161l - answer and counterclaim

Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 1 of 22 Robert G. Shepherd, Esq. (RGS-5946)
Brooks R. Bruneau, Esq. (BRB-5523)
MATHEWS, SHEPHERD, MCKAY & BRUNEAU, P.A.
100 Thanet Circle, Suite 306
Princeton, NJ 08540-3674
Telephone (609) 924-8555
Facsimile (609) 924-3036
Attorneys for Defendants and Counterclaimants,
RANBAXY PHARMACEUTICALS, INC.,
RANBAXY INC. AND
RANBAXY LABORATORIES LIMITED
) DEFENDANTS RANBAXY
) PHARMACEUTICALS, INC.’S,
) RANBAXY INC.’S AND RANBAXY
) LABORATORIES LIMITED’S
) ANSWER TO THE COMPLAINT
) AND COUNTERCLAIMS
________________________________________ )
RANBAXY PHARMACEUTICALS, INC.,
) Document Electronically Filed
Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 2 of 22 Defendants Ranbaxy Pharmaceuticals Inc., Ranbaxy Inc. and Ranbaxy Laboratories Limited (collectively “Ranbaxy”), hereby answer the Complaint of Plaintiffs AstraZeneca AB, Aktiebolaget Hässle, AstraZeneca LP, KBI Inc., and KBI-E Inc. (collectively “Plaintiffs”), as JURISDICTION AND VENUE
Ranbaxy admits that this court has jurisdiction over the subject matter alleged in the Complaint under 35 U.S.C. § 271(e) and 28 U.S.C. §§ 1331, 1338(a), 2201 and 2202. Ranbaxy admits that venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391(b), 1391(c), and 1400(b). Ranbaxy denies the remaining allegations of paragraph 1 of the Ranbaxy admits that Ranbaxy Laboratories Limited submitted an Abbreviated New Drug Application (“ANDA”), which was assigned No. 77-830, and related Drug Master File (“DMF”) to the FDA in order to obtain approval to engage in the commercial manufacture, use or sale of a drug product containing esomeprazole magnesium. Ranbaxy denies the remaining allegations of paragraph 2 of the Complaint. Ranbaxy admits that on October 14, 2005 it provided a notice letter to AstraZeneca entitled “Esomeprazole magnesium delayed-release capsules, 20 mg and 40 mg, ANDA No. 77-830, U.S. Patent Nos. 4,738,974; 4,786,505; 4,853,230; 5,690,960; 5,714,504; 5,877,192; 5,900,424; 6,147,103; 6,166,213; 6,191,148; 6,369,085; 6,428,810 and 6,875,872.” Ranbaxy denies the remaining allegations of paragraph 3 of the Complaint. Ranbaxy denies the allegations of paragraph 4 of the Complaint. Ranbaxy admits that there is an actual controversy between Ranbaxy and Plaintiffs regarding the invalidity and noninfringement of U.S. Patent Nos. 5,714,504 (“the ‘504 patent”); 5,877,192 (“the ‘192 patent”); 6,369,085 (“the ‘085 patent”); 6,428,810 (“the ‘810 patent”) 6,875,872 (“the ‘872 patent”); and 5,948,789 (“the ‘789 patent”). Ranbaxy denies the remaining allegations of paragraph 5 of the Complaint. To facilitate the Court’s comparison of the allegations in the Complaint and Ranbaxy’s responses thereto, Ranbaxy has incorporated the headings that appear in the Complaint. It should be understood that Ranbaxy does not necessarily agree with the characterization in such headings and does not waive any rights to object to such characterizations or their implications. Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 3 of 22 THE PARTIES
Ranbaxy 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 Ranbaxy 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 Ranbaxy 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 Ranbaxy 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 Ranbaxy 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 Ranbaxy admits the allegations of paragraph 11 of the Complaint. Ranbaxy admits Ranbaxy Pharmaceuticals, Inc. is a corporation organized and existing under the laws of the State of Florida with a principal place of business at 9431 Florida Mining Blvd. East, Jacksonville, Florida 32257. Ranbaxy denies the remaining allegations of Ranbaxy admits the allegations of paragraph 13 of the Complaint. Ranbaxy admits that Ranbaxy Pharmaceuticals, Inc. and Ranbaxy Inc. are wholly owned subsidiaries of Ranbaxy Laboratories Limited. Ranbaxy denies the remaining allegations Ranbaxy denies the allegations of paragraph 15 of the Complaint. FIRST CLAIM FOR RELIEF: ‘504 PATENT
Ranbaxy incorporates by reference and realleges each of the responses in paragraphs 1-15, above, as if set forth specifically here. Ranbaxy admits that a copy of the ‘504 patent is attached to the Complaint as Exhibit A, that the patent is titled “Compositions,” that the patent indicates an issue date of Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 4 of 22 February 3, 1998, that the patent lists Astra Aktiebolag as the assignee, and that the patent lists Per Lennart Lindberg and Sverker Von Unge as inventors. Ranbaxy denies the ‘504 patent has any valid claims covering pharmaceutical formulations comprising esomeprazole magnesium or methods of using esomeprazole magnesium. