Free COMPLAINT - District Court of Delaware - Delaware

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE TAKEDA PHARMACEUTICAL COMPANY LIMITED, a Japanese Corporation, and TAP PHARMACEUTICAL PRODUCTS INC., a Delaware Corporation, Plaintiffs, v. BARR PHARMACEUTICALS, INC., a Delaware Corporation, and BARR LABORATORIES, INC., a Delaware Corporation, Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) )

C.A. No. _______________

COMPLAINT Plaintiffs Takeda Pharmaceutical Company Limited and TAP Pharmaceutical Products Inc. (collectively, "Plaintiffs"), as and for their Complaint against defendants Barr Pharmaceuticals, Inc. and Barr Laboratories, Inc. ("Defendants"), allege as follows: THE PARTIES 1. Plaintiff Takeda Pharmaceutical Company Limited ("Takeda") is a

Japanese corporation, having a principal place of business at 1-1, Doshomachi 4-chome, Chuoku, Osaka, Japan. As part of its business, Takeda is involved in the research, development, and marketing of pharmaceutical products. 2. Plaintiff TAP Pharmaceutical Products Inc. ("TAP") is a Delaware

corporation, having a principal place of business at 675 North Field Drive, Lake Forest, Illinois 60045. As part of its business, TAP is involved in the research, development, and marketing of pharmaceutical products.

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3.

On information and belief, defendant Barr Pharmaceuticals, Inc. ("Barr

Pharmaceuticals") is a Delaware corporation, having a principal place of business located at 400 Chestnut Ridge Road, Woodcliff Lake, NJ 07677 and is engaged in the manufacture and sale of pharmaceutical products. 4. On information and belief, defendant Barr Laboratories, Inc. ("Barr Labs")

is a Delaware corporation, having a principal place of business located at Two Quaker Road, P.O. Box 2900, Pomona, NY 10970 and is engaged in the manufacture and sale of pharmaceutical products. 5. On information and belief, Barr Pharmaceuticals owns 100% of the

ownership and voting interest in Barr Labs. 6. Barr Pharmaceuticals. 7. On information and belief, Barr Pharmaceuticals conducts its North On information and belief, Barr Labs is controlled and/or dominated by

American operations, in part, through Barr Labs. JURISDICTION AND VENUE 8. This action arises under the patent laws of the United States of America,

Title 35, United States Code. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a). 9. Barr Pharmaceuticals is subject to personal jurisdiction in this District by

virtue of, inter alia, its incorporation in Delaware, its conduct of business in this District, its purposeful availment of the rights and benefits of Delaware law, and its substantial and continuing contacts with the State. 10. Barr Labs is subject to personal jurisdiction in this District by virtue of,

inter alia, its incorporation in Delaware, its conduct of business in this District, its purposeful

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availment of the rights and benefits of Delaware law, and its substantial and continuing contacts with the State. 11. (d), and 1400(b). FACTS PERTINENT TO ALL CLAIMS FOR RELIEF 12. On November 7, 1995, the United States Patent & Trademark Office Venue is proper in this District pursuant to 28 U.S.C. §§ 1391(b), (c) and

("PTO") issued U.S. Patent No. 5,464,632 ("the '632 Patent"), entitled "Rapidly Disintegratable Multiparticular Tablet," to Laboratoires Prographarm, the assignee of the named inventors Gerard Cousin, Etienne Bruna, and Edouard Gendrot. Laboratoires Prographarm granted

Plaintiff Takeda an exclusive license to the '632 Patent in the field of proton pump inhibitors with the right to sublicense. Ethypharm subsequently acquired Laboratoires Prographarm and is the record owner of the '632 Patent. Plaintiff TAP is the exclusive sublicensee to the '632 Patent. On February 20, 2001, the PTO issued a Reexamination Certificate for the '632 Patent. A copy of the '632 Patent and its Reexamination Certificate is attached hereto as Exhibit A. 13. On December 11, 2001, the PTO issued U.S. Patent No. 6,328,994 ("the

'994 Patent"), entitled "Orally Disintegrating Tablets," to Takeda Chemical Industries, Ltd. (now Takeda Pharmaceutical Company Limited), the assignee of the named inventors Toshihiro Shimizu, Shuji Morimoto, and Tetsuro Tabata. Plaintiff Takeda is the record owner of the '994 Patent, and Plaintiff TAP is the exclusive licensee. A copy of the '994 Patent is attached hereto as Exhibit B. 14. On August 30, 2002, the United States Food and Drug Administration

("FDA") approved New Drug Application ("NDA") No. 21-428 for lansoprazole delayed release orally disintegrating tablets, 15 and 30 mg. TAP is the holder of NDA No. 21-428 for

