Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 1 of 17 PageID: 57

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1 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 1 of 17 PageID: 57 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 (973) (telephone) Of Counsel William A. Rakoczy (wrakoczy@rmmslegal.com) Amy D. Brody (abrody@rmmslegal.com) Tara M. Raghavan (traghavan@rmmslegal.com) Thomas R. Burns (tburns@rmmslegal.com) Luke T. Shannon (lshannon@rmmslegal.com) Matthew V. Anderson (manderson@rmmslegal.com) RAKOCZY MOLINO MAZZOCHI SIWIK LLP 6 West Hubbard Street, Suite 500 Chicago, Illinois (312) (telephone) Attorneys for Defendant Lupin Limited UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY THE UNITED STATES OF AMERICA and THE ) BOARD OF TRUSTEES OF THE UNIVERSITY ) OF ILLINOIS, ) ) Plaintiffs, ) ) v. ) ) LUPIN LIMITED, ) ) Defendant. ) ) Civil Action No WHW-MAS FILED ELECTRONICALLY DEFENDANT LUPIN LIMITED S ANSWER, DEFENSES, AND COUNTERCLAIMS Defendant Lupin Limited ( Lupin Ltd. ) hereby answers the Complaint of The United States of America and The Board of Trustees of the University of Illinois (collectively, Plaintiffs ), for which every allegation not expressly admitted is denied, as follows:

2 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 2 of 17 PageID: 58 NATURE OF THE ACTION 1. This is an action for patent infringement under the patent laws of the United States, Title 35 of the United States Code, arising from Lupin s filing of an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (the FDA) seeking approval to commercially manufacture and market generic versions of the pharmaceutical drug product Prezista prior to the expiration of United States Patent No. 7,470,506 B1 (the 506 patent), which covers methods of using Prezista. Paragraph 1 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin Ltd. admits that this is an action for alleged patent infringement. Lupin Ltd. further admits that it has filed an Abbreviated New Drug Application ( ANDA ) seeking approval of the United States 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. 7,470,506 B1 ( the 506 patent ). Lupin Ltd. denies all remaining allegations of Paragraph 1. THE PARTIES 2. Plaintiff the United States of America is the government of the United States of America, which acts through its Department of Health and Human Services, National Institutes of Health, located in Bethesda, Maryland. Lupin Ltd. 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 Board of Trustees of the University of Illinois is a body corporate and politic of the State of Illinois, having a place of business in Urbana, Illinois. Lupin Ltd. 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. 4. Defendant Lupin Limited is a corporation organized and existing under the laws of India, having a principal place of business at B/4 Laxmi Towers, Bandra Kurla Complex, Bandra (E), Mumbai , India. On information and belief, Lupin is in the business of making and selling generic pharmaceutical products, which it distributes in the State of New Jersey and throughout the United States. Lupin has previously submitted to the jurisdiction of this Court, and has availed itself of the jurisdiction of this Court by filing lawsuits and asserting - 2 -

3 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 3 of 17 PageID: 59 counterclaims in lawsuits filed in the United States Court for the District of New Jersey. Lupin has also consented to jurisdiction in this District in other matters concerning the same ANDA. See The United States of America et al. v. Mylan Pharmaceuticals Inc. et al., Case No. 10-cv WHW-MAS, Tibotec Inc. et al v. Lupin Limited et al., Case No. 2:10-cv WHW- MAS, The United States of America et al. v. Teva Pharmaceuticals Inc. et al., Case No. 11-cv WHW-CCC, Tibotec Inc., et al. v. Teva Pharmaceuticals USA, Inc., et al., Case No. 2:11- cv whw-ccc, The United States of America et al. v. Hetero Drugs, Ltd. Unit III et al., 11-cv WHW-CCC, and Tibotec, Inc. and Tibotec Pharmaceuticals v. Hetero Pharmaceuticals USA, Inc., 11-cv-1696-WHW-CCC. Lupin Ltd. admits that it is an Indian corporation, having a place of business at B/4 Laxmi Towers, Bandra Kurla Complex, Bandra (E), Mumbai , India. In further answering, Lupin Ltd. admits that it develops and manufactures pharmaceutical products, including quality generic medicines. Lupin Ltd. denies all remaining allegations of Paragraph 4. JURISDICTION AND VENUE 5. This Court has subject matter jurisdiction over this action, pursuant to 28 U.S.C and 1338(a). Paragraph 5 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin Ltd. admits that subject matter jurisdiction is proper solely for the claims directed against it only under 35 U.S.C. 271(e)(2)(A). Lupin Ltd. denies all remaining allegations of Paragraph This Court has personal jurisdiction over Lupin by virtue of, inter alia, its having conducted business in New Jersey, having availed itself of the rights and benefits of New Jersey law, having previously consented to personal jurisdiction in this Court, having availed itself of the jurisdiction of this Court, and having engaged in systematic and continuous contacts with the State of New Jersey. Paragraph 6 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