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations of paragraph 17 of the Complaint and, therefore, denies the remaining allegations of paragraph 17 on this basis. Ranbaxy 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 Ranbaxy admits that Plaintiffs were notified pursuant to Section 505(j)(2)(B) of the Food, Drug and Cosmetic Act (“FDCA”) and 21 C.F.R. § 314.95 that ANDA No. 77-830 was submitted to the FDA in order to obtain approval to engage in the commercial manufacture, use or sale of a drug product containing esomeprazole magnesium and that the proprietary name of the drug product esomeprazole magnesium as listed in the 22nd edition of the FDA’s publication entitled Approved Drug Products With Therapeutic Equivalence Evaluations (2002) (the “Orange Book”) is Nexium®. Ranbaxy denies the remaining allegations of paragraph 19 of Ranbaxy admits that Plaintiffs were notified pursuant to FDCA Section 505(j)(2)(B) and 21 C.F.R. § 314.95 that ANDA No. 77-830 certifies under FDCA Section 505(j)(2)(A)(vii) paragraph IV, that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘504 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy denies the remaining allegations of paragraph 20 of the Complaint. Ranbaxy admits that at the time it sent its notification, Ranbaxy was aware of 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6). Ranbaxy denies the remaining allegations of Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘504 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy admits its notification contained the Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 5 of 22 information required by 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6) with respect to the ‘504 patent. Ranbaxy denies the remaining allegations of paragraph 22 of the Complaint. Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘504 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy admits its notification to Plaintiffs contained the information required by 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6) with respect to the ‘504 patent. Ranbaxy denies the remaining allegations of paragraph 23 of the Complaint. Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘504 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy admits its notification to Plaintiffs contained the information required by 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6) with respect to the ‘504 patent. Ranbaxy denies the remaining allegations of paragraph 24 of the Complaint. Ranbaxy denies the allegations of paragraph 25 of the Complaint. Ranbaxy denies the allegations of paragraph 26 of the Complaint. Ranbaxy denies the allegations of paragraph 27 of the Complaint. Ranbaxy admits that ANDA No. 77-830 seeks approval to engage in the commercial manufacture, use or sale of a drug product containing esomeprazole magnesium. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 28 of the Complaint regarding how Ranbaxy’s esomeprazole magnesium product will be administered if it is approved and, therefore, denies these allegations on this basis. Ranbaxy denies the remaining allegations of paragraph 28 of the Complaint. Ranbaxy admits that ANDA No. 77-830 seeks approval to engage in the commercial manufacture, use or sale of a drug product containing esomeprazole magnesium. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 29 of the Complaint regarding how Ranbaxy’s esomeprazole magnesium product will be administered if it is approved and, therefore, denies these allegations on this basis. Ranbaxy denies the remaining allegations of paragraph 29 of the Complaint. Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘504 patent Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 6 of 22 will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted and does not address noninfringement of Claims 1-3 and 5-10 of the ‘504 patent. Ranbaxy denies the remaining allegations of paragraph 30 of the Ranbaxy denies the allegations of paragraph 31 of the Complaint. Ranbaxy admits that its notification included an offer of confidential access to ANDA No. 77-830 and related DMF. Ranbaxy admits that this offer was rejected. Ranbaxy admits that, by letter dated October 25, 2005, counsel for Plaintiffs requested that Ranbaxy provide various attorneys and scientists access to certain highly confidential documents and samples without adequate safeguards of confidentiality. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations of paragraph 32 of the Complaint and, therefore, denies the remaining allegations of paragraph 32 on this basis. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 33 of the Complaint and, therefore, denies the allegations of Ranbaxy admits that its notification included an offer of confidential access to ANDA No. 77-830 and related DMF. Ranbaxy admits that this offer was rejected. Ranbaxy admits that, by letter dated October 25, 2005, counsel for Plaintiffs requested that Ranbaxy provide various attorneys and scientists access to certain highly confidential documents and samples without adequate safeguards of confidentiality. Ranbaxy denies the remaining allegations of paragraph 34 of the Complaint. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 35 of the Complaint and, therefore, denies the allegations of SECOND CLAIM FOR RELIEF: ‘192 PATENT
