Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 1 of 20 PageID: 141

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1 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 1 of 20 PageID: 141 James E. Cecchi (JCecchi@carellabyrne.com Melissa E. Flax (mflax@carellabyrne.com CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO, P.C. 5 Becker Farm Road Roseland, New Jersey ( (telephone Of Counsel William A. Rakoczy (wrakoczy@rmmslegal.com Amy D. Brody (abrody@rmmslegal.com Tara M. Raghavan (traghavan@rmmslegal.com Theodore J. Chiacchio (tchiacchio@rmmslegal.com Matthew V. Anderson (manderson@rmmslegal.com RAKOCZY MOLINO MAZZOCHI SIWIK LLP 6 West Hubbard Street, Suite 500 Chicago, Illinois ( (telephone Attorneys for Defendants Lupin Ltd. and Lupin Pharmaceuticals, Inc. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY JANSSEN PRODUCTS, L.P., JANSSEN R&D IRELAND, and G.D. SEARLE, LLC, v. LUPIN LIMITED and LUPIN PHARMACEUTICALS INC., Plaintiffs, Defendants. Civil Action No WHW-MCA (Consolidated with C.A. No (WHW(MCA FILED ELECTRONICALLY LUPIN LIMITED S AND LUPIN PHARMACEUTICALS, INC. S ANSWER, DEFENSES AND COUNTERCLAIMS Defendants Lupin Limited ( Lupin Ltd. and Lupin Pharmaceuticals, Inc. ( LPI (collectively, Lupin hereby answer the Complaint of Plaintiffs Janssen Products, L.P.

2 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 2 of 20 PageID: 142 and Janssen R&D Ireland (collectively, Janssen, and G.D. Searle, LLC ( Searle (collectively, Plaintiffs, for which every allegation not expressly admitted is denied, as follows: NATURE OF THE ACTION 1. This is a civil action for infringement of U.S. Patent No. RE42,889 (the 889 Patent arising under the patent laws of the United States, 35 U.S.C. 1 et seq. This action arises out of Defendants filing of Abbreviated New Drug Application ( ANDA seeking approval to sell generic copies of Plaintiffs highly successful PREZISTA (darunavir 75 mg, 150 mg, 300 mg, 400 mg, and 600 mg products prior to the expiration of the 889 Patent. Paragraph 1 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin admits that this is an action for alleged patent infringement. Lupin further admits that Lupin Ltd. has filed an Abbreviated New Drug Application ( ANDA seeking approval of the U.S. Food and Drug Administration ( FDA for Darunavir Ethanolate Tablets, 75 mg, 150 mg, 300 mg, 400 mg and 600 mg, prior to the expiration of U.S. Patent No. RE42,889 ( the 889 patent. Lupin denies all remaining allegations of Paragraph 1. THE PARTIES 2. Plaintiff Janssen Products, L.P., is a partnership organized under the laws of the State of New Jersey, having its headquarters and principal place of business at 800/850 Ridgeview Drive, Horsham, PA Lupin lacks knowledge or information sufficient to form a belief as to the truth of the allegations of Paragraph 2, and therefore denies all such allegations. 3. Plaintiff Janssen R&D Ireland (formerly known as Tibotec Pharmaceuticals is an Irish corporation having its principal place of business at Eastgate Village, Eastgate, Little Island, County Cork, Ireland. Lupin lacks knowledge or information sufficient to form a belief as to the truth of the allegations of Paragraph 3, and therefore denies all such allegations

