Shionogi et. al. v. Nostrum Laboratories et. al.
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Transcript of Shionogi et. al. v. Nostrum Laboratories et. al.
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Liza M. WalshRukhsanah L. Singh
CONNELL FOLEY LLP
85 Livingston AvenueRoseland, New Jersey 08608
(973) 535-0500
David A. Manspeizer
David B. Bassett
Christopher R. Noyes
WILMER CUTLER PICKERINGHALE & DORR LLP
399 Park Avenue
New York, New York 10022(212) 230-8800
Attorneys for Plaintiff Shionogi Inc.
Robert J. FettweisTRESSLER LLP
744 Broad Street, Suite 1510
Newark, New Jersey 07102(973) 848-2900
Gary E. HoodMark T. Deming
POLSINELLI SHUGHART PC
161 N. Clark Street, Suite 4200
Chicago, Illinois 60601(312) 819-1900
Graham L.W. DayRobyn Ast-Gmoser
POLSINELLI SHUGHART PC
100 Fourth Street, Suite 1000St. Louis, Missouri 63102
(314) 889-8000
Attorneys for Plaintiffs Andrx Corporation, Andrx
Pharmaceuticals, Inc. (N/K/A Watson
Laboratories, Inc.-Florida), Andrx
Pharmaceuticals, L.L.C., Andrx Laboratories (NJ),
Inc., Andrx EU Ltd., and Andrx Labs, L.L.C.
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
SHIONOGI INC., ANDRX
CORPORATION, ANDRX
PHARMACEUTICALS, INC. (N/K/A
WATSON LABORATORIES, INC.-FLORIDA), ANDRX
PHARMACEUTICALS, L.L.C., ANDRX
LABORATORIES (NJ), INC., ANDRX EULTD., AND ANDRX LABS, L.L.C.,
Plaintiffs,
v.
NOSTRUM LABORATORIES, INC. ANDNOSTRUM PHARMACEUTICALS LLC,
Defendants.
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Civil Action No. ___________
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COMPLAINT FOR PATENT INFRINGEMENT
For their complaint herein, Plaintiffs allege as follows:
1. Shionogi Inc. (Shionogi) is a corporation organized and existing underthe laws of the State of Delaware, having a principal place of business at 300 Campus Drive,
Florham Park, New Jersey 07932.
2. Andrx Corporation (Andrx Corp.) is a Delaware corporation andsubsidiary of Watson Pharmaceuticals, Inc., having a place of business at 4955 Orange Drive,
Davie, Florida 33314. Andrx Pharmaceuticals, Inc. (Andrx Pharmaceuticals) is a Florida
corporation and subsidiary of Andrx Corp., now known as Watson Laboratories, Inc.-Florida,
having a place of business at 4955 Orange Drive, Davie, Florida 33314. Andrx Pharmaceuticals,
L.L.C. and Andrx Labs, L.L.C. are Delaware limited liability companies and subsidiaries of
Andrx Corp., having a place of business at 4955 Orange Drive, Davie, Florida 33314. Andrx
Laboratories (NJ), Inc. is a Delaware corporation and a subsidiary of Andrx Corp., having a
place of business at 8151 Peters Road, 4th Floor, Plantation, Florida 33324. Andrx EU Limited
is a UK corporation and subsidiary of Andrx Corp., having a place of business at 8151 Peters
Road, 4th Floor, Plantation, Florida 33324. The Andrx companies are hereinafter referred to
collectively as Andrx.
3. Upon information and belief, Defendant Nostrum Laboratories, Inc.(Nostrum Labs.) is a corporation organized and existing under the laws of New Jersey, having
a principal place of business at 1800 N Topping Ave., Kansas City, MO 64120. Upon
information and belief, Defendant Nostrum Labs. manufactures, and/or distributes generic drugs
for sale and use throughout the United States, including in this judicial district.
