Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 1 of 22 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

Transcription

1 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 1 of 22 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE BRISTOL-MYERS SQUIBB CO., and BRISTOL-MYERS SQUIBB PHARMA CO. Plaintiffs, v. MYLAN PHARMACEUTICALS INC., MATRIX LABORATORIES LTD., and MATRIX LABORATORIES INC. Defendants. Civil Action No JJF ANSWER, DEFENSES, AND COUNTERCLAIMS OF MYLAN PHARMACEUTICALS INC. AND MATRIX LABORATORIES LTD. Defendants Mylan Pharmaceuticals Inc. and Matrix Laboratories Ltd. (collectively Defendants answer the Complaint of Plaintiffs Bristol-Myers Squibb Co. and Bristol-Myers Squibb Pharma Co. (collectively Plaintiffs as follows: The Parties 1. Bristol-Myers Squibb Co. is a corporation organized and existing under the laws of the State of Delaware, having its principal place of business at 345 Park Avenue, New York, NY Defendants lack sufficient knowledge and information to form a belief as to the truth of the allegations contained in paragraph 1 of the Complaint, and, on that basis, Defendants deny those allegations. 1

2 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 2 of Bristol-Myers Squibb Pharma Co., an indirect wholly-owned subsidiary of Bristol-Myers Squibb Co., is a general partnership organized and existing under the laws of the State of Delaware, having its principal place of business at Route 206 and Province Line Road, Lawrenceville, New Jersey Defendants lack sufficient knowledge and information to form a belief as to the truth of the allegations contained in paragraph 2 of the Complaint, and, on that basis, Defendants deny those allegations. 3. On information and belief, Defendant Mylan Pharms. is a corporation organized and existing under the laws of the State of West Virginia with its principal place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia On information and belief, Mylan Pharms. is wholly-owned or controlled by Mylan Laboratories, Inc. ( Mylan Labs., which is a corporation organized and existing under the laws of the Commonwealth of Pennsylvania, with a principal place of business at 1500 Corporate Drive, Suite 400, Canonsburg, Pennsylvania On information and belief, Mylan Pharms. is in the business of manufacturing generic pharmaceutical drugs that it distributes and sells in and throughout the United States including the State of Delaware. Defendants admit that Mylan Pharmaceuticals Inc. is a defendant in this action and is a corporation organized and existing under the laws of the State of West Virginia with its principal place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia Defendants admit that Mylan Pharmaceuticals Inc. is a wholly owned subsidiary of Mylan Inc., formerly known as Mylan Laboratories, Inc., which is a corporation organized and existing under the laws of the Commonwealth of Pennsylvania, with a principal place of business 2

3 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 3 of 22 at 1500 Corporate Drive, Suite 400, Canonsburg, Pennsylvania Defendants deny the remaining allegations in paragraph 3 of the Complaint. 4. On information and belief, Defendant Matrix Ltd. is wholly-owned or controlled by Mylan Labs, and is a corporation operating and existing under the laws of India with its principal place of business at /1, 4th Floor, Sal Ram Towers, Alexander Road, Secunderabad , Andhra, Pradesh, India. Defendants admit that Matrix Laboratories Ltd. ( Matrix Ltd. is a defendant in this action and is a wholly owned indirect subsidiary of Mylan Inc., formerly known as Mylan Laboratories, Inc., operating and existing under the laws of India with its principal place of business at /1, 4th Floor, Sal Ram Towers, Alexander Road, Secunderabad , Andhra, Pradesh, India. Defendants deny the remaining allegations in paragraph 4 of the Complaint. 5. On information and belief, Defendant Matrix Inc. is a subsidiary and the U.S. agent of Matrix Ltd., organized and existing under the laws of the State of Delaware with a principal place of business at 76 South Orange Avenue, Suite 301, South Orange, NJ Defendants admit that Matrix Inc. is an indirect subsidiary of Matrix Ltd. organized and existing under the laws of the State of Delaware with a principal place of business at 76 South Orange Avenue, Suite 301, South Orange, NJ 07079, and occasionally acts as the U.S. agent for Matrix Ltd. Defendants deny the remaining allegations in paragraph 5 of the Complaint. 6. On information and belief, Defendants collaborate to manufacture, import, distribute and sell pharmaceutical products (including generic drug products manufactured and 3

