Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 1 of 28 WINSTON & STRAWN LLP The Legal Center One Riverfront Plaza, 7th Floor Newark, New Jersey 07102 (973) 848-7676 James S. Richter Attorneys for Defendants Sun Pharma Global Inc., Sun Pharmaceutical Industries Inc., and Sun Pharmaceutical Industries Ltd. UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY x : SEPRACOR INC., : : Plaintiff, : : v. : : : TEVA PHARMACEUTICALS USA, INC., : TEVA PHARMACEUTICAL INDUSTRIES, : LTD., WOCKHARDT LTD., WOCKHARDT : USA, INC., DR. REDDY S LABORATORIES, : LTD., DR.REDDY S LABORATORIES, INC., : ROXANE LABORATORIES, INC., COBALT : LABORATORIES INC., COBALT : PHARMACEUTICALS INC., GLENMARK : GENERICS INC., USA, GLENMARK : GENERICS, LTD., GLENMARK : PHARMACEUTICALS, LTD., ORCHID : HEALTHCARE (a Division of ORCHID : CHEMICALS & PHARMACEUTICALS, : LTD.), ORCHID CHEMICALS & : PHARMACEUTICALS, LTD., ORGENUS : PHARMA INC., LUPIN : PHARMACEUTICALS, INC., LUPIN LTD., : SUN PHARMA GLOBAL INC., SUN : PHARMACEUTICAL INDUSTRIES INC., : SUN PHARMACEUTICAL INDUSTRIES : LTD., ALPHAPHARM PTY. LTD. and : MYLAN, INC., : : Defendants. : x Honorable Dennis M. Cavanaugh, U.S.D.J. Civil Action No. 09 CV 1302 (DMC)(MF) ANSWER, AFFIRMATIVE DEFENSES, AND COUNTERCLAIMS OF DEFENDANTS SUN PHARMA GLOBAL INC., SUN PHARMACEUTICAL INDUSTRIES INC., AND SUN PHARMACEUTICAL INDUSTRIES LTD. Electronically Filed
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 2 of 28 Defendants Sun Pharma Global Inc., Sun Pharmaceutical Industries Inc., and Sun Pharmaceutical Industries Ltd. (collectively Sun ), by and through their attorneys, answer the Complaint of Plaintiff Sepracor Inc. ( Sepracor ) as follows: AS TO THE PARTIES Answer to 1.A. Sun lacks knowledge or information sufficient to form a belief as to the truth of the allegations in this paragraph and on that basis denies them. Answer to 1.B 1.Y. Paragraphs 1.B. 1.Y. do not apply to Sun. Answer to 1.Z. Sun admits that Sun Pharma Global Inc. ( Sun Global ) is a corporation organized under the laws of the British Virgin Islands and that it maintains a post office box at International Trust Building, P.O. Box No. 659, Road Town, Tortola, British Virgin Islands. Sun admits that Sun Global appointed John L. Dauer Jr. as its agent for service of process in New Jersey in connection with ANDA No. 91-103. Sun further admits that Sun Global is a wholly owned subsidiary of Sun India Sun also admits that Sun Global has consented to personal jurisdiction in New Jersey for specific prior actions in this Court. The remaining allegations in Paragraph 1Z contain legal conclusions to which no answer is required. To the extent an answer it required, Sun denies those remaining allegations. Answer to 1.AA. Sun admits that Sun Pharmaceutical Industries Inc. ( Sun USA ) is a corporation organized and existing under the laws of the State of Michigan, with headquarters at 29714 Orion Ct., Farmington Hills, MI 48334, and that it leases a manufacturing facility at 270 Prospect Plains Rd., Cranbury, New Jersey 08512. Sun also admits that Sun USA, is a whollyowned subsidiary of Sun India. Sun also admits that John L. Dauer Jr. is an employee of Sun USA. Sun also admits that Sun USA is registered to do business in New Jersey and does business in this judicial district. Sun also admits that Sun USA has consented to personal 2
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 3 of 28 jurisdiction in New Jersey for specific prior actions in this Court. Sun denies the remaining allegations in Paragraph 1.AA and specifically denies that Dr. Ratnesh Shrivastava and Dr. Bharati Nadkarni are employees of Sun USA. Answer to 1.BB. Sun admits that Sun Pharmaceutical Industries Ltd. ( Sun India ) is an Indian corporation having a place of business at Acme Plaza, Andheri Kurla Road, Andheri (East), Mumbai 400 059, India. Sun further admits that Sun India is in the business of, among other things, manufacturing, marketing, importing and selling pharmaceutical drug products, including generic drug products. Sun admits that Sun India has consented to personal jurisdiction in New Jersey for specific prior actions in this Court. Answer to 1.CC. Admitted. Answer to 1.DD 1.FF. Paragraphs 1DD. 1.FF. do not apply to Sun. AS TO THE NATURE OF THE ACTION Answer to 2. Paragraph 2 contains legal conclusions to which no answer is required. To the extent an answer is required, Sun admits that Sepracor s Complaint purports to allege infringement of the 257, 926, 673 and 463 patents under the Patent Laws of the United States. Sun specifically denies that Sepracor is entitled to any relief pursuant to its Complaint. AS TO JURISDICTION AND VENUE Answer to 3. Paragraph 3 contains legal conclusions to which no answer is required. To the extent an answer is required, Sun admits that this Court has subject matter jurisdiction over Sepracor s infringement claims and further admits that venue is proper in the District of New Jersey. 3
