Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 1 of 36 PageID: 321 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY

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1 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 1 of 36 PageID: 321 JASON B. LATTIMORE LATHAM & WATKINS LLP One Newark Center, 16 th Floor Newark, New Jersey Telephone: Facsimile: Attorneys for Defendant and Counterclaimant Orchid Chemicals & Pharmaceuticals Ltd. and Defendants Orchid Healthcare and Orgenus Pharma Inc. UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY TEVA NEUROSCIENCE, INC., TEVA PHARMACEUTICALS USA, INC., and TEVA PHARMACEUTICAL INDUSTRIES, LTD., v. Plaintiffs, WATSON PHARMA, INC., WATSON LABORATORIES, INC., WATSON PHARMACEUTICALS, INC., WATSON PHARMA PRIVATE LTD. - UNIT IV, MYLAN PHARMACEUTICALS, INC., MYLAN INC., ORCHID CHEMICALS & PHARMACEUTICALS LTD., ORCHID HEALTHCARE (a division of Orchid Chemicals & Pharmaceuticals Ltd., and ORGENUS PHARMA INC. Defendants. Case No. 2:10-CV JLL-CCC ANSWER OF DEFENDANTS ORCHID CHEMICALS & PHARMACEUTICALS LTD., ORCHID HEALTHCARE, AND ORGENUS PHARMA INC., AND COUNTERCLAIMS OF ORCHID CHEMICALS & PHARMACEUTICALS LTD. STATEMENT PURSUANT TO L. CIV. R Defendant and Counterclaimant Orchid Chemicals & Pharmaceuticals Ltd. is a company organized and existing under the laws of India with a principal place of business at Orchid Towers, #313, Valluvar Kottam High Road, Nungambakkam, Chennai , Tamil Nadu, India. Defendant Orchid Healthcare is a division of Orchid Chemicals & Pharmaceuticals Ltd., a company organized and existing under the laws of India with a principal place of business at

2 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 2 of 36 PageID: 322 Orchid Towers, #313, Valluvar Kottam High Road, Nungambakkam, Chennai , Tamil Nadu, India. Defendant Orgenus Pharma Inc. is a corporation incorporated under the laws of the State of New Jersey with a principal place of business at 700 Alexander Park, Suite 104, Princeton, New Jersey ANSWER OF DEFENDANT AND COUNTERCLAIMANT ORCHID CHEMICALS & PHARMACEUTICALS LTD., AND DEFENDANTS ORCHID HEALTHCARE AND ORGENUS PHARMA INC. Defendant and Counterclaimant Orchid Chemicals & Pharmaceuticals Ltd., and Defendants Orchid Healthcare and Orgenus Pharma Inc. (all three entities collectively, Orchid hereby answer the Complaint of Plaintiffs and Counterclaim Defendants Teva Neuroscience, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries Ltd. (collectively, Teva ( the Teva Complaint. Orchid hereby denies all allegations not otherwise admitted or denied. 1. Orchid admits that Teva alleges that this is an action for infringement of United States Patent No. 5,453,446 ( the 446 patent. Orchid admits that Teva alleges that this action arises out of Defendants filing of Abbreviated New Drug Applications ( ANDAs seeking approval by the United States Food and Drug Administration ( FDA to sell generic versions of Azilect prior to the date of expiration of the 446 patent. Orchid denies that Teva s Azilect is an innovative oral treatment for idiopathic Parkinson s disease. RESPONSE TO THE PARTIES 1 Teva 2. Orchid lacks knowledge or information sufficient to form a belief as to the truth 1 To facilitate the Court s comparison of the allegations in the Complaint and Orchid s responses thereto, Orchid has incorporated modified Headings that appear in the Complaint. Orchid does not necessarily agree with characterizations in such Headings and does not waive any rights to object to such characterizations or their implications. 2

3 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 3 of 36 PageID: 323 of the allegations of paragraph 2 of the Complaint and, therefore, denies the allegations of paragraph 2 on that basis. 3. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 3 of the Complaint and, therefore, denies the allegations of paragraph 3 on that basis. 4. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 4 of the Complaint and, therefore, denies the allegations of paragraph 4 on that basis. Watson 5. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 5 of the Complaint and, therefore, denies the allegations of paragraph 5 on that basis. 6. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 6 of the Complaint and, therefore, denies the allegations of paragraph 6 on that basis. 7. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 7 of the Complaint and, therefore, denies the allegations of paragraph 7 on that basis. 8. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 8 of the Complaint and, therefore, denies the allegations of paragraph 8 on that basis. 9. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 9 of the Complaint and, therefore, denies the allegations of 3

4 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 4 of 36 PageID: 324 paragraph 9 on that basis. 10. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 10 of the Complaint and, therefore, denies the allegations of paragraph 10 on that basis. 11. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 11 of the Complaint and, therefore, denies the allegations of paragraph 11 on that basis. 12. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 12 of the Complaint and, therefore, denies the allegations of paragraph 12 on that basis. 13. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 13 of the Complaint and, therefore, denies the allegations of paragraph 13 on that basis. 14. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 14 of the Complaint and, therefore, denies the allegations of paragraph 14 on that basis. 15. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 15 of the Complaint and, therefore, denies the allegations of paragraph 15 on that basis. 16. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 16 of the Complaint and, therefore, denies the allegations of paragraph 16 on that basis. 17. Orchid lacks knowledge or information sufficient to form a belief as to the truth 4

