Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 1 of 27 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND

Transcription

1 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 1 of 27 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MARYLAND FLAMEL TECHNOLOGIES S.A., Parc Club du Moulin à Vent 33 avenue du Docteur Georges Lévy Venissieux Cedex, France, v. Plaintiff/ Counterclaim-Defendant, ANCHEN PHARMACEUTICALS, INC., 9601 Jeronimo Road Irvine, California 92618, v. Defendant/ Counterclaim-Plaintiff/ Third Party Complaint-Plaintiff, ENDO PHARMACEUTICALS, INC. 100 Endo Boulevard Chadds Ford, Pennsylvania 19317, GLAXOSMITHKLINE PLC, 1 Franklin Plaza Philadelphia, Pennsylvania 19101, SMITHKLINE BEECHAM (CORK LIMITED, d/b/a/ GLAXOSMITHKLINE, Currabinny, Carrigaline County Cork, Ireland, Third Party Complaint-Defendants. Case No. 1:11-cv BEL ANCHEN PHARMACEUTICALS, INC. S ANSWER AND AFFIRMATIVE DEFENSES TO FLAMEL TECHNOLOGIES S.A. S COMPLAINT, AND COUNTERCLAIMS AND THIRD PARTY COMPLAINT

2 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 2 of 27 I. ANSWER Through its attorneys, Anchen Pharmaceuticals, Inc. ( Anchen or Defendant hereby answers Flamel Technologies S.A. s ( Flamel or Plaintiff Complaint as follows: THE PARTIES 1. Denied. Anchen denies all allegations in paragraph 1 because it is without knowledge or information sufficient to form a belief as to the truth of the allegations. 2. Admitted. Par Pharmaceutical, Inc. acquired Anchen on November 17, Anchen is now a wholly-owned subsidiary of Anchen Incorporated, which is a wholly-owned subsidiary of Par Pharmaceutical, Inc., which is a wholly-owned subsidiary of Par Pharmaceutical Companies, Inc. NATURE OF THE ACTION 3. Denied in part. Anchen admits that Flamel s Complaint purports to state claims under the patent laws of the United States, but denies that Flamel has any such claim or that any such claim is justified. JURISDICTION AND VENUE 4. Anchen admits that the Complaint purports to state a cause of action and that this Court has subject matter jurisdiction under the patent laws of the United States solely for the claims directed against Anchen only under 35 U.S.C. 271(e(2(A. 5. Anchen does not contest personal jurisdiction to conserve the resources of the parties and the Court in this judicial district and for the limited purpose of this action only. Anchen denies the remaining allegations in paragraph 5 of the Complaint. 6. Anchen does not contest venue to conserve the resources of the parties and for the limited purpose of this action only.

3 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 3 of 27 CASE OR CONTROVERSY 7. Admitted. FACTS 8. Denied. Anchen denies the allegations in paragraph 8 because it is without knowledge or information sufficient to form a belief as to the truth of the allegations. 9. Denied in part. Anchen admits that U.S. Patent No. 6,022,562 ( the 562 patent indicates on its face that it was issued by the U.S. Patent and Trademark Office. Anchen denies the remaining allegations in paragraph 9 because it is without knowledge or information sufficient to form a belief as to the truth of the allegations. 10. Denied in part. Anchen admits that New Drug Application No indicates on its face that it was issued by the Food and Drug Administration ( FDA for 10mg, 20mg, 40mg, and 80mg carvedilol phosphate extended release capsules for indications of, inter alia, left ventricular dysfunction, and admits that such capsules are marketed in the United States under the trade name COREG CR. Anchen denies the remaining allegations in paragraph Admitted. 12. Anchen admits that it submitted an Abbreviated New Drug Application ( ANDA No to the FDA under 505(j of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j and 21 C.F.R ; admits that its counsel notified Flamel of the ANDA and that the 562 patent is invalid, unenforceable, and/or will not be infringed in a Notification Letter dated July 25, 2011; and admits that what purports to be a copy of the