4 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 4 of 17 PageID: Venue is proper in this District pursuant to 28 U.S.C and 1400(b). Paragraph 7 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 venue solely for the limited purposes of this action only. THE PATENT-IN-SUIT 8. On December 30, 2008, the United States Patent and Trademark Office issued the 506 patent, entitled Fitness Assay and Associated Methods. At the time of its issue, the 506 patent was assigned to the Plaintiffs, and the Plaintiffs currently hold title to the 506 patent. A copy of the 506 patent is attached hereto as Exhibit A. Paragraph 8 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin Ltd. admits that, according to the electronic records of the United States Patent and Trademark Office ( PTO ), the PTO issued the 506 patent, titled FITNESS ASSAY AND ASSOCIATED METHODS, on or about December 30, 2008, and that what purports to be a copy of the 506 patent is attached to the Complaint as Exhibit A. Lupin Ltd. admits that the electronic records of the PTO identify Government of the United States of America, Represented by the Secretary, Department of Health and Human Services and Board of Trustees of the University of Illinois as the purported assignees of the 506 patent. Lupin Ltd. denies all remaining allegations of Paragraph As authorized by a license agreement with the University of Illinois, the government granted a non-exclusive license of the 506 patent to Tibotec Pharmaceuticals, (formerly known as Tibotec Pharmaceuticals Ltd.). Tibotec Pharmaceuticals (Tibotec) is an Irish corporation having its principal place of business as Eastgate Village, Eastgate, Little Island, County Cork, Ireland. Paragraph 9 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin Ltd. lacks knowledge or information - 4 -

5 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 5 of 17 PageID: 61 sufficient to form a belief as to the truth of the allegations of Paragraph 9, and therefore denies all such allegations. PREZISTA 10. Tibotec holds approved New Drug Application (NDA) No for Duranavir [sic] Ethanolate Tablets, 75 mg, 150 mg, 400 mg, and 600 mg dosage strengths, which are sold by Tibotec under the trade name Prezista. Paragraph 10 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin Ltd. admits that FDA s Orange Book identifies TIBOTEC as the purported applicant for NDA No for PREZISTA. Lupin Ltd. denies all remaining allegations of Paragraph Pursuant to 21 U.S.C. 355(b)(1) and attendant FDA regulations, the 506 patent is listed in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) with respect to Prezista. Paragraph 11 contains legal conclusions to which no answer is required. To the extent an answer is required, Lupin Ltd. admits that FDA s Orange Book identifies the 506 patent in connection with PREZISTA. Lupin Ltd. denies all remaining allegations of Paragraph 11. LUPIN S ANDA 12. On information and belief, Lupin submitted ANDA No to the FDA pursuant to 12 U.S.C. 355(j), seeking approval to commercially manufacture, use, and market Darunavir Ethanolate Tablets, 75 mg, 150 mg, and 300 mg (Lupin s Product). Paragraph 12 contains legal conclusions to which no answer is required. To the extent an answer is required, denied. In further answering, Lupin Ltd. avers that it has filed with FDA an ANDA seeking approval for Darunavir Ethanolate Tablets, 75 mg, 150 mg, 300 mg, 400 mg and 600 mg. 13. Lupin s ANDA refers to, and rely upon, the Prezista NDA and contains data that, according to Lupin, demonstrates the bioequivalence of Lupin s Product to Prezista

