IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK

Transcription

1 Case 1:11-cv UA Document 13 Filed 06/01/11 Page 1 of 12 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK ) PURDUE PHARMA L.P., ) THE P.F. LABORATORIES, INC., ) PURDUE PHARMACEUTICALS L.P., ) RHODES TECHNOLOGIES, ) AND GRÜNENTHAL GMBH, ) ) Plaintiffs, ) Civil Action No. 1:11-CV-2037-UA ) v. ) ) TEVA PHARMACEUTICALS USA, INC., ) ) Defendant. ) ) TEVA PHARMACEUTICALS USA, INC. S ANSWER, AFFIRMATIVE DEFENSES AND COUNTERCLAIMS TO COMPLAINT Teva Pharmaceuticals USA, Inc. ( Teva ) hereby answers and counterclaims to the Complaint of Plaintiffs Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P., Rhodes Technologies, and Grünenthal GmbH ( Plaintiffs ) as follows, wherein each paragraph 1-25 responds to the same-numbered paragraph in the same-numbered paragraph in the Complaint: NATURE OF THE ACTION 1. The allegations of this paragraph state legal characterizations to which no responses are required. To the extent a response is required, denied. THE PARTIES 2. Teva is without information sufficient to form a belief as to the truth or falsity of the allegations in paragraph 2 of the Complaint; therefore, denied.

2 Case 1:11-cv UA Document 13 Filed 06/01/11 Page 2 of Teva is without information sufficient to form a belief as to the truth or falsity of the allegations in paragraph 3 of the Complaint; therefore, denied. 4. Teva is without information sufficient to form a belief as to the truth or falsity of the allegations in paragraph 4 of the Complaint; therefore, denied. 5. Teva is without information sufficient to form a belief as to the truth or falsity of the allegations in paragraph 5 of the Complaint; therefore, denied. 6. Teva is without information sufficient to form a belief as to the truth or falsity of the allegations in paragraph 6 of the Complaint; therefore, denied. 7. Teva is without information sufficient to form a belief as to the truth or falsity of the allegations in paragraph 7 of the Complaint; therefore, denied. 8. Admitted. 9. Teva admits that it holds a license in the State of New York issued by the New York Department of Education, Office of the Professions to the Distribution Centers as a Non- Resident Establishment Registered Wholesaler of Drugs and/or Devices, and that license numbers , , and expire on February 29, 2012, September 30, 2012, and August 31, 2012, respectively. Otherwise, denied. 10. Admitted. JURISDICTION AND VENUE 11. Teva admits that subject matter jurisdiction is proper for purposes of this action only. Otherwise, denied. 12. Paragraph 12 contains legal conclusions to which no answer is required. To the extent an answer is required, Teva does not contest personal jurisdiction in this judicial district for the limited purpose of this action only. Otherwise, denied. 2

3 Case 1:11-cv UA Document 13 Filed 06/01/11 Page 3 of Teva admits that venue is proper for purposes of this action only. Otherwise, denied. THE PATENTS IN SUIT 14. Teva admits that, according to the records of the United States Patent and Trademark Office ( PTO ), the PTO issued U.S. Patent No. 7,674,799 ( the 799 patent ) on or about March 9, 2010; that the 799 patent is titled Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone; that on its face, the 799 patent names Robert Chapman, Lonn S. Rider, Qi Hong, Donald Kyle and Robert Kupper as inventors; that the 799 patent is listed under the Patent and Exclusivity Information in the FDA s Orange Book relating to Oxycontin and the referenced NDA No ; that a copy of the 799 patent is attached as Exhibit A to Plaintiffs Complaint. Teva is without further information sufficient to admit or deny the remaining allegations of paragraph 14; therefore denied. 15. Teva admits that, according to the records of the United States Patent and Trademark Office ( PTO ), the PTO issued U.S. Patent No. 7,674,800 ( the 800 patent ) on or about March 9, 2010; that the 800 patent is titled Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone; that on its face, the 800 patent names Robert Chapman, Lonn S. Rider, Qi Hong, Donald Kyle and Robert Kupper as inventors; that the 800 patent is listed under the Patent and Exclusivity Information in the FDA s Orange Book relating to Oxycontin and the referenced NDA No ; that a copy of the 800 patent is attached as Exhibit B to Plaintiffs Complaint. Teva is without further information sufficient to admit or deny the remaining allegations of paragraph 15; therefore denied. 16. Teva admits that, according to the records of the United States Patent and Trademark Office ( PTO ), the PTO issued U.S. Patent No. 7,683,072 ( the 072 patent ) on or 3