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 4 of 28 Answer to 4. Paragraph 4 contains legal conclusions to which no answer is required. To the extent an answer is required, Sun consents to this Court s personal jurisdiction for purposes of the present litigation only. Answer to 5-21. Paragraphs 5-21 do not apply to Sun. Answer to 22. Paragraph 22 contains legal conclusions to which no answer is required. To the extent an answer is required, Sun denies the allegations of paragraph 22, but consents to this Court s personal jurisdiction over Sun Global for the purposes of this litigation only. Answer to 23. Paragraph 23 contains legal conclusions to which no answer is required. To the extent an answer is required, Sun admits that the Court has personal jurisdiction over Sun USA. Answer to 24. Paragraph 24 contains legal conclusions to which no answer is required. To the extent an answer is required, Sun India denies that it is subject to personal jurisdiction in New Jersey. Sun India has no presence in New Jersey and no systematic and continuous contacts with New Jersey. However, Sun consents to this Court s personal jurisdiction over Sun India for the purposes of this litigation only. Answer to 25-26. Paragraphs 25-26 do not apply to Sun. AS TO THE PATENTS Answer to 27. Sun admits that the 257 patent, titled Optically Active 5H-Pyrrolo [3,4-B] Pyrazine Derivative, Its Preparation and Pharmaceutical Compositions Containing It, was issued on March 8, 2005, to Sepracor as assignee. Sun further admits that the 257 patent is attached to the Complaint as Exhibit A. Sun denies that the 257 patent was duly and legally issued. Sun is without information sufficient to form a belief as to the truth or falsity of the remaining allegations of Paragraph 27, and therefore denies them. 4
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 5 of 28 Answer to 28. Sun admits that the 673 patent, titled Optically Active 5H-Pyrrolo [3,4-B] Pyrazine Derivative, Its Preparation and Pharmaceutical Compositions Containing It, was issued on September 3, 2002, to Sepracor as assignee. Sun further admits that the 673 patent is attached to the Complaint as Exhibit B. Sun denies that the 673 patent was duly and legally issued. Sun is without information sufficient to form a belief as to the truth or falsity of the remaining allegations of Paragraph 28, and therefore denies them. Answer to 29. Sun admits that the 926 patent, titled Optically Active 5H-Pyrrolo [3,4-B] Pyrazine Derivative, Its Preparation and Pharmaceutical Compositions Containing It, was issued on November 20, 2001, to Sepracor as assignee. Sun further admits that the 926 patent is attached to the Complaint as Exhibit C. Sun denies that the 926 patent was duly and legally issued. Sun is without information sufficient to form a belief as to the truth or falsity of the remaining allegations of Paragraph 29, and therefore denies them. Answer to 30. Sun admits that the 724 patent, titled Optically Active 5H-Pyrrolo [3,4-B] Pyrazine Derivative, Its Preparation and Pharmaceutical Compositions Containing Same, was issued on June 3, 2008, to Sepracor as assignee. Sun further admits that the 724 patent is attached to the Complaint as Exhibit D. Sun denies that the 724 patent was duly and legally issued. Sun is without information sufficient to form a belief as to the truth or falsity of the remaining allegations of Paragraph 30, and therefore denies them. AS TO COUNTS I VII Answer to 31-92. Counts I - VII and associated Paragraphs 31-92 do not apply to Sun. AS TO COUNT VIII Answer to 93. Sun realleges and reiterates its responses to Paragraphs 1-92 as if set forth fully herein. 5
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 6 of 28 Answer to 94. Sun admits the allegations of Paragraph 94. Answer to 95. Sun admits that ANDA No. 91-103 certified to the FDA that the claims of the 257 patent are either invalid or not infringed by the manufacture, use, sale, offer for sale, or importation of Sun s proposed drug product. Sun further admits that Sepracor received notice of the ANDA and its certification on February 25, 2009. Answer to 96. Sun admits that filing an ANDA containing a paragraph IV certification to an Orange Book listed patent is a technical act of infringement of the 257 patent under 35 U.S.C. 271(e), thus vesting this Court with subject matter jurisdiction. Sun denies the remaining allegations of Paragraph 96, including any implications that the 257 patent is valid and/or enforceable. Answer to 97. The allegations of Paragraph 97 state legal conclusions to which no answer is required. To the degree an answer is deemed to be required, Sun denies the allegations of Paragraph 97. Answer to 98. The allegations of Paragraph 98 state legal conclusions to which no answer is required. To the degree an answer is deemed to be required, Sun denies the allegations of Paragraph 98. Answer to 99. Sun admits the allegations of Paragraph 99. Answer to 100. Sun denies the allegations of Paragraph 100. Answer to 101. Sun denies the allegations of Paragraph 101 and specifically denies that Sepracor is entitled to any relief from its Complaint. AS TO COUNT IX Answer to 102-110. Count IX and associated Paragraphs 102-110 do not apply to Sun. 6