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lansoprazole delayed release orally disintegrating tablets, which it sells under the name Prevacid® SoluTabTM. 15. The '632 and '994 Patents (collectively, "the patents-in-suit") are listed in

a publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations (known as the "Orange Book") as covering Prevacid® SoluTabTM, delayed release orally disintegrating tablets, 15 and 30 mg. 16. On information and belief, through the coordinated efforts of research and

development staff at least in North America, Barr Pharmaceuticals seeks to constantly expand the range of generic products it sells. 17. On information and belief, Defendants collaborate in the manufacture,

marketing, and sale of many pharmaceutical products (including generic drug products manufactured and sold pursuant to an approved abbreviated new drug application) within the United States generally and the State of Delaware specifically. 18. On information and belief, Defendants actively review pharmaceutical

patents and seek opportunities to challenge those patents. 19. On information and belief, Defendants reviewed the patents-in-suit and

certain commercial and economic information relating to Prevacid® SoluTabTM, including estimates of the revenues generated by the sale of Prevacid® SoluTabTM, and decided to file an Abbreviated New Drug Application ("ANDA"), seeking approval to market lansoprazole delayed release orally disintegrating tablets. 20. On information and belief, Defendants collaborated in the research,

development, preparation and filing of Abbreviated New Drug Application ("ANDA") No. 90152 for lansoprazole delayed release orally disintegrating tablets.

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21.

On information and belief, Barr Labs submitted to the FDA ANDA

No. 90-152 to seek approval to engage in the commercial manufacture, use and sale of lansoprazole delayed-release orally disintegrating tablets, 15 and 30 mg, prior to the expiration of the patents-in-suit. 22. Plaintiffs have received a letter dated April 24, 2008, from Barr Labs

notifying them that Barr Labs's ANDA No. 90-152 includes a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a "Paragraph IV certification") that, in Barr Labs's opinion, the patentsin-suit are invalid, unenforceable or will not be infringed by the commercial manufacture, use or sale of the lansoprazole delayed release orally disintegrating tablet products described in ANDA No. 90-152. 23. On information and belief, Barr Pharmaceuticals made the ultimate

decision to file ANDA No. 90-152 with the FDA, and knowingly encouraged, directed and actively induced Barr Labs to file ANDA No. 90-152 and Paragraph IV certification, and Barr Labs did so at Barr Pharmaceuticals' direction. 24. On information and belief, Barr Pharmaceuticals was necessarily aware of

the patents-in-suit when it directed Barr Labs to file ANDA No. 90-152 and a Paragraph IV certification. 25. Plaintiffs commenced this action within 45 days of the date they received

Barr Labs's notice of ANDA No. 90-152 containing the Paragraph IV certification. 26. On information and belief, Defendants continue to collaborate in seeking

approval of ANDA No. 90-152 from the FDA and intend to collaborate in the commercial manufacture, marketing and sale of lansoprazole delayed release orally disintegrating tablets

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(including commercial marketing and sale of such products in the State of Delaware) in the event that FDA approves ANDA No. 90-152. FIRST CLAIM FOR RELIEF (Direct Infringement of the '632 Patent by Barr Labs and Barr Pharmaceuticals) 27. Plaintiffs repeat and reallege each and every allegation contained in

paragraphs 1 through 26 hereof, as if fully set forth herein. 28. Through the conduct alleged above, Defendants have directly infringed,

and continue to directly infringe, one or more claims of the '632 Patent. 29. By filing ANDA No. 90-152 with a Paragraph IV certification seeking

FDA approval to engage in the commercial manufacture, use and sale of lansoprazole delayed release orally disintegrating tablets, 15 and 30 mg, prior to the expiration of the '632 Patent, Defendants have infringed the '632 Patent under 35 U.S.C. § 271(e)(2). 30. Defendants were aware of the existence of the '632 Patent prior to filing

ANDA No. 90-152 but took such action knowing that it would constitute an infringement of the '632 Patent. 31. On information and belief, Defendants acted without a reasonable basis

for a good faith belief that they would not be liable for infringing the '632 Patent. 32. U.S.C. § 285. 33. Plaintiffs will be irreparably harmed if Defendants are not enjoined from Defendants' conduct renders this case "exceptional" as described in 35

infringing the '632 Patent. SECOND CLAIM FOR RELIEF (Inducement of Infringement of the '632 Patent by Barr Pharmaceuticals) 34. Plaintiffs repeat and reallege each and every allegation contained in

paragraphs 1 through 33 hereof, as if fully set forth herein.

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35.