Ranbaxy incorporates by reference and realleges each of the responses in paragraphs 1-15 and 19, above, as if set forth specifically here. Ranbaxy admits that a copy of the ‘192 patent is attached to the Complaint as Exhibit B, that the patent is titled “Method For The Treatment Of Gastric Acid-Related Diseases And Production Of Medication Using (-) Enantiomer Of Omeprazole,” that the patent indicates an issue date of March 2, 1999, that the patent lists Astra Aktiebolag as the assignee, and that the Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 7 of 22 patent lists Per Lindberg and Lars Weidolf as inventors. Ranbaxy denies the ‘192 patent has any valid claims covering methods for treatment of gastric acid related diseases by administering a therapeutically effective amount of esomeprazole magnesium. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations of paragraph 37 of the Complaint and, therefore, denies the remaining allegations of paragraph 37 on this basis. Ranbaxy 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 Ranbaxy admits that Plaintiffs were notified pursuant to FDCA Section 505(j)(2)(B) and 21 C.F.R. § 314.95 that ANDA No. 77-830 certifies under FDCA Section 505(j)(2)(A)(vii) paragraph IV, that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘192 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy denies the remaining allegations of paragraph 39 of the Complaint. Ranbaxy admits that at the time it sent its notification, Ranbaxy was aware of 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6). Ranbaxy denies the remaining allegations of Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘192 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy admits its notification contained the information required by 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6) with respect to the ‘192 patent. Ranbaxy denies the remaining allegations of paragraph 41 of the Complaint. Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘192 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy admits its notification to Plaintiffs contained the information required by 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6) with respect to the ‘192 patent. Ranbaxy denies the remaining allegations of paragraph 42 of the Complaint. Ranbaxy denies the allegations of paragraph 43 of the Complaint. Ranbaxy denies the allegations of paragraph 44 of the Complaint. Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 8 of 22 Ranbaxy denies the allegations of paragraph 45 of the Complaint. Ranbaxy admits that ANDA No. 77-830 seeks approval to engage in the commercial manufacture, use or sale of a drug product containing esomeprazole magnesium. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 46 of the Complaint regarding how Ranbaxy’s esomeprazole magnesium product will be administered if it is approved and, therefore, denies these allegations on this basis. Ranbaxy denies the remaining allegations of paragraph 46 of the Complaint. Ranbaxy admits that ANDA No. 77-830 seeks approval to engage in the commercial manufacture, use or sale of a drug product containing esomeprazole magnesium. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 47 of the Complaint regarding how Ranbaxy’s esomeprazole magnesium product will be administered if it is approved and, therefore, denies these allegations on this basis. Ranbaxy denies the remaining allegations of paragraph 47 of the Complaint. Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘192 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted and does not address noninfringement of Claims 1-7, 10- 19 and 21-23 of the ‘192 patent. Ranbaxy denies the remaining allegations of paragraph 48 of Ranbaxy denies the allegations of paragraph 49 of the Complaint. Ranbaxy admits that its notification included an offer of confidential access to ANDA No. 77-830 and related DMF. Ranbaxy admits that this offer was rejected. Ranbaxy admits that, by letter dated October 25, 2005, counsel for Plaintiffs requested that Ranbaxy provide various attorneys and scientists access to certain highly confidential documents and samples without adequate safeguards of confidentiality. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations of paragraph 50 of the Complaint and, therefore, denies the remaining allegations of paragraph 50 on this basis. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 51 of the Complaint and, therefore, denies the allegations of Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 9 of 22 Ranbaxy admits that its notification included an offer of confidential access to ANDA No. 77-830 and related DMF. Ranbaxy admits that this offer was rejected. Ranbaxy admits that, by letter dated October 25, 2005, counsel for Plaintiffs requested that Ranbaxy provide various attorneys and scientists access to certain highly confidential documents and samples without adequate safeguards of confidentiality. Ranbaxy denies the remaining allegations of paragraph 52 of the Complaint. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 53 of the Complaint and, therefore, denies the allegations of THIRD CLAIM FOR RELIEF: ‘872 PATENT