4 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 4 of 27 confidential Notification Letter is attached as Plaintiff s Exhibit 2. 1 Upon information and belief, Anchen admits that Flamel received the Notification Letter on or about July 26, Admitted. 14. Admitted. 15. Denied. 16. Denied in part. Anchen admits that it had actual notice of the 562 patent prior to filing ANDA No Anchen denies the remaining allegations in paragraph Denied. 18. Denied. Anchen denies all allegations in paragraph 18 because it is without knowledge or information sufficient to form a belief as to the truth of the allegations. COUNT I (Patent Infringement Anchen 19. Denied in part. Anchen restates its responses to paragraphs 1 through 18 of the Complaint, and incorporates them herein by reference. 20. Denied in part. Anchen admits that it submitted ANDA No to the FDA to obtain approval under the Federal Food, Drug, and Cosmetic Act to engage in the commercial manufacture, use, or sale of the Anchen Product throughout the United States. Anchen denies the remaining allegations. 21. Denied. 1 Flamel s disclosure of Anchen s Notification Letter, and the confidential and proprietary information it disclosed concerning Anchen s ANDA No , violated the terms and restrictions outlined in the Notification Letter. See Plaintiff s Exhibit 2, pp. 3 5.

5 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 5 of 27 COUNT II (Declaratory Judgment Anchen 22. Denied in part. Anchen restates its responses to paragraphs 1 through 21 of the Complaint, and incorporates them herein by reference. 23. Denied. Anchen denies all allegations in paragraph 23 because it is without knowledge or information sufficient to form a belief as to the truth of the allegations. 24. Denied in part. Anchen admits that Flamel is seeking a declaratory judgment relating to patent infringement of the 562 patent. Anchen denies the remaining allegations in paragraph 24. or otherwise. PLAINTIFF S REQUEST FOR RELIEF Anchen denies that Flamel is entitled to any relief, whether stated in its request for relief II. AFFIRMATIVE DEFENSES Without any admission as to the burden of proof or as to any of the allegations in the Complaint, Anchen asserts the following affirmative defenses: FIRST AFFIRMATIVE DEFENSE (Non-Infringement of the 562 Patent 25. The manufacture, use, offer for sale, and sale of the 40mg carvedilol phosphate extended-release capsules that are the subject of Anchen s ANDA No (the Proposed Generic Product does not and will not literally infringe any claim of the 562 patent. 26. The manufacture, use, offer for sale, and sale of the Proposed Generic Product does not and will not infringe any claim of the 562 patent by the doctrine of equivalents.

6 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 6 of Anchen has not, does not, and will not induce or contribute to any infringement of any valid and enforceable claim of the 562 patent and is not liable for any act that would be construed as any form of infringement of any valid and enforceable claim of the 562 patent. SECOND AFFIRMATIVE DEFENSE (Invalidity of the 562 Patent 28. Each and every claim of the 562 patent is invalid for failure to meet one or more of the requirements of Title 35, United States Code, including but not limited to Sections 41, 101, 102, 103, 112, 116, and/or for double-patenting. THIRD AFFIRMATIVE DEFENSE (Prosecution History Estoppel of the 562 Patent 29. By reason of the prior art and/or statements and representations made to the United States Patent and Trademark Office during the prosecution of the application that led to the issuance of the 562 patent, the 562 patent is so limited that no claim can be construed as covering any Anchen activity. FOURTH AFFIRMATIVE DEFENSE (Damages 30. Plaintiff has not suffered any damages. FIFTH AFFIRMATIVE DEFENSE (Irreparable Injury 31. Plaintiff is not suffering an irreparable injury.

7 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 7 of 27 III. COUNTERCLAIMS AGAINST FLAMEL TECHNOLOGIES, S.A. AND THIRD-PARTY COMPLAINT AGAINST ENDO PHARMACEUTICALS, INC., GLAXOSMITHKLINE PLC, AND SMITHKLINE BEECHAM (CORK LIMITED Anchen Pharmaceuticals, Inc. asserts the following claims against Flamel Technologies, S.A., Endo Pharmaceuticals, Inc., GlaxoSmithKline plc, Smithkline Beecham (CORK Limited, and Smithkline Beecham Corp.: THE PARTIES 1. Defendant/Counterclaim-Plaintiff Anchen Pharmaceuticals, Inc. ( Anchen is a corporation organized and existing under the laws of the State of California, with its principal place of business at 9601 Jeronimo Road, Irvine, California. Anchen is a wholly-owned subsidiary of Anchen Incorporated, which is a wholly-owned subsidiary of Par Pharmaceutical, Inc., which is a wholly-owned subsidiary of Par Pharmaceutical Companies, Inc. 2. On information and belief, Plaintiff/Counterclaim-Defendant Flamel Technologies, S.A. ( Flamel is a corporation organized and existing under the laws of France, with a principal place of business in Venissieux Cedex, France. 3. On information and belief, Third Party Defendant Endo Pharmaceuticals, Inc. ( Endo is a corporation organized and existing under the laws of Delaware, with a principal place of business at 100 Endo Boulevard, Chadds Ford, Pennsylvania On information and belief, Third Party Defendant GlaxoSmithKline plc ( GSK is a corporation organized and existing under the laws of England, with its U.S. headquarters at 1 Franklin Plaza, Philadelphia, Pennsylvania GSK has no parent corporation. 5. On information and belief, Third Party Defendant Smithkline Beecham (CORK Limited ( Smithkline Cork is a corporation organized and existing under the laws of Ireland, with a principal place of business at Currabinny, Carrigaline, County Cork, Ireland.