5 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 5 of 36 PageID: 325 of the allegations of paragraph 17 of the Complaint and, therefore, denies the allegations of paragraph 17 on that basis. 18. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 18 of the Complaint and, therefore, denies the allegations of paragraph 18 on that basis. Mylan 19. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 19 of the Complaint and, therefore, denies the allegations of paragraph 19 on that basis. 20. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 20 of the Complaint and, therefore, denies the allegations of paragraph 20 on that basis. 21. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 21 of the Complaint and, therefore, denies the allegations of paragraph 21 on that basis. 22. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 22 of the Complaint and, therefore, denies the allegations of paragraph 22 on that basis. 23. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 23 of the Complaint and, therefore, denies the allegations of paragraph 23 on that basis. 24. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 24 of the Complaint and, therefore, denies the allegations of 5

6 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 6 of 36 PageID: 326 paragraph 24 on that basis. Orchid 25. Orchid denies the allegations of paragraph 25 of the Complaint, except that it admits Orchid Chemicals & Pharmaceuticals Ltd. is a company organized and existing under the laws of India with a principal place of business at Orchid Towers, #313, Valluvar Kottam High Road, Nungambakkam, Chennai , Tamil Nadu, India. 26. Orchid denies the allegations of paragraph 26 of the Complaint, except that it admits Orchid Healthcare is a division of Orchid Chemicals & Pharmaceuticals Ltd., a company organized and existing under the laws of India with a principal place of business at Orchid Towers, #313, Valluvar Kottam High Road, Nungambakkam, Chennai , Tamil Nadu, India and that Orchid Healthcare conducts business at Plot Nos. B5(Pt. & B6(Pt., SIPCOT Industrial Park, Irungattukottai, Sriperumbudar , Kancheepuram Dist., Tamil Nadu, India. 27. Orchid denies the allegations of paragraph 27 of the Complaint, except that it admits Orgenus Pharma Inc. is a company organized and existing under the laws of New Jersey with a principal place of business at 700 Alexander Park, Suite 104, Princeton, New Jersey and that Orgenus Pharma Inc. is a wholly-owned subsidiary of Orchid Chemicals Inc., which is itself a wholly owned subsidiary of Orchid Chemicals and Pharmaceuticals Ltd. 28. Orchid denies the allegations of paragraph 28 of the Complaint, except that it admits the website identifies Orgenus as a subsidiary of Orchid Chemicals & Pharmaceuticals Ltd and the Primary Business Contact for US and Canada. Orchid further admits that the website identifies Mr. Satish Srinivasan as Orgenus s Executive Vice President Business Development 6

7 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 7 of 36 PageID: 327 & Operations. 29. Orchid denies the allegations of paragraph 29 of the Complaint, except that it admits Orchid Healthcare, a division of Orchid Chemicals & Pharmaceuticals Ltd., submitted ANDA No to FDA. 30. Orchid denies the allegations of paragraph 30 of the Complaint, except that it admits that ANDA No lists Ms. Diana M. Wilk of Orgenus Pharma Inc. as Authorized U.S. Agent. 31. Orchid denies each and every allegation and/or legal conclusion contained in paragraph 31 of the Complaint. 32. Orchid denies each and every allegation and/or legal conclusion contained in paragraph 32 of the Complaint. 33. Orchid denies Orchid denies each and every allegation and/or legal conclusion contained in paragraph 33 of the Complaint. RESPONSE TO JURISDICTION AND VENUE Subject Matter Jurisdiction 34. Orchid admits that this is an action for patent infringement that arises under 35 U.S.C Orchid admits that this Court has jurisdiction over the subject matter of this action insofar as it concerns Orchid pursuant to 28 U.S.C. 1331, 1338(a, 2201 and Personal Jurisdiction Over Watson 36. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 36 of the Complaint and, therefore, denies the allegations of paragraph 36 on that basis. 7

8 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 8 of 36 PageID: Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 37 of the Complaint and, therefore, denies the allegations of paragraph 37 on that basis. 38. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 38 of the Complaint and, therefore, denies the allegations of paragraph 38 on that basis. 39. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 39 of the Complaint and, therefore, denies the allegations of paragraph 39 on that basis. Personal Jurisdiction Over Mylan 40. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 40 of the Complaint and, therefore, denies the allegations of paragraph 40 on that basis. 41. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 41 of the Complaint and, therefore, denies the allegations of paragraph 41 on that basis. 42. Orchid lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 42 of the Complaint and, therefore, denies the allegations of paragraph 42 on that basis. Personal Jurisdiction Over Orchid 43. Orchid denies the allegations of paragraph 43 of the Complaint, except that it admits that Orchid Chemicals and Pharmaceuticals Ltd. is registered to do business in New Jersey, that Orchid Chemicals and Pharmaceuticals Ltd. has appointed Corporation Service 8

