Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 1 of 13 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

Transcription

1 Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 1 of 13 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA NOVARTIS AG and NOVARTIS PHARMACEUTICALS CORPORATION, Plaintiffs, v. Civil Action No.: 1:11-cv (EGS) ACCORD HEALTHCARE, INC. USA and INTAS PHARMACEUTICAL LTD., Defendants. ANSWER, AFFIRMATIVE DEFENSES AND COUNTERCLAIMS OF DEFENDANT ACCORD HEALTHCARE, INC., USA AND INTAS PHARMACEUTICAL LTD. Defendants Accord Healthcare, Inc. USA ( Accord ) and Intas Pharmaceuticals ( Intas ) (hereinafter collectively Defendants ), by and through their undersigned attorneys, hereby submit their Answer, Affirmative Defenses, and Counterclaims. Except as specifically admitted herein, Defendants deny the allegations contained in the Complaint by Plaintiffs Novartis AG and Novartis Pharmaceuticals Corporation ( Novartis or collectively as Plaintiffs ) and maintain that Plaintiffs are not entitled to any relief. NATURE OF THE ACTION 1. Paragraph 1 of the Complaint contains legal conclusions to which no response is PARTIES 2. Defendants are without knowledge or information sufficient to form a belief as to the truth of the allegations of Paragraph 2 of the Complaint and therefore deny them.

2 Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 2 of Defendants are without knowledge or information sufficient to form a belief as to the truth of the allegations of Paragraph 3 of the Complaint and therefore deny them. 4. Admitted. 5. Admitted. 6. Defendants admit that Accord is a wholly owned subsidiary of Intas and deny the remaining allegations contained in Paragraph 6 of the Plaintiffs Complaint. 7. Admitted. JURISDICTION AND VENUE 8. Paragraph 8 of the Complaint contains legal conclusions to which no response is To the extent that an answer may be required, Defendants admit that this Court has jurisdiction over the subject matter of this action, and deny the remaining allegations of this paragraph. 9. Paragraph 9 of the Complaint contains legal conclusions to which no response is To the extent that an answer may be required, Defendants do not challenge this Court s exercise of personal jurisdiction over Defendants for purposes of this action only, and deny the remaining allegations of this paragraph. 10. Paragraph 10 of the Complaint contains legal conclusions to which no response is To the extent that an answer may be required, Defendants admit that Intas manufactures pharmaceuticals products and deny the remaining allegations of this paragraph. 11. Paragraph 11 of the Complaint contains legal conclusions to which no response is To the extent that an answer may be required, Defendants do not challenge this Court s exercise of personal jurisdiction over Defendants for purposes of this action only, and deny the remaining allegations of this paragraph.

3 Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 3 of Paragraph 12 of the Complaint states a legal conclusion to which no response is To the extent that an answer may be required, Defendants consent to venue in this District solely for purposes of this action, and deny the remaining allegations of this paragraph. CLAIM FOR RELIEF-PATENT INFRINGEMENT 13. Defendants admit that Myfortic delayed-release tablets are indicated for prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids. Defendants further admit that Novartis sells Myfortic delayed-release tablets in the United States. Defendants are without knowledge or information sufficient to form a belief as to the truth of the remaining allegations of Paragraph 13 of the Complaint and therefore deny them. 14. Defendants are without knowledge or information sufficient to form a belief as to the truth of the allegations of Paragraph 14 of the Complaint and therefore deny them. 15. Defendants admit that U.S. Patent No. 6,025,391 ( the 391 patent ) issued on February 15, 2000, and what purports to be a copy of the 391 patent is attached to the Complaint as Exhibit A. Defendants further admit Novartis AG is listed as the assignee on the front page of the 391 patent, and deny the remaining allegations of this paragraph. 16. Paragraph 16 of the Complaint contains legal conclusions to which no response is 17. Paragraph 17 of the Complaint contains legal conclusions to which no response is 18. Defendants admit that U.S. Patent No. 6,172,107 ( the 107 patent ) issued on January 9, 2001, and what purports to be a copy of the 107 patent is attached to the Complaint