3 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 3 of 20 PageID: Plaintiff G.D. Searle, LLC is a Delaware limited liability company having a principal place of business at 235 East 42nd Street, New York, New York Lupin lacks knowledge or information sufficient to form a belief as to the truth of the allegations of Paragraph 4, and therefore denies all such allegations. 5. On information and belief, Lupin Ltd. is an Indian corporation having a place of business at B/4 Laxmi Towers, Bandra-Kurla Complex, Bandra (E, Mumbai , India, and having a registered office at 159 CST Road, Kalina, Santacruz (E, Mumbai , India. On information and belief, Lupin Ltd. is in the business of, among other things, manufacturing and selling generic copies of branded pharmaceutical products for the U.S. market through various operating subsidiaries, including Lupin Pharmaceuticals. Lupin admits that Lupin Ltd. is an Indian corporation, having a place of business at B/4 Laxmi Towers, Bandra Kurla Complex, Bandra (E, Mumbai , India and a registered office at 159 CST Road, Kalina, Santacruz (E, Mumbai , India. In further answering, Lupin admits that Lupin Ltd. develops and manufactures pharmaceutical products, including quality generic medicines. Lupin denies all remaining allegations of Paragraph On information and belief, Lupin Pharmaceuticals is a corporation organized and existing under the laws of the Commonwealth of Virginia, having a place of principal business at Harborplace Tower, 111 South Calvert Street, Baltimore, Maryland On information and belief, Lupin Pharmaceuticals is in the business of, among other things, manufacturing and selling generic copies of branded pharmaceutical products for the U.S. market. Lupin Pharmaceuticals is a wholly owned subsidiary of Lupin Ltd. Paragraph 6 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin admits that LPI is a Virginia corporation having a place of business at Harborplace Tower, 111 South Calvert Street, Baltimore, Maryland Lupin further admits that LPI is a wholly-owned subsidiary of Lupin Ltd. Lupin denies all remaining allegations of Paragraph

4 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 4 of 20 PageID: 144 JURISDICTION AND VENUE 7. This Court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C and 1338(a. Paragraph 7 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin admits that subject matter jurisdiction is proper solely for the claims directed against Lupin Ltd. only under 35 U.S.C. 271(e(2(A. Lupin denies that subject matter jurisdiction is proper as to LPI, and for any claims asserted under 35 U.S.C. 271(a, (b or (c. Lupin denies all remaining allegations of Paragraph On information and belief, this Court has personal jurisdiction over Lupin Ltd. because Lupin Ltd. has purposely availed itself of the benefits and protections of New Jersey s laws such that it should reasonably anticipate being haled into court here. On information and belief, Lupin Ltd. has had persistent and continuous contacts with this judicial district, including developing, manufacturing and/or selling pharmaceutical products that are sold in this judicial district. Paragraph 8 contains legal conclusions to which no answer is required. To the extent an answer is required, denied. Further answering, solely to conserve the resources of the parties and the Court, Lupin Ltd. does not contest personal jurisdiction in this judicial District solely for the limited purpose of this action only. 9. On information and belief, this Court has personal jurisdiction over Lupin Pharmaceuticals because Lupin Pharmaceuticals has purposely availed itself of the benefits and protections of New Jersey s laws such that it should reasonably anticipate being haled into court here. On information and belief, Lupin Pharmaceuticals has had persistent and continuous contacts with this judicial district, including developing, manufacturing and/or selling pharmaceutical products that are sold in this judicial district. Paragraph 9 contains legal conclusions to which no answer is required. To the extent an answer is required, denied. Further answering, Lupin denies that LPI is a proper party to this action. Further answering, solely to conserve the resources of the parties and the Court, LPI does not contest personal jurisdiction in this judicial District solely for the limited purpose of this action only

5 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 5 of 20 PageID: On information and belief, Lupin Ltd. and Lupin Pharmaceuticals operate and act in concert as an integrated, unitary business. For example, Lupin Ltd. includes within its Annual Report the activities of Lupin Pharmaceuticals, including revenue earned. Paragraph 10 contains legal conclusions to which no answer is required. To the extent an answer is required, denied. 11. On information and belief, Lupin Pharmaceuticals is registered to do business in New Jersey. Paragraph 11 contains legal conclusions to which no answer is required. To the extent an answer is required, admitted. 12. On information and belief, Lupin Pharmaceuticals has appointed National Registered Agents, Inc. of Princeton, New Jersey as its registered agent for the receipt of service of process. Lupin admits that LPI has appointed National Registered Agents, Inc. of Princeton, New Jersey, as its registered agent in New Jersey. Lupin denies all remaining allegations of Paragraph Lupin Ltd. and Lupin Pharmaceuticals have stipulated and/or consented to personal jurisdiction in this district in numerous prior patent cases, including in the related consolidated action, Janssen Products, L.P., et al. v. Lupin Limited, et al., 10-cv-5954 (WHW (MCA. Paragraph 13 contains legal conclusions to which no answer is required. To the extent an answer is required, denied. Further answering, solely to conserve the resources of the parties and the Court, Lupin Ltd. and LPI do not contest personal jurisdiction in this judicial District solely for the limited purpose of this action only. 14. Venue is proper in this Court pursuant to 28 U.S.C and 1400(b. Paragraph 14 contains legal conclusions to which no answer is required. To the extent an answer is required, denied. Further answering, solely to conserve the - 5 -

