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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE MERCK & CO., INC., Plaintiff and Counterclaim Defendant, v. RANBAXY INC., and RANBAXY LABORATORIES LIMITED, Defendants and Counterclaim Plaintiffs. ) ) ) ) ) ) ) ) ) )
C.A. No. 07-229 (GMS)
MERCK'S MOTION FOR LEAVE TO FILE ITS FIRST SUPPLEMENTAL COMPLAINT Pursuant to Fed. R. Civ. P. 15(d), plaintiff Merck & Co., Inc. ("Merck") hereby moves for leave to file its First Supplemental Complaint against Ranbaxy Inc. and Ranbaxy Laboratories Limited ("Ranbaxy"). The grounds for this motion are set forth in Merck's Brief In Support Of Its Motion For Leave To File Its First Supplemental Complaint. Pursuant to D. Del. L.R. 15.1, attached as Exhibit 1 is a copy of Merck's proposed supplemental pleading. Attached as Exhibit A to Exhibit 1 is United States Patent No. 5,147,868 without its certificate of correction, and attached as Exhibit B to Exhibit 1 is United States Patent No. 5,147,868 with its certificate of correction. Attached as Exhibit 2 is a copy of Merck's proposed supplemental pleading indicating the respects in which the supplemental pleading differs from the original pleading.
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MORRIS, NICHOLS, ARSHT & TUNNELL LLP
/s/ James W. Parrett, Jr. (#4292)
Mary B. Graham (#2256) James W. Parrett, Jr. (#4292) 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899-1347 302.658.9200 OF COUNSEL: Raymond N. Nimrod Gregory D. Bonifield JENNER & BLOCK LLP 919 N. Third Avenue 37th Floor New York, NY 10022-3908 212.891.1600 Aaron A. Barlow JENNER & BLOCK LLP 330 N. Wabash Avenue Chicago, IL 60611-7603 312.222.9350 Paul D. Matukaitis Charles M. Caruso MERCK & CO., INC. One Merck Drive Whitehouse Station, NJ 08889-0100 Edward W. Murray MERCK & CO., INC. 126 E. Lincoln Avenue Rahway, NJ 07065-0907 Dated: January 11, 2008
1381800
Attorneys for Merck & Co., Inc.
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RULE 7.1.1. CERTIFICATION Counsel for Merck requested that Ranbaxy agree to the filing of Merck's supplemental complaint and Ranbaxy refused on the grounds that it would be futile based on ISCO International, Inc. v. Conductus, Inc., 2002 U.S. Dist. LEXIS 21706 (D. Del. 2002) (Sleet, J.).
Dated: January 11, 2008
/s/ James W. Parrett, Jr. (#4292) James W. Parrett, Jr. (#4292)
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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE MERCK & CO., INC., Plaintiff and Counterclaim Defendant, v. RANBAXY INC., and RANBAXY LABORATORIES LIMITED, Defendants and Counterclaim Plaintiffs. ) ) ) ) ) ) ) ) ) )
C.A. No. 07-229 (GMS)
[PROPOSED] ORDER The Court, having considered plaintiff Merck & Co., Inc.'s Motion for Leave to File Its First Supplemental Complaint; IT IS ORDERED that Merck's Motion for Leave to File Its First Supplemental Complaint is GRANTED and shall be entered forthwith. SO ORDERED this ___ day of ______________, 2008 _________________________________ United States District Judge
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CERTIFICATE OF SERVICE I hereby certify that on January 11, 2008, I caused the foregoing to be electronically filed with the Clerk of the Court using CM/ECF which will send electronic notification of such filing to the following: Frederick L. Cottrell , III, Esquire RICHARDS, LAYTON & FINGER, P.A. Kelly E. Farnan, Esquire RICHARDS, LAYTON & FINGER, P.A. Additionally, I hereby certify that true and correct copies of the foregoing were caused to be served on January 11, 2008 upon the following individuals in the manner indicated: BY EMAIL AND HAND DELIVERY Frederick L. Cottrell , III, Esquire Kelly E. Farnan, Esquire RICHARDS, LAYTON & FINGER, P.A. One Rodney Square 920 North King Street Wilmington, DE 19801 [email protected] [email protected] BY EMAIL Mark Boland, Esquire SUGHRUE MION PLLC [email protected] Michael R. Dzwonczyk, Esquire SUGHRUE MION PLLC [email protected] Chid S. Iyer, Esquire SUGHRUE MION PLLC [email protected]
/s/ James W. Parrett, Jr.
