, Inc. v. Brzrr
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 tiled 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 l above, Teva will withdraw its Motion to Litt 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 y
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 ofthe ‘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 ofAppeal No. 05-l 284 in Ferring’s tavor.
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 ofany kind under or to
any Ferring patent or other form of intellectual property including but not limited to United
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Case 1:04-cv-00884-SLR Document 57 Filed 08/24/2005 Page 3 of 3
States Patent Nos. 5,047,398, 5,500,413, 5,647,850 and 5,763,407. Ifthis 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 ofthe entry ofthe 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 ofits 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 /s/ Josy W. Ingersoll
Francis DiGiovanni (#3189) Josy W. Ingersoll (#1088)
Connolly Bove Lodge & Hutz LLP Young Conaway Stargatt & Taylor LLP
The Nemours Building The Brandywine Building
1007 North Orange Street 1000 West Street, 17th Floor
P.O. Box 2207 Wilmington, DE 19899-0391
Wilmington, DE 19899 Telephone: (302) 571-6600
Telephone: (302) 658-9141 '|[email protected]
fd,igiovanni@ cblhcom Attorneys for Teva Pharmaceuticals USA,
Attorneys lbr Ferring B.V. Inc. and Teva Pharmaceutical Industries
Limited
SO ORDERED
Dated: Wilmington, Delaware
August ij, 2005 United States Dist t Judge
1-NY/1934827.4 3