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 7 of 28 AS TO COUNTS X - XVI Answer to 111-172. Counts X - XVI and associated Paragraphs 111-172 do not apply to Sun. AS TO COUNT XVII Answer to 173. Sun realleges and reiterates its responses to Paragraphs 1-172 as if set forth fully herein. Answer to 174. Sun admits the allegations of Paragraph 174. Answer to 175. Sun admits that ANDA No. 91-103 certified to the FDA that the claims of the 673 patent are either invalid or not infringed by the manufacture, use, sale, offer for sale, or importation of Sun s proposed drug product. Sun further admits that Sepracor received notice of the ANDA and its certification on February 25, 2009. Answer to 176. Sun admits that filing an ANDA containing a paragraph IV certification to an Orange Book listed patent is a technical act of infringement of the 673 patent under 35 U.S.C. 271(e) thus vesting this Court with subject matter jurisdiction. Sun denies the remaining allegations of Paragraph 176, including any implications that the 673 patent is valid and/or enforceable. Answer to 177. The allegations of Paragraph 177 state legal conclusions to which no answer is required. To the degree an answer is deemed to be required, Sun denies the allegations of Paragraph 177. Answer to 178. The allegations of Paragraph 178 state legal conclusions to which no answer is required. To the degree an answer is deemed to be required, Sun denies the allegations of Paragraph 178. Answer to 179. Sun admits the allegations of Paragraph 179. 7
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 8 of 28 Answer to 180. Sun denies the allegations of Paragraph 180. Answer to 181. Sun denies the allegations of Paragraph 181 and specifically denies that Sepracor is entitled to any relief from its Complaint. AS TO COUNT XVIII Answer to 183-190. Count XVIII and associated Paragraphs 183-190 do not apply to Sun. AS TO COUNTS XIX XXIV Answer to 191-243. Counts XIX XXIV and associated Paragraphs 191-243 do not apply to Sun. AS TO COUNT XXV Answer to 244. Sun realleges and reiterates its responses to Paragraphs 1-243 as if set forth fully herein. Answer to 245. Sun admits the allegations of Paragraph 245. Answer to 246. Sun admits that ANDA No. 91-103 certified to the FDA that the claims of the 926 patent are either invalid or not infringed by the manufacture, use, sale, offer for sale, or importation of Sun s proposed drug product. Sun further admits that Sepracor received notice of the ANDA and its certification on February 25, 2009. Answer to 247. Sun admits that filing an ANDA containing a paragraph IV certification to an Orange Book listed patent is a technical act of infringement of the 926 patent under 35 U.S.C. 271(e), thus vesting this Court with subject matter jurisdiction. Sun denies the remaining allegations of Paragraph 176, including any implications that the 926 patent is valid and/or enforceable. 8
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 9 of 28 Answer to 248. The allegations of Paragraph 248 state legal conclusions to which no answer is required. To the degree an answer is deemed to be required, Sun denies the allegations of Paragraph 248. Answer to 249. The allegations of Paragraph 249 state legal conclusions to which no answer is required. To the degree an answer is deemed to be required, Sun denies the allegations of Paragraph 249. Answer to 250. Sun admits the allegations of Paragraph 250. Answer to 251. Sun denies the allegations of Paragraph 251. Answer to 252. Sun denies the allegations of Paragraph 252 and expressly denies that Sepracor is entitled to any relief from its Complaint. AS TO COUNT XXVI Answer to 253-261. Count XXVI and associated Paragraphs 253-261 do not apply to Sun. AS TO COUNTS XXVII XXXII Answer to 262-313. Counts XXVII XXXII and associated Paragraphs 262-313 do not apply to Sun. AS TO COUNT XXXIII Answer to 314. Sun realleges and reiterates its responses to Paragraphs 1-313 as if set forth fully herein. Answer to 315. Sun admits the allegations of Paragraph 315. Answer to 316. Sun admits that ANDA No. 91-103 certified to the FDA that the claims of the 724 patent are either invalid or not infringed by the manufacture, use, sale, offer for sale, 9
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 10 of 28 or importation of Sun s proposed drug product. Sun further admits that Sepracor received notice of the ANDA and its certification on February 25, 2009. Answer to 317. Sun admits that filing an ANDA containing a paragraph IV certification to an Orange Book listed patent is a technical act of infringement of the 724 patent under 35 U.S.C. 271(e), thus vesting this Court with subject matter jurisdiction. Sun denies the remaining allegations of Paragraph 317, including any implications that the 724 patent is valid and/or enforceable. Answer to 318. The allegations of Paragraph 318 state legal conclusions to which no answer is required. To the degree an answer is deemed to be required, Sun denies the allegations of Paragraph 318. Answer to 319. The allegations of Paragraph 319 state legal conclusions to which no answer is required. To the degree an answer is deemed to be required, Sun denies the allegations of Paragraph 319. Answer to 320. Sun admits the allegations of Paragraph 320. Answer to 321. Sun denies the allegations of Paragraph 321. Answer to 322. Sun denies the allegations of Paragraph 322 and expressly denies that Sepracor is entitled to any relief from its Complaint. AS TO COUNT XXXIV Answer to 323-331. Count XXXIV and associated Paragraphs 323-331 do not apply to Sun. AS TO PLAINTIFF S PRAYER FOR RELIEF Sun denies that Sepracor is entitled to the relief requested. 10