8 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 8 of On information and belief, Smithkline-Cork is a wholly owned subsidiary of ultimate parent corporation, GSK. 7. On information and belief, GSK is the successor of SB Pharmco Puerto Rico, Inc. ( SB Pharmco and the current holder of New Drug Application ( NDA No JURISDICTION AND VENUE 8. These claims arise 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 This Court has original jurisdiction over the subject matter of these claims under 28 U.S.C. 1331, 1338(a, 2201, and 2202, 21 U.S.C. 355(j, and Rules 13 and 14 of the Federal Rules of Civil Procedure. 10. Personal jurisdiction over Flamel is proper in this district. Flamel, by bringing this action in this district, has consented to and is subject to personal jurisdiction in this district. 11. Personal jurisdiction over Endo is proper in this district. Endo has a substantial presence throughout the United States and, on information and belief, has engaged and is engaged in continuous and systematic contacts with the State of Maryland and has purposefully availed itself of the benefits and protections of the laws of Maryland. 12. Personal jurisdiction over GSK is proper in this district. GSK has a substantial presence throughout the United States and, on information and belief, has engaged and is engaged in continuous and systematic contacts with the State of Maryland and has purposefully availed itself of the benefits and protections of the laws of Maryland. On information and belief, GSK offers for sale and sells carvedilol controlled release capsules (under the brand name COREG CR in the United States and specifically in Maryland. Personal jurisdiction in this district is thus also proper pursuant to the Maryland long-arm statute, MD. CODE ANN

9 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 9 of Personal jurisdiction over Smithkline-Cork is proper in this district. Smithkline- Cork has a substantial presence throughout the United States and, on information and belief, has engaged and is engaged in continuous and systematic contacts with the State of Maryland and has purposefully availed itself of the benefits and protections of the laws of Maryland. Smithkline-Cork is a wholly-owned subsidiary of GSK and does business as GlaxoSmithKline. On information and belief, Smithkline-Cork manufactures the active ingredient in COREG CR ( Carvedilol API, contracts to supply Carvedilol API, and sells Carvedilol API to GSK for the COREG CR product sold in Maryland and throughout the United States. Personal jurisdiction in this district is thus also proper pursuant to the Maryland long-arm statute, MD. CODE ANN Venue is proper in this district pursuant to 28 U.S.C. 1391(b-(c and 1400(b. CASE OR CONTROVERSY 15. An actual, justiciable controversy exists between the parties to this action by virtue of the allegations of Flamel s Complaint and Anchen s Answer, Counterclaims, and Third Party Complaint. FACTS 16. On information and belief, the United States Patent and Trademark Office ( USPTO issued U.S. Patent No. 6,022,562 ( the 562 patent, entitled Medicinal and/or Nutritional Microcapsules for Oral Administration, on February 8, On information and belief, the USPTO issued the 562 patent to Pierre Autant, Jean-Philippe Selles, and Gerard Soula (the 562 patent named inventors.

