Free Amended Answer to Complaint - District Court of Delaware - Delaware

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UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ____________________________________ ) SANOFI-AVENTIS and ) SANOFI-AVENTIS U.S. LLC, ) ) Plaintiffs, ) ) v. ) ) ACTAVIS SOUTH ATLANTIC LLC, ) AUROBINDO PHARMA LTD., ) AUROBINDO PHARMA USA INC., ) MYLAN PHARMACEUTICALS INC., ) PAR PHARMACEUTICAL, INC., ) RANBAXY INC., RANBAXY ) LABORATORIES LIMITED, SUN ) PHARMACEUTICAL INDUSTRIES, ) INC., SUN PHARMACEUTICAL ) INDUSTRIES, LTD., TEVA ) PHARMACEUTICALS USA, INC., ) TORRENT PHARMA INC. and ) TORRENT PHARMACEUTICALS ) LIMITED ) ) Defendants. ) ____________________________________)

C.A. No. 1:07-cv-00572-GMS

FIRST AMENDED ANSWER AND COUNTERCLAIMS OF DEFENDANT ACTAVIS SOUTH ATLANTIC LLC TO PLAINTIFFS' COMPLAINT Defendant Actavis South Atlantic LLC ("Actavis") hereby responds to the corresponding paragraphs of the Complaint of the plaintiffs, sanofi-aventis and sanofiaventis U.S. LLC ("sanofi-aventis U.S.") as follows: 1. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 1 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof.

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2.

Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 2 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 3. 4. Actavis admits the allegations in Paragraph 3 of the Complaint. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 4 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 5. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 5 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 6. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 6 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 7. Upon information and belief, Actavis admits the allegations in Paragraph

7 of the Complaint. 8. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 8 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 9. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 9 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof.

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10.

Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 10 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 11. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 11 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 12. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 12 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 13. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 13 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 14. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 14 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 15. The allegations of Paragraph 15 of the Complaint set forth legal

conclusions and characterizations. The Complaint speaks for itself, and no further response by Actavis is required, except to state that the Complaint purports to state a cause of action under Title 35 of the U.S. Code. 16. 17. Actavis admits the allegations in Paragraph 16 of the Complaint. Actavis denies the allegations in Paragraph 17 of the Complaint, except to

state that it does not contest personal jurisdiction over itself in this proceeding. 18. Actavis admits the allegations in Paragraph 18 of the Complaint.

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19.

Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 19 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 20. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 20 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 21. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 21 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 22. Upon information and belief, Actavis admits the allegations in

Paragraph 22 of the Complaint. 23. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 23 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 24. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 24 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 25. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 25 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 26. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 26 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof.

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27.

Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 27 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 28. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 28 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 29. Actavis has insufficient knowledge to admit or deny the allegations in

Paragraph 29 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. 30. Actavis admits the allegations in Paragraph 30 of the Complaint with

respect to itself. Actavis has insufficient knowledge to admit or deny the allegations in Paragraph 30 of the Complaint with respect to any other defendant, and leaves sanofiaventis and sanofi-aventis U.S. to their proof. 31. Actavis admits that the `491 patent was issued by the United States Patent

and Trademark Office ("PTO" ) on April 28, 1987, that sanofi-aventis U.S. holds NDA No. 21-287 on Uroxtral® brand alfuzosin hydrochloride extended release tablets, and that the `491 patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations ("the Orange Book") with respect to Uroxtral®. Actavis denies that the `491 patent was duly and legally issued by the PTO. Actavis has insufficient knowledge to admit or deny the remaining allegations, and therefore denies the same. 32. Actavis admits that the `940 patent was issued by the PTO on November

21, 2000, and that the `940 patent is listed in the Orange Book with respect to Uroxtral®. Actavis denies that the `940 patent was duly and legally issued by the PTO. Actavis has