9 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 9 of 36 PageID: 329 Company of West Trenton, New Jersey to accept service on its behalf, that Orchid Chemicals and Pharmaceuticals Ltd. has previously consented to personal jurisdiction in this Judicial District, and that this Court has personal jurisdiction over Orchid Chemicals and Pharmaceuticals Ltd. with respect to this action. 44. Orchid denies the allegations of paragraph 44 of the Complaint, except that it admits Orchid Healthcare, a division of Orchid Chemicals & Pharmaceuticals Ltd., has previously consented to personal jurisdiction in this Judicial District and that this Court has personal jurisdiction over Orchid Healthcare with respect to this action. 45. Orchid denies the allegations of paragraph 45 of the Complaint, except that it admits that Orgenus Pharma Inc. has a principal place of business in Princeton, New Jersey, that Orgenus is incorporated in New Jersey, that Orgenus has previously consented to personal jurisdiction in this Judicial District, and that this Court has personal jurisdiction over Orgenus Pharma Inc. with respect to this action. Venue 46. In response to paragraph 46 of the Complaint, Orchid admits that venue is proper in this Judicial District under 28 U.S.C and 1400(b. RESPONSE TO BACKGROUND The Patent-in-Suit 47. Orchid denies the allegations of paragraph 47 of the Complaint, except that it admits the 446 patent, entitled Use of the R-Enantiomers of N-Propargyl 1-Aminoindan Compounds for Treating Parkinson s Disease, issued on September 26, 1995 to Moussa B.H. Youdim, John P. M. Finberg, Ruth Levy, Jeffrey Sterling, David Lerner, Tirtsah Berger-Paskin and Haim Yellin. Orchid further admits that the 446 patent is listed in the FDA publication 9

10 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 10 of 36 PageID: 330 Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as The Orange Book ( Orange Book with respect to Azilect. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations that the Technion Research and Development Foundation Ltd. ( Technion subsequently assigned to Teva Ltd. its rights in the 446 patent, and, therefore, denies the allegations on that basis. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations that Teva Ltd. is the sole owner by assignment of all rights, title and interest in the 446 patent, and, therefore, denies the allegations on that basis. Orchid specifically denies that the 446 patent was duly and lawfully issued and that Moussa B.H. Youdim, John P. M. Finberg, Ruth Levy, Jeffrey Sterling, David Lerner, Tirtsah Berger-Paskin and Haim Yellin invented the subject matter claimed therein. The Azilect Drug Product 48. Orchid denies the allegations of paragraph 48 of the Complaint, except that it admits that Teva obtained approval to make, sell, promote and/or market rasagiline mesylate tablet products known as Azilect. 49. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraph 49 of the Complaint, and, therefore, denies the allegations on that basis. 50. Orchid denies the allegations of paragraph 50 of the Complaint, except that it admits that Azilect is indicated for the treatment of the signs and symptoms of idiopathic Parkinson s disease as initial monotherapy and as adjunct therapy to levodopa. 51. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraph 51 of the Complaint, and, therefore, denies the allegations on that 10

11 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 11 of 36 PageID: 331 basis. The Watson ANDA 52. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraph 52 of the Complaint, and, therefore, denies the allegations on that basis. 53. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraph 53 of the Complaint, and, therefore, denies the allegations on that basis. 54. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraph 54 of the Complaint, and, therefore, denies the allegations on that basis. 55. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraph 55 of the Complaint, and, therefore, denies the allegations on that basis. 56. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraph 56 of the Complaint, and, therefore, denies the allegations on that basis. The Mylan ANDA 57. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraph 57 of the Complaint, and, therefore, denies the allegations on that basis. 58. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraph 58 of the Complaint, and, therefore, denies the allegations on that 11

12 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 12 of 36 PageID: 332 basis. 59. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraph 59 of the Complaint, and, therefore, denies the allegations on that basis. 60. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraph 60 of the Complaint, and, therefore, denies the allegations on that basis. 61. Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraph 61 of the Complaint, and, therefore, denies the allegations on that basis. The Orchid ANDA 62. Orchid denies the allegations of paragraph 62 of the Complaint, except that it admits Orchid Healthcare, a division of Orchid Chemicals & Pharmaceuticals Ltd., filed with the FDA in Rockville, Maryland, an ANDA under 21 U.S.C. 355(j seeking approval to manufacture, use, offer for sale, sell in and import into the United States 0.5 and 1.0 mg rasagiline mesylate tablets prior to the expiration of the 446 patent. 63. In response to paragraph 63 of the Complaint, Orchid admits that the FDA assigned Orchid Healthcare ANDA No Orchid denies the allegations of paragraph 64 of the Complaint, except that it admits Orchid Healthcare filed with the FDA, pursuant to U.S.C. 355(j(2(A(vii(IV, a certification alleging that the claims of the 446 patent are invalid, unenforceable and/or would not be infringed by the manufacture, use, importation, sale or offer for sale of Orchid s rasagiline mesylate product ( Orchid s Paragraph IV Certification. 12

13 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 13 of 36 PageID: Orchid denies the allegations of paragraph 65 of the Complaint, except that it admits that by letter dated August 18, 2010, Orchid Healthcare notified Plaintiffs pursuant to and in compliance with U.S.C. 355(j(2(B that it had filed an ANDA seeking approval to market Orchid s rasagiline mesylate products prior to the expiration of the 446 patent ( Orchid Notice Letter. 66. In response to paragraph 66 of the Complaint, Orchid admits that this action was commenced (as to the 446 patent before the expiration of forty-five days from the date of receipt of the Orchid Notice Letter. RESPONSE TO COUNT I FOR INFRINGEMENT OF U.S. PATENT NO. 5,453,446 BY WATSON reference. 67. The responses to paragraphs 1-66 are reasserted and incorporated herein by Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraphs of the Complaint, and, therefore, denies the allegations on that basis. RESPONSE TO COUNT ONE FOR INFRINGEMENT OF U.S. PATENT NO. 5,453,446 BY MYLAN reference. 82. The responses to paragraphs 1-66 are reasserted and incorporated herein by Orchid lacks knowledge and information sufficient to form a belief as to the truth of the allegations of paragraphs of the Complaint, and, therefore, denies the allegations on that basis. RESPONSE TO COUNT ONE FOR INFRINGEMENT OF U.S. PATENT NO. 5,453,446 BY ORCHID reference. 97. The responses to paragraphs 1-66 are reasserted and incorporated herein by 13