6 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 6 of 17 PageID: 62 Lupin Ltd. admits that the Reference Listed Drug product that is the basis for Lupin Ltd. s ANDA is Prezista. Lupin Ltd. further states that its ANDA contains information and data required by FDA for the submission of an ANDA. Lupin Ltd. denies all remaining allegations of Paragraph The government and the University of Illinois received letters from Lupin, dated June 3, 2011, and attached memoranda (collectively, Lupin s Notifications), stating that Lupin had included certifications in its ANDA, pursuant to 21 U.S.C. 355(j)(2)(A)(vii)(IV), that the 506 patent is invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale of Lupin s Product (the Paragraph IV certifications). The Plaintiffs are filing this complaint within the 45 day interval of receipt of Lupin s ANDA as specified by 21 U.S.C. 355(c)(3)(C). Lupin Ltd. admits that, in a letter dated June 3, 2011, it gave written notification to, among others, Plaintiffs that it had filed an ANDA with FDA seeking approval for Darunavir Ethanolate Tablets, which ANDA contains a certification pursuant to 21 U.S.C. 355(j)(2)(A)(vii)(IV) stating, among other things, that in its opinion and to the best of its knowledge, the 506 patent is invalid, unenforceable and/or will not be infringed by the manufacture, use, sale, offer for sale and/or importation of its proposed ANDA products. In further answering, Lupin Ltd. admits that, according to online records of this judicial District, Plaintiffs filed the instant action on or about July 14, Lupin Ltd. denies all remaining allegations of Paragraph 14. COUNT ONE: INDUCEMENT OF INFRINGEMENT OF THE 506 PATENT 15. Plaintiffs reallege and incorporate by reference the allegations of paragraphs 1-14 of this Complaint. Lupin Ltd. restates and incorporates by reference its answers to the allegations of Paragraphs 1 through 14 as though fully set forth herein. 16. Under 35 U.S.C. 271(b), [w]hoever actively induces infringement of a patent shall be liable as an infringer

7 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 7 of 17 PageID: 63 Paragraph 16 states legal conclusions to which no answer is required. To the extent an answer is required, denied. 17. The proposed generic versions of Prezista as described in ANDA No , if utilized in treatment according to their proposed indications, will infringe every limitation of at least one claim of the 506 patent. 18. Lupin is thus knowingly, intentionally, and deliberately seeking approval of a product that, if used according to its indications, will infringe the 506 patent. 19. In addition, if ANDA No is approved, Lupin will be knowingly, intentionally, deliberately and actively involved in inducing treating physicians, among others, to utilize Lupin s Product in a manner that infringes the 506 patent. 20. Lupin is therefore liable under 35 U.S.C. 271(e)(2) for inducement of infringement of the 506 patent. COUNT TWO: CONTRIBUTORY INFRINGEMENT OF THE 506 PATENT 21. Plaintiffs reallege and incorporate by reference the allegations of paragraphs 1-20 of this Complaint. Lupin Ltd. restates and incorporates by reference its answers to the allegations of Paragraphs 1 through 20 as though fully set forth herein. 22. The proposed generic versions of Prezista as described in ANDA No , if utilized in treatment according to their proposed indications, will infringe every limitation of at least one claim of the 506 patent. 23. Lupin is thus knowingly, intentionally, and deliberately seeking approval of a product that, if used according to its indications, will infringe the 506 patent

8 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 8 of 17 PageID: Lupin s commercial manufacture, use, offer to sell, or sale of Lupin s Product within the United States, or importation of Lupin s Product into the United States while knowing Lupin s Product to be especially made or especially adapted for use is an infringement of the 506 patent, and not a staple article or commodity of commerce suitable for substantial noninfringing use during the term of the 506 patent will contributorily infringe the 506 patent under 35 U.S.C. 271(a), (b), and/or (c). 25. The Plaintiffs will be substantially and irreparably harmed if Lupin is not enjoined from infringing the 506 patent. 26. The Plaintiffs have no adequate remedy at law. 27. This case is an exceptional one, and Plaintiffs are entitled to an award of attorneys fees under 35 U.S.C * * * Lupin Ltd. denies all remaining allegations not specifically admitted herein. Lupin Ltd. further denies that Plaintiffs are entitled to the relief requested, or to any relief whatsoever. Lupin Ltd. respectfully requests that the Court: (a) dismiss the Complaint with prejudice; (b) enter judgment in favor of Lupin Ltd.; (c) award Lupin Ltd. the reasonable attorneys fees and costs of defending this action pursuant to 35 U.S.C. 285; and (d) award Lupin Ltd. such further relief as the Court deems just and appropriate