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 11 of 28 AFFIRMATIVE DEFENSES Further answering the Complaint, Sun asserts the following defenses in response to the allegations in the Complaint, undertaking the burden of proof only as to those defenses required by law, regardless of how such defenses are denominated below. Sun reserves the right to amend the Answers with additional defenses as further information is obtained. First Defense Non-Infringement of the 257 Patent The manufacture, use, sale, offer for sale, or importation of the proposed products that are the subject of Sun s ANDA No. 91-103 would not infringe any valid and enforceable claim of the 257 patent. Second Defense Invalidity of the 257 Patent The claims of the 257 patent are invalid under one or more provisions of 35 U.S.C. 101, 102, 103 and/or 112. Third Defense Non-Infringement of the 673 Patent The manufacture, use, sale, offer for sale, or importation of the proposed products that are the subject of Sun s ANDA No. 91-103 would not infringe any valid and enforceable claim of the 673 patent. Fourth Defense Invalidity of the 673 Patent The claims of the 673 patent are invalid under one or more provisions of 35 U.S.C. 101, 102, 103 and/or 112. 11
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 12 of 28 Fifth Defense Non-Infringement of the 926 Patent The manufacture, use, sale, offer for sale, or importation of the proposed products that are the subject of Sun s ANDA No. 91-103 would not infringe any valid and enforceable claim of the 926 patent. Sixth Defense Invalidity of the 926 Patent The claims of the 926 patent are invalid under one or more provisions of 35 U.S.C. 101, 102, 103 and/or 112. Seventh Defense Non-Infringement of the 724 Patent The manufacture, use, sale, offer for sale, or importation of the proposed products that are the subject of Sun s ANDA No. 91-103 would not infringe any valid and enforceable claim of the 724 patent. Eighth Defense Invalidity of the 724 Patent The claims of the 724 patent are invalid under one or more provisions of 35 U.S.C. 101, 102, 103 and/or 112. Ninth Defense Additional Defenses Any additional defenses or counterclaims that discovery may reveal. COUNTERCLAIMS FOR DECLARATORY JUDGMENT For its counterclaims against Counterdefendant Sepracor Inc. ( Sepracor ), Counterplaintiff Sun Pharma Global Inc. ( Sun Global ) alleges as follows: 12
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 13 of 28 1. This is an action arising under the Declaratory Judgment Act, 28 U.S.C. 2201 and 2202, and the United States Patent Act, 35 U.S.C. 1 et seq. Sun Global seeks a declaratory judgment to settle an actual controversy between the parties to this action as to the validity, infringement, and enforceability of U.S. Patents Nos. 6,864,257 ( the 257 patent ), 6,444,673 ( the 673 patent ), 6,319,926 ( the 926 patent ), and 7,381,724 ( the 724 patent ) (collectively, the patents in suit ). PARTIES 2. On information and belief, and according to its Complaint filed in this action, Sepracor is a Delaware corporation having its principal place of business at 84 Waterford Drive, Marlborough, Massachusetts. 3. Sun Global is a corporation organized and existing under the laws of the British Virgin Islands and maintains a post office box at International Trust Building, P.O. Box No. 659, Road Town, Tortola, British Virgin Islands. JURISDICTION AND VENUE 4. This Court has jurisdiction over the subject matter of these counterclaims under 28 U.S.C. 1331, 2201 and 2202. 5. Personal jurisdiction over Sepracor is proper because it has voluntarily submitted to the jurisdiction of this Court by filing its Complaint For Patent Infringement in this Court. 6. Venue is proper under 28 U.S.C. 1391 and 1400. BACKGROUND A. FDA Approval of New Brand-Name Drugs 7. The Food, Drug, and Cosmetic Act ( FDCA ), 21 U.S.C. 301 et seq., as amended by the Hatch-Waxman Amendments, sets forth the rules that the Food and Drug 13