6 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 6 of 20 PageID: 146 resources of the parties and the Court, Lupin does not contest venue as to Lupin Ltd. and LPI solely for the limited purposes of this action only. BACKGROUND 15. On November 1, 2011, the United States Patent and Trademark Office ( the PTO issued the 889 Patent, entitled α- and β-amino Acid Hydroxyethylamino Sulfonamides Useful as Retroviral Protease Inhibitors. A true and correct copy of the 889 Patent is attached hereto as Exhibit A. Paragraph 15 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin admits that, according to the electronic records of the United States Patent and Trademark Office ( PTO, the PTO issued the 889 patent, titled α- AND β-amino ACID HYDROXYETHYLAMINO SULFONAMIDES USEFUL AS RETROVIRAL PROTEASE INHIBITORS, on or about November 1, 2011, and that what purports to be a copy of the 645 patent is attached to the Complaint as Exhibit A. Lupin denies all remaining allegations of Paragraph Plaintiff Searle holds title to the 889 Patent. Paragraph 16 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin admits that the records of the PTO identify G.D. Searle LLC as the purported assignee of the 889 patent. Lupin denies all remaining allegations of Paragraph The 889 Patent is a reissue of U.S. Patent No. 5,968,942 ( the 942 Patent. Paragraph 17 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin admits that the records of the PTO indicate that the 889 patent issued from a reissue application of U.S. Patent No. 5,968,942 ( the 942 patent. Lupin denies all remaining allegations of Paragraph The 942 Patent was filed on August 23, 1994, and issued on October 19,

7 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 7 of 20 PageID: 147 Paragraph 18 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin admits that according to the records of the PTO, the 942 patent issued on or about October 19, 1999, from U.S. Application 08/294,468, which was filed on or about August 23, Lupin denies all remaining allegations of Paragraph Plaintiff Janssen R&D Ireland has an exclusive license to the 889 Patent. Paragraph 19 contains legal conclusions to which no answer is required. Lupin lacks knowledge or information sufficient to form a belief as to the truth of the allegations of Paragraph 19, and therefore denies all such allegations. 20. The 889 Patent expires on October 19, Paragraph 20 contains legal conclusions to which no answer is required. To the extent an answer is required, denied. 21. The United States Food and Drug Administration ( FDA has awarded 6 months of pediatric exclusivity for PREZISTA. The period of pediatric exclusivity applicable to the 889 Patent does not expire until April 19, Paragraph 21 contains legal conclusions to which no answer is required. To the extent an answer is required, denied. 22. Janssen Products, L.P., is the holder of approved New Drug Application ( NDA No for PREZISTA. The NDA was formerly held by Tibotec Inc. The NDA was transferred to Janssen Products, L.P., on December 23, Paragraph 22 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin admits that FDA s Orange Book identifies JANSSEN PRODS as the purported applicant for NDA No for PREZISTA. Lupin denies all remaining allegations of Paragraph