10 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 10 of On information and belief, the 562 patent named inventors assigned all interest in the 562 patent to Flamel, in an assignment that was recorded with the USPTO on December 13, Flamel purports to own and have the right to enforce the 562 patent. 19. On information and belief, Flamel granted a 36-page exclusive license of the 562 patent to Endo, 5 pages of which were recorded with the USPTO on August 17, Endo owns substantial, proprietary rights in the 562 patent. 21. Without joining Endo, there is a substantial risk that Anchen could incur double, multiple, or otherwise inconsistent obligations relating to the 562 patent and ANDA No Because Anchen has contested the validity of the 562 patent, there is a substantial risk that disposing of the action without joining Endo could impair or impede Endo s ability to protect its interest in the 562 patent. 23. On information and belief, SB Pharmco a subsidiary of GSK which has since been dissolved listed the 562 patent in the Orange Book. 24. On information and belief, the USPTO issued U.S. Patent No. 5,902,821 ( the 821 patent, entitled Use of Carbazole Compounds for the Treatment of Congestive Heart Failure, on May 11, See attached Exhibit A. 25. On information and belief, the USPTO issued the 821 patent to Mary Ann Lukas- Laskey, Robert Ruffolo Jr., Neil Shusterman, Gisbert Sponer, and Klaus Strein (the 821 patent named inventors. 2 Endo subsequently assigned a security interest in the 562 patent to Morgan Stanley Senior Funding, Inc. on June 17, The United States Patent and Trademark Office recorded the assignment on July 8, 2011.

11 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 11 of On information and belief, the 821 patent named inventors assigned all interest in the 821 patent to Boehringer Mannheim Pharmaceuticals Corporation and Smith Kline Beecham Corporation Limited Partnership No. 1, in an assignment that was recorded with the USPTO on December 29, On information and belief, Boehringer Mannheim Pharmaceuticals Corporation and Smith Kline Beecham Corporation assigned all interest in the 821 patent to Roche Therapeutics, Inc., in an assignment that was recorded with the USPTO on September 10, On information and belief, Roche Therapeutics, Inc. assigned all interest in the 821 patent to SB Pharmco, in an assignment that was recorded with the USPTO on September 16, On information and belief, SB Pharmco a subsidiary of GSK which has since been dissolved listed the 821 patent in the Orange Book. 30. On information and belief, SB Pharmco assigned all interest in the 821 patent to Smithkline-Cork in an assignment that was recorded with the USPTO on August 21, On information and belief, the USPTO issued U.S. Patent No. 7,268,156 ( the 156 patent, entitled Carvedilol Phosphate Salts and/or Solvates Thereof, Corresponding Compositions and/or Methods of Treatment, on September 11, See attached Exhibit B. 32. On information and belief, the USPTO issued the 156 patent to Christopher S. Brook, Wei Chen, and Paul G. Spoors (the 156 patent named inventors. 33. On information and belief, the 156 patent named inventors assigned all interest in the 156 patent to SB Pharmco, in an original assignment that was recorded with the USPTO on June 22, 2010.

12 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 12 of On information and belief, SB Pharmco a subsidiary of GSK which has since been dissolved listed the 156 patent in the Orange Book. 35. On information and belief, Charles S. Brisbane, Wei Chen, Philip C. Dell Orco, Lee M. Katrincic, Ann Marie Louvet, Choon K. Oh, Paul G. Spoors, and Christopher Werner assigned all interest in the 156 patent to SB Pharmco, in a corrected assignment that was recorded with the USPTO on July 13, On information and belief, Charles S. Brook, Wei Chen, Philip C. Dell Orco, Lee M. Katrincic, Ann Marie Louvet, Choon K. Oh, Paul G. Spoors, and Christopher Werner (the 156 patent corrected inventors assigned all interest in the 156 patent to SB Pharmco, in a second corrected assignment that was recorded with the USPTO on July 28, On information and belief, SB Pharmco assigned all interest in the 156 patent to Smithkline-Cork in an assignment that was recorded with the USPTO on August 21, On information and belief, the USPTO issued U.S. Patent No. RE40,000 (the RE40,000 patent, entitled Method of Treatment for Decreasing Mortality Resulting from Congestive Heart Failure, on January 8, See attached Exhibit C. 39. On information and belief, the USPTO issued the RE40,000 patent to Mary Ann Lukas-Laskey, Robert Ruffolo, Jr., Neil Howard Shusterman, Gisbert Sponer, and Klaus Strein (the RE40,000 patent named inventors. 40. On information and belief, the RE40,000 patent issued from U.S. Patent Application No. 10/721,020 (the 020 application, filed on November 25, On information and belief, the 020 application sought reissued claims over previously issued U.S. Patent No. 5,760,069 ( the 069 patent, which issued on June 2, 1998.