James W. Parrett, Jr. (#4292)
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EXHIBIT 1
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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE MERCK & CO., INC., Plaintiff, v. RANBAXY INC., and RANBAXY LABORATORIES LIMITED, Defendants. ) ) ) ) ) ) ) ) ) ) )
C.A. No. 07-229 (GMS)
FIRST SUPPLEMENTAL COMPLAINT FOR PATENT INFRINGEMENT Pursuant to Rule 15(d) of the Federal Rules of Civil Procedure, Plaintiff Merck & Co., Inc. ("Merck"), hereby submits this First Supplemental Complaint for Patent Infringement against defendants, Ranbaxy Inc. and Ranbaxy Laboratories Limited (collectively "Defendants"). Merck alleges as follows: PARTIES 1. Plaintiff Merck is a corporation incorporated under the laws of New Jersey
with its principal place of business at One Merck Drive, Whitehouse Station, New Jersey 08889. 2. On information and belief, defendant Ranbaxy Inc. is a corporation
organized and existing under the laws of the state of Delaware, having a principal place of business at 600 College Road East, Princeton, New Jersey 08540. On information and belief, Ranbaxy Inc. is engaged in the development, manufacturing, marketing and sale of pharmaceutical products in the United States, and conducts business in the state of Delaware. 3. On information and belief, defendant Ranbaxy Laboratories Limited
("Ranbaxy Labs") is a corporation organized and existing under the laws of India, having its principal place of business at Plot No. 90, Sector 32, Gurgaon-122 001, Haryana, India. On
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information and belief, Ranbaxy Labs is engaged in the development, manufacture, marketing and sale of pharmaceutical products in the United States, and conducts business in the state of Delaware. On information and belief, Ranbaxy Inc. is the wholly owned subsidiary of Ranbaxy Labs and is the agent of Ranbaxy Labs in the United States. 4. On information and belief, the acts of Ranbaxy Inc. asserted herein were
done at the direction of, or with the cooperation, participation and assistance of, Ranbaxy Labs. JURISDICTION AND VENUE 5. This is an action for patent infringement arising under the patent laws of
the United States, 35 U.S.C. § 101, et seq., and for declaratory judgment of patent infringement arising under 28 U.S.C. §§ 2201 and 2202 and the patent laws of the United States, 35 U.S.C. § 101, et seq. This Court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331 and 1338(a) and pursuant to 28 U.S.C. §§ 2201 and 2202. 6. 1400(b). MERCK'S PATENT 7. On September 15, 1992, the United States Patent and Trademark Office Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391(c) and (d) and
("Patent Office") duly and lawfully issued United States Patent No. 5,147,868 ("the `868 patent," a copy of which is attached as Exhibit A), entitled THIENAMYCIN RENAL PEPTIDASE INHIBITORS, to Merck as assignee of the inventors Donald W. Graham, Edward F. Rogers and Frederick M. Kahan. At all times subsequent to issuance of the `868 patent, Merck has been the owner of the entire right, title and interest in and to the `868 patent, including the right to sue and recover for infringement. The term of the `868 patent expires September 15, 2009. The claims of the `868 patent cover, inter alia, the compounds cilastatin and cilastatin sodium.
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8.
Merck currently sells PRIMAXIN® I.M. which is an injectable suspension
containing imipenem and cilastatin sodium. Merck also currently sells PRIMAXIN® I.V., which is an injection containing imipenem and cilastatin sodium. 9. Merck is the holder of approved New Drug Applications ("NDAs") under
Section 505 of the Federal Food Drug and Cosmetic Act, 21 U.S.C. § 355, for imipenem and cilastatin for injectable suspension (NDA 50-630) and imipenem and cilastatin for injection (NDA 50-587). DEFENDANTS' ACTIONS 10. Prior to the filing of the original Complaint on April 30, 2007, Defendants
filed an Abbreviated New Drug Application ("ANDA") for imipenem-cilastatin and associated drug master file(s), seeking approval to engage in the commercial manufacture, use, and sale of injectable products comprising imipenem and cilastatin sodium ("ANDA products") before the `868 patent expires. 11. By letter dated January 22, 2007, Defendants sent written notice of their
filing to Merck, which notice was received by Merck. The notice alleged that Defendants' ANDA products will not infringe any valid claim of the `868 patent. Defendants also informed Merck that Defendants are seeking approval from the FDA to market the ANDA products before the `868 patent expires and that Defendants plan to begin marketing the ANDA products immediately upon approval. Defendants sought a covenant from Merck not to sue under the `868 patent. Merck did not give Defendants a covenant not to sue. 12. On information and belief, Defendants are systematically attempting to
meet the applicable regulatory requirements to obtain FDA approval for the ANDA products. On information and belief, Defendants have developed and tested the ANDA products. On
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information and belief, Ranbaxy Labs already manufactures and sells a pharmaceutical composition containing cilastatin or cilastatin sodium outside the United States. On information and belief, Defendants are preparing to import the ANDA products into the United States or manufacture the ANDA products in the United States. On information and belief, Defendants have the capacity to begin marketing and manufacturing the ANDA products immediately upon receiving regulatory approval from the FDA. COUNT I - DECLARATORY JUDGMENT 13. Merck restates and incorporates by reference the allegations of the
foregoing paragraphs 1-12 as though fully set forth herein. 14. On information and belief, Defendants have made meaningful
preparations for, and engaged in activities directed toward, infringing the `868 patent. 15. The acts of Defendants indicate a refusal to change the course of their
actions in the face of acts by Merck sufficient to create a reasonable apprehension that a suit by Merck will be forthcoming. 16. Defendants' manufacture, use, sale or offer for sale of the ANDA products
in the United States or importation of the ANDA products into the United States will constitute patent infringement under 35 U.S.C. § 271 (a), (b) or (c). 17. An actual controversy now exists between Merck and Defendants with
respect to the infringement of the `868 patent. 18. Merck will be irreparably harmed if Defendants are not enjoined from
infringing or actively inducing or contributing to infringement of the `868 patent. 19. Merck does not have an adequate remedy at law.
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20.
Merck should be granted relief provided by 35 U.S.C. §283 and by
28 U.S.C. §§ 2201 and 2202, including an order of this Court declaring that Defendants' ANDA products will infringe the `868 patent and an order of this Court preliminarily and permanently enjoining them from manufacturing, using, selling and offering for sale the ANDA products. 21. On information and belief, Defendants were aware of the existence of the
`868 patent and were aware that the marketing, manufacture, use, offer for sale and sale of the ANDA products would constitute an act of infringement of the `868 patent. 22. Defendants' written notice of the factual and legal bases for its opinion
regarding the alleged invalidity and noninfringement of the `868 patent is devoid of an objective good faith basis in either the facts or the law. 23. On information and belief, Defendants have acted with willful disregard
for Merck's patent rights. 24. This case is an exceptional one, and Merck should be granted an award of
its reasonable attorneys' fees under 35 U.S.C. § 285. COUNT II - PATENT INFRINGEMENT 25. Merck restates and incorporates by reference the allegations of the
foregoing paragraphs 1-24 as though fully set forth herein. 26. On information and belief, Defendants filed an ANDA under Section
505(j) of the Federal Food Drug and Cosmetic Act, 21 U.S.C. § 355(j), for a drug claimed in the `868 patent. 27. Defendants seek approval of their ANDA to engage in the commercial
manufacture, use or sale of a drug or drug formulation claimed in the `868 patent before it expires.