8 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 8 of 20 PageID: PREZISTA is included in the FDA s list of Approved Drug Products With Therapeutic Equivalence Evaluations also known as the Orange Book. Approved drugs may be used as the basis of a later applicant s ANDA to obtain approval of the ANDA applicant s drug product under the provisions of 21 U.S.C. 355(j. Paragraph 23 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin admits that FDA s Orange Book lists PREZISTA. Lupin denies all remaining allegations of Paragraph The FDA s Orange Book also lists patents associated with approved drugs. The 889 Patent is listed in the Orange Book in association with PREZISTA (darunavir. The claims of the 889 Patent cover PREZISTA. Lupin admits that FDA s Orange Book identifies the 889 patent in connection with PREZISTA. Lupin denies all remaining allegations of Paragraph On information and belief, Lupin Ltd., itself and/or through its subsidiary, agent and alter ego, Lupin Pharmaceuticals, submitted ANDA No to the FDA under 505(j of the Federal Food, Drug and Cosmetic Act ( FDCA, 21 U.S.C. 355(j, seeking approval to engage in the commercial manufacture, use, offer for sale, and sale of generic versions of the PREZISTA 75 mg, 150 mg, 300 mg, 400 mg and 600 mg tablets ( Lupin s Generic Tablets. Paragraph 25 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin admits that Lupin Ltd. filed with FDA an ANDA seeking approval for Darunavir Ethanolate Tablets, 75 mg, 150 mg, 300 mg, 400 mg and 600 mg. Lupin denies all remaining allegations of Paragraph On information and belief, Lupin Ltd. and Lupin Pharmaceuticals collaborated in the research, development, preparation and filing of ANDA No for Lupin s Generic Tablets. Denied. 27. On information and belief, Lupin Pharmaceuticals will market and/or distribute Lupin s Generic Tablets if ANDA No is approved by the FDA. Denied

9 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 9 of 20 PageID: On information and belief, Lupin Pharmaceuticals participated in, contributed to, aided, abetted and/or induced the submission to the FDA of ANDA No Denied. 29. On or about March 30, 2012, Plaintiffs received a letter dated March 28, 2012 (the March 2012 Lupin Paragraph IV Letter stating that Defendants had submitted ANDA No seeking approval to manufacture, use and sell Lupin s Generic Tablets prior to the expiration of the 889 Patent. Lupin admits that, in a letter dated March 28, 2012, Lupin Ltd. gave written notification to, among others, Plaintiffs that Lupin Ltd. filed an ANDA with FDA seeking approval for Darunavir Ethanolate Tablets, 75 mg, 150 mg, 300 mg, 400 mg and 600 mg, before the expiration of the 889 patent. Lupin denies all remaining allegations of Paragraph The March 2012 Lupin Paragraph IV Letter also stated that Lupin ANDA No included a certification, pursuant to 21 U.S.C. 355(j(2(A(vii(IV, that the claims of the 889 Patent are invalid and/or not infringed. Lupin admits that, in a letter dated March 28, 2012, Lupin Ltd. gave written notification to, among others, Plaintiffs that Lupin Ltd. filed an ANDA with FDA for approval for Darunavir Ethanolate Tablets, 75 mg, 150 mg, 300 mg, 400 mg and 600 mg, which ANDA contains a certification pursuant to 21 U.S.C. 355(j(2(A(vii(IV stating, among other things, that in Lupin Ltd. s opinion and to the best of its knowledge, the 889 patent is invalid. Lupin denies all remaining allegations of Paragraph On information and belief, Lupin Ltd. and Lupin Pharmaceuticals continue to collaborate in seeking approval of ANDA No from the FDA and intend to collaborate in the commercial manufacture, marketing and sale of Lupin s Generic Tablets (including the commercial marketing and sale of such products in the State of New Jersey in the event that the FDA approves ANDA No Denied