13 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 13 of On information and belief, the USPTO issued the 069 patent to Mary Ann Lukas- Laskey, Robert Ruffolo Jr., Neil Shusterman, Gisbert Sponer, and Klaus Strein (the 069 patent named inventors. 43. On information and belief, the 069 patent named inventors assigned all interest in the 069 patent to Boehringer Mannheim Pharmaceuticals Corporation and Smith Kline Beecham Corporation Limited Partnership No. 1, in an assignment that was recorded with the USPTO on November 6, On information and belief, Boehringer Mannheim Pharmaceuticals Corporation and Smith Kline Beecham Corporation assigned all interest in the 069 patent to Roche Therapeutics, Inc., in an assignment that was recorded with the USPTO on September 10, On information and belief, Roche Therapeutics, Inc. assigned all interest in the 069 patent to SB Pharmco, in an assignment that was recorded with the USPTO on September 16, On information and belief, SB Pharmco a subsidiary of GSK which has since been dissolved listed the RE40,000 patent in the Orange Book. 47. On information and belief, SB Pharmco assigned all interest in the RE40,000 patent to Smithkline-Cork in an assignment that was recorded with the USPTO on August 21, On information and belief, SB Pharmco was the owner of NDA No and was responsible for the listing of the patents on the FDA website for Approved New Drug Products with Therapeutic Equivalence Evaluations ( Orange Book for COREG CR (Carvedilol CR, including the 562 patent, 156 patent, 821 patent, and RE40,000 patent. On information and belief, SB Pharmco was dissolved, and GSK is the current owner of NDA No.

14 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 14 of and is responsible for the listing of the patents in the Orange Book for COREG CR (Carvedilol CR, including the 562 patent, 156 patent, 821 patent, and RE40,000 patent. 49. Anchen submitted Abbreviated New Drug Application ( ANDA No to the Food and Drug Administration, seeking approval to market the Proposed Generic Product. 50. Anchen s ANDA includes confidential information concerning the Proposed Generic Product. FIRST COUNTERCLAIM (Declaration of Non-Infringement of the 562 Patent 51. Anchen repeats and re-alleges paragraphs 1 through 50 of the counterclaim. 52. Flamel has asserted the 562 patent against Anchen. Flamel alleges and Anchen denies that the claims of the 562 patent cover the Proposed Generic Product either literally or under the doctrine of equivalents. 53. Anchen has not infringed, does not infringe, and would not infringe the 562 patent if it made, used, sold, offered for sale, marketed, or imported the Proposed Generic Product. 54. Anchen has not, does not, and will not induce or contribute to any infringement of any valid and enforceable claim of the 562 patent and is not liable for any act that would be construed as any form of infringement of any valid and enforceable claim of the 562 patent. 55. Anchen and Flamel have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and Flamel of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding Anchen s non-infringement of the 562 patent. 56. Anchen and Endo have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and Endo of sufficient immediacy and reality to

15 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 15 of 27 warrant the issuance of a declaratory judgment regarding Anchen s non-infringement of the 562 patent. 57. Anchen is entitled to a judicial declaration that any manufacture, use, sale, offer for sale, marketing, or importation of the Proposed Generic Product has not infringed, does not infringe, and would not infringe the 562 patent or any claim thereof, either literally or under the doctrine of equivalents. SECOND COUNTERCLAIM (Declaration of Invalidity of the 562 Patent 58. Anchen repeats and re-alleges paragraphs 1 through 57 of the counterclaim. 59. The 562 patent and all its claims are invalid under 35 U.S.C. 41, 101, 102, 103, 112, 116, and/or for double-patenting. 60. Flamel alleges and Anchen denies that the claims of the 562 patent are valid and enforceable. 61. Anchen and Flamel have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and Flamel of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding the invalidity of the 562 patent. 62. Anchen and Endo have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and Endo of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding the invalidity of the 562 patent. 63. Anchen is entitled to a judicial declaration that the 562 patent and each claim thereof is invalid.