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28. 29.
Defendants have infringed the `868 patent under 35 U.S.C. § 271(e)(2). Merck should be granted relief provided by 35 U.S.C. § 271(e)(4),
including an order of this Court that the effective date of the approval of Ranbaxy's ANDA be a date that is not earlier than the present expiration date of the `868 patent, or any later expiration of exclusivity to which Merck is or becomes entitled and an order of this Court preliminarily and permanently enjoining Defendants from commercially manufacturing, using, selling and offering for sale the ANDA products. 30. On information and belief, Defendants were aware of the existence of the
`868 patent and were aware that the manufacture, use, offer for sale and sale of the ANDA products would constitute an act of infringement of the `868 patent. 31. Defendants' written notice of the factual and legal bases for its opinion
regarding the alleged invalidity and noninfringement of the `868 patent is devoid of an objective good faith basis in either the facts or the law. 32. On information and belief Defendants have acted with willful disregard
for Merck's patent rights and have willfully infringed the `868 patent. 33. This case is an exceptional one, and Merck should be granted an award of
its reasonable attorneys' fees under 35 U.S.C. § 285. COUNT III - DECLARATORY JUDGMENT OF PATENT INFRINGEMENT OF THE `868 PATENT WITH CERTIFICATE OF CORRECTION 34. Merck restates and incorporates by reference the allegations of the
foregoing paragraphs 1-33 as though fully set forth herein. 35. On November 6, 2007, subsequent to the filing of this lawsuit, the Patent
Office duly and lawfully issued a Certificate of Correction for the `868 patent under 35 U.S.C. § 255. A copy of the `868 patent with the Certificate of Correction is attached as Exhibit B. The -6-
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Certificate of Correction resulted from a Request for Expedited Certificate to Correct the Patent Under 37 CFR 1.323, filed by Merck on May 17, 2007, to correct an error on the face of the `868 patent and an error in the first paragraph of the specification related to the recitation of U.S. Application Serial Number 06/188,178. 36. On November 13, 2007, Merck provided Defendants with a copy of the
Certificate of Correction. 37. On information and belief, Defendants have made meaningful
preparations for, and engaged in activities directed toward, infringing the `868 patent with Certificate of Correction, including activities that occurred after the Certificate of Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007. 38. Defendants have continued to litigate this action after the Certificate of
Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007. 39. The acts of Defendants indicate a refusal to change the course of their
actions in the face of acts by Merck sufficient to create a reasonable apprehension that Merck would assert that the ANDA products will infringe the `868 patent with Certificate of Correction. 40. Defendants' manufacture, use, sale or offer for sale of the ANDA products
in the United States or importation of the ANDA products into the United States will constitute patent infringement under 35 U.S.C. § 271 (a), (b) or (c). 41. An actual controversy now exists between Merck and Defendants with
respect to the future infringement of the `868 patent with Certificate of Correction.
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42.
Merck will be irreparably harmed if Defendants are not enjoined from
infringing or actively inducing or contributing to infringement of the `868 patent with Certificate of Correction. 43. 44. Merck does not have an adequate remedy at law. Merck should be granted relief provided by 35 U.S.C. § 283 and by
28 U.S.C. §§ 2201 and 2202, including an order of this Court declaring that Defendants' ANDA products will infringe the `868 patent with Certificate of Correction and an order of this Court preliminarily and permanently enjoining Defendants from manufacturing, using, selling and offering for sale the ANDA products. 45. On information and belief, Defendants were aware of the existence of the
`868 patent, were aware of the existence of the Certificate of Correction to the `868 patent, and were aware that the marketing, manufacture, use, offer for sale and sale of the ANDA products would constitute an act of infringement of the `868 patent with Certificate of Correction. 46. On information and belief, Defendants have acted with willful disregard
for Merck's patent rights. 47. This case is an exceptional one, and Merck should be granted an award of
its reasonable attorneys' fees under 35 U.S.C. § 285. COUNT IV - DECLARATORY JUDGMENT OF PATENT INFRINGEMENT RELATING TO DEFENDANTS' PRODUCT II 48. Merck restates and incorporates by reference the allegations of the
foregoing paragraphs 1-47 as though fully set forth herein. 49. In summer, 2007, subsequent to the filing of this lawsuit, Defendants filed
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commercial manufacture, use, and sale of Product II comprising imipenem and cilastatin sodium before the `868 patent expires. 50. On September 14, 2007, Defendants informed Merck that Ranbaxy had
filed their ANDA II. On October 17, 2007, Defendants produced at least a portion of their ANDA II to Merck. 51. On information and belief, Defendants have made meaningful
preparations for, and engaged in activities directed toward, infringing the `868 patent, including activities that occurred after the Certificate of Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007. 52. Defendants have continued to litigate this action after the Certificate of
Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007. 53. The acts of Defendants indicate a refusal to change the course of their
actions in the face of acts by Merck sufficient to create a reasonable apprehension that Merck would assert that Product II will infringe the `868 patent. 54. Defendants' manufacture, use, sale or offer for sale of Product II in the
United States or importation of the Product II into the United States will constitute patent infringement under 35 U.S.C. § 271 (a), (b) or (c). 55. An actual controversy now exists between Merck and Defendants with
respect to the future infringement of the `868 patent by Product II. 56. Merck will be irreparably harmed if Defendants are not enjoined from
infringing or actively inducing or contributing to infringement of the `868 patent.