4 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 4 of 22 sold pursuant to approved abbreviated new drug applications in the United States generally, and the State of Delaware specifically. Defendants deny the allegations in paragraph 6 of the Complaint. Nature of the Action 7. This is an action for patent infringement of United States Patent Number 6,673,372 B1 ( the 372 patent arising under the patent laws of the United States, Title 35, United States Code, 100 et seq., and in particular under 35 U.S.C. 271(e. This action relates to Abbreviated New Drug Application ( ANDA No , which Matrix Ltd. filed or caused to be filed under 21 U.S.C. 355(j with the United States Food and Drug Administration ( FDA for approval to market a generic version of BMS s successful Sustiva tablets that are sold in the United States, including this district. Defendants admit that Plaintiffs purport to assert one or more claims of infringement of the 372 patent. Defendants admit that Plaintiffs purport to assert such claims under the patent laws of the United States, Title 35, United States Code, 100 et seq., and in particular under 35 U.S.C. 271(e. Defendants admit that Plaintiffs purport to have asserted patent infringement claims related to ANDA No , which Matrix Ltd. filed or caused to be filed under 21 U.S.C. 355(j with the FDA seeking approval for Matrix Ltd. s generic efavirenz product, and that ANDA No speaks for itself. Defendants deny the remaining allegations in paragraph 7 of the Complaint. Jurisdiction and Venue 8. This Court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C and 1338(a. 4

5 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 5 of 22 Defendants deny that that the Court may exercise jurisdiction over this action under 28 U.S.C and 1338(a. 9. Defendants sell various prescription products and conduct business throughout the United States, including this District. Defendants deny the allegations in paragraph 9 of the Complaint. 10. Defendants manufacture bulk pharmaceuticals and pharmaceutical products that are regularly sold and used throughout the United States, including this District. Defendants sell their products in the United States, including this District, through retail drug store chains, wholesalers, distributors, health care organizations and governmental concerns. Defendants deny the allegations in paragraph 10 of the Complaint. 11. This Court has personal jurisdiction over each Defendant by virtue of the fact that, inter alia, each Defendant has committed, or aided, abetted, contributed to and/or participated in the commission of, the tortious act of patent infringement that has led to foreseeable harm and injury to BMS, a Delaware corporation. This court has personal jurisdiction over each of the Defendants for the additional reasons set forth below. Defendants do not contest personal jurisdiction in this Court for the purpose of this action only. Defendants deny the remaining allegations in paragraph 11 of the Complaint. 12. This Court has personal jurisdiction over Mylan Pharms. by virtue of, inter alia, its having conducted business in Delaware, having availed itself of the rights and benefits of Delaware law, and having engaged in substantial and continuing contacts with the State. In 5