Through the conduct alleged above, Barr Pharmaceuticals has knowingly

and actively induced Barr Labs to infringe, and continue to infringe, one or more claims of the '632 Patent. 36. By reason of Barr Pharmaceuticals' inducement of Barr Labs's direct

infringement of the '632 Patent, Barr Pharmaceuticals has caused and continues to cause irreparable harm to Plaintiffs. 37. On information and belief, Barr Pharmaceuticals' inducement of Barr

Labs's direct infringement of the '632 Patent will continue unless enjoined by this Court. 38. Plaintiffs have no adequate remedy at law for Barr Pharmaceuticals'

inducement of Barr Labs's direct infringement of the '632 Patent. 39. This is an exceptional case within the meaning of 35 U.S.C. § 285, which

warrants reimbursement of Plaintiffs' reasonable attorney fees. THIRD CLAIM FOR RELIEF (Direct Infringement of the '994 Patent by Barr Labs and Barr Pharmaceuticals) 40. Plaintiffs repeat and reallege each and every allegation contained in

paragraphs 1 through 39 hereof, as if fully set forth herein. 41. Through the conduct alleged above, Defendants have directly infringed,

and continue to directly infringe, one or more claims of the '994 Patent. 42. By filing ANDA No. 90-152 with a Paragraph IV certification seeking

FDA approval to engage in the commercial manufacture, use and sale of lansoprazole delayed release orally disintegrating tablets, 15 and 30 mg, prior to the expiration of the '994 Patent, Defendants have infringed the '994 Patent under 35 U.S.C. § 271(e)(2).

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43.

Defendants were aware of the existence of the '994 Patent prior to filing

ANDA No. 90-152 but took such action knowing that it would constitute an infringement of the '994 Patent. 44. On information and belief, Defendants acted without a reasonable basis

for a good faith belief that they would not be liable for infringing the '994 Patent. 45. U.S.C. § 285. 46. Plaintiffs will be irreparably harmed if Defendants are not enjoined from Defendants' conduct renders this case "exceptional" as described in 35

infringing the '994 Patent. FOURTH CLAIM FOR RELIEF (Inducement of Infringement of the '994 Patent by Barr Pharmaceuticals) 47. Plaintiffs repeat and reallege each and every allegation contained in

paragraphs 1 through 46 hereof, as if fully set forth herein. 48. Through the conduct alleged above, Barr Pharmaceuticals has knowingly

and actively induced Barr Labs to infringe, and continue to infringe, one or more claims of the '994 Patent. 49. By reason of Barr Pharmaceuticals' inducement of Barr Labs's direct

infringement of the '994 Patent, Barr Pharmaceuticals has caused and continues to cause irreparable harm to Plaintiffs. 50. On information and belief, Barr Pharmaceuticals' inducement of Barr

Labs's direct infringement of the '994 Patent will continue unless enjoined by this Court. 51. Plaintiffs have no adequate remedy at law for Barr Pharmaceuticals'

inducement of Barr Labs's direct infringement of the '994 Patent.

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52.

This is an exceptional case within the meaning of 35 U.S.C. § 285, which

warrants reimbursement of Plaintiffs' reasonable attorneys' fees. WHEREFORE, Plaintiffs respectfully request the following relief: A. patents-in-suit; B. An order adjudging and decreeing that Barr Pharmaceuticals has induced An order adjudging and decreeing that Defendants have infringed the

infringement of the patents-in-suit; C. An order pursuant to 35 U.S.C. § 271(e)(4)(A) decreeing that the effective

date of any approval of ANDA No. 90-152 be no earlier than the expiration date of the last of the patents-in-suit, including any extensions; D. A preliminary and permanent injunction pursuant to 35 U.S.C.

§ 271(e)(4)(B) restraining and enjoining Barr Labs and Barr Pharmaceuticals, their officers, agents, attorneys, and employees, and those acting in privity or concert with them, from engaging in the commercial manufacture, use, offer for sale, or sale within the United States, or importation into the United States, of the lansoprazole products described in ANDA No. 90-152 or any other ANDA not colorably different from ANDA No. 90-152 until the expiration date of the last of the patents-in-suit, including any extensions; E. A declaration that this case is exceptional and an award of attorneys' fees

under 35 U.S.C. § 285 and costs and expenses in this action; and F. Such other and further relief as the Court may deem just and proper.

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MORRIS, NICHOLS, ARSHT & TUNNELL LLP

/s/ Rodger D. Smith II
Jack B. Blumenfeld (#1014) Mary B. Graham (#2256) Rodger D. Smith II (#3778) James W. Parrett, Jr. (#4292) 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 [email protected] Attorneys for Takeda Pharmaceutical Company Limited and TAP Pharmaceutical Products Inc.