Ranbaxy incorporates by reference and realleges each of the responses in paragraphs 1-15 and 19, above, as if set forth specifically here. Ranbaxy admits a copy of the ‘872 patent is attached to the Complaint as Exhibit C, that the patent is titled “Compounds,” that the patent indicates an issue date of April 5, 2005, that the patent lists AstraZeneca as the assignee, and that the patent lists Per Lennart Lindberg and Sverker Von Unge as inventors. Ranbaxy denies the ‘872 patent has any valid claims covering esomeprazole magnesium salts. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations of paragraph 55 of the Complaint and, therefore, denies the remaining allegations of paragraph 55 on this basis. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 56 of the Complaint and, therefore, denies the allegations of Ranbaxy admits that Plaintiffs were notified pursuant to FDCA Section 505(j)(2)(B) and 21 C.F.R. § 314.95 that ANDA No. 77-830 certifies under FDCA Section 505(j)(2)(A)(vii) paragraph IV, that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘872 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy denies the remaining allegations of paragraph 57 of the Complaint. Ranbaxy admits that at the time it sent its notification, Ranbaxy was aware of 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6). Ranbaxy denies the remaining allegations of Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 10 of 22 Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘872 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy admits its notification to Plaintiffs contained the information required by 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6) with respect to the ‘872 patent. Ranbaxy denies the remaining allegations of paragraph 59 of the Complaint. Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘872 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy admits its notification to Plaintiffs contained the information required by 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6) with respect to the ‘872 patent. Ranbaxy denies the remaining allegations of paragraph 60 of the Complaint. Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘872 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy admits its notification to Plaintiffs contained the information required by 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6) with respect to the ‘872 patent. Ranbaxy denies the remaining allegations of paragraph 61 of the Complaint. Ranbaxy denies the allegations of paragraph 62 of the Complaint. Ranbaxy denies the allegations of paragraph 63 of the Complaint. Ranbaxy denies the allegations of paragraph 64 of the Complaint. Ranbaxy admits that ANDA No. 77-830 seeks approval to engage in the commercial manufacture, use or sale of a drug product containing esomeprazole magnesium. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 65 of the Complaint regarding how Ranbaxy’s esomeprazole magnesium product will be administered if it is approved and, therefore, denies these allegations on this basis. Ranbaxy denies the remaining allegations of paragraph 65 of the Complaint. Ranbaxy admits that ANDA No. 77-830 seeks approval to engage in the commercial manufacture, use or sale of a drug product containing esomeprazole magnesium. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 66 of the Complaint regarding how Ranbaxy’s esomeprazole Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 11 of 22 magnesium product will be administered if it is approved and, therefore, denies these allegations on this basis. Ranbaxy denies the remaining allegations of paragraph 66 of the Complaint. Ranbaxy admits that its notification to Plaintiffs alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘872 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted and does not address noninfringement of Claims 1, 2, 4, 5, 7, 8, 10 and 11 of the ‘872 patent. Ranbaxy denies the remaining allegations of Ranbaxy denies the allegations of paragraph 68 of the Complaint. Ranbaxy admits that its notification included an offer of confidential access to ANDA No. 77-830 and related DMF. Ranbaxy admits that this offer was rejected. Ranbaxy admits that, by letter dated October 25, 2005, counsel for Plaintiffs requested that Ranbaxy provide various attorneys and scientists access to certain highly confidential documents and samples without adequate safeguards of confidentiality. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations of paragraph 69 of the Complaint and, therefore, denies the remaining allegations of paragraph 69 on this basis. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 70 of the Complaint and, therefore, denies the allegations of Ranbaxy admits that its notification included an offer of confidential access to ANDA No. 77-830 and related DMF. Ranbaxy admits that this offer was rejected. Ranbaxy admits that, by letter dated October 25, 2005, counsel for Plaintiffs requested that Ranbaxy provide various attorneys and scientists access to certain highly confidential documents and samples without adequate safeguards of confidentiality. Ranbaxy denies the remaining allegations of paragraph 71 of the Complaint. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 72 of the Complaint and, therefore, denies the allegations of FOURTH CLAIM FOR RELIEF: ‘810 PATENT