6 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 6 of 22 addition, it sells various products and does business throughout the United States, including specifically in the State of Delaware. Defendants do not contest personal jurisdiction in this Court for the purpose of this action only. Defendants deny the remaining allegations in paragraph 12 of the Complaint. 13. On information and belief, Mylan Pharms. has previously availed itself of this forum for purposes of litigating its patent disputes. For example, in 2002, Mylan Pharms. filed a patent infringement lawsuit styled Mylan Pharmaceuticals Inc. v. Kremers Urban Development Company et al., C.A. No (D. Del.. Mylan Pharms. also has submitted to the jurisdiction of this Court by asserting counterclaims in other civil actions initiated in this jurisdiction. For example, Mylan Pharms. admitted jurisdiction (for purposes of the litigation and filed counterclaims in AstraZeneca LP v. Mylan Pharmaceuticals. Inc., C.A. No (D. Del.; AstraZeneca Pharmaceuticals LP v. Mylan Pharmaceuticals, Inc., C.A. No (D. Del.; Sciele Pharma Inc. v. Mylan Pharmaceuticals. Inc., C.A. No (D. Del.; Boehringer Ingelheim International GMBH v. Mylan Pharmaceuticals, Inc., C.A. No (D. Del.; and Janssen Pharmaceutica N.V. v. Mylan Pharmaceuticals, Inc., C.A. No (D. Del.. Defendants do not contest personal jurisdiction in this Court for the purpose of this action only. Defendants admit that Mylan Pharmaceuticals Inc. has been a party to the actions identified in paragraph 13 of the Complaint but deny the implied legal conclusion in paragraph 13 of the Complaint that Mylan Pharmaceuticals Inc. s participation in such actions gives rise to personal jurisdiction over Mylan Pharmaceuticals Inc. in the District of Delaware in any other action. Defendants deny the remaining allegations in paragraph 13 of the Complaint. 6

7 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 7 of This Court has personal jurisdiction over Matrix Ltd. and Matrix Inc. by virtue of, inter alia, their having conducted business in Delaware, having availed itself of the rights and benefits of Delaware law, and having engaged in substantial and continuing contacts with the State. In addition, they sell various products and do business throughout the United States, including specifically in the State of Delaware. Defendants deny that Matrix Inc. is a proper party to this action. Defendants do not contest personal jurisdiction in this Court for the purpose of this action only. Defendants deny the remaining allegations in paragraph 14 of the Complaint. 15. On information and belief, Matrix Inc., the United States agent and subsidiary of Matrix Ltd., is a Delaware corporation. Matrix Ltd., through Matrix Inc., is registered to do business in Delaware and has a registered agent in Delaware. In addition, it sells various products and does business throughout the United States, including specifically in the State of Delaware. Defendants deny that Matrix Inc. is a proper party to this action. Defendants admit that Matrix Inc. is an indirect subsidiary of Matrix Ltd. and is organized under the laws of the State of Delaware. Defendants further admit that Matrix Inc. occasionally acts as U.S. agent for Matrix Ltd. Defendants do not contest personal jurisdiction in this Court for the purpose of this action only. Defendants deny the remaining allegations in paragraph 15 of the Complaint. 16. Venue is proper in this judicial district pursuant to 28 U.S.C and 1400(b. Defendants do not contest venue in this judicial district, but Defendants deny that this judicial district is the most appropriate and convenient forum venue for this action. 7

8 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 8 of 22 The Patents-In-Suit 17. The 372 patent was duly and legally issued by the United States Patent and Trademark Office on January 6, Bristol-Myers Squibb Pharma Co. is the owner by assignment of the 372 patent and has the right to sue for infringement thereof. A true and correct copy of the 372 patent is attached as Exhibit A. Defendants admit that the 372 patent purports to have issued from the United States Patent and Trademark Office on January 6, Defendants deny that the 372 patent was duly and legally issued. Upon information and belief, Defendants admit that Bristol- Myers Squibb Pharma Co. is an assignee of the 372 patent. Defendants admit that Plaintiffs purport to attach a true and correct copy of the 372 patent as Exhibit A to the Complaint. Defendants lack sufficient knowledge and information to form a belief as to the truth of the remaining allegations contained in paragraph 17 of the Complaint, and, on that basis, Defendants deny those allegations. The Infringing Conduct by Defendants 18. Bristol-Myers Squibb Co. is the holder of approved New Drug Application ( NDA No for efavirenz tablets, which BMS markets and sells under the trademark Sustiva. BMS manufactures and sells a 600 mg dosage strength of Sustiva tablets in the United States under NDA No Defendants admit that Plaintiffs are indicated in the records of the FDA as the holder of NDA No for efavirenz tablets. Defendants lack sufficient knowledge and information to form a belief as to the truth of the remaining allegations contained in paragraph 18 of the Complaint, and, on that basis, Defendants deny those allegations. 8