4 Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 4 of 13 as Exhibit B. Defendants further admit Novartis AG is listed as the assignee on the front page of the 107 patent, and deny the remaining allegations of this paragraph. 19. Paragraph 19 of the Complaint contains legal conclusions to which no response is 20. Paragraph 20 of the Complaint contains legal conclusions to which no response is 21. Defendants admit that U.S. Patent No. 6,306,900 ( the 900 patent ) issued on October 23, 2001, and what purports to be a copy of the 900 patent is attached to the Complaint as Exhibit C. Defendants further admit Novartis AG is listed as the assignee on the front page of the 900 patent, and deny the remaining allegations of this paragraph. 22. Paragraph 22 of the Complaint contains legal conclusions to which no response is 23. Paragraph 23 of the Complaint contains legal conclusions to which no response is 24. Paragraph 24 of the Complaint states a legal conclusion to which no response is To the extent that an answer may be required, Defendants admit that Accord has submitted ANDA No to the FDA for Mycophenolic Acid Delayed Release 360 mg Oral tablets, and deny the remaining allegations of this paragraph. 25. Defendants admit that Accord has submitted ANDA No to the FDA to seek approval to engage in the commercial manufacture, use, and/or sale of Mycophenolic Acid Delayed Release 360 mg Oral tablets before the expiration of the 391, 107 and 900 patents, and deny the remaining allegations of this paragraph.

5 Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 5 of Paragraph 26 of the Complaint contains legal conclusions to which no response is To the extent that an answer may be required, Defendants deny the allegations of this paragraph. 27. Paragraph 27 of the Complaint contains legal conclusions to which no response is To the extent that an answer may be required, Defendants deny the allegations of this paragraph. 28. Defendants admit that a Paragraph IV Certification pursuant to 21 C.F.R was made stating that the 391, 107, and 900 patents are invalid and/or will not be infringed by the Accord Mycophenolic Acid Delayed Release 360 mg Oral Tablets. Defendants deny the remaining allegations of this paragraph. 29. Denied. 30. Denied. 31. Denied. Defendants deny all remaining allegations not specifically admitted herein. Defendants further deny that the Plaintiffs are entitled to the relief requested, or to any relief whatsoever. DEFENDANTS AFFIRMATIVE DEFENSES Without prejudice to the denials set forth in this Answer, without admitting any allegations of the Complaint not otherwise admitted, and without undertaking any of the burdens imposed by law on the Plaintiffs, Defendants allege and assert the following defenses to the Complaint: FIRST DEFENSE 32. Plaintiffs Complaint fails to state a claim upon which relief can be granted. SECOND DEFENSE

6 Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 6 of Plaintiffs are not entitled to relief because they have not appropriately shown or proven adequate standing for the relief sought. THIRD DEFENSE 34. Plaintiffs are estopped from asserting any scope for one or more of the claims of the 391, 107, and 900 patents that would cover Accord s ANDA Products because of amendments, representations, assertions, disclaimers and/or admissions made during the course of proceedings in the United States Patent and Trademark Office ( PTO ) during prosecution of the application leading to the issuance of the 391, 107, and 900 patents. FOURTH DEFENSE 35. To the extent not encompassed by Defendants Third Defense, Plaintiffs are estopped from construing the claims of the 391, 107, and 900 patents to cover and include Accord s ANDA Products. FIFTH DEFENSE 36. Each and every claim of the 391, 107, and 900 patents is invalid for failure to meet the statutory requirements of Title 35 of the United States Code, including, but not limited to, the failure to comply with one or more of the requirements of 35 U.S.C. 101, 102, 103, 112 and/or 116. Further, each and every claim of the 391, 107, and 900 patents is invalid for failing to meet judicially-created requirements for patentability and enforceability of patents. SIXTH DEFENSE 37. The manufacture, use, sale, offer for sale, or importation of the Mycophenolic Acid Delayed Release 360 mg Oral Tablets that are the subject of ANDA No has not infringed, does not infringe, and would not - if made, used, sold, offered for sale, imported, or

7 Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 7 of 13 marketed - infringe any valid and enforceable claim of the 391, 107, and 900 patents, either literally or under the doctrine of equivalents. SEVENTH DEFENSE 38. Defendants have not induced, do not induce, and will not induce infringement of any valid and/or enforceable claim of the 391, 107, and 900 patents. EIGHTH DEFENSE 39. Defendants have not contributed, do not contribute, and will not contribute to the infringement of any valid and/or enforceable claim of the 391, 107, and 900 patents. WHEREFORE, Defendants Accord Healthcare, Inc., USA, and Intas Pharmaceuticals Ltd., hereby demand judgment dismissing Plaintiffs Complaint with prejudice, judgment for costs and fees for suit, and for other such relief as the Court may deem just. COUNTERCLAIMS Defendants/ CounterPlaintiffs Accord Healthcare, Inc., USA ( Accord ) and Intas Pharamceuticals Ltd. ( Intas )(collectively referred to as Defendants or CounterPlaintiffs ) bring the following Counterclaims against Plaintiff/Counterdefendant Novartis AG and Novartis Pharmaceuticals Corporation ( Novartis or collectively as Plaintiffs or Counterdefendants ): PARTIES, JURISDICTION AND VENUE 40. Accord is a company organized and existing under the laws of the State of North Carolina, having its principal place of business at Accord Healthcare, Inc., USA, 1009 Slater Road, Suite 210-B, Durham, North Carolina, Intas is a company organized under the laws of India, having a place of business at Chinubhai Centre, off Nehru Bridge, Ashram Road, Ahmedabad , Gujarat, India.