16 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 16 of 27 THIRD COUNTERCLAIM (Declaratory Judgment of Improper Listing of the 562 Patent 64. Anchen repeats and re-alleges paragraphs 1 through 63 of the counterclaim. 65. The 562 patent should not be listed in the Orange Book because the 562 patent does not cover the COREG CR product. 66. Each non-method claim of the 562 patent requires microcapsules that have, among other things: particles of AP each coated with at least one coating film of specific following composition: 1 at least one film-forming polymer (P1... consisting of at least one non-hydrosoluble cellulose derivate, ethylcellulose and/or cellulose acetate being preferred. 67. Thus, the microcapsules claimed in the 562 patent must contain at least one nonhydrosoluble, cellulose-derivative, and film-forming polymer. 68. As shown in attached Exhibit D, the approved labeling for COREG CR indicates that the product contains: Active ingredient: carvedilol phosphate Inactive ingredients: crospovidone, hydrogenated castor oil, hydrogenated vegetable oil, magnesium stearate, methacrylic acid copolymers, microcrystalline cellulose, and povidone. 69. None of the ingredients listed in the approved labeling for the capsule product is a non-hydrosoluble, cellulose-derivative, film-forming polymer. 70. Of the ingredients listed in the approved labeling for the COREG CR capsule product, only microcrystalline cellulose is a cellulose derivate, however it is not a film-forming polymer. 71. Thus, the COREG CR product does not have at least one coating film of the claimed specific [listed] composition.

17 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 17 of Because the limitation of at least one film-forming polymer (P1... consisting of at least one non-hydrosoluble cellulose derivative is missing from the COREG CR product, the claims of the 562 patent do not cover the COREG CR product. 73. The 562 patent is irrelevant and improperly listed in the Orange Book for the COREG CR product (Carvedilol CR. 74. Anchen and Flamel have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and Flamel of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding the improper listing of the 562 patent in the Orange Book. 21 U.S.C. 355(j(5(C(ii. 75. Anchen and Endo have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and Endo of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding the improper listing of the 562 patent in the Orange Book. 21 U.S.C. 355(j(5(C(ii. 76. Anchen and GSK have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and GSK of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding the improper listing of the 562 patent in the Orange Book. 21 U.S.C. 355(j(5(C(ii. 77. Anchen is entitled to a judicial declaration that the 562 patent is improperly listed in the Orange Book. 78. Anchen is entitled to an Order requiring the FDA to instruct the holder of NDA No , on information and belief believed to be GSK, to remove the 562 patent from the Orange Book listing for COREG CR (Carvedilol CR.

18 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 18 of 27 FOURTH COUNTERCLAIM (Declaration of Non-Infringement of the 821 Patent 79. Anchen repeats and re-alleges paragraphs 1 through 78 of the counterclaim. 80. Anchen has not infringed, does not infringe, and would not infringe the 821 patent if it made, used, sold, offered for sale, marketed, or imported the Proposed Generic Product. 81. Anchen has not, does not, and will not induce or contribute to any infringement of any valid and enforceable claim of the 821 patent and is not liable for any act that would be construed as any form of infringement of any valid and enforceable claim of the 821 patent. 82. Anchen and GSK have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and GSK of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding Anchen s non-infringement of the 821 patent. 83. Anchen and Smithkline-Cork have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and Smithkline-Cork of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding Anchen s non-infringement of the 821 patent. 84. Anchen is entitled to a judicial declaration that any manufacture, use, sale, offer for sale, marketing, or importation of the Proposed Generic Product has not infringed, does not infringe, and would not infringe the 821 patent or any claim thereof, either literally or under the doctrine of equivalents. FIFTH COUNTERCLAIM (Declaration of Invalidity of the 821 Patent 85. Anchen repeats and re-alleges paragraphs 1 through 84 of the counterclaim.

19 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 19 of The 821 patent and all its claims are invalid under 35 U.S.C. 41, 101, 102, 103, 112, 116, and/or for double-patenting. 87. Anchen and GSK have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and GSK of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding the invalidity of the 821 patent. 88. Anchen and Smithkline-Cork have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and Smithkline-Cork of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding the invalidity of the 821 patent. 89. Anchen is entitled to a judicial declaration that the 821 patent and each claim thereof is invalid. SIXTH COUNTERCLAIM (Declaration of Non-Infringement of the 156 Patent 90. Anchen repeats and re-alleges paragraphs 1 through 89 of the counterclaim. 91. Anchen has not infringed, does not infringe, and would not infringe the 156 patent if it made, used, sold, offered for sale, marketed, or imported the Proposed Generic Product. 92. Anchen has not, does not, and will not induce or contribute to any infringement of any valid and enforceable claim of the 156 patent and is not liable for any act that would be construed as any form of infringement of any valid and enforceable claim of the 156 patent. 93. Anchen and GSK have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and GSK of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding Anchen s non-infringement of the 156 patent.