9 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 9 of On information and belief, Defendants filed with the FDA ANDA No under 21 U.S.C. 3 55(j(2(B, seeking to obtain approval to commercially manufacture, use, offer for sale and sell, before the expiration of the 372 patent, a generic version of Sustiva for the treatment of human immunodeficiency virus type 1 infection. Defendants admit that Matrix Ltd. filed or caused to be filed with the FDA ANDA No under 21 U.S.C. 355(j(2(B prior to the expiration of the 372 patent seeking approval for Matrix Ltd. s generic efavirenz product, and that ANDA No speaks for itself. Defendants deny the remaining allegations in paragraph 19 of the Complaint. 20. On or about July 16, 2009, BMS received a letter ( Defendants Notice Letter dated July 16, 2009, from Defendants stating that Matrix Labs. Ltd. had filed Defendants ANDA seeking approval to manufacture, use, offer for sale and sell a generic version of Sustiva efavirenz tablets before the expiration of U.S. Patent Nos. 6,639,071 and 6,939,964, owned by Merck & Co., Inc. by assignment. Defendants Notice Letter provides a detailed statement of the factual and legal basis for Defendants paragraph IV certification regarding U.S. Patent Nos. 6,639,071 and 6,939,964, owned by Merck & Co., Inc. by assignment. Defendants Notice Letter did not provide a detailed statement of the factual and legal basis for any claim of noninfringement of any claim of the 372 patent. Defendants admit that by letter dated July 16, 2009 (the July 16 letter, and addressed to Mr. James M. Cornelius, Chairman and CEO, Bristol-Meyers Squibb, 345 Park Avenue, New York, New York 10154, and Mr. Richard T. Clark, Chairman, President and CEO, Merck & Co., Inc., One Merck Drive, Whitehouse Station, New Jersey 08889, Defendants provided notification of paragraph IV certifications regarding Patent Nos. 6,639,071 and 9

10 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 10 of 22 6,939,964, as well as a detailed statement of the factual and legal basis for the paragraph IV certifications. Defendants admit that the July 16 letter did not and was not required to include a detailed statement of the factual and legal basis for any claim of noninfringement of any claim of the 372 patent. Defendants lack sufficient knowledge and information to form a belief as to the truth of the remaining allegations contained in paragraph 20 of the Complaint, and, on that basis, Defendants deny those allegations. 21. Defendants Notice Letter contained an X-ray powder diffraction ( XRPD analysis related to generic efavirenz tablets that are the subject of ANDA No Defendants Notice Letter contained, inter alia, two figures that purported to be the XRPD pattern of efavirenz form-ß (dry and the XRPD pattern of efavirenz form-ß (wet. Defendants Notice Letter also contained, inter alia, two tables that purported to be the XRPD data for efavirenz form- ß (dry and the XRPD data of efavirenz form- ß (wet. Defendants admit that the July 16 letter contained, inter alia, information pertaining to XRPDs of the efavirenz product that that is the subject of ANDA No Defendants further admit that the July 16 letter included, inter alia, two figures depicting the XRPD patterns of efavirenz form-ß (dry and the XRPD pattern of efavirenz form-ß (wet. Defendants further admit that the July 16 letter included, inter alia, two tables detailing the XRPD data for efavirenz form-ß (dry and the XRPD data of efavirenz form-ß (wet. Defendants deny the remaining allegations in paragraph 21 of the Complaint. 22. At least ten (10 of the D-spacings for both the efavirenz form- ß (dry and efavirenz form- ß (wet as reported in Defendants Notice Letter correspond to the 20 values for Form 5 efavirenz as taught and claimed in the 372 patent. Form 5 of crystalline efavirenz is 10