4. Upon information and belief, Defendant Nostrum Pharmaceuticals, LLC(Nostrum Pharma) is a corporation organized and existing under the laws of Delaware, with a
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principal place of business at 11D Jules Lane, New Brunswick, NJ 08901. Upon information
and belief, Defendant Nostrum Pharma, itself and through its wholly-owned subsidiary and agent
Defendant Nostrum Labs. (collectively Nostrum), manufactures generic drugs for sale and use
throughout the United States, including in this judicial district.
JURISDICTION AND VENUE
5. This action arises under the patent laws of the United States, 35 U.S.C. 100 et seq., and jurisdiction exists under 28 U.S.C. 1331 and 1338(a).
6. This Court has personal jurisdiction over Defendant Nostrum Pharma byvirtue of, inter alia, its systematic and continuous contacts with New Jersey and because it has a
principal place of business in New Jersey.
7. Upon information and belief, Nostrum Pharma has also previouslysubmitted itself to the jurisdiction of this Court, by initiating suit in this Court. See, e.g.,
Nostrum Pharms. LLC v. F.D.A., Civ. Action No. 11-3111 (JAP/TJB) (D.N.J.) (complaint filed
on May 27, 2011).
8. This Court has personal jurisdiction over Defendant Nostrum Labs. byvirtue of, inter alia, its systematic and continuous contacts with New Jersey and because it has
submitted itself to the jurisdiction of courts in New Jersey by virtue of its incorporation under
New Jersey law.
9. Venue is proper in this Court under 28 U.S.C. 1391(c) and 1400(b).PATENTS IN SUIT
10. Andrx is the owner of United States Patent No. 6,099,859 (the 859patent), which was duly and legally issued on August 8, 2000, and is titled Controlled Release
Oral Tablet Having A Unitary Core. Shionogi has an exclusive license under the 859 patent in
the United States. A copy of the 859 patent is attached as Exhibit A.
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11. Andrx is the owner of United States Patent No. 6,866,866 (the 866patent), which was duly and legally issued on March 15, 2005, and is titled Controlled Release
Metformin Compositions. Shionogi has an exclusive license under the 866 patent in the
United States. A copy of the 866 patent is attached as Exhibit B.
ACTS GIVING RISE TO THIS ACTION
12. Andrx Labs is the holder of New Drug Application (NDA) No. 21-574,by which the United States Food and Drug Administration (FDA) granted approval for 500 mg
and 1000 mg extended-release metformin hydrochloride tablets. The metformin hydrochloride
tablets described in Andrxs NDA are indicated as an adjunct to diet and exercise to lower blood
glucose to improve glycemic control in adults with Type 2 diabetes mellitus. Shionogi markets
these tablets in the United States under the tradename Fortamet.
13. Upon information and belief, Nostrum submitted to the FDA AbbreviatedNew Drug Application (ANDA) No. 203-832, which included a certification with respect to
the 859 and 866 patents under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
355(j)(2)(A)(vii)(IV), seeking approval to manufacture, use, and sell 500 mg and 1000 mg
extended-release metformin hydrochloride tablets (the ANDA products) prior to the expiration
of those patents.
14. Upon information and belief, Nostrum Pharma participated in studies andclinical research that was reported in ANDA No. 203-832. Further, upon information and belief,
Nostrum Pharma directed the activities of Nostrum Labs. complained of herein, including the
filing of ANDA No. 203-832.
15. On or about May 24, 2012, Nostrum Labs. sent a letter (Notice Letter)to Shionogi, Pharmaceuticals, Inc., Andrx Pharmaceuticals, LLC and Andrx Laboratories, LLC
in which it represented that it had filed an ANDA for the ANDA products, including
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certifications with respect to the 859 and 866 patents, and that it sought approval of its ANDA
prior to the expiration of those patents.
16. This action is being commenced within forty-five days from the date ofthe receipt of the Notice Letter by Shionogi, May 30, 2012.
FIRST COUNT FOR INFRINGEMENT
OF UNITED STATES PATENT NO. 6,099,859
17. Plaintiffs reallege paragraphs 1-16 as if fully set forth herein.18. Nostrums ANDA Product is covered by one or more claims of the 859
patent.