10 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 10 of 20 PageID: Plaintiffs commenced this action within forty-five days of the date they received the March 2012 Lupin Paragraph IV Letter, containing the Paragraph IV certification for the 889 Patent. Paragraph 32 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin admits that, according to online records of this judicial District, Plaintiffs filed the instant action on or about May 10, Lupin denies all remaining allegations of Paragraph 32. COUNT I Infringement of the 889 Patent by Defendants 33. Plaintiffs repeat and reallege each and every allegation contained in paragraphs 1 through 32 hereof, as if fully set forth herein. Lupin restates and incorporates by reference its answers to the allegations of Paragraphs 1 through 32 as though fully set forth herein. 34. Defendants have infringed the 889 Patent under 35 U.S.C. 271(e(2(A by submitting ANDA No with a Paragraph IV certification and seeking FDA approval of ANDA No prior to the expiration of the 889 Patent. Denied. 35. Defendants had actual and constructive notice of the 889 Patent prior to filing the March 2012 Lupin Paragraph IV Letter for ANDA No Denied. 36. Plaintiffs have no adequate remedy at law to redress the infringement by Defendants. Denied. 37. Plaintiffs will be irreparably harmed if Defendants are not enjoined from infringing or actively inducing or contributing to infringement of the 889 Patent. Denied. * * *

11 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 11 of 20 PageID: 151 Lupin denies all remaining allegations not specifically admitted herein. Lupin further denies that Plaintiffs are entitled to the relief requested, or to any relief whatsoever. Lupin respectfully requests that the Court: (a dismiss the Complaint with prejudice; (b enter judgment in favor of Lupin; (c award Lupin the reasonable attorneys fees and costs of defending this action pursuant to 35 U.S.C. 285; and (d award Lupin such further relief as the Court deems just and appropriate

12 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 12 of 20 PageID: 152 SEPARATE DEFENSES Without prejudice to the denials set forth in its Answer, without admitting any averments of the Complaint not otherwise admitted, and without undertaking any of the burdens imposed by law on the Plaintiffs, Lupin Limited ( Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, Lupin aver and assert the following separate defenses to the Complaint: First Defense The claims of U.S. Patent No. RE42,889 E ( the 889 patent are invalid for failure to comply with one or more of the conditions for patentability set forth in Title 35 of the United States Patent Code. Second Defense The manufacture, sale, use, offer for sale, and/or importation of Lupin Ltd. s proposed Darunavir Ethanolate Tablets that are the subject of its Abbreviated New Drug Application, would not infringe, either directly or indirectly, any valid and enforceable claim of the 889 patent, either literally or under the doctrine of equivalents. Third Defense Lupin Pharmaceuticals, Inc. is not a proper defendant under 35 U.S.C. 271(e(2(A. Fourth Defense The Court lacks subject matter jurisdiction over any and all claims asserted against Lupin Pharmaceuticals, Inc. and any and all claims asserted under 35 U.S.C. 271(a, (b or (c. Fifth Defense The Complaint fails to state a claim upon which relief can be granted

13 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 13 of 20 PageID: 153 Sixth Defense The Complaint fails to state a claim for willful infringement and/or exceptional case. Seventh Defense Any additional defenses or counterclaims that discovery may reveal, including unenforceability. * * *

14 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 14 of 20 PageID: 154 COUNTERCLAIMS Defendants/Counterclaim-Plaintiffs Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively, Lupin for their Counterclaims against Plaintiffs/Counterclaim-Defendants Janssen Products, L.P., Janssen R&D Ireland and G.D. Searle, LLC (collectively, Plaintiffs, allege as follows: The Parties 1. Lupin Limited ( Lupin Ltd. is a corporation organized and existing under the laws of India, having a place of business at B/4 Laxmi Towers, Bandra Kurla Complex, Bandra (E, Mumbai , India. 2. Lupin Pharmaceuticals, Inc. is a corporation organized and existing under the laws of the Commonwealth of Virginia, having a place of business at Harborplace Tower, 111 South Calvert Street, Baltimore, Maryland Plaintiff Janssen Products, L.P., purports to be a partnership organized under the laws of the State of New Jersey, having its headquarters and principal place of business at 800/850 Ridgeview Drive, Horsham, Pennsylvania Plaintiff Janssen R&D Ireland (formerly known as Tibotec Pharmaceuticals purports to be an Irish corporation having its principal place of business at Eastgate Village, Eastgate, Little Island, County Cork, Ireland. 5. Plaintiff G.D. Searle, LLC purports to be a Delaware limited liability company having its principal place of business at 235 East 42 nd Street, New York, New York Jurisdiction and Venue 6. These Counterclaims 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