8 Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 8 of On information and belief, Novartis AG is a corporation organized and existing under the laws of Switzerland, having an office and place of business at Lichstrasse 35, CH- 4056, Basel Switzerland. 43. On information and belief, Novartis Pharmaceuticals Corporation is a corporation organized and existing under the laws of the State of Delaware, having a principle place of business at 59 Route 10, East Hanover, New Jersey This Court has subject matter jurisdiction over these counterclaims pursuant to 28 U.S.C. 1331, 1338(a), 1367(a), 2201 and 2202, and 35 U.S.C. 1, et seq. 45. Plaintiffs/Counterdefendants have submitted to the personal jurisdiction of this Court. 46. Venue is proper in this district pursuant to 28 U.S.C and 1400 and because this suit was filed in this district by the Plaintiffs/Counterdefendants. THE CONTROVERSY 47. This is an action based on an actual controversy between Defendants and Plaintiffs concerning the invalidity and/or noninfringement of U.S. Patent Nos. 6,025,391 ( the 391 patent ), 6,172,107 ( the 107 patent ), and 6,306,900 ( the 900 patent ), and Accord s right to continue to seek approval of ANDA No for Mycophenolic Acid Delayed Release 360 mg Oral Tablets ( Accord ANDA Products ), and upon approval by the FDA, to manufacture, use, sell and offer to sell and import into the United States Accord ANDA Product. 48. The 391 patent, entitled Enteric-Coated Pharmaceutical Compositions of Mycophenolate, bears an issue date from the United States Patent and Trademark Office ( USPTO ) of February 15, 2000, and lists Novartis AG as the assignee, and Barbara Haeberlin, Ching-Pong Mak, Armin Meinzer, and Jacky Vonderscher as the inventors.

9 Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 9 of The 107 patent, entitled Enteric-Coated Pharmaceutical Compositions, bears an issue date from the USPTO of January 9, 2001, and lists Novartis AG as the assignee, and Barbara Haeberlin, Ching-Pong Mak, Armin Meinzer, and Jacky Vonderscher as the inventors. 50. The 900 patent, entitled Enteric-Coated Pharmaceutical Compositions, bears an issue date from the USPTO of October 23, 2001, and lists Novartis AG as the assignee, and Barbara Haeberlin, Ching-Pong Mak, Armin Meinzer, and Jacky Vonderscher as the inventors. 51. Upon information and belief, Novartis AG is the holder of NDA for Myfortic delayed-release tablets. 52. Plaintiffs/Counterdefendants have represented that one or more claims of the 391, 107, and 900 patents relates to its commercially marketed product Myfortic delayedrelease tablets, which contains the active ingredient mycophenolic acid. 53. Plaintiffs/Counterdefendants have alleged that one or more claims of the 391, 107, and 900 patents would be infringed by Accord s ANDA product, and that the filing of Accord s ANDA constitutes infringement of the 391, 107, and 900 patents. 54. Accord has submitted, and is continuing to seek FDA approval of an ANDA directed to products containing mycophenolic acid, and approval to engage in the commercial manufacture, use, offer for sale and importation into the United States, of its proposed injectable products under that ANDA, before the expiration of the 391, 107, and 900 patents. 55. On July 26, 2011, Accord notified Novartis that it had submitted to FDA its ANDA directed to its Accord ANDA Product, and stated that the manufacture, use, offer for sale, sale or importation of its Accord ANDA Product would not infringe any valid claim of the 391, 107, and 900 patents.