4 Case 1:11-cv UA Document 13 Filed 06/01/11 Page 4 of 12 about March 23, 2010; that the 072 patent is titled Oxycodone Hydrochloride Having Less Than 25 PPM 14-Hydroxycodeinone; that on its face, the 072 patent names Robert Chapman, Lonn S. Rider, Qi Hong, Donald Kyle and Robert Kupper as inventors; that the 072 patent is listed under the Patent and Exclusivity Information in the FDA s Orange Book relating to Oxycontin and the referenced NDA No ; that a copy of the 072 patent is attached as Exhibit C to Plaintiffs Complaint. Teva is without further information sufficient to admit or deny the allegations of paragraph 16; therefore denied. 17. Teva admits that, according to the records of the United States Patent and Trademark Office ( PTO ), the PTO issued U.S. Patent No. 7,776,314 ( the 314 patent ) on or about August 17, 2010; that the 314 patent is titled Abuse-Proofed Dosage System; that on its face, the 314 patent names Johannes Bartholomäus and Heinrich Kugelmann as inventors; that the 314 patent is listed under the Patent and Exclusivity Information in the FDA s Orange Book relating to Oxycontin and the referenced NDA No ; that a copy of the 314 patent is attached as Exhibit D to Plaintiffs Complaint. Teva is without further information sufficient to admit or deny the remaining allegations of paragraph 17; therefore denied. DEFENDANT S ANDA 18. Teva denies that the quoted statement proposed generic copies of Oxycontin is accurate. Otherwise, admitted. 19. Teva denies that the quoted statement in brackets [proposed generic copies of Oxycontin ] accurately reflects any statement within Teva s Paragraph IV certification. Otherwise, admitted. 20. Teva is without information sufficient to admit or deny when Plaintiffs received its Notice Letter. Teva denies that the quoted statement proposed generic copies of 4

5 Case 1:11-cv UA Document 13 Filed 06/01/11 Page 5 of 12 Oxycontin accurately reflects any statement within Teva s Notice Letter. Otherwise, admitted. 21. Teva admits that the filing of Teva s ANDA No to obtain approval to engage in the commercial manufacture, use, offer to sell, or sale of generic oxycodone controlled-release products prior to the expiration of the 799, 800, 072, and 314 patents constitutes a technical act of infringement under 35 U.S.C. 271(e)(2)(A) to the extent the 799, 800, 072, or 314 patents are valid and enforceable. Otherwise, denied. 22. Denied. 23. Denied. 24. Denied. 25. Denied. PLAINTIFFS PRAYER FOR JUDGMENT (A) Teva denies that Plaintiffs are entitled to the relief as requested in paragraph A. (B) Teva denies that Plaintiffs are entitled to the relief as requested in paragraph B. (C) Teva denies that Plaintiffs are entitled to the relief as requested in paragraph C. (D) Teva denies that Plaintiffs are entitled to the relief as requested in paragraph D. (E) Teva denies that Plaintiffs are entitled to the relief as requested in paragraph E. DEFENSES While expressly reserving its right to assert any additional defenses that discovery may reveal, Teva asserts the following affirmative defenses: FIRST DEFENSE 1. The manufacture, use, sale, offer for sale, or importation of the oxycodone controlled-release products that are the subject of Teva s ANDA No has not infringed, 5