19. Nostrums submission of ANDA No. 203-832 for the purpose of obtainingapproval to engage in the commercial manufacture, use, offer for sale, and/or sale of Nostrums
ANDA Product before the expiration of the 859 patent is an act of infringement of the 859
patent.
20. The commercial manufacture, use, offer for sale, sale and/or importationof Nostrums ANDA Product would infringe one or more claims of the 859 patent.
21. Unless Nostrum is enjoined from infringing the 859 patent, Plaintiffs willsuffer irreparable injury. Plaintiffs have no adequate remedy at law.
SECOND COUNT FOR INFRINGEMENT
OF UNITED STATES PATENT NO. 6,866,866
22. Plaintiffs reallege paragraphs 1-21 as if fully set forth herein.23. Nostrums ANDA Product is covered by one or more claims of the 866
patent.
24. Nostrums submission of ANDA No. 203-832 for the purpose of obtainingapproval to engage in the commercial manufacture, use, offer for sale, and/or sale of Nostrums
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ANDA Product before the expiration of the 866 patent is an act of infringement of the 866
patent.
25. The commercial manufacture, use, offer for sale, sale and/or importationof Nostrums ANDA Product would infringe one or more claims of the 866 patent.
26. Unless Nostrum is enjoined from infringing the 866 patent, Plaintiffs willsuffer irreparable injury. Plaintiffs have no adequate remedy at law.
PRAYER FOR RELIEF
27. Wherefore, Plaintiffs request that:a. Judgment be entered that Defendants have infringed the 859 and
866 patents by filing the aforesaid ANDA;
b. Judgment be entered that the making, using, selling, offering forsale, or import of Nostrums ANDA product would infringe the 859 and 866 patents;
c. A permanent injunction be issued, pursuant to 35 U.S.C. 271(e)(4)(B), restraining and enjoining said Defendants, their officers, agents, attorneys, and
employees, and those acting in privity or concert with them, from engaging in the commercial
manufacture, use, offer to sell, or sale within the United States, or importation into the United
States, of the drugs or methods of administering drugs claimed in the 859 and 866 patents;
d. An order be issued pursuant to 35 U.S.C. 271(e)(4)(A) that theeffective date of any approval of ANDA No. 203-832 be a date that is not earlier than the
expiration date of the 859 and 866 patents, or any later expiration of exclusivity for the 859
and 866 patents to which Plaintiffs are or become entitled;
e. Judgment be entered that this case is exceptional, and thatPlaintiffs are entitled to their reasonable attorney fees pursuant to 35 U.S.C. 285; and
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f. They be granted such other and further relief as the Court maydeem just and proper under the circumstances.
Dated: July 13, 2012
CONNELL FOLEY LLP
By: s/Liza M. WalshLiza M. Walsh
Rukhsanah L. Singh
85 Livingston AvenueRoseland, New Jersey 08608
(973) 535-0500
David A. ManspeizerDavid B. Bassett
Christopher R. Noyes
WILMER CUTLER PICKERINGHALE & DORR LLP
399 Park Avenue
New York, New York 10022(212) 230-8800
Attorneys for Plaintiff Shionogi Inc.
TRESSLER LLP
By: s/Robert J. Fettweis
Robert J. Fettweis
744 Broad Street, Suite 1510
Newark, New Jersey 07102(973) 848-2900
Gary E. Hood
Mark T. DemingPOLSINELLI SHUGHART PC
161 N. Clark Street, Suite 4200
Chicago, Illinois 60601(312) 819-1900
Graham L.W. DayRobyn Ast-Gmoser
POLSINELLI SHUGHART PC
100 Fourth Street, Suite 1000
St. Louis, Missouri 63102(314) 889-8000
Attorneys for Plaintiffs Andrx
Corporation, Andrx Pharmaceuticals,
Inc. (N/K/A Watson Laboratories, Inc.-
Florida), Andrx Pharmaceuticals,
L.L.C., Andrx Laboratories (NJ), Inc.,
Andrx EU Ltd., and Andrx Labs, L.L.C.