10 Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 10 of Accord has undertaken substantial efforts in developing and seeking approval for its proposed Accord ANDA Products set forth in its ANDA. 57. In view of the foregoing, an actual justiciable controversy exists by virtue of Accord s notification to Novartis of its ANDA filing, and Novartis s subsequent filing of the present suit. COUNT I Declaration of Non-Infringement of the 391, 107, and 900 Patents 58. Defendants re-allege and incorporate the allegations of the foregoing paragraphs This counterclaim 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 and 2202, and seeks a declaration that no valid claim of the 391, 107, and 900 patents will be infringed by the manufacture, use, offer for sale, sale, or importation of Accord s proposed mycophenolic acid product. 60. There exists a definite and concrete, real and substantial, justiciable controversy between the parties, herein, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment. A declaration of rights between the parties is both appropriate and necessary to establish that Defendants do not infringe any claim of the 391, 107, and 900 patents. 61. The manufacture, use, offer for sale, sale, or importation of Accord s proposed mycophenolic acid product that are the subject of its ANDA has not infringed, does not infringe, and would not, if marketed, infringe any valid and enforceable claim of the 391, 107, and 900 patents.

11 Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 11 of Defendants are entitled to a judicial declaration that the manufacture, use, offer for sale, sale, or importation of the mycophenolic acid products that are the subject of Accord s ANDA has not infringed, does not infringe, and would not, if marketed, infringe any valid and enforceable claim of the 391, 107, and 900 patents. COUNT II Declaratory Judgment of Invalidity of the 391, 107, and 900 Patents 63. Defendants re-allege and incorporate the allegations of the foregoing paragraphs There exists a definite and concrete, real and substantial, justiciable controversy between the parties, herein, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment. A declaration of rights between the parties is both appropriate and necessary to establish the invalidity of the 391, 107, and 900 patents. 65. The claims of the 391, 107, and 900 patents are invalid for failure to comply with one or more of the conditions for patentability set forth in Title 35 of the United States Code. PRAYER FOR RELIEF WHEREFORE, Defendants/CounterPlaintiffs pray that the Court enter judgment in its favor and against Plaintiffs/CounterDefendants: a. Declaring that the manufacture, use, offer for sale, sale, or importation of the mycophenolic acid products that are the subject of Accord s ANDA has not infringed, does not infringe, and would not, if marketed, infringe any valid and enforceable claim of the 391, 107, and 900 patents; b. Declaring that the claims of the 391, 107, and 900 patents are invalid;

12 Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 12 of 13 c. Ordering that Plaintiffs Complaint be dismissed with prejudice and judgment entered in favor of Defendants; d. Ordering that Plaintiffs to delist the 391, 107, and 900 patents from the Orange Book and that the patent information therein be corrected for Myfortic brand tablets pursuant to 21 U.S.C. 355(c)(3)(D)(ii)(I)(bb); e. Ordering that Plaintiffs, its officers, agents, servants, employees and attorneys, and those persons in active concert or participation with them, be preliminarily and permanently enjoined from threatening or initiating further infringement litigation against Defendants or any of its customers, dealers or suppliers, or any prospective sellers, dealers, distributors or customers of Accord, or charging any of them either orally or in writing with infringement of the 391, 107, and 900 patents. f. Declaring this an exceptional case in favor of Defendants and awarding attorneys fees, costs and expenses pursuant to 35 U.S.C. 285; g. Awarding any and all such other relief as the Court determines to be just and proper. Dated: April 25, 2012 Respectfully Submitted, /s/ Raja Saliba Raja N Saliba (DC Bar No ) SUGHRUE MION PLLC Pennsylvania Ave., N.W. Washington, D.C (202) (202) rsaliba@sughrue.com Attorney for Defendants Accord Healthcare, Inc. USA and Intas Pharmaceutical LTD.

13 Case 1:11-cv EGS Document 10 Filed 04/25/12 Page 13 of 13 CERTIFICATE OF SERVICE The undersigned hereby certifies that on April 25, 2012, a true copy of the Answer, Affirmative Defenses and Counterclaims of Defendant Accord Healthcare, Inc., USA and Intas Pharmaceutical Ltd. was electronically filed with the Clerk of the Court using the CM/ECF system and served by electronic notification of such filing addressed to the following: Edmund J. Haughey FITZPATRICK, CELLA, HARPER & SCINTO 975 F Street, N.W. Washington, D.C ehaughey@fchs.com Attorney for Plaintiffs Novartis AG and Novartis Pharmaceutical Corporation This the 25th day of April, 2012 /s/ Raja Saliba Raja N Saliba (DC Bar No ) SUGHRUE MION PLLC Pennsylvania Ave., N.W. Washington, D.C (202) (202) rsaliba@sughrue.com Attorney for Defendants Accord Healthcare, Inc. USA and Intas Pharmaceutical LTD.