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insufficient knowledge to admit or deny the remaining allegations, and therefore denies the same. 33. 34. Actavis admits the allegations in Paragraph 33 of the Complaint. The statements made in Actavis' ANDA No. 79-055 speak for themselves

and require no further response by Actavis. Actavis has insufficient knowledge to admit or deny the remaining allegations in Paragraph 34 of the Complaint, and leaves sanofiaventis and sanofi-aventis U.S. to their proof. 35. 36. 37. 38. 39. 40. 41. Actavis denies the allegations in Paragraph 35 of the Complaint. Actavis denies the allegations in Paragraph 36 of the Complaint. Actavis denies the allegations in Paragraph 37 of the Complaint. Actavis denies the allegations in Paragraph 38 of the Complaint. Actavis denies the allegations in Paragraph 39 of the Complaint. Actavis admits the allegations in Paragraph 40 of the Complaint. The statements made in Actavis' ANDA No. 79-055 speak for themselves

and require no further response by Actavis. Actavis has insufficient knowledge to admit or deny the remaining allegations in Paragraph 41 of the Complaint, and leaves sanofiaventis and sanofi-aventis U.S. to their proof. 42. 43. 44. 45. 46. Actavis denies the allegations in Paragraph 42 of the Complaint. Actavis denies the allegations in Paragraph 43 of the Complaint. Actavis denies the allegations in Paragraph 44 of the Complaint. Actavis denies the allegations in Paragraph 45 of the Complaint. Actavis denies the allegations in Paragraph 46 of the Complaint.

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47. ­ 108.

Actavis has insufficient knowledge to respond to the allegations in

Paragraphs 47 ­ 108 of the Complaint, and leaves sanofi-aventis and sanofi-aventis U.S. to their proof. FIRST AFFIRMATIVE DEFENSE Invalidity 1. The `491 patent is invalid and unenforceable by reason of the failure of the

'491 patent to satisfy one or more conditions of patentability specified in Title 35 of the United States Code, including but not limited to §§ 101, 102, 103 and 112. 2. The `940 patent is invalid and unenforceable by reason of the failure of

the '940 patent to satisfy one or more conditions of patentability specified in Title 35 of the United States Code, including but not limited to §§ 101, 102, 103 and 112. COUNTERCLAIMS The Parties 1. Actavis South Atlantic LLC ("Actavis") is a limited liability company

established under the laws of Delaware, having a principal place of business at 13800 NW 2nd Street, Suite 190, Fort Lauderdale, Florida 33325. 2. Upon information and belief, sanofi-aventis is a corporation organized and

existing under the laws of France, having its principal place of business at 174 avenue de France, Paris, France 75013. 3. Upon information and belief, sanofi-aventis U.S. is a limited liability

company organized and existing under the laws of Delaware, with its North American headquarters located at 55 Corporate Drive, Bridgewater, New Jersey 08807.

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Declaration of Noninfringement and Invalidity 4. 5. Actavis repeats and realleges Paragraphs 1-3 of the counterclaims. This claim arises under the patent laws of the United States, 35 U.S.C. § 1,

et seq., and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202. This court has subject matter jurisdiction under 28 U.S.C. §§ 1331 and 1338. 6. In their Complaint, sanofi-aventis and sanofi-aventis U.S. assert that

Actavis infringed United States Patent No. 4,661,491 ("the `491 patent") and United States Patent No. 6,149,940 ("the '940 patent") by submitting Abbreviated New Drug Application ("ANDA") No. 79-055 including the § 505(j)(2)(A)(vii)(IV) allegations to the Food and Drug Administration ("FDA"), and that through ANDA No. 79-055 Actavis seeks FDA approval to manufacture and sell alfuzosin hydrochloride extended release tablets prior to the expiration of the `491 and `940 patents. 7. Actavis seeks a declaration that the `491 and `940 patents are not infringed

and that the `491 and `940 patents are invalid. 8. The `491 patent was issued by the PTO on April 28, 1987, and currently

names sanofi-aventis as the assignee of the named inventor Francois Regnier. 9. In their Complaint, sanofi-aventis and sanofi-aventis U.S. maintain, and

Actavis denies, that Actavis' submission of ANDA No. 79-055 infringes the `491 patent under 35 U.S.C. § 271(e)(2)(A) and that Actavis' commercial use, offer for sale or sale of its alfuzosin hydrochloride extended release tablets would infringe the `491 patent. In their Complaint, sanofi-aventis and sanofi-aventis U.S. maintain, and Actavis denies, that the `491 patent is valid.