11 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 11 of 22 characterized by the presence of at least four (4 20 values from the group of 10.2±0.2, 11.4±0.2, 11.6±0.2, 12.6±0.2, 19.1±0.2, 20.6±0.2, 21.3±0.2, 22.8±0.2, 24.8±0.2, 27.4±0.2, 28.2±0.2, and 31.6±0.2. The characteristics of the Defendants efavirenz form-ß (dry and efavirenz form-ß (wet as reported in Defendants Notice Letter indicate the presence of more than four of the required values. Defendants deny the allegations in paragraph 22 of the Complaint. 23. Therefore, based on the information provided in Defendants Notice Letter, efavirenz form-ß, as described in ANDA No , infringes one or more of the claims of the 372 patent, including at least claim 16. Defendants deny the allegations in paragraph 23 of the Complaint. Count I Patent Infringement of the 372 Patent 24. BMS re-alleges and incorporates by reference paragraphs 1-23 as if fully recited herein. Defendants reassert and incorporate by reference their responses to paragraph 1-23 above as if fully set forth herein. 25. Through the filing of ANDA No , Defendants have infringed one or more claims of the 372 patent covering efavirenz and uses thereof under 35 U.S.C. 271(e(2, and such infringement will cause BMS irreparable harm unless enjoined by this Court. Defendants deny the allegations in paragraph 25 of the Complaint. 11

12 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 12 of 22 Count II Declaratory Judgment of Patent Infringement of the 372 Patent 26. BMS re-alleges and incorporates by reference paragraphs 1-23 as if fully recited herein. Defendants reassert and incorporate by reference their responses to paragraph 1-23 above as if fully set forth herein. 27. This claim arises under the Declaratory Judgment Act, 28 U.S.C. 2201, 2202, based upon an actual controversy between the parties. Defendants have taken immediate and active steps to obtain FDA permission to sell in the United States and, after obtaining FDA permission, to commence sale in the United States of Defendants efavirenz product before the expiration date of the 372 patent. There is a real and actual controversy between the parties with respect to Defendants activities and infringement of the 372 patent. Defendants deny the allegations in paragraph 27 of the Complaint. 28. The manufacture and sale by Defendants of their efavirenz tablets during the term of the 372 patent will constitute patent infringement of the 372 Patent under 35 U.S.C. 271(a. Defendants deny the allegations in paragraph 28 of the Complaint. 29. On information and belief, by seeking FDA approval for the efavirenz product as described in Defendants Notice Letter, Defendants intend to import into the United States and/or offer to sell, sell or use within the United States, all for purposes not exempt under 35 U.S.C. 271 (e( 1, the efavirenz product that is the subject of ANDA No , which would infringe, and the use of which would infringe, the 372 patent. Defendants deny the allegations in paragraph 29 of the Complaint. 12

13 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 13 of BMS will be irreparably harmed if Defendants are not enjoined from infringing the 372 patent. Defendants deny the allegations in paragraph 30 of the Complaint. GENERAL DENIAL Any allegation in Plaintiffs Complaint not expressly admitted by Defendants is hereby denied. Having answered Plaintiffs Complaint, Defendants deny that Plaintiffs are entitled to the relief requested in Plaintiffs Prayer for Relief or to any relief whatsoever. DEFENSES Without prejudice to the denials set forth in their Answer to the Complaint, and without admitting any allegations of the Complaint not otherwise admitted, Defendants assert the following defenses to the Complaint: FIRST DEFENSE The manufacture, use, or sale, offer for sale, or importation of the products that are the subject of Defendants ANDA No ( Defendants Products have not infringed, do not infringe, and would not, if marketed, manufactured, used, sold, offered for sale, or imported, infringe any valid or enforceable claim of the 372 patent. SECOND DEFENSE The claims of the 372 patent are invalid for failure to satisfy one or more of the conditions for patentability contained in 35 U.S.C. 101, 102, 103, 112 and/or 116. THIRD DEFENSE By virtue of the prosecution proceedings before the United States Patent and Trademark Office of the patent application leading to the 372 patent, Plaintiffs are estopped from 13