Ranbaxy incorporates by reference and realleges each of the responses in paragraphs 1-15 and 19, above, as if set forth specifically here. Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 12 of 22 Ranbaxy admits that a copy of the ‘810 patent is attached to the Complaint as Exhibit D, that the patent is titled “Pharmaceutical Formulation Comprising Omeprazole,” that the patent indicates an issue date of August 6, 2002, that the patent lists AstraZeneca AB as the assignee, and that the patent lists Pontus Bergstrand and Peter Wang as inventors. Ranbaxy denies the ‘810 patent has any valid claims covering pharmaceutical formulations for esomeprazole magnesium and methods for treatment using the formulation. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations of paragraph 74 of the Complaint and, therefore, denies the remaining allegations of paragraph Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 75 of the Complaint and, therefore, denies the allegations of Ranbaxy admits that Plaintiffs were notified pursuant to FDCA Section 505(j)(2)(B) and 21 C.F.R. § 314.95 that ANDA No. 77-830 certifies under FDCA Section 505(j)(2)(A)(vii) paragraph IV, that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘810 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy denies the remaining allegations of paragraph 76 of the Complaint. Ranbaxy admits that at the time it sent its notification, Ranbaxy was aware of 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6). Ranbaxy denies the remaining allegations of Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘810 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy admits its notification to Plaintiffs contained the information required by 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6) with respect to the ‘810 patent. Ranbaxy denies the remaining allegations of paragraph 78 of the Complaint. Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘810 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy admits its notification to Plaintiffs contained Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 13 of 22 the information required by 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6) with respect to the ‘810 patent. Ranbaxy denies the remaining allegations of paragraph 79 of the Complaint. Ranbaxy denies the allegations of paragraph 80 of the Complaint. Ranbaxy denies the allegations of paragraph 81 of the Complaint. Ranbaxy denies the allegations of paragraph 82 of the Complaint. Ranbaxy admits that ANDA No. 77-830 seeks approval to engage in the commercial manufacture, use or sale of a drug product containing esomeprazole magnesium. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 83 of the Complaint regarding how Ranbaxy’s esomeprazole magnesium product will be administered if it is approved and, therefore, denies these allegations on this basis. Ranbaxy denies the remaining allegations of paragraph 83 of the Complaint. Ranbaxy admits that ANDA No. 77-830 seeks approval to engage in the commercial manufacture, use or sale of a drug product containing esomeprazole magnesium. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 84 of the Complaint regarding how Ranbaxy’s esomeprazole magnesium product will be administered if it is approved and, therefore, denies these allegations on this basis. Ranbaxy denies the remaining allegations of paragraph 84 of the Complaint. Ranbaxy denies the allegations of paragraph 85 of the Complaint. Ranbaxy admits that its notification included an offer of confidential access to ANDA No. 77-830 and related DMF. Ranbaxy admits that this offer was rejected. Ranbaxy admits that, by letter dated October 25, 2005, counsel for Plaintiffs requested that Ranbaxy provide various attorneys and scientists access to certain highly confidential documents and samples without adequate safeguards of confidentiality. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations of paragraph 86 of the Complaint and, therefore, denies the remaining allegations of paragraph 86 on this basis. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 87 of the Complaint and, therefore, denies the allegations of Ranbaxy admits that its notification included an offer of confidential access to ANDA No. 77-830 and related DMF. Ranbaxy admits that this offer was rejected. Ranbaxy admits that, by letter dated October 25, 2005, counsel for Plaintiffs requested that Ranbaxy Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 14 of 22 provide various attorneys and scientists access to certain highly confidential documents and samples without adequate safeguards of confidentiality. Ranbaxy denies the remaining allegations of paragraph 88 of the Complaint. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 89 of the Complaint and, therefore, denies the allegations of FIFTH CLAIM FOR RELIEF: ‘085 PATENT