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10.

Actavis' submission of ANDA No. 79-055 does not infringe the `491

patent under 35 U.S.C. § 271(e)(2)(A), and Actavis' commercial use, offer for sale or sale of its alfuzosin hydrochloride extended release tablets would not infringe the `491 patent. 11. The `491 patent is invalid by reason of its failure to satisfy one or more

conditions of patentability specified in Title 35 of the United States Code, including but not limited to §§ 101, 102, 103 and 112. 12. The `940 patent was issued by the PTO on November 21, 2000, and

currently names sanofi-aventis and Jagotec AG as the assignees of the named inventors Lauretta Maggi, Ubaldo Conte, Pascal Grenier, Guy Vergnault, Alain Dufour, Francois Xavier Jarreau, and Clemence Rauch-Desanti. 13. In their Complaint, sanofi-aventis and sanofi-aventis U.S. maintain, and

Actavis denies, that Actavis' submission of ANDA No. 79-055 infringes the `940 patent under 35 U.S.C. § 271(e)(2)(A) and that Actavis' commercial use, offer for sale or sale of its alfuzosin hydrochloride extended release tablets would infringe the `940 patent. In their Complaint, sanofi-aventis and sanofi-aventis U.S. maintain, and Actavis denies, that the `940 patent is valid. 14. Actavis' submission of ANDA No. 79-055 does not infringe the

`940 patent under 35 U.S.C. § 271(e)(2)(A), and Actavis' commercial use, offer for sale or sale of its alfuzosin hydrochloride extended release tablets would not infringe the `940 patent.

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15.

The `940 patent is invalid by reason of its failure to satisfy one or more

conditions of patentability specified in Title 35 of the United States Code, including but not limited to §§ 101, 102, 103 and 112. 16. Actual and justiciable controversies exist between Actavis and sanofi-

aventis/sanofi-aventis U.S. regarding the infringement and validity of the `491 and '940 patents. 17. Actavis is entitled to declarations that Actavis' submission of ANDA No.

79-055 does not infringe the `491 and `940 patents under 35 U.S.C. § 271(e)(2)(A) and that Actavis' commercial use, offer for sale or sale of its alfuzosin hydrochloride extended release tablets would not infringe the `491 and `940 patents. 18. invalid. PRAYER FOR RELIEF WHEREFORE, Actavis demands judgment in its favor and against sanofi-aventis, and respectfully request that this Court: (a) Dismiss the Complaint with prejudice and deny each request for relief Actavis is entitled to declarations that the `491 and '940 patents are

made by sanofi-aventis and sanofi-aventis U.S.; (b) (c) (d) (e) (f) Adjudge the claims of the '491 patent not infringed; Adjudge the claims of the '940 patent not infringed; Adjudge the claims of the '491 patent invalid; Adjudge the claims of the '940 patent invalid; Declare this case to be exceptional under 35 U.S.C. § 285;

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(g)

Award Actavis its attorneys' fees pursuant to 35 U.S.C. § 285, other

statutes or rules, or general power of the Court; (h) Preliminarily and permanently enjoin sanofi-aventis and sanofi-aventis

U.S., their officers, agents, servants, employees, attorneys and any person who acts in concert or participation with sanofi-aventis and/or sanofi-aventis U.S., from utilizing the '491 patent to block, hamper, hinder or obstruct FDA approval of the product described in ANDA No. 79-055; (i) Preliminarily and permanently enjoin sanofi-aventis and sanofi-aventis