14 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 14 of 36 PageID: Orchid denies each and every allegation and/or legal conclusion contained in paragraph 98 of the Complaint. 99. Orchid denies each and every allegation and/or legal conclusion contained paragraph 99 of the Complaint Orchid denies each and every allegation and/or legal conclusion contained in paragraph 100 of the Complaint Orchid denies each and every allegation and/or legal conclusion contained in paragraph 101 of the Complaint Orchid denies each and every allegation and/or legal conclusion contained in paragraph 102 of the Complaint Orchid denies the allegations of paragraph 103 of the Complaint, except that it admits Orchid Healthcare was aware of the 446 patent when it submitted ANDA No to the FDA Orchid denies each and every allegation and/or legal conclusion contained in paragraph 104 of the Complaint Orchid denies each and every allegation and/or legal conclusion contained in paragraph 105 of the Complaint Orchid denies each and every allegation and/or legal conclusion contained in paragraph 106 of the Complaint Orchid denies each and every allegation and/or legal conclusion contained in paragraph 107 of the Complaint Orchid denies each and every allegation and/or legal conclusion contained in paragraph 108 of the Complaint. 14

15 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 15 of 36 PageID: Orchid denies each and every allegation and/or legal conclusion contained in paragraph 109 of the Complaint Orchid denies each and every allegation and/or legal conclusion contained in paragraph 110 of the Complaint Orchid denies each and every allegation and/or legal conclusion contained in paragraph 111 of the Complaint. RESPONSE TO PRAYER FOR RELIEF Orchid denies that Teva is entitled to any of the relief that it seeks in the prayer. AFFIRMATIVE DEFENSES Orchid alleges and asserts the following affirmative defenses in response to the allegations in the Complaint: First Affirmative Defense Invalidity of the 446 patent 112. Each claim of the 446 patent is invalid for failure to meet one or more of the requirements of Title 35, United States Code, including, inter alia, 101, 102, 103, 112, and/or for double patenting. Second Affirmative Defense Non-Infringement of the 446 Patent 113. The commercial manufacture, use, offer for sale, sale or importation of the product described in ANDA No does not and will not infringe (either literally or under the doctrine of equivalents, directly or indirectly (either by inducement or contributorily, any valid and enforceable claim of the 446 patent. For this reason, the submission of ANDA No to FDA was not an act of infringement under 35 U.S.C. 271(e. 15

16 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 16 of 36 PageID: 336 Third Affirmative Defense Unenforceability of the 446 Patent 114. The 446 patent is unenforceable due to inequitable conduct before United States Patent and Trademark Office in violation of 35 U.S.C. 282 and 37 C.F.R During prosecution of at least the application leading to United States Patent No. 5,387,612 ( the 612 patent, one or more of the persons responsible for the prosecution (the Applicants including, but not limited to, Clifford M. Davidson, John P. White, Moussa B.H. Youdim and John P.M. Finberg made one or more false and misleading statements to the examiner and/or withheld material prior art In the course of prosecution, the Applicants made the following false and misleading statements to the examiner: [O]n the basis of the above specified properties of the structurally related compounds [methyl AGN 1135] and deprenyl one of ordinary skill in the art would not have been led to believe that it would be advantageous to separate the enantiomers of racemic-[agn 1135] and that this would lead to the finding that one of the enantiomers would most adequately meet the requirement set out in clause 3 above. 612 patent application, Response dated 8/12/92 at p. 11. With regard to the Examiner s statement that it is known to use MAO-B inhibitors for the treatment of Parkinson s disease... none of the references cited [by the Examiner] suggests treating Parkinson s by administering a selective MAO-B inhibitor alone, much less the specific selective MAO-B inhibitor R(+[AGN 1135]. 612 patent application, Response dated 11/29/93 at p. 13. [T]reating Parkinson s disease solely with a MAO-B inhibitor that lacks amphetamine and neurotransmitter-uptake-inhibiting activities, such as R-PAI, would not have been obvious. *** The prior art does not disclose treating Parkinson s disease with MAO-B inhibitors generally, or the specific MAO-B inhibitor R-[AGN 1135], except as an adjunct to L-DOPA therapy. The beneficial effect of deprenyl alone on 16

