% AO 120 Rev. 3/04
TO Mail Stop 8 REPORT ON THE
` Director of the U.S. Patent and Trademark Office FILING OR DETERMINATION OF AN
P.O. Box 1450 ACTION REGARDING A PATENT OR
Alexandria, VA 22313-1450 TRADEMARK
In Compliance with 35 U.S.C. § 290 and/or 15 U.S.C. § ll 16 you are hereby advised that a court action has been
tiled in the U.S. District Court Delaware on the following X Patents or T1‘21(l€I`I1E1I'I
08cv65 1/31/08 DISTRICT OF DELAWARE
PLAINTIFF DEFENDANT
Boehringer Ingelheim Pharmaceuticals, Inc. Apotex Inc. and Apotex Corp.
PATENT OR DATE OF PATENT
TRADEMARK NO- OR TRADEMARK HOLDER OF PATENT OR TRADEMARK
1 5,098,715 3/24/92 Burroughs Wellcome Co.
3 __
3
3
3
In the above»entit1ed case, the following patent(s)/ trademark(s) have been included:
DATE INCLUDED INCLUDED BY
I:] Amendment I] Answer I:] Cross Bill I] Other Pleading
PATENT OR DATE OF PATENT
TRADEMARK NO- OR TRADEMARK HOLDER OF PATENT OR TRADEMARK
3 -_
3 __
3 __
3 __
3 __
In the aboveéentitled case, the following decision has been rendered or judgement issued:
DECISION/.1 UDGEME T `
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G/li Jrét rl A
CLERK 03 l>, EPUTY CLEHQ DATE
PETER T. DALLEO CLERK OF COURT llllll ` ¤ N 8
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7
Copy 1-Upon initiation of action, mail this copy to Director Copy 3—-Upon termination of action, mail this copy to Director
Copy Z—Upon tiling document adding patent(s), mail this copy to Director Copy 4—Case iile copy
Case 1:08-cv-00065-SLR Document 23-2 Filed 06/19/2008 Page 1 of 3
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
BOEHRINGER INGELI-IEIM )
PHARMACEUTICALS, INC., )
Plaintiff, g
I V. g C.A. No. 08-65 (SLR)
APOTEX INC. and APOTEX CORP. g
Defendants. g
STIPULATED DISMISSAL AND ORDER
R IT IS HEREBY STIPULATED AND AGREED between Boehringer Ingelheim
Pharmaceuticals, Inc. ("Boehringer"), by its undersigned counsel, and Apotex Inc. and Apotex
Corp. ("Apotex"), by their undersigned counsel, that:
1. Boehringer is the holder of approved NDA No. 02-1698 for Ranitidine
Hydrochloiide tablets OTC, which are sold under the trademark ZANTAC® 150 and
ZANTAC® 150 Cool (hereinafter "ZANTAC® 150 OTC products"). Boehringer also is the
assignee of United States Patent No. 5,098,715 ("the ‘7l5 Patentâ€).
_ 2. By letter dated December 18, 2008, Apotex informed Boehringer that it
had submitted Abbreviated New Drug Application ("ANDA") No. 79-127 to the Food and Ding
Adniinistration for the purpose of obtaining regulatory approval to engage in the commercial
manufacture, use, and/or sale of generic Ranitidine Hydrochloride Tablets USP 150 mg (OTC)
described therein prior to the expiration of the ‘7 15 Patent, which is listed in the FDA’s Orange
Book for Boehringer’s Zantac ® 150 mg OTC product.
3. Boehringer tiled a complaint against Apotex in this Court on January 31,
2008, charging Apotex with inningement of the ‘7l5 Patent pursuant to 35 U.S.C. § 271(e)(2).
Case 1:08-cv-00065-SLR Document 23-2 Filed 06/19/2008 Page 2 of 3
" 4. On February 21, 2008, Apotex counterclairned, asserting that Apotex’s
manufacture, use, sale, offer to sell or importation of its proposed ranitidine hydrochloride tablets
would not infringe the ‘7l5 patent and that the ‘7l5 patent is invalid.
. 5. Apotex has since represented to Boehringer and this Court that it has
withdrawn its ANDA N0. 79-127 for Ranitidine Hydrochloride Tablets USP 150 mg (OTC) in
accordance with 21 CFR § 314.65 and that it will not reiile or reopen ANDA No. 79-127 prior to
the expiration ofthe ‘7l5 Patent, including any extension thereof
6. Based on Apotex’s representations Apotex and Boehringer agree that no
justiciable case or controversy is presented by Boehringer’s complaint or any of Apotex’s
counterclairns.
NOW THEREFORE, based on the above stipulations, the Court hereby
ORDERS that:
l. The Court hereby dismisses without prejudice the claim for infringement
in the complaint.
2. The court also dismisses without prejudice Apotex’s counterclaims
relating to noninningement and invalidity of the ‘7l5 Patent.
3. Each party shall bear its own fees and costs in connection with this action,
including att0rneys’ fees.
2
Case 1 :08-cv-00065-SLR Document 23-2 Filed 06/19/2008 Page 3 of 3
Momus, Nicnots, Ansar & TUNNELL LLP MURPHY & LA1~1DoN
/s/]acE,Q3. Q3[ume1@lZ{ Francis J. Murphy
Jack B. Blumenfeld (#1014) Francis J. Murphy, (#223)
` Maryellen Noreika (#3208) Jonathan L. Parshall, (#3247)
1201 North Market Street 1011 Centre Road
P.O. Box 1347 Suite 210
Wilmington, DE 19899-1347 Wilmington, DE 19805
(302) 658-9200 (302) 472-8103
[email protected] [email protected]
[email protected] j [email protected]
Attorneys for Boehringer Ingelheim Attorneys for Apotex Inc.
Pharmaceuticals, Inc. and Apotex Corp.
Of Counsel: Of Counsel :
Kenneth G. Schuler Keith D. Parr
Amanda J. Hollis Scott B. Feder
LATHAM & WAr1qNs LLP Kevin M. Nelson
. Sears Tower, Suite 5800 David B. Abramowitz
Chicago, IL 60606 LocK Lono BISSELL & LIDDELL LLP
(312) 876-7700 111 South Wacker Dr.
Chicago, IL 60606
Carisa S. Yee (312) 443-0700
LATHAM ‘& WAT1¤Ns LLP
140 Soctt Drive
Menlo Park, CA 94025
(650) 328-4600
June 17, 2008
SO ORDERED this day of June, 2008.
United States District Judge
3
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