9 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 9 of 17 PageID: 65 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. ) avers and asserts the following separate defenses to the Complaint: First Defense The claims of U.S. Patent No. 7,470,506 B1 ( the 506 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, use, sale, offer for sale and/or importation of Lupin Ltd. s proposed Darunavir Ethanolate Tablets that are the subject of its Abbreviated New Drug Application ( ANDA ), would not infringe, either directly or indirectly, any valid and enforceable claim of the 506 patent, either literally or under the doctrine of equivalents. Third Defense Lupin Ltd. has not and will not induce or contribute to infringement of any valid and enforceable claim of the 506 patent. Fourth Defense The Court lacks subject matter jurisdiction over 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

10 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 10 of 17 PageID: 66 Sixth Defense Any claim of infringement of the 506 patent would be limited by the doctrine of prosecution history estoppel. Seventh Defense The Complaint fails to state a claim for willful infringement and/or exceptional case. Eighth Defense Any additional defenses or counterclaims that discovery may reveal, including unenforceability. * * *

11 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 11 of 17 PageID: 67 COUNTERCLAIMS Defendant/Counterclaim-Plaintiff Lupin Limited, for its Counterclaims against Plaintiffs/Counterclaim-Defendants The United States of America and The Board of Trustees of the University of Illinois (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. Plaintiff The United States of America purports to be the government of the United States of America, which acts through its Department of Health and Human Services, National Institutes of Health, located in Bethesda, Maryland. 3. Plaintiff The Board of Trustees of the University of Illinois purports to be a body corporate and politic of the State of Illinois, having a place of business in Urbana, Illinois. Jurisdiction and Venue 4. 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 This Court has original jurisdiction over the subject matter of these Counterclaims under 28 U.S.C and 1338(a). 6. 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 Ltd. in this District. 7. Venue is proper in this District under 28 U.S.C and 1400(b)

12 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 12 of 17 PageID: 68 Patent-in-Suit 8. On or about December 30, 2008, the U.S. Patent and Trademark Office ( PTO ) issued U.S. Patent No. 7,470,506 B1 ( the 506 patent ), entitled FITNESS ASSAY AND ASSOCIATED METHODS, to John W. Erickson, Sergei V. Gulnik, Hiroaki Mitsuya and Arun K. Ghosh. patent. 9. Plaintiffs purport and claim to own, and to have the right to enforce, the The 506 patent was submitted to the United States 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 ( NDA ) for PREZISTA (darunavir) Tablets, 75 mg, 150 mg, 300 mg, 400 mg and 600 mg tablets. 11. On or about July 14, 2011, Plaintiffs sued Lupin Ltd. in this District alleging infringement of the 506 patent under 35 U.S.C. 271(e)(2)(A) and 35 U.S.C. 271(a)-(c). Count I (Declaratory Judgment of Non-Infringement of the 506 Patent) 12. Lupin Ltd. adopts by reference, repeats, and realleges its specific allegations and averments in the preceding paragraphs above as if fully set forth herein. 13. A definite and concrete, real and substantial, justiciable controversy of sufficient immediacy and reality exists between Lupin Ltd. and Plaintiffs regarding non-infringement of the 506 patent. 14. 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 506 patent

13 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 13 of 17 PageID: Lupin Ltd. 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 506 patent. Count II (Declaratory Judgment of Invalidity of the 506 Patent) 16. Lupin Ltd. adopts by reference, repeats, and realleges its specific allegations and averments in the preceding paragraphs above as if fully set forth herein. 17. A definite and concrete, real and substantial, justiciable controversy of sufficient immediacy and reality exists between Lupin Ltd. and Plaintiffs regarding, inter alia, the invalidity of the 506 patent. 18. The claims of the 506 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. invalid. 19. Lupin Ltd. is entitled to a judicial declaration that the claims of the 506 patent are against Plaintiffs: Prayer for Relief WHEREFORE, Lupin Ltd. respectfully prays for judgment in its favor and (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 506 patent; (b) Declaring that the claims of the 506 patent are invalid;