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LOCAL CIVIL RULE 11.2 CERTIFICATION
I certify that, to the best of my knowledge, the matter in controversy between these
parties is not the subject of any other pending or anticipated litigation in any court or arbitration
proceeding, nor are there any non-parties known to Plaintiffs that should be joined to this action,
with the exception that the patents at issue in this Complaint are the subject of the following
actions that have been pending in the United States District for the District of Delaware:
Sciele Pharma, Inc. et al.v. Lupin Ltd. et al., C.A. No. 09-037 (RBK/JS) (D. Del.) (filedJanuary 15, 2009); and
Shionogi Pharma, Inc. et al. v. Mylan, Inc. et al.. C.A. No. 10-135 (RBK/JS) (D. Del.)
(filed February 18, 2010).
Dated: July 13, 2012
CONNELL FOLEY LLP
By: s/Liza M. Walsh
Liza M. Walsh
Rukhsanah L. Singh
85 Livingston AvenueRoseland, New Jersey 08608
(973) 535-0500
David A. Manspeizer
David B. Bassett
Christopher R. NoyesWILMER CUTLER PICKERING
HALE & DORR LLP
399 Park Avenue
New York, New York 10022(212) 230-8800
Attorneys for Plaintiff Shionogi Inc.
TRESSLER LLP
By: s/Robert J. Fettweis
Robert J. Fettweis
744 Broad Street, Suite 1510
Newark, New Jersey 07102(973) 848-2900
Gary E. HoodMark T. Deming
POLSINELLI SHUGHART PC
161 N. Clark Street, Suite 4200Chicago, Illinois 60601
(312) 819-1900
Graham L.W. DayRobyn Ast-Gmoser
POLSINELLI SHUGHART PC
100 Fourth Street, Suite 1000St. Louis, Missouri 63102
(314) 889-8000
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Attorneys for Plaintiffs Andrx
Corporation, Andrx Pharmaceuticals,
Inc. (N/K/A Watson Laboratories, Inc.-
Florida), Andrx Pharmaceuticals,
L.L.C., Andrx Laboratories (NJ), Inc.,
Andrx EU Ltd., and Andrx Labs, L.L.C.
LOCAL CIVIL RULE 201.1 CERTIFICATION
I hereby certify that the above-captioned matter is not subject to compulsory arbitration
in that declaratory and injunctive relief is sought.
Dated: July 13, 2012
CONNELL FOLEY LLP
By: s/Liza M. WalshLiza M. Walsh
Rukhsanah L. Singh
85 Livingston AvenueRoseland, New Jersey 08608
(973) 535-0500
David A. Manspeizer
David B. BassettChristopher R. Noyes
WILMER CUTLER PICKERING
HALE & DORR LLP399 Park Avenue
New York, New York 10022
(212) 230-8800
Attorneys for Plaintiff Shionogi Inc.
TRESSLER LLP
By: s/Robert J. Fettweis
Robert J. Fettweis
744 Broad Street, Suite 1510
Newark, New Jersey 07102(973) 848-2900
Gary E. HoodMark T. Deming
POLSINELLI SHUGHART PC161 N. Clark Street, Suite 4200
Chicago, Illinois 60601
(312) 819-1900
Graham L.W. Day
Robyn Ast-Gmoser
POLSINELLI SHUGHART PC100 Fourth Street, Suite 1000
St. Louis, Missouri 63102
(314) 889-8000
Attorneys for Plaintiffs Andrx
Corporation, Andrx Pharmaceuticals,
Inc. (N/K/A Watson Laboratories, Inc.-
Florida), Andrx Pharmaceuticals,
L.L.C., Andrx Laboratories (NJ), Inc.,
Andrx EU Ltd., and Andrx Labs, L.L.C.
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EXHIBIT A
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EXHIBIT B
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