15 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 15 of 20 PageID: This Court has original jurisdiction over the subject matter of these Counterclaims under 28 U.S.C and 1338(a. 8. This Court has personal jurisdiction over Plaintiffs because Plaintiffs have availed themselves of the rights and privileges, and subjected themselves to the jurisdiction, of this forum by suing Lupin in this District, and/or because Plaintiffs conduct substantial business in this District. 9. Venue is proper in this District under 28 U.S.C. 1391(b and 1400(b. Patents-in-Suit 10. On or about November 1, 2011, the U.S. Patent and Trademark Office ( PTO issued U.S. Patent No. RE42,889 E ( the 889 patent, entitled α- AND β-amino ACID HYDROXYETHYLAMINO SULFONAMIDES USEFUL AS RETROVIRAL PROTEASE INHIBITORS, to Michael L. Vazquez, Richard A. Mueller, John J. Talley, Daniel P. Getman, Gary A. DeCrescenzo, John N. Freskos, Robert M. Heintz, and Deborah E. Bertenshaw. 11. G.D. Searle, LLC purports and claims to own, and to have the right to enforce, the 889 patent. 12. Plaintiffs submitted the 889 patent to the U.S. Food and Drug Administration ( FDA for listing in FDA s publication, Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book, in connection with approved New Drug Application for PREZISTA (darunavir Tablets, 75 mg, 150 mg, 300 mg, 400 mg and 600 mg tablets. 13. On or about May 10, 2012, Plaintiffs sued Lupin in this District alleging infringement of the 889 patent under 35 U.S.C. 271(e(2(A and 35 U.S.C. 271(a-(c

16 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 16 of 20 PageID: 156 Count I (Declaratory Judgment of Non-Infringement of the 889 Patent 14. Lupin adopts by reference, repeats, and realleges its specific allegations and averments in the preceding paragraphs above as if fully set forth herein. 15. A definite and concrete, real and substantial, justiciable controversy of sufficient immediacy and reality exists between Lupin and Plaintiffs regarding non-infringement of the 889 patent. 16. The manufacture, use, sale, offer for sale and/or importation of the Darunavir Ethanolate Tablets that are the subject of Lupin Ltd. s Abbreviated New Drug Application ( ANDA have not infringed, do not infringe, and would not, if marketed, infringe any valid and/or enforceable claim of the 889 patent. 17. Lupin is entitled to a judicial declaration that the manufacture, use, sale, offer for sale and/or importation of the Darunavir Ethanolate Tablets that are the subject of Lupin Ltd s ANDA have not infringed, do not infringe, and would not, if marketed, infringe any valid and/or enforceable claim of the 889 patent. Count II (Declaratory Judgment of Invalidity of the 889 Patent 18. Lupin adopts by reference, repeats, and realleges its specific allegations and averments in the preceding paragraphs above as if fully set forth herein. 19. A definite and concrete, real and substantial, justiciable controversy of sufficient immediacy and reality exists between Lupin and Plaintiffs regarding, inter alia, the invalidity of the 889 patent. 20. The claims of the 889 patent are invalid for failure to comply with one or more of the conditions of patentability set forth in Title 35 of the United States Patent Code

17 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 17 of 20 PageID: 157 invalid. 21. Lupin is entitled to a judicial declaration that the claims of the 889 patent are Prayer for Relief Plaintiffs: WHEREFORE, Lupin respectfully prays for judgment in its favor and against (a Declaring that the manufacture, use, sale, offer for sale and/or importation of the Darunavir Ethanolate Tablets that are the subject of Lupin Ltd. s ANDA have not infringed, do not infringe, and would not, if marketed, infringe any valid and/or enforceable claim of the 889 patent; (b (c Declaring that the claims of the 889 patent are invalid; Ordering that Plaintiffs Complaint be dismissed with prejudice and judgment entered in favor of Lupin; (d Declaring this case exceptional and awarding Lupin its reasonable attorneys fees and costs of these Counterclaims under 35 U.S.C. 285; and (e Awarding Lupin such other and further relief as the Court may deem just and proper. DEMAND FOR JURY TRIAL Lupin hereby demands a jury trial on all issues so triable