14 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 14 of 22 maintaining that any valid or enforceable claim of the 372 patent is infringed by the Defendants Products. FOURTH DEFENSE This Court may not exercise subject matter jurisdiction over the claims asserted in the Complaint, as there is no present case or controversy between the Plaintiffs and Defendants. FIFTH DEFENSE Plaintiffs have failed to state a claim upon which relief can be granted. SIXTH DEFENSE Any and all additional defenses and counterclaims that discovery may reveal. COUNTERCLAIMS For their counterclaims against Plaintiffs/Counterclaim Defendants Bristol-Myers Squibb Co. and Bristol-Myers Squibb Pharma Co. (collectively Counterclaim Defendants, Defendants/Counterclaim Plaintiffs Mylan Pharmaceuticals Inc. and Matrix Laboratories Ltd. (collectively Counterclaim Plaintiffs state as follows: PARTIES 1. Upon information and belief, Counterclaim Defendant Bristol-Myers Squibb Co. purports and claims to be a corporation organized and existing under the laws of the State of Delaware, having its principal place of business at 345 Park Avenue, New York, NY Upon information and belief, Bristol-Myers Squibb Pharma Co. purports and claims to be an indirect, wholly-owned subsidiary of Bristol-Myers Squibb Co. and a general partnership organized and existing under the laws of the State of Delaware, having its principal place of business at Route 206 and Province Line Road, Lawrenceville, New Jersey

15 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 15 of Counterclaim Plaintiff Mylan Pharmaceuticals Inc. ( Mylan is a corporation organized under the laws of the State of West Virginia, having its headquarters at 781 Chestnut Ridge Road, Morgantown, West Virginia Counterclaim Defendant Matrix Laboratories Ltd. ( Matrix is a public limited company organized under the laws of India having its headquarters at /1, 4th Floor, Sal Ram Towers, Alexander Road, Secunderabad , Andhra, Pradesh, India. JURISDICTION AND VENUE 5. These counterclaims arise under the Patent Laws of the United States, 35 U.S.C. 100 et seq., and the Declaratory Judgment Act, 28 U.S.C and The Court has original jurisdiction over the subject matter of these counterclaims pursuant to 28 U.S.C and 1338(a. 7. The Court has personal jurisdiction over Counterclaim Defendants because Counterclaim Defendants have availed themselves of the rights and privileges of this forum by suing Mylan and Matrix in this judicial District; because Counterclaim Defendants are Delaware companies; and because of Counterclaim Defendants systematic and continuous contacts with Delaware by virtue of Counterclaim Defendants distribution of drugs for sale and use in Delaware. 8. Venue for these Counterclaims is proper in this judicial District pursuant to 28 U.S.C. 1391(b and 1400(b. PATENTS IN SUIT 9. On or about January 6, 2004, the United States Patent and Trademark Office ( USPTO issued United States Patent No. 6,673,372 ( the 372 patent, titled Cyrstalline 15

16 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 16 of 22 Efavirenz. Counterclaim Defendant Bristol Myers Squibb Pharma Co. is indicated in the records of the USPTO as the owner or assignee of the 372 patent. 10. Upon information and belief, Counterclaim Defendants are indicated in the records of the United States Food and Drug Administration as the holders of New Drug Application No for Sustiva brand efavirenz tablets, which are sold by Counterclaim Defendants. 11. On or about October 28, 2003, the United States Patent and Trademark Office ( USPTO issued United States Patent No. 6,639,071 ( the 071 patent, titled Cyrstal Forms of (--6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1, 4-dihydro-2H-3, 1-ben zoxazin-2- one. Non-party Merck & Co., Inc., is indicated in the records of the USPTO as the owner or assignee of the 071 patent. 12. The 071 patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations ( the Orange Book for Sustiva. 13. On or about September 6, 2005, the United States Patent and Trademark Office ( USPTO issued United States Patent No. 6,939,964 ( the 964 patent, titled Cyrstal Forms of (--6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1, 4-dihydro-2H-3, 1-ben zoxazin-2- one. Non-party Merck & Co., Inc., is indicated in the records of the USPTO as the owner or assignee of the 071 patent. 14. The 964 patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations ( the Orange Book for Sustiva. 16