17 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 17 of 36 PageID: 337 Parkinson s disease would not have made it obvious to treat Parkinson s disease with R-PAI in the absence of L-DOPA because it was not known whether the effect of deprenyl in the absence of L-DOPA is caused by deprenyl s MAO-B inhibitory activity or by properties of deprenyl which R-[AGN 1135] lacks. 612 patent application, Response dated 2/14/94 at pp The foregoing statements were false and/or misleading because they are contradicted by one or more prior art publications authored by one or more of the Applicants. publications: 118. In addition, the Applicants withheld each of the following material prior art Kalir et al., Br. J. Pharmac., 1981, 73, 55. In the Kalir publication, Applicant Moussa B.H. Youdim reported that the IC 50 of AGN 1135 for MAO-B occurs at a 25-times lower concentration than for MAO-A, and the IC 50 of deprenyl for MAO-B occurs at a 16-times lower concentration than for MAO-A. The IC 50 s of AGN 1135 and deprenyl for MAO-B are similar, and AGN 1135 is less inhibitory of MAO-A compared to deprenyl. See Table 1. The Kalir publication also reports that AGN 1135 possesses a tyramine antagonistic effect similar to that described for deprenyl. However, unlike deprenyl, high doses of AGN 1135 do not produce CNS or cardiovascular effects. Finberg et al., Br. J. Pharmac., 1981, 73, 65. In the Finberg publication, Applicants Moussa B.H. Youdim and John P.M. Finberg reported that the selective MAO-B inhibitor (--deprenyl does not potentiate the pressor action of tyramine in man. The mechanism of this effect has largely been attributed to inhibition of neuronal uptake of tyramine. (+-Deprenyl, in contrast, is more potent as an inhibitor of noradrenalin uptake. The Applicants Youdim and Finberg further reported that AGN 1135 produces selective inhibition of MAO-B similar to that produce by deprenyl and possesses a similar tyramine antagonistic effect; that (--deprenyl and AGN 1135 show a similar spectrum of activity against PEA and 5-HT deamination; and that they were determining whether the spectrum of MAO inhibitory activity and tyramine-antagonistic effect shown by AGN 1135 would make it suitable for clinical evaluation. Heikkila et al., Eur. J. Pharmac., 1985, 116, 313. In the Heikkila publication, Applicants Moussa B.H. Youdim and John P.M. Finberg reported that AGN 1135 is approximately 24,000 times more potent as an inhibitor of MAO-B than of MAO-A, and that deprenyl is approximately 6,400 times more potent as an inhibitor of MAO-B than of MAO-A. See Table 1. The Heikkila publication also reports that AGN 1135, like deprenyl, protects against MPTP-induced parkinsonism. Youdim et al., Adv. Neurology, 1986, 45, 127. In the Youdim publication, Applicants Moussa B.H. Youdim and John P.M. Finberg reported that AGN 1135 and L-deprenyl have almost identical properties, and that of the various MAO inhibitors, AGN 1135 appears to be most suitable because of its restricted structural resemblance to L-deprenyl. The Youdim publication indicates that the notion that the 17

18 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 18 of 36 PageID: 338 success of L-deprenyl in the treatment of PD may be related to a unique intrinsic pharmacology of this drug is now not considered to be valid. The Youdim publication reports that the foregoing conclusion is borne out by the fact that a number of other MAO-B inhibitors, including AGN 1135, now have been described that share a similar pharmacology with L-deprenyl. The absence of amphetamine property in these compounds may be related to how much of L- deprenyl s antiparkinson action is related to its sympathomimetic-amphetamine action, even though amphetamine has been shown to be ineffective in parkinsonism The foregoing prior art references were material because they (1 contradict one or more statements made by the Applicants during prosecution; and (2 either alone or in combination establish a prima facie case of unpatentability because, inter alia, they establish that it was obvious to separate the enantiomers of AGN 1135 just as had been done with deprenyl. The withholding of this prior art authored by one or more named inventors constitutes inequitable conduct rendering the patent unenforceable The above discussed omitted prior art also contains teachings that are contrary to the position taken by the Applicants during prosecution. The withheld prior art taught that separation of the enantiomers of deprenyl improved selectivity for MAO-B inhibition, that AGN 1135 had nearly identical properties and was structurally similar to deprenyl, and that like deprenyl, AGN 1135 protects against MPTP-induced parkinsonism. Thus, a person of ordinary skill in the art would have expected that one of the enantiomers of AGN 1135 would be more selective at inhibiting MAO-B and that this selective MAO-B inhibitor would protect against PD when administered as monotherapy, as with L-deprenyl. At a minimum, a reasonable examiner would have wanted to consider these references before allowing the claims Given the high level of materiality of the references, and on information and belief, one or more of the Applicants (1 deliberately concealed the material references with the intent to deceive the examiner; and (2 made false and/or misleading statements to the Patent Office in order to deceive the examiner. 18

19 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 19 of 36 PageID: 339 COUNTERCLAIMS FOR DECLARATORY RELIEF Defendant/Counterclaimant Orchid Chemicals and Pharmaceuticals Ltd. ( Counterclaimant brings the following Counterclaims against Plaintiffs/Counterdefendants Teva Neuroscience, Inc. ( Teva Neuroscience, Teva Pharmaceuticals USA, Inc. ( Teva USA, and Teva Pharmaceutical Industries Ltd. ( Teva Ltd. (collectively, Counterdefendants. The Parties 1. Counterclaimant Orchid Chemicals and Pharmaceuticals Ltd. is a company organized and existing under the laws of India with a principal place of business at Orchid Towers, #313, Valluvar Kottam High Road, Nungambakkam, Chennai , Tamil Nadu, India. 2. On information and belief, Counterdefendant Teva Neuroscience, Inc. ( Teva Neuroscience is a Delaware corporation with a principal place of business at 901 E. 104th Street, Suite 900, Kansas City, Missouri On information and belief, Counterdefendant Teva Pharmaceuticals USA, Inc. ( Teva USA is a Delaware corporation with a principal place of business at 1090 Horsham Road, North Wales, Pennsylvania On information and belief, Counterdefendant Teva Pharmaceuticals Industries Ltd. ( Teva Ltd. is an Israeli company with a principal place of business at 5 Basel Street, Petach Tivka, 49131, Israel. Nature of the Action 5. This is a declaratory judgment action seeking a declaration of patent noninfringement, invalidity, unenforceability and/or patent de-listing of United States Patent Nos. 5,453,446 ( the 446 patent, 5,532,415 ( the 415 patent ; 6,126,968 ( the 968 patent ; and 19