18 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 18 of 20 PageID: 158 Dated: July 23, 2012 Respectfully submitted, CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO, P.C. Attorneys for Defendants/Counterclaim-Plaintiffs Lupin Ltd. and Lupin Pharmaceuticals, Inc. By: /s/ Melissa E. Flax James E. Cecchi Melissa E. Flax 5 Becker Farm Road Roseland, New Jersey ( (telephone Of Counsel William A. Rakoczy Amy D. Brody Tara M. Raghavan Theodore J. Chiacchio Matthew V. Anderson RAKOCZY MOLINO MAZZOCHI SIWIK LLP 6 West Hubbard Street, Suite 500 Chicago, Illinois ( (telephone

19 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 19 of 20 PageID: 159 CERTIFICATION PURSUANT TO LOCAL CIVIL RULE 11.2 & 40.1 On behalf of Defendants/Counterclaim-Plaintiffs Lupin Ltd. and Lupin Pharmaceuticals, Inc., I hereby certify that the following pending actions are related: Janssen Products, L.P. et al. v. Lupin Limited et al., Case No. 10-cv WHW-MCA (consolidated and Tibotec Inc. et al. v. Hetero Drugs, Ltd. Unit III et al., Case No. 11-cv WHW-MCA. I further certify that, to the best of my knowledge, the matter in controversy is not the subject of any other action pending in any court in this jurisdiction, or of any pending arbitration or administrative proceedings. Dated: July 23, 2012 Respectfully submitted, CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO, P.C. Attorneys for Defendants/Counterclaim-Plaintiffs Lupin Ltd. and Lupin Pharmaceuticals, Inc. By: /s/ Melissa E. Flax James E. Cecchi (JCecchi@carellabyrne.com Melissa E. Flax (mflax@carellabyrne.com 5 Becker Farm Road Roseland, New Jersey ( (telephone Of Counsel William A. Rakoczy (wrakoczy@rmmslegal.com Amy D. Brody (abrody@rmmslegal.com Tara M. Raghavan (traghavan@rmmslegal.com Theodore J. Chiacchio (tchiacchio@rmmslegal.com Matthew V. Anderson (manderson@rmmslegal.com RAKOCZY MOLINO MAZZOCHI SIWIK LLP 6 West Hubbard Street, Suite 500 Chicago, Illinois ( (telephone

20 Case 2:12-cv WHW-MCA Document 10 Filed 07/23/12 Page 20 of 20 PageID: 160 CERTIFICATION PURSUANT TO L. CIV. R Pursuant to Local Civil Rule 201.1, the undersigned counsel for Defendants/Counterclaim-Plaintiffs Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively, Lupin hereby certifies that Lupin s counterclaims herein seek injunctive relief and damages, excluding interest, costs and punitive damages, in excess $150,000. This action is, therefore, not appropriate for compulsory arbitration. Respectfully submitted, CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO, P.C. Attorneys for Defendants/Counterclaim-Plaintiffs Lupin Limited and Lupin Pharmaceuticals, Inc. By: /s/ Melissa E. Flax James E. Cecchi (JCecchi@carellabyrne.com Melissa E. Flax (mflax@carellabyrne.com 5 Becker Farm Road Roseland, New Jersey ( (telephone Dated: July 23, 2012 Of Counsel William A. Rakoczy (wrakoczy@rmmslegal.com Amy D. Brody (abrody@rmmslegal.com Tara M. Raghavan (traghavan@rmmslegal.com Theodore J. Chiacchio (tchiacchio@rmmslegal.com Matthew V. Anderson (manderson@rmmslegal.com RAKOCZY MOLINO MAZZOCHI SIWIK LLP 6 West Hubbard Street, Suite 500 Chicago, Illinois ( (telephone