17 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 17 of Upon information and belief, one or both of the Counterclaim Defendants is, individually, or are collectively, the exclusive licensee of the purported inventions claimed in the 071 and 964 patents. 16. By letter dated July 16, 2009, Counterclaim Plaintiffs sent Counterclaim Defendants and non-party Merck & Co, Inc., notice of Matrix Ltd. s ANDA No , which implicated the 071 and 964 patents. 17. On August 28, 2009, Counterclaim Defendants sued Matrix and Mylan in this judicial district, alleging infringement of the 372 patent but not the 071 and 964 patents. FIRST CLAIM FOR RELIEF (Declaratory Judgment of Invalidity of the 372 Patent 18. Counterclaim Plaintiffs restate and reallege each of the foregoing paragraphs as if fully set forth herein. 19. Counterclaim Defendants have accused Matrix and Mylan of infringing the 372 patent. 20. Matrix and Mylan deny infringement of the 372 patent and allege that the 372 patent is invalid for failure to comply with one or more of the requirements for patentability set forth in Title 35 of the U.S. Patent Code, including 35 U.S.C. 101, 102, 103, 112, and/or In view of this Court s ruling denying Matrix and Mylan s Motion to Dismiss, there is an actual, substantial, and continuing justiciable case or controversy between Counterclaim Plaintiffs and Counterclaim Defendants regarding the infringement and validity of the 372 patent. 17

18 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 18 of Counterclaim Plaintiffs are entitled to a judicial declaration that one or more of the claims of the 372 patent are invalid. SECOND CLAIM FOR RELIEF (Declaratory Judgment of Non-Infringement of the 372 Patent 23. Counterclaim Plaintiffs restate and reallege each of the foregoing paragraphs as if fully set forth herein. 24. Counterclaim Defendants have accused Matrix and Mylan of infringing the 372 patent. 25. Matrix and Mylan deny infringement of the 372 patent and allege that the manufacture, use, sale, offer for sale, or importation of the products that are the subject of Matrix s ANDA No have not infringed, do not infringe, and would not, if manufactured, used, sold, offered for sale, or imported, infringe any valid or enforceable claim of the 372 patent 26. In view of this Court s ruling denying Matrix and Mylan s Motion to Dismiss, there is an actual, substantial, and continuing justiciable case or controversy between Counterclaim Plaintiffs and Counterclaim Defendants regarding the infringement and validity of the 372 patent. 27. Counterclaim Plaintiffs are entitled to a judicial declaration that the manufacture, use, sale, offer for sale, or importation of the products that are the subject of Matrix s ANDA No have not infringed, do not infringe, and would not, if manufactured, used, sold, offered for sale, or imported, infringe any valid or enforceable claim of the 372 patent. 18

19 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 19 of 22 THIRD CLAIM FOR RELIEF (Declaratory Judgment of Non-Infringement of the 071 Patent 28. Counterclaim Plaintiffs restate and reallege each of the foregoing paragraphs as if fully set forth herein. 29. The 071 patent, which is implicated by Matrix s ANDA No , is listed in the Orange Book for Sustiva, and Counterclaim Defendants have accused Matrix and Mylan of infringing the 372 patent, which Counterclaim Defendants allege covers the product that is the subject of Matrix s ANDA No The manufacture, use, sale, offer for sale, or importation of the products that are the subject of Matrix s ANDA No have not infringed, do not infringe, and would not, if manufactured, used, sold, offered for sale, or imported, infringe any valid or enforceable claim of the 071 patent. 31. In view of this Court s ruling denying Matrix and Mylan s Motion to Dismiss, there is an actual, substantial, and continuing justiciable case or controversy between Counterclaim Plaintiffs and Counterclaim Defendants regarding the infringement of the 071 patent. 32. Counterclaim Plaintiffs are entitled to a judicial declaration that the manufacture, use, sale, offer for sale, or importation of the products that are the subject of Matrix s ANDA No have not infringed, do not infringe, and would not, if manufactured, used, sold, offered for sale, or imported, infringe any valid or enforceable claim of the 071 patent. 19