20 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 20 of Anchen and Smithkline-Cork have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and Smithkline-Cork of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding Anchen s non-infringement of the 156 patent. 95. Anchen is entitled to a judicial declaration that any manufacture, use, sale, offer for sale, marketing, or importation of the Proposed Generic Product has not infringed, does not infringe, and would not infringe the 156 patent or any claim thereof, either literally or under the doctrine of equivalents. SEVENTH COUNTERCLAIM (Declaration of Invalidity of the 156 Patent 96. Anchen repeats and re-alleges paragraphs 1 through 95 of the counterclaim. 97. The 156 patent and all its claims are invalid under 35 U.S.C. 41, 101, 102, 103, 112, 116, and/or for double-patenting. 98. Anchen and GSK have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and GSK of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding the invalidity of the 156 patent. 99. Anchen and Smithkline-Cork have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and Smithkline-Cork of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding the invalidity of the 156 patent Anchen is entitled to a judicial declaration that the 156 patent and each claim thereof is invalid.

21 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 21 of 27 EIGHTH COUNTERCLAIM (Declaration of Non-Infringement of the RE40,000 Patent 101. Anchen repeats and re-alleges paragraphs 1 through 100 of the counterclaim Anchen has not infringed, does not infringe, and would not infringe the RE40,000 patent if it made, used, sold, offered for sale, marketed, or imported the Proposed Generic Product Anchen has not, does not, and will not induce or contribute to any infringement of any valid and enforceable claim of the RE40,000 patent and is not liable for any act that would be construed as any form of infringement of any valid and enforceable claim of the RE40,000 patent Anchen and GSK have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and GSK of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding Anchen s non-infringement of the RE40,000 patent Anchen and Smithkline-Cork have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and Smithkline-Cork of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding Anchen s non-infringement of the RE40,000 patent Anchen is entitled to a judicial declaration that any manufacture, use, sale, offer for sale, marketing, or importation of the Proposed Generic Product has not infringed, does not infringe, and would not infringe the RE40,000 patent or any claim thereof, either literally or under the doctrine of equivalents.

22 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 22 of 27 NINTH COUNTERCLAIM (Declaration of Invalidity of the RE40,000 Patent 107. Anchen repeats and re-alleges paragraphs 1 through 106 of the counterclaim The RE40,000 patent and all its claims are invalid under 35 U.S.C. 41, 101, 102, 103, 112, 116, and/or for double-patenting Anchen and GSK have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and GSK of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding the invalidity of the RE40,000 patent Anchen and Smithkline-Cork have adverse legal interests, and there is an actual, substantial, and continuing controversy between Anchen and Smithkline-Cork of sufficient immediacy and reality to warrant the issuance of a declaratory judgment regarding the invalidity of the RE40,000 patent Anchen is entitled to a judicial declaration that the RE40,000 patent and each claim thereof is invalid. TENTH COUNTERCLAIM (Damages 112. Anchen repeats and re-alleges paragraphs 1 through 111 of the counterclaim Anchen has not sold its Proposed Generic Product in the United States Flamel has not suffered any damages Endo has not suffered any damages. ELEVENTH COUNTERCLAIM (Irreparable Injury 116. Anchen repeats and re-alleges paragraphs 1 through Error! Reference source not found. of the counterclaim Flamel has not suffered an irreparable injury.