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57. 58.
Merck does not have an adequate remedy at law. Merck should be granted relief provided by 35 U.S.C. § 283 and by
28 U.S.C. §§ 2201 and 2202, including an order of this Court declaring that Defendants' Product II will infringe the `868 patent and an order of this Court preliminarily and permanently enjoining Defendants from manufacturing, using, selling and offering for sale Product II. 59. On information and belief, Defendants were aware of the existence of the
`868 patent, were aware of the existence of the Certificate of Correction to the `868 patent, and were aware that the marketing, manufacture, use, offer for sale and sale of Product II would constitute an act of infringement of the `868 patent 60. On information and belief, Defendants have acted with willful disregard
for Merck's patent rights. 61. This case is an exceptional one, and Merck should be granted an award of
its reasonable attorneys' fees under 35 U.S.C. § 285. COUNT V - DECLARATORY JUDGMENT OF PATENT INFRINGEMENT RELATING TO DEFENDANTS' PRODUCT III 62. Merck restates and incorporates by reference the allegations of the
foregoing paragraphs 1-61 as though fully set forth herein. 63. In summer, 2007, subsequent to the filing of this lawsuit, Defendants filed
a third ANDA ("ANDA III") for yet another different injectable product, which contains imipenem and cilastatin sodium ("Product III"). Defendants' ANDA III seeks approval to engage in the commercial manufacture, use, and sale of Product III comprising imipenem and cilastatin sodium before the `868 patent expires.
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64.
On September 14, 2007, Defendants informed Merck that Defendants had
filed their ANDA III. On October 17, 2007, Defendants produced at least a portion of their ANDA III to Merck. 65. On information and belief, Defendants have made meaningful
preparations for, and engaged in activities directed toward, infringing the `868 patent, including activities that occurred after the Certificate of Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007. 66. Defendants have continued to litigate this action after the Certificate of
Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007. 67. The acts of Defendants indicate a refusal to change the course of their
actions in the face of acts by Merck sufficient to create a reasonable apprehension that Merck would assert that Product III will infringe the `868 patent. 68. Defendants' manufacture, use, sale or offer for sale of Product III in the
United States or importation of Product III into the United States will constitute patent infringement under 35 U.S.C. § 271 (a), (b) or (c). 69. An actual controversy now exists between Merck and Defendants with
respect to the future infringement of the `868 patent by Product III. 70. Merck will be irreparably harmed if Defendants are not enjoined from
infringing or actively inducing or contributing to infringement of the `868 patent. 71. Merck does not have an adequate remedy at law.
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72.
Merck should be granted relief provided by 35 U.S.C. § 283 and by
28 U.S.C. §§ 2201 and 2202, including an order of this Court declaring that Defendants' Product III will infringe the `868 patent and an order of this Court preliminarily and permanently enjoining Defendants from manufacturing, using, selling and offering for sale Product III. 73. On information and belief, Defendants were aware of the existence of the
`868 patent, were aware of the existence of the Certificate of Correction to the `868 patent, and were aware that the marketing, manufacture, use, offer for sale and sale of Product III would constitute an act of infringement of the `868 patent. 74. On information and belief, Defendants have acted with willful disregard
for Merck's patent rights. 75. This case is an exceptional one, and Merck should be granted an award of
its reasonable attorneys' fees under 35 U.S.C. § 285. COUNT VI - DECLARATORY JUDGMENT THAT THE `868 PATENT WITH CERTIFICATE OF CORRECTION IS NOT INVALID 76. Merck restates and incorporates by reference the allegations of the
foregoing paragraphs 1-75 as though fully set forth herein. 77. On June 21, 2007, Defendants filed the Answer and Counterclaims of
Defendants Ranbaxy Inc. and Ranbaxy Laboratories Limited ("Defendants' Answer and Counterclaims.") Defendants' Answer and Counterclaims asserted, as an affirmative defense and as a counterclaim, that the `868 patent was invalid for "failure to comply with one or more of the requirements of 35 U.S.C. §§ 101, 102, 103, and/or 112." 78. On November 6, 2007, the Patent Office duly and lawfully issued a
Certificate of Correction to the `868 patent under 35 U.S.C. § 255.
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79.
On November 13, 2007, Merck provided Defendants with a copy of the
Certificate of Correction. 80. On information and belief, Defendants have made meaningful
preparations for, and engaged in activities directed toward, infringing the `868 patent with Certificate of Correction, including preparations and activities that occurred after the Certificate of Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007. 81. Defendants have continued to litigate this action and pursue their
affirmative defense and counterclaim asserting invalidity of the `868 patent after the Certificate of Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007. 82. The acts of Defendants indicate a refusal to change the course of their
actions in spite of the issuance of the Certificate of Correction. 83. An actual controversy now exists between Merck and Defendants with
respect to the alleged invalidity of the `868 patent with Certificate of Correction. 84. Merck should be granted relief including an order of this Court declaring
that the `868 patent with Certificate of Correction is not invalid. PRAYER FOR RELIEF WHEREFORE, plaintiff Merck respectfully requests that: a. Judgment be entered that Defendants have infringed the `868
patent by submitting the aforesaid ANDA;
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b.