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 14 of 28 Administration ( FDA ) follows when considering whether to approve both brand-name and generic drugs. 8. Under the Hatch-Waxman Amendments, an applicant seeking to market a new brand-name drug must prepare a New Drug Application ( NDA ) for consideration by FDA. See 21 U.S.C. 355. 9. An NDA must include, among other things, the number of any patent that claims the drug or a method of using [the] drug for which the NDA was submitted and for which a claim of patent infringement could reasonably be asserted against an unauthorized party. See 21 U.S.C. 355(b)(1) and (c)(2); 21 C.F.R. 314.53(b) and (c)(2). 10. Upon approval of the NDA, the FDA publishes patent information for the approved drug in Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. See 21 U.S.C. 355(j)(7)(A)(iii). B. Generic Competition Abbreviated New Drug Applications ( ANDAs ) 11. Generic drugs are versions of brand-name prescription drugs that typically contain the same active ingredients, but not necessarily the same inactive ingredients as the brand-name original. 12. Before 1984, a company that wished to make a generic version of an FDAapproved drug had to file an application containing new studies showing the already-approved drug s safety and effectiveness. Preparing such an application was as time-consuming and costly as the original NDA. 13. In 1984, however, Congress enacted the Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Amendments. See Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified at 21 U.S.C. 355 and 35 U.S.C. 156 and 271(e)). Congress 14
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 15 of 28 passed the Hatch-Waxman Amendments, which simplified the procedure for obtaining approval of generic drugs, for the purpose of decreasing the cost of pharmaceuticals through increased competition. Under the Hatch-Waxman Amendments, a generic manufacturer submits what is called an Abbreviated New Drug Application ( ANDA ). 14. To receive approval of its ANDA, an applicant must show that its generic drug is bioequivalent to the listed reference drug. See 21 U.S.C. 355(j)(4)(F). 15. When filing an ANDA seeking approval of a generic version of a drug listed in the Orange Book, the ANDA applicant must also certify that any patent information listed in the Orange Book does not preclude FDA approval of the ANDA applicant s generic version of the drug. See 21 U.S.C. 355(j)(2)(A)(vii); 21 C.F.R. 314.94(a)(12). 16. A so-called paragraph IV certification asserts that the listed patent is invalid, unenforceable, and/or will not be infringed and, on that basis, seeks FDA approval of the generic product prior to patent expiration. See 21 U.S.C. 355(j)(2)(A)(vii)(IV). 17. An applicant submitting an ANDA containing a paragraph IV certification must notify both the patent holder and NDA holder of its paragraph IV certification. See 21 U.S.C. 355(j)(2)(B)(i). 18. Upon receiving notice of the paragraph IV certification, the patent holder has 45 days in which to file an infringement suit against the generic manufacturer. See 21 U.S.C. 355(j)(5)(B)(iii); 35 U.S.C. 271(e)(2)(A). 19. Patent holders have a significant strategic incentive to file suit because doing so, regardless of merit, prevents the FDA from approving the generic maker s ANDA for a period of 30 months. See 21 U.S.C. 355(j)(5)(B)(iii). 15
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 16 of 28 20. If the court hearing the infringement action decides the patent is valid, enforceable, and would be infringed by the product proposed in the ANDA, the FDA will not approve the ANDA until the patent expires. See 21 U.S.C. 355(j)(5)(B)(iii). If, however, the court hearing the infringement action rules before the expiration of the 30-month period that the patent is invalid, unenforceable, and/or not infringed, the FDA may approve the ANDA. Id. C. Sun Global s Eszopiclone ANDA. 21. Sun Global filed an ANDA (No. 91-103) with the FDA seeking approval to manufacture, use, and sell generic tablets containing 1 mg, 2 mg, or 3 mg of the active ingredient eszopiclone prior to the expiration of the patents-in-suit. The ANDA shows that Sun Global s eszopiclone tablets are bioequivalent to the eszopiclone tablets that are the subject of the patents in suit. 22. Because Sun Global seeks FDA approval to market its generic eszopiclone tablets before expiration of the patents in suit that Sepracor listed in the Orange Book, Sun Global s ANDA includes paragraph IV certifications to all four patents in suit. D. The 257 Patent 23. The 257 patent was issued on March 8, 2005, to Cotrel and assigned to Sepracor. On information and belief, Sepracor is the current owner of the 257 patent, which is scheduled to expire no later than August 30, 2012. 24. Sepracor listed the 257 patent in the Orange Book in connection with NDA No. 021476. 25. To have the 257 patent listed in the Orange Book, the law required Sepracor to certify to the FDA, under oath, that the 257 patent claims the drug eszopiclone or a method 16