23 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 23 of Endo has not suffered any irreparable injury. PRAYER FOR RELIEF WHEREFORE, Anchen demands judgment in its favor and against Flamel, Endo, GSK, and Smithkline-Cork as follows: (a Dismissing the Complaint with prejudice and denying each request for relief made by Flamel, Endo, GSK, and/or Smithkline-Cork; (b Issuing a declaratory judgment that the 562 patent is not infringed by Anchen s ANDA filing; (c Issuing a declaratory judgment that the 821 patent is not infringed by Anchen s ANDA filing; (d Issuing a declaratory judgment that the 156 patent is not infringed by Anchen s ANDA filing; (e Issuing a declaratory judgment that the RE40,000 patent is not infringed by Anchen s ANDA filing; (f Issuing a declaratory judgment that the 562 patent is not infringed by any manufacture, use, sale, offer for sale, marketing, or importation of the Proposed Generic Product; (g Issuing a declaratory judgment that the 821 patent is not infringed by any manufacture, use, sale, offer for sale, marketing, or importation of the Proposed Generic Product; (h Issuing a declaratory judgment that the 156 patent is not infringed by any manufacture, use, sale, offer for sale, marketing, or importation of the Proposed Generic Product; (i Issuing a declaratory judgment that the RE40,000 patent is not infringed by any manufacture, use, sale, offer for sale, marketing, or importation of the Proposed Generic Product; (j Issuing a declaratory judgment that the 562 patent and all its claims are invalid;

24 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 24 of 27 (k (l (m Issuing a declaratory judgment that the 821 patent and all its claims are invalid; Issuing a declaratory judgment that the 156 patent and all its claims are invalid; Issuing a declaratory judgment that the RE40,000 patent and all its claims are invalid; (n Issuing a declaratory judgment that the 562 patent is improperly listed in the Orange Book and an Order requiring the FDA to instruct the holder of NDA No , formerly SB Pharmco and on information and belief believed to be GSK, to remove the 562 patent from the Orange Book listing for COREG CR (Carvedilol CR; (o Enjoining Flamel, its officers, agents, servants, employees, attorneys, and any person who acts in concert or participation with Flamel from threatening to assert or otherwise attempting to enforce the 562 patent, 821 patent, 156 patent, and/or RE40,000 patent (collectively, the listed patents against Anchen, its customers, suppliers, subsidiaries, parents, or anyone in privity with Anchen; (p Enjoining Endo, its officers, agents, servants, employees, attorneys, and any person who acts in concert or participation with Endo from threatening to assert or otherwise attempting to enforce the listed patents against Anchen, its customers, suppliers, subsidiaries, parents, or anyone in privity with Anchen; (q Enjoining GSK, its officers, agents, servants, employees, attorneys, and any person who acts in concert or participation with GSK from threatening to assert or otherwise attempting to enforce the listed patents against Anchen, its customers, suppliers, subsidiaries, parents, or anyone in privity with Anchen; (r Enjoining SmithKline-Cork, its officers, agents, servants, employees, attorneys, and any person who acts in concert or participation with Smithkline-Cork from threatening to

25 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 25 of 27 assert or otherwise attempting to enforce the listed patents against Anchen, its customers, suppliers, subsidiaries, parents, or anyone in privity with Anchen; (s (t (u Awarding Anchen its attorneys fees; Awarding Anchen its costs and expenses; and Awarding Anchen such other and further relief as the Court deems just and proper.

26 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 26 of 27 Respectfully submitted, _/s/ Janine A. Carlan (Bar No Aziz Burgy (Bar No ARENT FOX LLP 1050 Connecticut Avenue NW Washington, DC Tel.: ( Fax: ( CoregCR@arentfox.com Attorneys for Defendant/Counterclaim- Plaintiff/Third Party Complaint- Plaintiff Anchen Pharmaceuticals, Inc. Dated January 30, 2012

27 Case 1:11-cv BEL Document 9 Filed 01/30/12 Page 27 of 27 CERTIFICATE OF SERVICE The undersigned hereby certifies on this 30 th day of January, 2012, a true and correct copy of the foregoing was served using the Court s CM/ECF system with electronic notification of such filing to the following counsel of record: Richard J. Oparil Patton Boggs, LLP 2550 M Street, N.W. Washington, D.C Kevin M. Bell Scott Chambers Lacy Kolo Patton Boggs LLP 8484 Westpark Drive McLean, VA Carline C. Maxwell Patton Boggs LLP 2000 McKinney Avenue, Suite 1700 Dallas, TX _/s/ Janine A. Carlan (Bar No Aziz Burgy (Bar No ARENT FOX LLP 1050 Connecticut Avenue NW Washington, DC Tel.: ( Fax: ( CoregCR@arentfox.com Attorneys for Defendant/Counterclaim- Plaintiff/Third Party Complaint-Plaintiff Anchen Pharmaceuticals, Inc.