Judgment be entered declaring that Defendants will infringe the
`868 patent by marketing, manufacturing, using, offering for sale or selling Defendants' ANDA products; c. A preliminary and permanent injunction be issued, pursuant to
35 U.S.C. §§ 271(e)(4)(B) and 283 and 28 U.S.C. §§ 2201 and 2202, restraining and enjoining Defendants, their officers, agents, attorneys and employees, and those acting in privity or concert with them, from engaging in the manufacture, use, offer for sale, or sale within the United States, or importation into the United States, of compounds or formulations as claimed in the `868 patent, or from practicing any method as claimed in the `868 patent, or from actively inducing or contributing to infringement of the `868 patent; d. An order be issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the
effective date of any approval of Defendants' ANDA be a date which is not earlier than the present expiration date for the `868 patent, or any later expiration of exclusivity to which the `868 patent is or becomes entitled to; e. Judgment be entered declaring that Defendants will infringe the
`868 patent by marketing, manufacturing, using, offering for sale or selling Defendants' Product II; f. An order be issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the
effective date of any approval of Defendants' ANDA II be a date which is not earlier than the present expiration date for the `868 patent, or any later expiration of exclusivity to which the `868 patent is or becomes entitled to;
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g.
Judgment be entered declaring that Defendants will infringe the
`868 patent by marketing, manufacturing, using, offering for sale or selling Defendants' Product III; h. An order be issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the
effective date of any approval of Defendants' ANDA III be a date which is not earlier than the present expiration date for the `868 patent, or any later expiration of exclusivity to which the `868 patent is or becomes entitled to; i. judgment be entered declaring that the `868 patent, as originally
issued and with Certificate of Correction, is not invalid; j. Judgment be entered that Defendants acted with willful disregard
for Merck's rights under the `868 patent; k. `868 patent; l. Judgment be entered that this case is an exceptional one and that Judgment be entered that Defendants have willfully infringed the
Merck should be awarded its reasonable attorneys' fees pursuant to 35 U.S.C. § 285; and m. Such other and further relief as the Court may deem just and
proper under the circumstances.
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MORRIS, NICHOLS, ARSHT & TUNNELL LLP
OF COUNSEL: Raymond N. Nimrod Gregory D. Bonifield JENNER & BLOCK LLP 919 N. Third Avenue 37th Floor New York, NY 10022-3908 212.891.1600 Aaron A. Barlow JENNER & BLOCK LLP 330 N. Wabash Avenue Chicago, IL 60611-7603 312.222.9350 Paul D. Matukaitis Charles M. Caruso MERCK & CO., INC. One Merck Drive Whitehouse Station, NJ 08889-0100 Edward W. Murray MERCK & CO., INC. 126 E. Lincoln Avenue Rahway, NJ 07065-0907
Mary B. Graham (#2256) James W. Parrett, Jr. (#4292) 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899-1347 302.658.9200 Attorneys for Merck & Co., Inc.
Dated: January 11, 2008
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EXHIBIT 2
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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE MERCK & CO., INC., Plaintiff, v. RANBAXY INC., and RANBAXY LABORATORIES LIMITED, Defendants. ) ) ) ) ) ) ) ) ) ) )
C.A. No. _______________07-229 (GMS)
FIRST SUPPLEMENTAL COMPLAINT FOR PATENT INFRINGEMENT Pursuant to Rule 15(d) of the Federal Rules of Civil Procedure, Plaintiff Merck & Co., Inc. ("Merck"), by its undersigned attorneys, brings this actionhereby submits this First Supplemental Complaint for Patent Infringement against defendants, Ranbaxy Inc. and Ranbaxy Laboratories Limited (collectively "Defendants"), for patent infringement, and. Merck alleges as follows: PARTIES 1. Plaintiff Merck is a corporation incorporated under the laws of New
Jersey with its principal place of business at One Merck Drive, Whitehouse Station, New Jersey 08889. 2. On information and belief, defendant Ranbaxy Inc. is a corporation
organized and existing under the laws of the state of Delaware, having a principal place of business at 600 College Road East, Princeton, New Jersey 08540. On information and belief, Ranbaxy Inc. is engaged in the development, manufacturing, marketing and sale of pharmaceutical products in the United States, and conducts business in the state of Delaware.
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3.
On information and belief, defendant Ranbaxy Laboratories Limited
("Ranbaxy Labs") is a corporation organized and existing under the laws of India, having its principal place of business at Plot No. 90, Sector 32, Gurgaon-122 001, Haryana, India. On information and belief, Ranbaxy Labs is engaged in the development, manufacture, marketing and sale of pharmaceutical products in the United States, and conducts business in the state of Delaware. On information and belief, Ranbaxy Inc. is the wholly owned subsidiary of Ranbaxy Labs and is the agent of Ranbaxy Labs in the United States. 4. On information and belief, the acts of Ranbaxy Inc. asserted herein were
done at the direction of, or with the cooperation, participation and assistance of, Ranbaxy Labs. JURISDICTION AND VENUE 5. This is an action for patent infringement arising under the patent laws of
the United States, 35 U.S.C. § 101, et seq., and for declaratory judgment of patent infringement arising under 28 U.S.C. §§ 2201 and 2202 and the patent laws of the United States, 35 U.S.C. § 101, et seq. This Court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331 and 1338(a) and pursuant to 28 U.S.C. §§ 2201 and 2202. 6. 1400(b). MERCK'S PATENT 7. On September 15, 1992, the United States Patent and Trademark Office Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391(c) and (d) and
("Patent Office") duly and lawfully issued United States Patent No. 5,147,868 ("the `868 patent," a copy of which is attached as Exhibit A), entitled THIENAMYCIN RENAL PEPTIDASE INHIBITORS, to Merck as assignee of the inventors Donald W. Graham, Edward F. Rogers and Frederick M. Kahan. At all times subsequent to issuance of the `868 patent,