20 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 20 of FOURTH CLAIM FOR RELIEF (Declaratory Judgment of Non-Infringement of the 964 Patent 34. Counterclaim Plaintiffs restate and reallege each of the foregoing paragraphs as if fully set forth herein. 35. The 964 patent, which is implicated by Matrix s ANDA No , is listed in the Orange Book for Sustiva, and Counterclaim Defendants have accused Matrix and Mylan of infringing the 372 patent, which Counterclaim Defendants allege covers the product that is the subject of Matrix s ANDA No The manufacture, use, sale, offer for sale, or importation of the products that are the subject of Matrix s ANDA No have not infringed, do not infringe, and would not, if manufactured, used, sold, offered for sale, or imported, infringe any valid or enforceable claim of the 964 patent. 37. In view of this Court s ruling denying Matrix and Mylan s Motion to Dismiss, there is an actual, substantial, and continuing justiciable case or controversy between Counterclaim Plaintiffs and Counterclaim Defendants regarding the infringement of the 964 patent. 38. Counterclaim Plaintiffs are entitled to a judicial declaration that the manufacture, use, sale, offer for sale, or importation of the products that are the subject of Matrix s ANDA No have not infringed, do not infringe, and would not, if manufactured, used, sold, offered for sale, or imported, infringe any valid or enforceable claim of the 964 patent. 20

21 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 21 of 22 PRAYER FOR RELIEF WHEREFORE, Defendants/Counterclaim Plaintiffs respectfully pray for judgment in their favor and against Plaintiffs/Counterclaim Defendants: (a Declaring that the manufacture, use, sale, offer for sale, or importation of the drug products that are the subject of Defendants ANDA No have not infringed, do not infringe and would not, if manufactured, used, sold offered for sale, or imported, infringe any valid or enforceable claim of the 372 patent, the 071 patent, or the 964 patent, either literally or under the doctrine of equivalents; (b Declaring that the manufacture, use, sale, offer for sale, or importation of the drug products that are the subject of Defendants ANDA No have not infringed, do not infringe and would not, if manufactured, used, sold offered for sale, or imported, induce the infringement of any valid or enforceable claim of the 372 patent, the 071 patent, or the 964 patent; (c Declaring that the manufacture, use, sale, offer for sale, or importation of the drug products that are the subject of Defendants ANDA No have not infringed, do not infringe and would not, if manufactured, used, sold offered for sale, or imported, contributorily infringe any valid or enforceable claim of the 372 patent, the 071 patent, or the 964 patent; (d (e Declaring that the claims of the 372patent are invalid; Ordering that Plaintiffs/Counterclaim Defendants Complaint be dismissed with prejudice and judgment entered in favor of Defendants/Counterclaim Plaintiffs; 21

22 Case 1:09-cv JJF Document 36 Filed 02/09/10 Page 22 of 22 (f Declaring this case exceptional and awarding Defendants/Counterclaim Plaintiffs their reasonable attorney s fees and costs of these Counterclaims pursuant to 35 U.S.C. 285; and (g Awarding Defendants/Counterclaim Plaintiffs such other and further relief as the Court may deem just and proper. Dated: February 9, 2010 Of counsel: /s/mary B. Matterer Mary B. Matterer (I.D. #2696 Richard K. Herrmann (I.D. #405 Amy A. Quinland (I.D. #3021 MORRIS JAMES LLP 500 Delaware Avenue, Suite 1500 Wilmington, DE ( (telephone mmatterer@morrisjames.com ( Attorneys for Defendants Timothy H. Kratz Robert L. Florence George J. Barry III McGuireWoods LLP 1170 Peachtree Street Suite 2100 Atlanta, Georgia (facsimile 22