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 17 of 28 of using eszopiclone and is a patent for which a claim of patent infringement could reasonably be asserted against an authorized party. 26. By bringing suit against Sun Global, Sepracor has taken active steps to block Sun Global s attempt to launch a generic 1 mg, 2 mg, or 3 mg eszopiclone tablet. 27. The claims of the 257 patent are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale, offer for sale, or importation of Sun Global s proposed 1 mg, 2 mg, or 3 mg eszopiclone tablets. 28. Because of the foregoing facts, there is a real, substantial, and continuing justiciable controversy between Sun Global and Sepracor as to liability for infringement of the 274 patent. E. The 673 Patent 29. The 673 patent was issued on September 3, 2002, to Cotrel and assigned to Sepracor. On information and belief, Sepracor is the current owner of the 673 patent, which is scheduled to expire no later than January 16, 2012. 30. Sepracor listed the 673 patent in the Orange Book in connection with NDA No. 021476. 31. To have the 673 patent listed in the Orange Book, the law required Sepracor to certify to the FDA, under oath, that the 673 patent claims the drug eszopiclone or a method of using eszopiclone and is a patent for which a claim of patent infringement could reasonably be asserted against an authorized party. 32. By bringing suit against Sun Global, Sepracor has taken active steps to block Sun Global s attempt to launch a generic 1 mg, 2 mg, or 3 mg eszopiclone tablet. 17
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 18 of 28 33. The claims of the 673 patent are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale, offer for sale, or importation of Sun Global s proposed 1 mg, 2 mg, or 3 mg eszopiclone tablets. 34. Because of the foregoing facts, there is a real, substantial, and continuing justiciable controversy between Sun Global and Sepracor as to liability for infringement of the 673 patent. F. The 926 Patent 35. The 926 patent was issued on November 20, 2001, to Cotrel and assigned to Sepracor. On information and belief, Sepracor is the current owner of the 926 patent, which is scheduled to expire no later than January 16, 2012. 36. Sepracor listed the 926 patent in the Orange Book in connection with NDA No. 021476. 37. To have the 926 patent listed in the Orange Book, the law required Sepracor to certify to the FDA, under oath, that the 926 patent claims the drug eszopiclone or a method of using eszopiclone and is a patent for which a claim of patent infringement could reasonably be asserted against an authorized party. 38. By bringing suit against Sun Global, Sepracor has taken active steps to block Sun Global s attempt to launch a generic 1 mg, 2 mg, or 3 mg eszopiclone tablet. 39. The claims of the 926 patent are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale, offer for sale, or importation of Sun Global s proposed 1 mg, 2 mg, or 3 mg eszopiclone tablets. 18
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 19 of 28 40. Because of the foregoing facts, there is a real, substantial, and continuing justiciable controversy between Sun Global and Sepracor as to liability for infringement of the 926 patent. F. The 724 Patent 41. The 724 patent was issued on June 3, 2008, to Cotrel and assigned to Sepracor. On information and belief, Sepracor is the current owner of the 724 patent, which is scheduled to expire no later than January 16, 2012. 42. Sepracor listed the 724 patent in the Orange Book in connection with NDA No. 021476. 43. To have the 724 patent listed in the Orange Book, the law required Sepracor to certify to the FDA, under oath, that the 724 patent claims the drug eszopiclone or a method of using eszopiclone and is a patent for which a claim of patent infringement could reasonably be asserted against an authorized party. 44. By bringing suit against Sun Global, Sepracor has taken active steps to block Sun Global s attempt to launch a generic 1 mg, 2 mg, or 3 mg eszopiclone tablet. 45. The claims of the 724 patent are invalid, unenforceable and/or will not be infringed by the manufacture, use, sale, offer for sale, or importation of Sun Global s proposed 1 mg, 2 mg, or 3 mg eszopiclone tablets. 46. Because of the foregoing facts, there is a real, substantial, and continuing justiciable controversy between Sun Global and Sepracor as to liability for infringement of the 724 patent. 19
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 20 of 28 COUNTERCLAIM I Declaration of Non-Infringement of the 257 Patent 47. Sun Global realleges and incorporates by reference the allegations of Paragraphs 1-46 as if fully set forth herein. 48. The manufacture, use, sale, offer for sale, or importation of Sun Global s proposed 1 mg, 2 mg, or 3 mg eszopiclone tablets would not infringe any valid and/or enforceable claim of the 257 patent. 49. Sun Global is entitled to a judicial declaration that its proposed eszopiclone tablets would not infringe any valid and/or enforceable claim of the 257 patent. COUNTERCLAIM II Declaration of Invalidity of the 257 Patent 50. Sun Global realleges and incorporates by reference the allegations of Paragraphs 1-49 as if fully set forth herein. 51. There is an actual and justiciable controversy between Sun Global and Sepracor regarding whether the claims of the 257 patent are invalid for failure to meet the requirements of 35 U.S.C. 1 et seq., including but not limited to 35 U.S.C. 101, 102, 103, and 112. 52. The claims of the 257 patent are invalid under the provisions of 35 U.S.C. 101, 102, 103 and/or 112 for one or more of the following reasons: (a) the alleged inventions claimed in those patents were known or used by others in this country, or patented and described in a printed publication in this or a foreign country, before the invention thereof by the alleged inventor; (b) the differences between the subject matter sought to be patented and the prior art are such that the subject matter sought to be patented as a whole would have been obvious at the time the alleged invention was made to a person having ordinary skill in the art to which the subject matter pertains. 20