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Merck has been the owner of the entire right, title and interest in and to the `868 patent, including the right to sue and recover for infringement. The term of the `868 patent expires September 15, 2009. The claims of the `868 patent cover, inter alia, the compounds cilastatin and cilastatin sodium. 8. Merck currently sells PRIMAXIN® I.M. which is an injectable suspension
containing imipenem and cilastatin sodium. Merck also currently sells PRIMAXIN® I.V., which is an injection containing imipenem and cilastatin sodium. 9. Merck is the holder of approved New Drug Applications ("NDAs") under
Section 505 of the Federal Food Drug and Cosmetic Act, 21 U.S.C. § 355, for imipenem and cilastatin for injectable suspension (NDA 50-630) and imipenem and cilastatin for injection (NDA 50-587). DEFENDANTS' ACTIONS 10. On information and belief,Prior to the filing of the original Complaint on
April 30, 2007, Defendants filed an Abbreviated New Drug Application ("ANDA") for imipenem-cilastatin and associated drug master file(s), seeking approval to engage in the commercial manufacture, use, and sale of injectable products comprising imipenem and cilastatin sodium ("ANDA products") before the `868 patent expires. 11. By letter dated January 22, 2007, Defendants sent written notice of their
filing to Merck, which notice was received by Merck. The notice alleged that Defendants' ANDA products will not infringe any valid claim of the `868 patent. Defendants also informed Merck that Defendants are seeking approval from the FDA to market the ANDA products before the `868 patent expires and that Defendants plan to begin marketing the ANDA products
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immediately upon approval. Defendants sought a covenant from Merck not to sue under the `868 patent. Merck did not give Defendants a covenant not to sue. 12. On information and belief, Defendants are systematically attempting to
meet the applicable regulatory requirements to obtain FDA approval for the ANDA products. On information and belief, Defendants have developed and tested the ANDA products. On information and belief, Ranbaxy Labs already manufactures and sells a pharmaceutical composition containing cilastatin or cilastatin sodium outside the United States. On information and belief, Defendants are preparing to import the ANDA products into the United States or manufacture the ANDA products in the United States. On information and belief, Defendants have the capacity to begin marketing and manufacturing the ANDA products immediately upon receiving regulatory approval from the FDA. COUNT I - DECLARATORY JUDGMENT 13. Merck restates and incorporates by reference the allegations of the
foregoing paragraphs 1-12 as though fully set forth herein. 14. On information and belief, Defendants have made meaningful
preparations for, and engaged in activities directed toward, infringing the `868 patent. 15. The acts of Defendants indicate a refusal to change the course of their
actions in the face of acts by Merck sufficient to create a reasonable apprehension that a suit by Merck will be forthcoming. 16. Defendants' manufacture, use, sale or offer for sale of the ANDA products
in the United States or importation of the ANDA products into the United States will constitute patent infringement under 35 U.S.C. § 271 (a), (b) or (c).
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17.
An actual controversy now exists between Merck and Defendants with
respect to the infringement of the `868 patent. 18. Merck will be irreparably harmed if Defendants are not enjoined from
infringing or actively inducing or contributing to infringement of the `868 patent. 19. 20. Merck does not have an adequate remedy at law. Merck should be granted relief provided by 35 U.S.C. §283 and by 28
U.S.C. §§ 2201 and 2202, including an order of this Court declaring that Defendants' ANDA products will infringe the `868 patent and an order of this Court preliminarily and permanently enjoining them from manufacturing, using, selling and offering for sale the ANDA products. 21. On information and belief, Defendants were aware of the existence of the
`868 patent and were aware that the marketing, manufacture, use, offer for sale and sale of the ANDA products would constitute an act of infringement of the `868 patent. 22. Defendants' written notice of the factual and legal bases for its opinion
regarding the alleged invalidity and noninfringement of the `868 patent is devoid of an objective good faith basis in either the facts or the law. 23. On information and belief, Defendants have acted with willful disregard
for Merck's patent rights. 24. This case is an exceptional one, and Merck should be granted an award of
its reasonable attorneys' fees under 35 U.S.C. § 285. COUNT II - PATENT INFRINGEMENT 25. Merck restates and incorporates by reference the allegations of the
foregoing paragraphs 1-24 as though fully set forth herein.
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26.
On information and belief, Defendants filed an ANDA under Section
505(j) of the Federal Food Drug and Cosmetic Act, 21 U.S.C. § 355(j), for a drug claimed in the `868 patent. 27. Defendants seek approval of their ANDA to engage in the commercial
manufacture, use or sale of a drug or drug formulation claimed in the `868 patent before it expires. 28. 29. Defendants have infringed the `868 patent under 35 U.S.C. § 271(e)(2). Merck should be granted relief provided by 35 U.S.C. § 271(e)(4),
including an order of this Court that the effective date of the approval of Ranbaxy's ANDA be a date that is not earlier than the present expiration date of the `868 patent, or any later expiration of exclusivity to which Merck is or becomes entitled and an order of this Court preliminarily and permanently enjoining Defendants from commercially manufacturing, using, selling and offering for sale the ANDA products. 30. On information and belief, Defendants were aware of the existence of the
`868 patent and were aware that the manufacture, use, offer for sale and sale of the ANDA products would constitute an act of infringement of the `868 patent. 31. Defendants' written notice of the factual and legal bases for its opinion
regarding the alleged invalidity and noninfringement of the `868 patent is devoid of an objective good faith basis in either the facts or the law. 32. On information and belief Defendants have acted with willful disregard
for Merck's patent rights and have willfully infringed the `868 patent. 33. This case is an exceptional one, and Merck should be granted an award of
its reasonable attorneys' fees under 35 U.S.C. § 285.