Ranbaxy incorporates by reference and realleges each of the responses in paragraphs 1-15 and 19, above, as if set forth specifically here. Ranbaxy admits that a copy of the ‘085 patent is attached to the Complaint as Exhibit E, that the patent is titled “Form of S-Omeprazole,” that the patent indicates an issue date of April 9, 2002, that the patent lists AstraZeneca AB as the assignee, and that the patent lists Hanna Cotton, Anders Kronstrom, Anders Mattson and Eva Moller as inventors. Ranbaxy denies the ‘085 patent has any valid claim covering magnesium salts of esomeprazole trihydrate, pharmaceutical compositions comprising the claimed salts, or methods of treatment using the claimed salts. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations of paragraph 91 of the Complaint and, therefore, denies the remaining allegations of paragraph 91 on this basis. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 92 of the Complaint and, therefore, denies the allegations of Ranbaxy admits that Plaintiffs were notified pursuant to FDCA Section 505(j)(2)(B) and 21 C.F.R. § 314.95 that ANDA No. 77-830 certifies under FDCA Section 505(j)(2)(A)(vii) paragraph IV, that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘085 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy denies the remaining allegations of paragraph 93 of the Complaint. Ranbaxy admits that at the time it sent its notification, Ranbaxy was aware of 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6). Ranbaxy denies the remaining allegations of Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 15 of 22 Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘085 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy admits its notification to Plaintiffs contained the information required by 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6) with respect to the ‘085 patent. Ranbaxy denies the remaining allegations of paragraph 95 of the Complaint. Ranbaxy admits that its notification alleges that in the opinion of Ranbaxy Laboratories Ltd. and to the best of its knowledge, no valid and relevant claim of the ‘085 patent will be infringed by the manufacture, use, sale or offer to sell of the drug product for which ANDA No. 77-830 has been submitted. Ranbaxy admits its notification to Plaintiffs contained the information required by 21 U.S.C. § 355(j)(2) and 21 C.F.R. § 314.95(c)(6) with respect to the ‘085 patent. Ranbaxy denies the remaining allegations of paragraph 96 of the Complaint. Ranbaxy denies the allegations of paragraph 97 of the Complaint. Ranbaxy denies the allegations of paragraph 98 of the Complaint. Ranbaxy denies the allegations of paragraph 99 of the Complaint. Ranbaxy admits that ANDA No. 77-830 seeks approval to engage in the commercial manufacture, use or sale of a drug product containing esomeprazole magnesium. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 100 of the Complaint regarding how Ranbaxy’s esomeprazole magnesium product will be administered if it is approved and, therefore, denies these allegations on this basis. Ranbaxy denies the remaining allegations of paragraph 100 of the Complaint. Ranbaxy admits that ANDA No. 77-830 seeks approval to engage in the commercial manufacture, use or sale of a drug product containing esomeprazole magnesium. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 101 of the Complaint regarding how Ranbaxy’s esomeprazole magnesium product will be administered if it is approved and, therefore, denies these allegations on this basis. Ranbaxy denies the remaining allegations of paragraph 101 of the Complaint. Ranbaxy denies the allegations of paragraph 102 of the Complaint. Ranbaxy admits that its notification included an offer of confidential access to ANDA No. 77-830 and related DMF. Ranbaxy admits that this offer was rejected. Ranbaxy admits that, by letter dated October 25, 2005, counsel for Plaintiffs requested that Ranbaxy Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 16 of 22 provide various attorneys and scientists access to certain highly confidential documents and samples without adequate safeguards of confidentiality. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations of paragraph 103 of the Complaint and, therefore, denies the remaining allegations of paragraph 103 on this Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 104 of the Complaint and, therefore, denies the allegations of Ranbaxy admits that its notification included an offer of confidential access to ANDA No. 77-830 and related DMFs. Ranbaxy admits that this offer was rejected. Ranbaxy admits that, by letter dated October 25, 2005, counsel for Plaintiffs requested that Ranbaxy provide various attorneys and scientists access to certain highly confidential documents and samples without adequate safeguards of confidentiality. Ranbaxy denies the remaining allegations of paragraph 105 of the Complaint. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 106 of the Complaint and, therefore, denies the allegations of SIXTH CLAIM FOR RELIEF: ‘789 PATENT