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 21 of 28 invalid. 53. Sun Global is entitled to a judicial declaration that claims of the 257 patent are COUNTERCLAIM III Declaration of Non-Infringement of the 673 Patent 54. Sun Global realleges and incorporates by reference the allegations of Paragraphs 1-53 as if fully set forth herein. 55. The manufacture, use, sale, offer for sale, or importation of Sun Global s proposed 1 mg, 2 mg, or 3 mg eszopiclone tablets would not infringe any valid and/or enforceable claim of the 673 patent. 56. Sun Global is entitled to a judicial declaration that its proposed eszopiclone tablets would not infringe any valid and/or enforceable claim of the 673 patent. COUNTERCLAIM IV Declaration of Invalidity of the 673 Patent 57. Sun Global realleges and incorporates by reference the allegations of Paragraphs 1-56 as if fully set forth herein. 58. There is an actual and justiciable controversy between Sun Global and Sepracor regarding whether the claims of the 673 patent are invalid for failure to meet the requirements of 35 U.S.C. 1 et seq., including but not limited to 35 U.S.C. 101, 102, 103, and 112. 59. The claims of the 673 patent are invalid under the provisions of 35 U.S.C. 101, 102, 103 and/or 112 for one or more of the following reasons: (a) the alleged inventions claimed in those patents were known or used by others in this country, or patented and described in a printed publication in this or a foreign country, before the invention thereof by the alleged inventor; (b) the differences between the subject matter sought to be patented and the prior art are such that the subject matter sought to be patented as a whole would have been obvious at the 21
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 22 of 28 time the alleged invention was made to a person having ordinary skill in the art to which the subject matter pertains. invalid. 60. Sun Global is entitled to a judicial declaration that claims of the 673 patent are COUNTERCLAIM V Declaration of Non-Infringement of the 926 Patent 61. Sun Global realleges and incorporates by reference the allegations of Paragraphs 1-60 as if fully set forth herein. 62. The manufacture, use, sale, offer for sale, or importation of Sun Global s proposed 1 mg, 2 mg, or 3 mg eszopiclone tablets would not infringe any valid and/or enforceable claim of the 926 patent. 63. Sun Global is entitled to a judicial declaration that its proposed eszopiclone tablets would not infringe any valid and/or enforceable claim of the 926 patent. COUNTERCLAIM VI Declaration of Invalidity of the 926 Patent 64. Sun Global realleges and incorporates by reference the allegations of Paragraphs 1-63 as if fully set forth herein. 65. There is an actual and justiciable controversy between Sun Global and Sepracor regarding whether the claims of the 926 patent are invalid for failure to meet the requirements of 35 U.S.C. 1 et seq., including but not limited to 35 U.S.C. 101, 102, 103, and 112. 66. The claims of the 926 patent are invalid under the provisions of 35 U.S.C. 101, 102, 103 and/or 112 for one or more of the following reasons: (a) the alleged inventions claimed in those patents were known or used by others in this country, or patented and described in a printed publication in this or a foreign country, before the invention thereof by the alleged inventor; (b) the differences between the subject matter sought to be patented and the prior art 22
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 23 of 28 are such that the subject matter sought to be patented as a whole would have been obvious at the time the alleged invention was made to a person having ordinary skill in the art to which the subject matter pertains. invalid. 67. Sun Global is entitled to a judicial declaration that claims of the 926 patent are COUNTERCLAIM VII Declaration of Non-Infringement of the 724 Patent 68. Sun Global realleges and incorporates by reference the allegations of Paragraphs 1-67 as if fully set forth herein. 69. The manufacture, use, sale, offer for sale, or importation of Sun Global s proposed 1 mg, 2 mg, or 3 mg eszopiclone tablets would not infringe any valid and/or enforceable claim of the 724 patent. 70. Sun Global is entitled to a judicial declaration that its proposed eszopiclone tablets would not infringe any valid and/or enforceable claim of the 724 patent. COUNTERCLAIM VIII Declaration of Invalidity of the 724 Patent 71. Sun Global realleges and incorporates by reference the allegations of Paragraphs 1-70 as if fully set forth herein. 