6 Case 1:11-cv UA Document 13 Filed 06/01/11 Page 6 of 12 does not infringe, and would not if made, used, sold, offered for sale, imported, or marketed infringe any valid and enforceable claim of the 799, the 800, the 072, or the 314 patent, either literally or under the doctrine of equivalents. SECOND DEFENSE 2. Teva s actions in defending this case do not give rise to an exceptional case under 35 U.S.C COUNTERCLAIMS FOR DECLARATORY JUDGMENT Teva, by way of counterclaim against Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P., Rhodes Technologies, and Grünenthal GmbH, alleges: THE PARTIES 1. Teva is a Delaware corporation with its principal place of business at 1090 Horsham Road, P.O. Box 1090, North Wales, Pennsylvania Upon information and belief, as alleged in Counterclaim Defendants Complaint, Counterclaim Defendant Purdue Pharma L.P. ( Purdue Pharma ) is a limited partnership organized and existing under the laws of the State of Delaware, having a place of business at One Stamford Forum, 201 Tresser Boulevard, Stamford, CT Upon information and belief, as alleged in Counterclaim Defendants Complaint, Counterclaim Defendant The P.F. Laboratories, Inc. ( P.F. Labs ) is a corporation organized and existing under the laws of the State of New Jersey, having a place of business at 700 Union Boulevard, Totowa, NJ Upon information and belief, as alleged in Counterclaim Defendants Complaint, Counterclaim Defendant Purdue Pharmaceuticals L.P. ( Purdue Pharmaceuticals ) is a limited 6

7 Case 1:11-cv UA Document 13 Filed 06/01/11 Page 7 of 12 liability partnership organized and existing under the laws of the State of Delaware, having a place of business at 4701 Purdue Drive, Wilson, NC Upon information and belief, as alleged in Counterclaim Defendants Complaint, Counterclaim Defendant Rhodes Technologies ( Rhodes ) is a corporation organized and existing under the laws of the State of Delaware, having a place of business at 498 Washington Street, Coventry, RI Upon information and belief, as alleged in Counterclaim Defendants Complaint, Counterclaim Defendant Grünenthal GmbH ( Grünenthal ) is a corporation organized and existing under the laws of Germany, having an address at Aachen, Zieglerstrasse 6, Germany. 7. Counterclaim Defendants allege that Purdue Pharma is an owner of United States Patent Nos. 7,674,799 ( the 799 patent ), 7,674,800 ( the 800 patent ), and 7,683,072 ( the 072 patent ), and an exclusive licensee of United States Patent No. 7,776,314 ( the 314 patent ). Counterclaim Defendants also allege that Purdue Pharma is also the holder of New Drug Application ( NDA ) No for oxycodone controlled-release medication (OxyContin ). 8. Counterclaim Defendants allege that P.F. Labs is an owner of the 799, the 800, and the 072 patent. 9. Counterclaim Defendants allege that Purdue Pharmaceuticals is an owner of the 799, the 800, and the 072 patent. 10. Counterclaim Defendants allege that Rhodes is an owner of the 799, the 800, and the 072 patent. 11. Counterclaim Defendants allege that Grünenthal is the owner of the 314 patent. 7

8 Case 1:11-cv UA Document 13 Filed 06/01/11 Page 8 of Teva submitted Abbreviated New Drug Application ( ANDA ) No for oxycodone controlled-release products ( Proposed Products ) to the Food and Drug Administration ( FDA ). 13. Counterclaim Defendants have alleged in the present action that Teva has infringed and will infringe the 799, the 800, the 072, and the 314 patent (collectively, the Patents-in-Suit ) by filing ANDA No with the FDA, and/or commercially selling, offering for sale, using, and/or manufacturing Teva s Proposed Products. 14. As a consequence of the foregoing, there is an actual and justiciable controversy between Teva and the Counterclaim Defendants as to whether the claims of the Patents-in-Suit are being infringed or will be infringed by Teva s ANDA No or the products described therein. JURISDICTION 15. This counterclaim arises under the Patent Laws of the United States, 35 U.S.C. 1 et seq., and under the Declaratory Judgment Act, 28 U.S.C and This Court has jurisdiction over the subject matter of this Counterclaim pursuant to 28 U.S.C. 1331, 1338(a), 2201, and Counterclaim Defendants, by bringing this action in this District, has consented to and is subject to personal jurisdiction in this District. FIRST COUNT (Declaration of Non-Infringement of the Patents-in-Suit) 18. Teva repeats and re-alleges paragraphs 1 through 17 of the counterclaims. 19. Counterclaim Defendants have asserted the Patents-in-Suit against Teva. Counterclaim Defendants allege and Teva denies that the claims of the Patents-in-Suit cover Teva s Proposed Products. 8