U.S., their officers, agents, servants, employees, attorneys and any person who acts in concert or participation with sanofi-aventis and/or sanofi-aventis U.S., from utilizing the '940 patent to block, hamper, hinder or obstruct FDA approval of the product described in ANDA No. 79-055; (j) Permanently enjoin sanofi-aventis and sanofi-aventis U.S., its officers,

agents, servants, employees, attorneys and any person who acts in concert or participation with sanofi-aventis and/or sanofi-aventis U.S., from asserting or otherwise seeking to enforce the '491 patent against Actavis or anyone in privity with Actavis; (k) Permanently enjoin sanofi-aventis and sanofi-aventis U.S., its officers,

agents, servants, employees, attorneys and any person who acts in concert or participation with sanofi-aventis and/or sanofi-aventis U.S., from asserting or otherwise seeking to enforce the '940 patent against Actavis or anyone in privity with Actavis; and (l) proper. Award Actavis such other and further relief as the Court deems just and

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/s/ Dominick T. Gattuso Andre G. Bouchard (No. 2504) Dominick T. Gattuso (No. 3630) BOUCHARD, MARGULES & FRIEDLANDER, P.A. 222 Delaware Avenue, Suite 1400 Wilmington, DE 19801 Telephone: (302) 573-3500 [email protected] [email protected] Attorneys for Defendant Actavis South Atlantic LLC OF COUNSEL: John Will Ongman Sanjay B. Sitlani AXINN, VELTROP & HARKRIDER LLP 1330 Connecticut Avenue, NW Washington, DC 20036 (202) 912-4700 Chad A. Landmon AXINN, VELTROP & HARKRIDER LLP 90 State House Square Hartford, CT 06103-3702 (860) 275-8100 Attorneys for Defendant Actavis South Atlantic LLC

Dated: November 16, 2007

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CERTIFICATE OF SERVICE I, Dominick T. Gattuso, hereby certify that on November 16, 2007, I caused to be electronically filed a true and correct copy of the First Amended Answer and Counterclaims with the Clerk of the Court using CM/ECF that will send notification of such filing to the following counsel of record: Jack. B. Blumenfeld, Esquire Maryellen Noreika, Esquire James W. Parrett, Jr., Esquire MORRIS, NICHOLS, ARSHT AND TUNNELL LLP Mary B. Matterer, Esquire MORRIS JAMES LLP Richard L. Horwitz, Esquire David E. Moore, Esquire POTTER, ANDERSON & CORROON LLP Phillip A. Rovner, Esquire POTTER, ANDERSON & CORROON LLP Francis J. Murphy, Jr., Esquire MURPHY, SPADARO & LANDON Josy W. Ingersoll, Esquire John W. Shaw, Esquire YOUNG, CONAWAY, STARGATT & TAYLOR , LLP Frederick L. Cortell, II, Esquire Jameson A.L. Tweedie, Esquire RICHARDS, LAYTON & FINGER, P.A.

I further certify that on November 16, 2007, I caused copies of the foregoing document to be served by e-mail on the following.

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Christine J. Siwik, Esquire Paul J. Molino, Esquire Deanne M. Mazzochi, Esquire RAKOCZY MOLINO MAZZOCHI SIWIK LLP 6 West Hubbard Street, Suite 500 Chicago, IL 60610 Counsel for Aurobindo Pharma USA Inc. Christopher J. Sorenson, Esquire MERCHANT & GOULD An Intellectual Property Law Firm 80 South 8th Street 3200 IDS Center Minneapolis, MN 55402 Counsel for Teva Pharmaceuticals USA, Inc.

Mary B. Matterer, Esquire MORRIS JAMES LLP 500 Delaware Avenue Suite 1500 Wilmington, DE 19801 Counsel for Aurobindo Pharma USA Inc.