72. There is an actual and justiciable controversy between Sun Global and Sepracor regarding whether the claims of the 724 patent are invalid for failure to meet the requirements of 35 U.S.C. 1 et seq., including but not limited to 35 U.S.C. 101, 102, 103, and 112. 73. The claims of the 724 patent are invalid under the provisions of 35 U.S.C. 101, 102, 103 and/or 112 for one or more of the following reasons: (a) the alleged inventions claimed in those patents were known or used by others in this country, or patented and described in a printed publication in this or a foreign country, before the invention thereof by the alleged 23
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 24 of 28 inventor; (b) the differences between the subject matter sought to be patented and the prior art are such that the subject matter sought to be patented as a whole would have been obvious at the time the alleged invention was made to a person having ordinary skill in the art to which the subject matter pertains. 74. Sun Global is entitled to a judicial declaration that claims of the 724 patent are invalid. REQUEST FOR RELIEF WHEREFORE, Counterplaintiff Sun Global respectfully requests that this Court enter a Judgment and Order in its favor and against Counterdefendant Sepracor Corporation as follows: a) declaring that Sun Global has not infringed any valid and enforceable claim of U.S. Patent No. 6,864,257; b) declaring that claims of U.S. Patent No. 6,864,257 are invalid; c) declaring that Sun Global has not infringed any valid and enforceable claim of U.S. Patent No. 6,444,673; d) declaring that claims of U.S. Patent No. 6,44,673 are invalid e) declaring that Sun Global has not infringed any valid and enforceable claim of U.S. Patent No. 6,319,926; f) declaring that claims of U.S. Patent No. 6,319,926 are invalid g) declaring that Sun Global has not infringed any valid and enforceable claim of U.S. Patent No. 7,381,724; h) declaring that claims of U.S. Patent No. 7,381,724 are invalid 24
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 25 of 28 i) declaring that this is an exceptional case under 35 U.S.C. 285 and awarding Sun Global its attorneys fees, costs and expenses in this action; and j) awarding Sun Global any further and additional relief as the Court deems just and proper. WINSTON & STRAWN LLP Attorneys for Defendants Sun Pharma Global Inc., Sun Pharmaceutical Industries Inc., and Sun Pharmaceutical Industries Ltd. By: s/ James S. Richter James S. Richter jrichter@winston.com Dated: April 20, 2009 OF COUNSEL: James F. Hurst WINSTON & STRAWN LLP 35 West Wacker Drive Chicago, Illinois 60601 Gail J. Standish Peter E. Perkowski WINSTON & STRAWN LLP 333 South Grand Avenue, 38th Floor Los Angeles, California 90071 25
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 26 of 28 JURY DEMAND Defendant and Counterclaim Plaintiffs, Sun Pharma Global Inc., Sun Pharmaceutical Industries Inc., and Sun Pharmaceutical Industries Ltd. requests a jury trial on all issues so triable. WINSTON & STRAWN LLP Attorneys for Defendants Sun Pharma Global Inc., Sun Pharmaceutical Industries Inc., and Sun Pharmaceutical Industries Ltd. By: s/ James S. Richter James S. Richter jrichter@winston.com Dated: April 20, 2009 OF COUNSEL: James F. Hurst WINSTON & STRAWN LLP 35 West Wacker Drive Chicago, Illinois 60601 Gail J. Standish Peter E. Perkowski WINSTON & STRAWN LLP 333 South Grand Avenue, 38th Floor Los Angeles, California 90071 26
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 27 of 28 CERTIFICATION PURSUANT TO LOCAL CIVIL RULES 11.2 AND 40.1 Pursuant to Local Civil Rules 11.2 and 40.1, the undersigned counsel for Defendants Sun Pharma Global Inc., Sun Pharmaceutical Industries Inc., and Sun Pharmaceutical Industries Ltd. certifies that, to the best of their knowledge, information and belief, the matter in controversy is not the subject of any other action or proceeding. s/ James S. Richter James S. Richter Dated: April 20, 2009 CERTIFICATION PURSUANT TO LOCAL CIVIL RULE 201.1 Pursuant to Local Civil Rule 201.1, the undersigned counsel for Defendants Sun Pharma Global Inc., Sun Pharmaceutical Industries Inc., and Sun Pharmaceutical Industries Ltd. hereby certifies that Sun s causes of action as asserted in its counterclaims seek primarily declaratory judgment relief. This action is, therefore, not appropriate for compulsory arbitration. s/ James S. Richter James S. Richter Dated: April 20, 2009 27
Case 2:09-cv-01302-DMC-MF Document 17 Filed 04/20/2009 Page 28 of 28 CERTIFICATION OF SERVICE The undersigned attorney certifies that he caused a copy of the foregoing ANSWER, AFFIRMATIVE DEFENSES, COUNTERCLAIMS AND JURY DEMAND to be served by electronic mail on the 20th day of April, 2009 upon: Charles M. Lizza William C. Baton SAUL EWING One Riverfront Plaza Newark, New Jersey 07102 Dated: April 20, 2009 s/ James S. Richter James S. Richter LA:240924.5 28