9 Case 1:11-cv UA Document 13 Filed 06/01/11 Page 9 of The claims of the Patents-in-Suit do not, either literally or under the doctrine of equivalents, cover Teva s Proposed Products. Thus, Teva has not infringed and will not infringe any claim of the Patents-in-Suit by making, using, selling, offering for sale, marketing, or importing the Proposed Products. 21. Teva and Counterclaim Defendants have adverse legal interests, and there is a substantial controversy between Counterclaim Defendants and Teva of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding the non-infringement of the Patents-in-Suit. 22. Teva is entitled to a judicial declaration that Teva has not infringed and will not infringe any claim of the Patents-in-Suit by making, using, selling, offering for sale, marketing, or importing the Proposed Products. WHEREFORE, Teva prays for judgment in its favor and against Counterclaim Defendants/Plaintiffs as follows: (a) Dismissing the Complaint with prejudice and denying each request for relief made by Counterclaim Defendants/Plaintiffs; (b) Declaring the 799 patent not infringed by the making, using, selling, offering for sale, marketing, or importing of Teva s Proposed Products and not infringed by any process used to make Teva s Proposed Products; (c) Declaring the 800 patent not infringed by the making, using, selling, offering for sale, marketing, or importing of Teva s Proposed Products and not infringed by any process used to make Teva s Proposed Products; 9

10 Case 1:11-cv UA Document 13 Filed 06/01/11 Page 10 of 12 (d) Declaring the 072 patent not infringed by the making, using, selling, offering for sale, marketing, or importing of Teva s Proposed Products and not infringed by any process used to make Teva s Proposed Products; (e) Declaring the 314 patent not infringed by the making, using, selling, offering for sale, marketing, or importing of Teva s Proposed Products and not infringed by any process used to make Teva s Proposed Products; (f) (g) Awarding Teva its costs; and Awarding Teva such other and further relief as the Court deems just and equitable. Respectfully submitted, Dated: June 1, 2011 s/david M. Hashmall David M. Hashmall (DH9966) GOODWIN PROCTER LLP The New York Times Building 620 Eighth Avenue New York, NY Telephone: (202) Facsimile: (202) dhashmall@goodwinprocter.com Of Counsel: Mark D. Schuman Jennell C. Bilek Carlson, Caspers, Vandenburgh & Lindquist 225 South Sixth Street, Suite 3200 Minneapolis, Minnesota Telephone: (612) Facsimile: (612) mschuman@ccvl.com Attorneys for Teva Pharmaceuticals USA Inc. 10

11 Case 1:11-cv UA Document 13 Filed 06/01/11 Page 11 of 12 CERTIFICATE OF SERVICE I hereby certify that on June 1, 2011, I caused TEVA PHARMACEUTICALS USA, INC. S ANSWER, AFFIRMATIVE DEFENSES AND COUNTERCLAIMS TO COMPLAINT to be filed with the Clerk of the United States District Court for the Southern District of New York via CM/ECF. Copies of the foregoing were caused to be served, via and Federal Express, on June 1, 2011 upon the following attorneys of record at the following addresses: Pablo D. Hendler Sona De ROPES & GRAY LLP 1211 Avenue of the Americas New York, NY (212) pablo.hendler@ropesgray.com sona.de@ropesgray.com Robert J. Goldman 1900 University Avenue, 6th Floor East Palo Alto, CA (650) robert.goldman@ropesgray.com Attorneys for Plaintiffs Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P., and Rhodes Technologies Robert M. Kunstadt (RK-7230) Ilaria Maggioni (IM-7220) R. KUNSTADT, P.C. 875 Sixth Avenue, Suite 1800 New York, New York (212) mail@rkunstadtpc.com Attorneys for Plaintiff Grünenthal GmbH OF COUNSEL: Dale H. Hoscheit

12 Case 1:11-cv UA Document 13 Filed 06/01/11 Page 12 of 12 Joseph M. Skerpon Robert F. Altherr BANNER & WITCOFF, LTD th Street, NW, Suite 1200 Washington, DC (202) s/ David M. Hashmall David M. Hashmall 12