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COUNT III - DECLARATORY JUDGMENT OF PATENT INFRINGEMENT OF THE `868 PATENT WITH CERTIFICATE OF CORRECTION 34. Merck restates and incorporates by reference the allegations of the
foregoing paragraphs 1-33 as though fully set forth herein. 35. On November 6, 2007, subsequent to the filing of this lawsuit, the Patent
Office duly and lawfully issued a Certificate of Correction for the `868 patent under 35 U.S.C. § 255. A copy of the `868 patent with the Certificate of Correction is attached as Exhibit B. The Certificate of Correction resulted from a Request for Expedited Certificate to Correct the Patent Under 37 CFR 1.323, filed by Merck on May 17, 2007, to correct an error on the face of the `868 patent and an error in the first paragraph of the specification related to the recitation of U.S. Application Serial Number 06/188,178. 36. On November 13, 2007, Merck provided Defendants with a copy of the
Certificate of Correction. 37. On information and belief, Defendants have made meaningful
preparations for, and engaged in activities directed toward, infringing the `868 patent with Certificate of Correction, including activities that occurred after the Certificate of Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007. 38. Defendants have continued to litigate this action after the Certificate of
Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007.
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39.
The acts of Defendants indicate a refusal to change the course of their
actions in the face of acts by Merck sufficient to create a reasonable apprehension that Merck would assert that the ANDA products will infringe the `868 patent with Certificate of Correction. 40. Defendants' manufacture, use, sale or offer for sale of the ANDA products
in the United States or importation of the ANDA products into the United States will constitute patent infringement under 35 U.S.C. § 271 (a), (b) or (c). 41. An actual controversy now exists between Merck and Defendants with
respect to the future infringement of the `868 patent with Certificate of Correction. 42. Merck will be irreparably harmed if Defendants are not enjoined from
infringing or actively inducing or contributing to infringement of the `868 patent with Certificate of Correction. 43. Merck does not have an adequate remedy at law. 44. Merck should be granted relief provided by 35 U.S.C. § 283 and by 28
U.S.C. §§ 2201 and 2202, including an order of this Court declaring that Defendants' ANDA products will infringe the `868 patent with Certificate of Correction and an order of this Court preliminarily and permanently enjoining Defendants from manufacturing, using, selling and offering for sale the ANDA products. 45. On information and belief, Defendants were aware of the existence of the
`868 patent, were aware of the existence of the Certificate of Correction to the `868 patent, and were aware that the marketing, manufacture, use, offer for sale and sale of the ANDA products would constitute an act of infringement of the `868 patent with Certificate of Correction. 46. On information and belief, Defendants have acted with willful disregard
for Merck's patent rights.
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47.
This case is an exceptional one, and Merck should be granted an award of
its reasonable attorneys' fees under 35 U.S.C. § 285. COUNT IV - DECLARATORY JUDGMENT OF PATENT INFRINGEMENT RELATING TO DEFENDANTS' PRODUCT II 48. Merck restates and incorporates by reference the allegations of the
foregoing paragraphs 1-47 as though fully set forth herein. 49. In summer, 2007, subsequent to the filing of this lawsuit, Defendants filed
a second ANDA ("ANDA II") for a different injectable product, which also contains imipenem and cilastatin sodium ("Product II"). Defendants' ANDA II seeks approval to engage in the commercial manufacture, use, and sale of Product II comprising imipenem and cilastatin sodium before the `868 patent expires. 50. On September 14, 2007, Defendants informed Merck that Ranbaxy had
filed their ANDA II. On October 17, 2007, Defendants produced at least a portion of their ANDA II to Merck. 51. On information and belief, Defendants have made meaningful
preparations for, and engaged in activities directed toward, infringing the `868 patent, including activities that occurred after the Certificate of Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007. 52. Defendants have continued to litigate this action after the Certificate of
Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007.
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53.
The acts of Defendants indicate a refusal to change the course of their
actions in the face of acts by Merck sufficient to create a reasonable apprehension that Merck would assert that Product II will infringe the `868 patent. 54. Defendants' manufacture, use, sale or offer for sale of Product II in the
United States or importation of the Product II into the United States will constitute patent infringement under 35 U.S.C. § 271 (a), (b) or (c). 55. An actual controversy now exists between Merck and Defendants with
respect to the future infringement of the `868 patent by Product II. 56. Merck will be irreparably harmed if Defendants are not enjoined from
infringing or actively inducing or contributing to infringement of the `868 patent. 57. Merck does not have an adequate remedy at law. 58. Merck should be granted relief provided by 35 U.S.C. § 283 and by 28
U.S.C. §§ 2201 and 2202, including an order of this Court declaring that Defendants' Product II will infringe the `868 patent and an order of this Court preliminarily and permanently enjoining Defendants from manufacturing, using, selling and offering for sale Product II. 59. On information and belief, Defendants were aware of the existence of the
`868 patent, were aware of the existence of the Certificate of Correction to the `868 patent, and were aware that the marketing, manufacture, use, offer for sale and sale of Product II would constitute an act of infringement of the `868 patent 60. On information and belief, Defendants have acted with willful disregard
for Merck's patent rights. 61. This case is an exceptional one, and Merck should be granted an award of
its reasonable attorneys' fees under 35 U.S.C. § 285.