OF COUNSEL: Eric J. Lobenfeld Tedd W. Van Buskirk Arlene L. Chow Dillon Kim HOGAN & HARTSON LLP 875 Third Avenue New York, NY 10022 (212) 918-3000 Philippe Y. Riesen HOGAN & HARTSON LLP Shinjuku Center Building, 46th Floor 25-1 Nishi-Shinjuku 1-chome Shinjuku, Tokyo 163-0646 Japan (81) 3-5908-4070 Attorneys for Takeda Pharmaceutical Company Limited William F. Cavanaugh Stuart E. Pollack Chad J. Peterman Patrick S. Almonrode PATTERSON BELKNAP WEBB & TYLER LLP 1133 Avenue of the Americas New York, NY 10036 (212) 336-2000 Attorneys for TAP Pharmaceutical Products Inc. June 9, 2008
2356622

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EXHIBIT A

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O AO 440 (Rev. 03/08) Civil Summons

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UNITED STATES DISTRICT COURT
for the

District of Delaware __________ District of __________
Takeda Pharmaceutical Company Limited, et al.
Plaintiff

v.
Barr Pharmaceuticals, Inc., et al.
Defendant

) ) ) ) )

Civil Action No.

Summons in a Civil Action To: (Defendant's name and address)
Barr Laboratories, Inc. c/o Corporation Service Company 2711 Centerville Road - Suite 400 Wilmington, DE 19808

A lawsuit has been filed against you. Within 20 days after service of this summons on you (not counting the day you received it), you must serve on the plaintiff an answer to the attached complaint or a motion under Rule 12 of the Federal Rules of Civil Procedure. The answer or motion must be served on the plaintiff's attorney, whose name and address are:
Rodger D. Smith II Morris, Nichols, Arsht & Tunnell LLP 1201 North Market Street; P.O. Box 1347 Wilmington, DE 19899-1347

If you fail to do so, judgment by default will be entered against you for the relief demanded in the complaint. You also must file your answer or motion with the court.

Name of clerk of court

Date:
Deputy clerk's signature

(Use 60 days if the defendant is the United States or a United States agency, or is an officer or employee of the United States allowed 60 days by Rule 12(a)(3).)

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O AO 440 (Rev. 03/08) Civil Summons (Page 2)

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Proof of Service

I declare under penalty of perjury that I served the summons and complaint in this case on by: (1) personally delivering a copy of each to the individual at this place, ; or (2) leaving a copy of each at the individual's dwelling or usual place of abode with who resides there and is of suitable age and discretion; or (3) delivering a copy of each to an agent authorized by appointment or by law to receive it whose name is ; or (4) returning the summons unexecuted to the court clerk on My fees are $ for travel and $ . for services, for a total of $
0.00 0.00

,

.

Date:
Server's signature

Printed name and title

Server's address

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Case 1:99-mc-09999
O AO 440 (Rev. 03/08) Civil Summons

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Filed 06/09/2008

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UNITED STATES DISTRICT COURT
for the

District of Delaware __________ District of __________
Takeda Pharmaceutical Company Limited, et al.
Plaintiff

v.
Barr Pharmaceuticals, Inc., et al.
Defendant

) ) ) ) )

Civil Action No.

Summons in a Civil Action To: (Defendant's name and address)
Barr Pharmaceuticals, Inc. c/o Corporation Service Company 2711 Centerville Road - Suite 400 Wilmington, DE 19808

A lawsuit has been filed against you. Within 20 days after service of this summons on you (not counting the day you received it), you must serve on the plaintiff an answer to the attached complaint or a motion under Rule 12 of the Federal Rules of Civil Procedure. The answer or motion must be served on the plaintiff's attorney, whose name and address are:
Rodger D. Smith II Morris, Nichols, Arsht & Tunnell LLP 1201 North Market Street; P.O. Box 1347 Wilmington, DE 19899-1347

If you fail to do so, judgment by default will be entered against you for the relief demanded in the complaint. You also must file your answer or motion with the court.

Name of clerk of court

Date:
Deputy clerk's signature

(Use 60 days if the defendant is the United States or a United States agency, or is an officer or employee of the United States allowed 60 days by Rule 12(a)(3).)

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O AO 440 (Rev. 03/08) Civil Summons (Page 2)

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Proof of Service

I declare under penalty of perjury that I served the summons and complaint in this case on by: (1) personally delivering a copy of each to the individual at this place, ; or (2) leaving a copy of each at the individual's dwelling or usual place of abode with who resides there and is of suitable age and discretion; or (3) delivering a copy of each to an agent authorized by appointment or by law to receive it whose name is ; or (4) returning the summons unexecuted to the court clerk on My fees are $ for travel and $ . for services, for a total of $
0.00 0.00

,

.

Date:
Server's signature

Printed name and title

Server's address

Print

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Export

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Reset