14 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 14 of 17 PageID: 70 (c) Ordering that Plaintiffs Complaint be dismissed with prejudice and judgment entered in favor of Lupin Ltd.; (d) Declaring this case exceptional and awarding Lupin Ltd. its reasonable attorneys fees and costs of these Counterclaims under 35 U.S.C. 285; and (e) Awarding Lupin Ltd. such other and further relief as the Court may deem just and proper. DEMAND FOR JURY TRIAL Lupin Ltd. hereby demands a jury trial on all issues so triable. Respectfully submitted, CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO, P.C. Attorneys for Defendant Lupin Limited By: /s/ Melissa E. Flax James E. Cecchi (JCecchi@carellabyrne.com) Melissa E. Flax (mflax@carellabyrne.com) 5 Becker Farm Road Roseland, New Jersey (973) (telephone) Of Counsel William A. Rakoczy (wrakoczy@rmmslegal.com) Amy D. Brody (abrody@rmmslegal.com) Tara M. Raghavan (traghavan@rmmslegal.com) Thomas R. Burns (tburns@rmmslegal.com) Luke T. Shannon (lshannon@rmmslegal.com) Matthew V. Anderson (manderson@rmmslegal.com) RAKOCZY MOLINO MAZZOCHI SIWIK LLP 6 West Hubbard Street, Suite 500 Chicago, Illinois (312) (telephone) Dated: September 12,

15 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 15 of 17 PageID: 71 CERTIFICATION PURSUANT TO LOCAL CIVIL RULES 11.2 & 40.1 On behalf of defendants Lupin Ltd., I hereby certify that the following actions are related: Tibotec Inc. et al v. Lupin Limited et al., Case No. 10-cv WHW-MAS; The United States of America et al. v. Mylan Pharmaceuticals Inc. et al., Case No. 10-cv WHW-MCA; The United States of America et al. v. Teva Pharmaceuticals Inc. et al., Case No. 11-cv-1461-WHW-MCA; Tibotec Inc. et al. v. Teva Pharmaceuticals USA, Inc. et al., Case No. 11-cv WHW-MCA; Tibotec Inc. et al. v. Hetero Drugs, Ltd. Unit III et al., Case No. 11- cv whw-mca; Tibotec Inc. et al. v. Lupin Limited et al., Case No. 11-cv WHW- MAS; and Tibotec Inc. et al. v. Lupin Limited 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. Respectfully submitted, CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO, P.C. Attorneys for Defendant Lupin Limited By: /s/ Melissa E. Flax James E. Cecchi (JCecchi@carellabyrne.com) Melissa E. Flax (mflax@carellabyrne.com) 5 Becker Farm Road Roseland, New Jersey (973) (telephone) Of Counsel William A. Rakoczy (wrakoczy@rmmslegal.com) Amy D. Brody (abrody@rmmslegal.com) Tara M. Raghavan (traghavan@rmmslegal.com) Thomas R. Burns (tburns@rmmslegal.com) Luke T. Shannon (lshannon@rmmslegal.com) Matthew V. Anderson (manderson@rmmslegal.com) RAKOCZY MOLINO MAZZOCHI SIWIK LLP

16 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 16 of 17 PageID: 72 Dated: September 12, West Hubbard Street, Suite 500 Chicago, Illinois (312) (telephone)

17 Case 2:11-cv WHW -MCA Document 7 Filed 09/12/11 Page 17 of 17 PageID: 73 CERTIFICATION PURSUANT TO L. CIV. R Pursuant to Local Civil Rule 201.1, the undersigned counsel for Defendant/Counterclaim-Plaintiff Lupin Limited hereby certifies that Lupin Limited 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. Dated: September 12, 2011 Respectfully submitted, CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO, P.C. Attorneys for Defendant Lupin Limited By: /s/ Melissa E. Flax James E. Cecchi (JCecchi@carellabyrne.com) Melissa E. Flax (mflax@carellabyrne.com) 5 Becker Farm Road Roseland, New Jersey (973) (telephone) Of Counsel William A. Rakoczy (wrakoczy@rmmslegal.com) Amy D. Brody (abrody@rmmslegal.com) Tara M. Raghavan (traghavan@rmmslegal.com) Thomas R. Burns (tburns@rmmslegal.com) Luke T. Shannon (lshannon@rmmslegal.com) Matthew V. Anderson (manderson@rmmslegal.com) RAKOCZY MOLINO MAZZOCHI SIWIK LLP 6 West Hubbard Street, Suite 500 Chicago, Illinois (312) (telephone)