Ranbaxy incorporates by reference and realleges each of the responses in paragraphs 1-15 and 19, above, as if set forth specifically here. Ranbaxy admits that a copy of the ‘789 patent is attached to the Complaint as Exhibit F, that the patent is titled “Process For Synthesis Of Substituted Sulphoxides,” that the patent indicates an issue date of September 7, 1999, that the patent lists Astra Aktiebolag as the assignee, and that the patent lists Magnus Erik Larsson, Urban Jan Stenhede, Henrik Sorensen, Sverker Per Oskar von Unge and Hanna Kristina Cotton as inventors. Ranbaxy denies the ‘789 patent has any valid and relevant claims covering esomeprazole magnesium or its method of use. Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the remaining allegations of paragraph 108 of the Complaint and, therefore, denies the remaining allegations of paragraph 108 on this basis. Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 17 of 22 Ranbaxy lacks knowledge or information sufficient to form a belief as to the truth of the allegations of paragraph 109 of the Complaint and, therefore, denies the allegations of Ranbaxy admits that Plaintiffs were notified pursuant to FDCA Section 505(j)(2)(B) and 21 C.F.R. § 314.95 that ANDA No. 77-830 was submitted to the FDA in order to obtain approval to engage in the commercial manufacture, use or sale of a drug product containing esomeprazole magnesium and that the proprietary name of the drug product esomeprazole magnesium as listed in the 22nd edition of the FDA’s publication entitled Approved Drug Products With Therapeutic Equivalence Evaluations (2002) (the “Orange Book”) is Nexium®. Ranbaxy denies the remaining allegations of paragraph 110 of the Ranbaxy denies the allegations of paragraph 111. AFFIRMATIVE DEFENSES
Ranbaxy does not infringe any valid and relevant claim of the ‘504, ‘192, ‘872, The relevant claims of the ‘504, ‘192, ‘872, ‘810, ‘085, and ‘789 patents are invalid under one or more of the provisions of Title 35 of the United States Code, including 35 U.S.C. §§ 101, 102, 103, 112, 282 and/or for double patenting. Plaintiffs have waived any defect in Ranbaxy’s October 14, 2005 notification Plaintiffs are estopped from asserting any alleged defect in Ranbaxy’s October 14, 2005 notification letter or its service. Plaintiffs’ request for a judgment of willfulness fails to state a claim upon which COUNTERCLAIMS
Defendants/Counterclaimants Ranbaxy Pharmaceuticals, Inc., Ranbaxy Inc. and Ranbaxy Laboratories Limited, (“Ranbaxy”) bring the following Counterclaims against Plaintiffs/Counterdefendants AstraZeneca AB, Aktiebolaget Hässle, AstraZeneca LP, KBI Inc., and KBI-E Inc. (“Counterdefendants”). JURISDICTION AND VENUE
Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 18 of 22 This is an action based upon an actual controversy between the parties concerning the invalidity and noninfringement of the ‘504, ‘192, ‘872, ‘810, ‘085 and ‘789 patents and Ranbaxy’s right to continue to seek approval of Ranbaxy’s ANDA No. 77-830, and upon approval by the FDA, to manufacture, use, market, sell, and offer to sell the product described in The Court has jurisdiction over these counterclaims pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201, 2202 and 35 U.S.C. § 271(e)(2). Venue is proper under 28 U.S.C. §§ 1391(b)-(d) and 1400, and by Ranbaxy has been and presently is engaged in the submission of documents for FDA approval to engage in the commercial manufacture, use, or sale of an esomeprazole magnesium product, which Counterdefendants have alleged infringes or will infringe the ‘504, ‘192, ‘872, ‘810, ‘085 and ‘789 patents. In view of the foregoing, a conflict of asserted rights has arisen between Ranbaxy and Counterdefendants with respect to the infringement and validity of the relevant claims of the ‘504, ‘192, ‘872, ‘810, ‘085 and ‘789 patents and as to Ranbaxy’s right to obtain FDA approval to engage in the commercial manufacture, use or sale of an esomeprazole magnesium product. An actual controversy exists between Ranbaxy and Counterdefendants. Ranbaxy Pharmaceuticals, Inc. is a corporation organized and existing under the laws of the State of Florida with a principal place of business at 9431 Florida Mining Blvd. East, Ranbaxy Inc. is a corporation organized and existing under the laws of the State of Delaware with a principal place of business at 600 College Road East, Princeton, New Jersey Ranbaxy Laboratories Limited is a corporation organized and existing under the laws of India with a principal place of business at Plot 89, 90, 91 Sector 32, Gurgaon -122001 Counterdefendants allege that AstraZeneca AB is a Swedish company having its principal place of business at Södertälje, Sweden. Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 19 of 22 Counterdefendants allege that Aktiebolaget Hässle is a Swedish company having its principal place of business at Mölndal, Sweden. Counterdefendants allege that AstraZeneca LP is Delaware limited partnership having its principal place of business at Wilmington, Delaware. Counterdefendants allege that KBI Inc. is a Delaware corporation having its principal place of business at Whitehouse Station, New Jersey. Counterdefendants allege that KBI-E Inc. is a Delaware corporation having its principal place of business at Wilmington, Delaware. COUNTERCLAIMS FOR JUDGMENT OF PATENT NONINFRINGEMENT