Josy W. Ingersoll, Esquire John W. Shaw, Esquire The Brandywine Building 1000 West Street 17th Floor Wilmington, DE 19801 YOUNG, CONAWAY, STARGATT & TAYLOR , LLP Counsel for Teva Pharmaceuticals USA, Inc. Chad A. Landmon, Esquire AXINN, VELTROP & HARKRIDER LLP 90 State House Square Hartford, CT 06103-3702 Counsel for Actavis South Atlantic LLC and Par Pharmaceutical, Inc.

John Will Ongman, Esquire Sanjay B. Sitlani, Esquire AXINN, VELTROP & HARKRIDER LLP 1330 Connecticut Avenue, NW Washington, DC 20036 Counsel for Actavis South Atlantic LLC and Par Pharmaceutical, Inc. Timothy H. Kratz, Esquire Robert J. Waddell Jr., Esquire Robert L. Florence, Esquire MCGUIRE WOODS LLP 1170 Peachtree Street, Suite 2100 Atlanta, GA 30309 Counsel for Mylan Pharmaceuticals Inc. Lynn E. Eccleston, Esquire MCGUIRE WOODS LLP 1750 Tysons Boulevard Suite 1800 McLean, VA 22102-4215 Counsel for Mylan Pharmaceuticals Inc.

Richard L. Horwitz, Esquire David E. Moore, Esquire POTTER, ANDERSON & CORROON LLP Hercules Plaza 1313 North Market St. Wilmington, DE 19801 Counsel for Mylan Pharmaceuticals Inc.

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Keith D. Parr, Esquire Kevin M. Nelson, Esquire David B. Abramowitz, Esquire LOCKE LORD BISSELL & LIDDELL LLP 111 South Wacker Drive, Chicago, IL 60606 Counsel for Torrent Pharma Inc. and Torrent Pharmaceuticals, Ltd. Robert B. Breisblatt, Esquire Steven E. Feldman, Esquire Sherry L. Rollo, Esquire WELSH & KATZ LTD. 120 S. Riverside Plaza, 22nd Floor Chicago, IL 60606 Counsel for Sun Pharmaceutical Industries, Inc. and Sun Pharmaceuticals Industries, Ltd. Darrell L. Olson, Esquire William R. Zimmerman, Esquire KNOBBE, MARTENS, OLSON & BEAR 2040 Main Street, 14th Floor Irvine, CA 29614 Counsel for Ranbaxy, Inc. and Ranbaxy Laboratories Limited.

Francis J. Murphy, Jr., Esquire MURPHY, SPADARO & LANDON 1011 Centre Road, Suite 210 Wilmington, DE 19805 Counsel for Torrent Pharma Inc. and Torrent Pharmaceuticals, Ltd.

Phillip A. Rovner, Esquire POTTER, ANDERSON & CORROON LLP Hercules Plaza 1313 North Market St. Wilmington, DE 19801 Counsel for Sun Pharmaceutical Industries, Inc. and Sun Pharmaceuticals Industries, Ltd.

Frederick L. Cortell, II, Esquire Jameson A.L. Tweedie, Esquire RICHARDS, LAYTON & FINGER, P.A. One Rodney Square 920 North King Street Wilmington, DE 19801 Counsel for Ranbaxy, Inc. and Ranbaxy Laboratories Limited.

John Desmarais, Esquire Gerald J. Flattmann, Jr., Esquire William T. Vuk, Esquire KIRKLAND & ELLIS LLP Citigroup Center 153 E. 53rd Street New York, NY 10022 Counsel for sanofi-aventis and sanofi-aventis U.S. LLC

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/s/ Dominick T. Gattuso Andre G. Bouchard (No. 2504) Dominick T. Gattuso (No. 3630) BOUCHARD, MARGULES & FRIEDLANDER, P.A. 222 Delaware Avenue, Suite 1400 Wilmington, DE 19801 Telephone: (302) 573-3500 [email protected] [email protected] Attorneys for Defendant Actavis South Atlantic LLC

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