Free Letter - District Court of Delaware - Delaware

Case 1:04-cv-00179-SLR Document 144-3 Filed 11/21/2007 Page 1 of 4

Case 1:04-cv-00179-SLR Document 144-3 Filed 11/21/2007 Page 2 of 4
IN THE UNETED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
BAYER AG, BAYER HEALTHCARE AG, )
and BAYER PHARI\fIACEIJTlCAI..S )
CORPORATION, )
)
Plaintiffs and )
Counterclaim Defendants, )
)
v. ) Civil Action No. 04-179 (SLR)
)
DR. REDDY°S LABORATORIES, LTD. and )
DR. REDDY’S LABORATORIES, INC., )
)
Defendants )
and Counterclaimants. )

FINAL JUDGMENT ORDER
The Court, having conducted atrial in the above-referenced matter and having
issued its Opinion on October 25, 2007, hereby enters judgment in the above—ret`erenced matter
as follows:
1. The moxifloxacin hydrochloride tablet product of Dr. Reddy’s
Laboratories, Ltd. and Dr., Reddy°s Laboratories, Incfs (collectively, “Reddy") Abbreviated New
Drug Application (°‘ANDA") No. 76-938 infringes each of claims 1, 2, 8, and 9 of`U.S. Patent
No. 4,990,517 ("the ’5l7 patent") and each of claims 1, 2, 3, and 4 of U.S. l’atent 5,607,942
("the ’942 patent"). The bulk active pharmaceutical ingredient of Reddy’s DMF 16999 infringes
each of claims 1 and 2 ofthe ’517 patent and each of claims E, 2, 3 and 4 ofthe ’942 patent. The
use ofthe moxitloxacin hydrochloride tablet product of Reddy’s ANDA No. 76-938 when used
in accord with any label submitted now or in the future in Reddy’s ANDA 76-938 infringes each
of claims 1, 2, 8, 9, and ll ofthe ’5l.7 patent and each of claims l, 2, 3, 4, 5, and 7 of the ’942
patent (“the Assorted Clairns").

Case 1:04-cv-00179-SLR Document 144-3 Filed 11/21/2007 Page 3 of 4
2. The Assorted Claims of the ’5l7 and ’942 patents are not invalid.
3. The ’5l7 patent and the ’942 patent are not unenforceable.
4. Pursuant to 35 U.S.C, § 27t(e)(4)(A), the effective date of any Food and
Drug Administration approval of Reddy’s ANDA No. 76-938 shall be no earlier than the earlier
of March 4, 2014 or the date upon which all ofthe Asserted Claims are adjudged to be invalid or
unenforceable, by a United States Court of Appeals or in a Final Judgment of a United States
District Court from which no appeal can be taken, or otherwise become unenforceable,
5. Pursuant to 35 U.S.C, § 27l(e)(4)(B), Reddy, their officers, agents,
attorneys and employees, and those acting in privity or concert with any of them, are hereby
enjoined from engaging in the cornrnercial manufacture, use, offer for sale, or sale within the
United States, or importation into the United States, of moxifloxacin hydrochloride or any drug
product containing rnoxitloxacin hydrochloride or any other compound or drug product within
the scope of claims l or 2 ofthe ’942 patent prior to the earlier of March 5, 20l4 or the date
upon which all ofthe Asserted Claims are adjudged to be invalid or unenforceable, by a United
States Court of Appeals or in a Final Judgment of a United States District Court from which no
appeal can be taken, or otherwise become unenforceable, except as provided in 35 U.S.C. §
27l(e)(l).
6, Judgment is hereby entered in favor of Plaintiffs and against Defendants
on Plaintiffs’ claims of infringement of the Asserted Claims.
7, Judgment is hereby entered in favor of Plaintiffs and against Defendants
on Defendants’ counterclairns that the Asserted Claims are invalid and that the ’5 l7 and ’942
patents are unenforceable
SO ORDERED this ____ day of , 2007
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Sue L. Robinson
United States District Judge
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