Free Letter - District Court of Delaware - Delaware

Case 1:04-cv-00179-SLR Document 144-2 Filed 11/21/2007 Page 1 of 3

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

FINAL JUDGMENT ORDER
The Court, having conducted a trial 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, Inc.’s (collectively, "Reddy") Abbreviated New
Drug Application ("ANDA") No. 76-938 infringes each of claims I, 2, 8, and 9 ofU,S. Patent
No, 4,990,517 (‘°the ’5l7 patent") and each of claims 1, 2, 3, and 4 of U.S. Patent 5,607,942
("tl1e ’942 patent"). The bulk active pharmaceutical ingredient of Reddy’s DMI? 16999 infringes
each of claims 1 and 2 ofthe ’5l7 patent and each of claims 1, 2, 3 and 4 ofthe ’942 patent, The
use ofthe moxifioxacin hydrochloride tablet product of Reddy’s ANDA No, 76-9.38 when used
in accord with any label submitted now or in the future in Rc-:ddy’s ANDA 76—938 infringes each
ofclaims I, 2, 8, 9, and ll ofthe ’5l7 patent and each of claims I, 2, 3, 4, 5, and 7 ofthe ’942
patent ("the Assertecl Claims").

Case 1:04-cv-00179-SLR Document 144-2 Filed 11/21/2007 Page 3 of 3
2r The Asserted Claims ofthe ’5 l 7 and ’942 patents are not invalid.
3. The ”517 patent and the ’942 patent are not unenforceable.
4. Pursuant to 35 U.S.C. § 27l(e)(4)(A), the effective date of any Food and
Drug Administration approval of R.eddy’s ANDA No. 76-938 shall be no earlier than March 4,
2014.
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 commercial manufacture, use, offer for sale, or sale within the
United States, or importation into the United States, of moxitloxacin hydrochloride or any drug
product containing moxifioxacin hydrochloride or any other compound or drug product within
the scope of claims l or 2 ofthe ’942 patent prior to March 5, 2014, 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 counterciaims that the Asserted Claims are invalid and that the ’517 and ’942
patents are unenforceable.
SO ORDERED this ______ day of , 2007

United States District Judge
2

Case 1:04-cv-00179-SLR

Document 144-2

Filed 11/21/2007

Page 1 of 3

Case 1:04-cv-00179-SLR

Document 144-2

Filed 11/21/2007

Page 2 of 3

Case 1:04-cv-00179-SLR

Document 144-2

Filed 11/21/2007

Page 3 of 3