20 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 20 of 36 PageID: 340 7,572,834 ( the 834 patent. The action arises under the Declaratory Judgment Act, 28 U.S.C et seq., the Patent Laws of the United States, 35 U.S.C. 1 et seq.; and 21 U.S.C. 355(j(5(C. Jurisdiction and Venue 6. This Court has jurisdiction over these Counterclaims pursuant to 28 U.S.C. 1331, 1338(a, 2201, and 2202, and the Patent Laws of the United States, 35 U.S.C. 1 et seq.; and 21 U.S.C. 355(j(5(C. 7. This Court has personal jurisdiction over Counterdefendants at least for the reason that Counterdefendants initiated its action alleging infringement of the 446 patent in this Court and thereby consented to jurisdiction. 8. Venue is proper in this Judicial District pursuant to 28 U.S.C. 1391(b-(d and 1400, as well as Counterdefendants choice of forum. 9. Counterdefendants have created an actual controversy between themselves and Orchid through listing the 446 patent, the 415 patent, the 968 patent, and the 834 patent in the Orange Book, as well as by virtue of allegations that Orchid s submission of ANDA No to FDA constituted an act of infringement under 35 U.S.C. 271(e with regard to one or more claims of the 446 patent. The Patents and Related Drug Product 10. Pursuant to 21 U.S.C. 355(j, the Federal Food, Drug and Cosmetic Act ( FDCA authorizes a generic drug company to file an ANDA with FDA for approval of a generic drug product that has the same active ingredient as, and is bioequivalent to, a drug product that FDA has already approved pursuant to a New Drug Application ( NDA. 11. Pursuant to 21 U.S.C. 355(b, the FDCA requires NDA holders to submit to 20

21 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 21 of 36 PageID: 341 FDA the patent numbers and expiration dates of any patent that claims the drug or a method of using the drug for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture use, or sale of this drug. FDA then lists those patents in The Orange Book. 12. Pursuant to 21 U.S.C. 355(j(2(A(vii(IV, if a drug company seeks approval to market a generic drug product prior to the expiration of a patent listed in the Orange Book, the drug company is required by law to include a certification in its ANDA that the patent is invalid, unenforceable, or will not be infringed by the generic drug product ( Paragraph IV Certification. 13. Pursuant to 21 U.S.C. 355(j(2(B, if a drug company includes a Paragraph IV Certification in its ANDA, the drug company must send the NDA holder and the patent owner notice of that certification, including a detailed statement of the factual and legal basis for the generic drug company s opinion that the patent is invalid, unenforceable or will not be infringed ( Notice Letter. 14. Pursuant to 21 U.S.C. 355(j(5(B(iii, if a suit for patent infringement is brought within 45 days of receiving the Notice Letter, FDA generally may not grant final approval for the drug company s ANDA for 30 months or until resolution of the patent infringement action. 15. On information and belief, Teva is the current holder of a NDA No ( NDA for Azilect tablets (.5 mg and 1 mg which contain the active ingredient rasagiline mesylate and are used for the treatment of the signs and symptoms of idiopathic Parkinson s disease as initial monotherapy and as adjunct therapy to levodopa. 16. On information and belief, Teva is the owner of the 446 patent, the 415 patent, 21

22 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 22 of 36 PageID: 342 the 968 patent, the 834 patent, and United States Patent Nos. 5,387,612 ( the 612 patent, 5,457,133 ( the 133 patent, and 5,786,390 ( the 390 patent. A copy of the 446 patent is attached as Exhibit A to the Teva Complaint. Copies of the 415 patent, the 968 patent, the 834 patent, the 612 patent, the 133 patent, and the 390 patent are attached to this Answer and Counterclaim as Exhibits A, B, C, D, E, and F. 17. On information and belief, in connection with its NDA for rasagiline mesylate, Teva caused seven patents to be listed in the Orange Book: the 612 patent; the 446 patent; the 133 patent; the 415 patent; the 390 patent; the 968 patent; and the 834 patent. 18. On May 15, 2010, Orchid filed ANDA No with FDA seeking approval to engage in the commercial manufacture, use, importation, offer for sale, and/or sale of the rasagiline mesylate tablet product described in its ANDA prior to the expiration of the 612 patent, the 446 patent, the 133 patent, the 415 patent, the 390 patent, the 968 patent, and the 834 patent. Orchid included in ANDA No a Paragraph IV Certification stating that, in the opinion of Orchid, and to the best of its knowledge, the 612 patent, the 446 patent, the 133 patent, the 415 patent, the 390 patent, the 968 patent, and the 834 patent are invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, importation, offer for sale, or sale of the rasagiline mesylate tablet product described in its ANDA. 19. By letter dated August 18, 2010, Orchid Healthcare sent Counterdefendants Teva Neuroscience and Teva Ltd. a Notice Letter, in accordance with 35 U.S.C. 355(j(2(B(i and (ii, that included a detailed statement of the factual and legal basis for Orchid Healthcare s opinion that its rasagiline mesylate ANDA product would not infringe any valid and enforceable claim of the 612 patent, the 446 patent, the 133 patent, the 415 patent, the 390 patent, the 968 patent, or the 834 patent. Pursuant to 21 U.S.C. 355(j(5(C, the Notice Letter was 22