Ranbaxy realleges paragraphs 116-128, above, as if set forth specifically here. Ranbaxy does not infringe any valid and relevant claim of the ‘504 patent. Ranbaxy does not infringe any valid and relevant claim of the ‘192 patent. Ranbaxy does not infringe any valid and relevant claim of the ‘872 patent. Ranbaxy does not infringe any valid and relevant claim of the ‘810 patent. Ranbaxy does not infringe any valid and relevant claim of the ‘085 patent. Ranbaxy does not infringe any valid and relevant claim of the ‘789 patent. COUNTERCLAIMS FOR JUDGMENT OF PATENT INVALIDITY
Ranbaxy realleges paragraphs 116-128, above, as if set forth specifically here. The claims of the ‘504 patent are invalid for violation of one or more provisions of 35 U.S.C. §§ 101, 102, 103, 112, 282, and/or for double patenting. The claims of the ‘192 patent are invalid for violation of one or more provisions of 35 U.S.C. §§ 101, 102, 103, 112, 282, and/or for double patenting. The claims of the ‘872 patent are invalid for violation of one or more provisions of 35 U.S.C. §§ 101, 102, 103, 112, 282, and/or for double patenting. The claims of the ‘810 patent are invalid for violation of one or more provisions of 35 U.S.C. §§ 101, 102, 103, 112, 282, and/or for double patenting. The claims of the ‘085 patent are invalid for violation of one or more provisions of 35 U.S.C. §§ 101, 102, 103, 112, 282, and/or for double patenting. The claims of the ‘789 patent are invalid for violation of one or more provisions of 35 U.S.C. §§ 101, 102, 103, 112, 282, and/or for double patenting. COUNTERCLAIMS FOR ATTORNEYS’ FEES AND COSTS
Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 20 of 22 Ranbaxy realleges paragraphs 116-128, above, as if set forth specifically here. This case is exceptional under 35 U.S.C. § 285. Therefore, Counterdefendants should be ordered to pay Ranbaxy’s reasonable attorneys’ fees and costs under 35 U.S.C. § 285. DEMAND FOR JUDGMENT
WHEREFORE, Ranbaxy prays for the following relief: That all claims against Ranbaxy be dismissed with prejudice and that all relief requested by Plaintiffs/Counterdefendants be denied; That a judgment be entered declaring Ranbaxy has not infringed and does not infringe any valid and relevant claim of the ‘504, ‘192, ‘872, ‘810 ‘085 or ‘789 patents, that Ranbaxy Laboratories Limited has a lawful right to obtain FDA approval of ANDA 77-380 for its esomeprazole magnesium product, and further that Ranbaxy has a lawful right to manufacture, use, sell and/or offer to sell its ANDA product once approved by the FDA; That a judgment be entered declaring the claims of the ‘504, ‘192, ‘872, ‘810, That Plaintiffs/Counterdefendants and their agents, representatives, attorneys and those persons in active concert or participation with them who receive actual notice thereof, be preliminarily and permanently enjoined from threatening or initiating infringement litigation against Ranbaxy or any of its customers, dealers or suppliers, or any prospective or present sellers, dealers, distributors or customers of Ranbaxy, or charging any of them either orally or in writing with infringement of the ‘504, ‘192, ‘872, ‘810, ‘085 or ‘789 patents; That a judgment be entered declaring this action is an exceptional case within the meaning of 35 U.S.C. § 285, and that Ranbaxy is entitled to recover its reasonable attorneys’ fees That Ranbaxy be awarded such other and further relief as is just and proper. Robert G. Shepherd, Esq. Brooks R. Bruneau, Esq. Attorneys for Defendants and Counterclaimants, RANBAXY PHARMACEUTICALS, INC., RANBAXY INC. AND RANBAXY LABORATORIES LIMITED Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 21 of 22
OF COUNSEL:
Darrell L. Olson, Esq.
John P. Giezentanner, Esq.
Douglas G. Muehlhauser, Esq.
William R. Zimmerman, Esq.
Payson LeMeilleur, Esq.
Benjamin A. Katzenellenbogen, Esq.
KNOBBE, MARTENS, OLSON & BEAR, LLP
2040 Main Street, 14th Floor
Irvine, CA 92614
Telephone (949) 760-0404
Facsimile (949) 760-9502

Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 22 of 22 CERTIFICATE OF SERVICE
It is hereby certified that the undersigned has this day served a true and correct copy of DEFENDANTS RANBAXY PHARMACEUTICALS, INC.’S, RANBAXY INC.’S AND
RANBAXY LABORATORIES LIMITED’S ANSWER TO THE COMPLAINT AND
COUNTERCLAIMS to the following counsel in the manner indicated below:
VIA FEDERAL EXPRESS
VIA FIRST CLASS MAIL
McCARTER & ENGLISH LLP Four Gateway Center 100 Mulberry Street

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