23 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 23 of 36 PageID: 343 accompanied by an Offer of Confidential Access to ANDA No On or about August 20, 2010, Counterdefendants received the Notice Letter. 20. On or about October 1, 2010, Counterdefendants filed a Complaint in the District of New Jersey against Orchid Chemicals and Pharmaceuticals Ltd., Orchid Healthcare, a division of Orchid Chemicals & Pharmaceuticals Ltd., and Orgenus Pharma Inc. alleging infringement of the 446 patent. 21. Counterdefendants assertion against Orchid of claims of infringement of the 446 patent after being advised by Orchid Healthcare in its Notice Letter that there is no basis for those claims renders Orchid Chemicals and Pharmaceuticals Ltd. s case exceptional within the meaning of 35 U.S.C Orchid Chemicals and Pharmaceuticals Ltd. has no adequate remedy at law. The actions and assertions made by Counterdefendants with respect to the 446 patent have caused and will continue to cause irreparable injury to the rights of Orchid. 23. In the October 1, 2010 Teva Complaint, Counterdefendants did not assert the 612 patent, the 133 patent, the 415 patent, the 390 patent, the 968 patent, and the 834 patent (collectively, the unasserted patents. Because the 415 patent, the 968 patent, and the 834 patent are listed in the Orange Book for rasagiline mesylate, Teva s failure to initiate litigation concerning these three patents has created a clear and substantial risk of impairing Orchid Chemicals and Pharmaceuticals Ltd. s ability to bring its generic form of rasagiline mesylate to market in a timely fashion. Orchid Chemicals and Pharmaceuticals Ltd. thus seeks a declaratory judgment of non-infringement, invalidity, and/or unenforceability of the 415 patent, the 968 patent, and the 834 patent. 24. Under 35 U.S.C. 271(e(2(A, Orchid Healthcare s submission of the 23

24 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 24 of 36 PageID: 344 Paragraph IV certification to FDA constitutes an artificial, purely notional act of patent infringement for subject matter jurisdiction purposes for each of the patents listed in the Orange Book. Further, 35 U.S.C. 271(e(5 specifically provides that the Court shall have subject matter jurisdiction under section 2201 of Title 28 for a declaratory judgment that an unasserted Orange Book patent is invalid or not infringed. 25. Because Counterdefendants filed the Teva Complaint alleging that Orchid infringed the 446 patent, Counterdefendants have demonstrated their intent to enforce their patents concerning rasagiline mesylate. 26. Counterdefendants have never disavowed, in the Teva Complaint or elsewhere, an intent to assert that Orchid s submission of its ANDA No constituted an act of infringement of one or more claims of the 612 patent, the 133 patent, the 415 patent, the 390 patent, the 968 patent, or the 834 patent. 27. Orchid has made, and will continue to make, substantial preparation in the United States to manufacture, sell, and offer to sell, Orchid s rasagiline mesylate tablets. 28. Because Counterdefendants caused FDA to list the 612 patent, the 133 patent, the 415 patent, the 390 patent, the 968 patent, and the 834 patent in the Orange Book but failed to assert those patents in the Teva Complaint, even though the 612 patent, the 133 patent, the 415 patent, the 390 patent, the 968 patent, and the 834 patent purport to cover the same technology and share substantial content with the 446 patent, Orchid has a reasonable apprehension that Counterdefendants will sue Orchid for infringement of the 415 patent, the 968 patent, and the 834 patent. 29. An actual and justiciable controversy exists between the parties as to the infringement, invalidity, and/or unenforceability of the 415 patent, the 968 patent, and the

25 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 25 of 36 PageID: 345 patent. 30. To avoid legal uncertainty and to protect its substantial investment (and anticipated future investment in Orchid Healthcare s rasagiline mesylate tablets, Orchid Chemicals and Pharmaceuticals Ltd. has brought these declaratory judgment claims against the 446 patent, the 415 patent, the 968 patent, and the 834 patent. Prosecution of Teva s Patents 31. On or about December 21, 1990, Moussa B.H. Youdim, John P. Finberg, Ruth Levy, Jeffrey Sterling, David Lerner, Tirtsah Berger-Paskin, and Haim Yellin (collectively, the Applicants filed patent application No. 07/632,184 that disclosed a compound, composition, method of manufacture, and method of use of rasagiline mesylate ( the 184 application. The 184 application claimed priority to Israel application No The Applicants abandoned the 184 application in favor of U.S. continuation application No. 08/063,455 (the 455 application, filed on or about May 18, The 455 application claimed priority to the 184 application and disclosed a method of treating Parkinson s Disease with rasagiline both by itself or combined with L-DOPA and/or decarboxylase inhibitors. The 455 application issued as the 612 patent on or about February 7, In addition to the 455 application, on or about May 18, 1993, the Applicants also filed U.S. continuation application No. 08/063,461 ( the 461 application which is a continuation of the 184 application and is directed to rasagiline, a composition comprising rasagiline and decarboxylase inhibitors, and a composition comprising rasagiline and L-DOPA. 34. The Applicants abandoned the 461 application in favor of U.S. continuation application No. 08/198,205 ( the 205 application filed on or about February 17, The 25

26 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 26 of 36 PageID: application is directed to pharmaceutical compositions containing rasagiline, and issued as the 133 patent on or about October 10, On or about June 7, 1994 the Applicants filed U.S. continuation application No. 08/255,046 ( the 046 application which is a continuation of the 455 application and is directed to a method of treating Parkinson s Disease with the combination of rasagiline and decarboxylase inhibitors. The 046 application issued as the 446 patent on September 26, On or about October 18, 1993 the Applicants filed U.S. continuation-in-part application No. 08/139,517 ( the 517 application which is a continuation-in-part of the 455 application, and it disclosed rasagiline and its pharmaceutically acceptable salts. The Applicants abandoned the 517 application in favor of U.S. continuation application No. 08/411,398 ( the 398 application, which was filed on or about March 28, The 398 application, a continuation of the 517 application and directed to mesylate salt of R-(+-AGN 1135, issued as the 415 patent on July 2, Application No. 08/470,161 ( the 161 application was filed on June 6, 1995 as a divisional application of the 398 application and is directed to a pharmaceutical composition of R-(+-N-propargyl-1-aminoindan and pharmaceutically acceptable salts thereof. The 161 application claims priority to the 184 application, and issued as the 390 patent on July 28, Application No. 09/043,475 ( the 475 application was filed September 18, 1996 and claims priority to Israel application No. 115,357 ( Israel 357 application, filed September 20, The 475 application is directed to a pharmaceutical composition comprising as active ingredient a racemic S-(-, and R-(+-N-propargyl-1-aminoindan or a pharmaceutically acceptable salt thereof, and at least one pentahydric or hexahydric alcohol, or, 26

27 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 27 of 36 PageID: 347 optionally, citric acid and magnesium stearate. The 475 application issued as the 968 patent on October 3, Application No. 11/634,916 ( the 916 application was filed December 5, 2006 and claims the benefit of the provisional application No. 60/742,823 ( the 823 application filed December 6, The 916 application is directed to pharmaceutical compositions of R- (+-AGN 1135 and processes of preparing compositions of R-(+-AGN 1135 mesylate. The 916 application thereafter issued as the 834 patent on August 11, Teva s Misrepresentations During Prosecution of the Patent 455 Application And Failure To Correct Those Misrepresentations During Prosecution Of The 046 Application 41. On information and belief, on or about August 12, 1992, during prosecution of the 455 application (the first application in the patent family to which the 446 patent, the 612 patent, the 133 patent, the 415 patent, and the 390 patent belong, the Applicants (including Clifford M. Davidson, John P. White, Moussa B.H. Youdim and John P.M. Finberg represented to the United States Patent and Trademark Office patent examiner: [O]n the basis of the above specified properties of the structurally related compounds [methyl AGN 1135] and deprenyl one of ordinary skill in the art would not have been led to believe that it would be advantageous to separate the enantiomers of racemic [AGN 1135] and that this would lead to the finding that one of the enantiomers would most adequately meet the requirement set out in clause 3 above. 42. On information and belief, on or about November 29, 1993, the Applicants (including Clifford M. Davidson, John P. White, Moussa B.H. Youdim and John P.M. Finberg also represented to the examiner that [w]ith regard to the Examiner s statement that it is known to use MAO-B inhibitors for the treatment of Parkinson s Disease none of the references cited by [the Examiner] suggests treating Parkinson s by administering a selective MAO-B inhibitor alone, much less the specific selective MAO-B inhibitor [rasagiline]. 43. On information and belief, on or about February 10, 1994, the examiner and two 27

28 Case 2:10-cv JLL -CCC Document 38 Filed 12/03/10 Page 28 of 36 PageID: 348 of the Applicants (Messrs. Kreisler and Chan participated in a telephone interview where they represented to the examiner that they were aware of no reference indicating that MAO-B inhibitors are useful for treating [Parkinson s Disease]. 44. On information and belief, on or about February 14, 1994, the Applicants (including Clifford M. Davidson, John P. White, Moussa B.H. Youdim and John P.M. Finberg represented to the examiner that treating Parkinson s disease solely with a MAO-B inhibitor that lacks amphetamine and neurotransmitter-uptake-inhibiting activities, such as [rasagiline], would not have been obvious. *** The prior art does not disclose treating Parkinson s disease with MAO-B inhibitors generally, or the specific MAO-B inhibitor [rasagiline], except as an adjunct to L-DOPA therapy. The beneficial effect of deprenyl [a MAO-B inhibitor] alone on Parkinson s disease would not have made it obvious to treat Parkinson s disease with [rasagiline] in the absence of L-DOPA because it was known whether the effect of deprenyl in the absence of L-DOPA is caused by deprenyl s MAO-B inhibitory activity or by properties of deprenyl which [rasagiline] lacks. 45. On information and belief, the Applicants February 14, 1994 communication with the examiner was the last communication before the examiner allowed the claims of the 446 patent to issue on or about March 8, On information and belief, prior to 1990 the priority date for Israel Application No to which the 455 application claims priority Applicants Moussa B.H. Youdim and John P.M. Finberg published numerous articles in scientific journals which contradict (or at least bear upon the veracity of the representations they made to the examiner during prosecution of the 455 application. 47. On information and belief, in or about 1981, Applicant Youdim published an article in the British Journal of Pharmacology in which he reported that a compound containing rasagiline, racemic AGN 1135, was a specific inhibitor of MAO-B and exhibited properties 28