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COUNT V - DECLARATORY JUDGMENT OF PATENT INFRINGEMENT RELATING TO DEFENDANTS' PRODUCT III 62. Merck restates and incorporates by reference the allegations of the
foregoing paragraphs 1-61 as though fully set forth herein. 63. In summer, 2007, subsequent to the filing of this lawsuit, Defendants filed
a third ANDA ("ANDA III") for yet another different injectable product, which contains imipenem and cilastatin sodium ("Product III"). Defendants' ANDA III seeks approval to engage in the commercial manufacture, use, and sale of Product III comprising imipenem and cilastatin sodium before the `868 patent expires. 64. On September 14, 2007, Defendants informed Merck that Defendants had
filed their ANDA III. On October 17, 2007, Defendants produced at least a portion of their ANDA III to Merck. 65. On information and belief, Defendants have made meaningful
preparations for, and engaged in activities directed toward, infringing the `868 patent, including activities that occurred after the Certificate of Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007. 66. Defendants have continued to litigate this action after the Certificate of
Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007. 67. The acts of Defendants indicate a refusal to change the course of their
actions in the face of acts by Merck sufficient to create a reasonable apprehension that Merck would assert that Product III will infringe the `868 patent.
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68.
Defendants' manufacture, use, sale or offer for sale of Product III in the
United States or importation of Product III into the United States will constitute patent infringement under 35 U.S.C. § 271 (a), (b) or (c). 69. An actual controversy now exists between Merck and Defendants with
respect to the future infringement of the `868 patent by Product III. 70. Merck will be irreparably harmed if Defendants are not enjoined from
infringing or actively inducing or contributing to infringement of the `868 patent. 71. Merck does not have an adequate remedy at law. 72. Merck should be granted relief provided by 35 U.S.C. § 283 and by 28
U.S.C. §§ 2201 and 2202, including an order of this Court declaring that Defendants' Product III will infringe the `868 patent and an order of this Court preliminarily and permanently enjoining Defendants from manufacturing, using, selling and offering for sale Product III. 73. On information and belief, Defendants were aware of the existence of the
`868 patent, were aware of the existence of the Certificate of Correction to the `868 patent, and were aware that the marketing, manufacture, use, offer for sale and sale of Product III would constitute an act of infringement of the `868 patent. 74. On information and belief, Defendants have acted with willful disregard
for Merck's patent rights. 75. This case is an exceptional one, and Merck should be granted an award of
its reasonable attorneys' fees under 35 U.S.C. § 285.
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COUNT VI - DECLARATORY JUDGMENT THAT THE `868 PATENT WITH CERTIFICATE OF CORRECTION IS NOT INVALID 76. Merck restates and incorporates by reference the allegations of the
foregoing paragraphs 1-75 as though fully set forth herein. 77. On June 21, 2007, Defendants filed the Answer and Counterclaims of
Defendants Ranbaxy Inc. and Ranbaxy Laboratories Limited ("Defendants' Answer and Counterclaims.") Defendants' Answer and Counterclaims asserted, as an affirmative defense and as a counterclaim, that the `868 patent was invalid for "failure to comply with one or more of the requirements of 35 U.S.C. §§ 101, 102, 103, and/or 112." 78. On November 6, 2007, the Patent Office duly and lawfully issued a
Certificate of Correction to the `868 patent under 35 U.S.C. § 255. 79. On November 13, 2007, Merck provided Defendants with a copy of the
Certificate of Correction. 80. On information and belief, Defendants have made meaningful
preparations for, and engaged in activities directed toward, infringing the `868 patent with Certificate of Correction, including preparations and activities that occurred after the Certificate of Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007. 81. Defendants have continued to litigate this action and pursue their
affirmative defense and counterclaim asserting invalidity of the `868 patent after the Certificate of Correction was issued on November 6, 2007 and after Merck provided Defendants with a copy of the Certificate of Correction on November 13, 2007.
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82.
The acts of Defendants indicate a refusal to change the course of their
actions in spite of the issuance of the Certificate of Correction. 83. An actual controversy now exists between Merck and Defendants with
respect to the alleged invalidity of the `868 patent with Certificate of Correction. 84. Merck should be granted relief including an order of this Court declaring
that the `868 patent with Certificate of Correction is not invalid. PRAYER FOR RELIEF WHEREFORE, plaintiff Merck respectfully requests that: a. Judgment be entered that Defendants have infringed the `868
patent by submitting the aforesaid ANDA; b. Judgment be entered declaring that Defendants will infringe the
`868 patent by marketing, manufacturing, using, offering for sale or selling Defendants' ANDA products; c. A preliminary and permanent injunction be issued, pursuant to 35
U.S.C. §§ 271(e)(4)(B) and 283 and 28 U.S.C. §§ 2201 and 2202, restraining and enjoining Defendants, their officers, agents, attorneys and employees, and those acting in privity or concert with them, from engaging in the manufacture, use, offer for sale, or sale within the United States, or importation into the United States, of compounds or formulations as claimed in the `868 patent, or from practicing any method as claimed in the `868 patent, or from actively inducing or contributing to infringement of the `868 patent; d. An order be issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the
effective date of any approval of Defendants' ANDA be a date which is not earlier than the
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present expiration date for the `868 patent, or any later expiration of exclusivity to which the `868 patent is or becomes entitled to; e. Judgment be entered declaring that Defendants will infringe the
`868 patent by marketing, manufacturing, using, offering for sale or selling Defendants' Product II; f. An order be issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the
effective date of any approval of Defendants' ANDA II be a date which is not earlier than the present expiration date for the `868 patent, or any later expiration of exclusivity to which the `868 patent is or becomes entitled to; g. Judgment be entered declaring that Defendants will infringe the
`868 patent by marketing, manufacturing, using, offering for sale or selling Defendants' Product III; h. An order be issued pursuant to 35 U.S.C. § 271(e)(4)(A) that the
effective date of any approval of Defendants' ANDA III be a date which is not earlier than the present expiration date for the `868 patent, or any later expiration of exclusivity to which the `868 patent is or becomes entitled to; i. judgment be entered declaring that the `868 patent, as originally
issued and with Certificate of Correction, is not invalid; j. e. Judgment be entered that Defendants acted with willful
disregard for Merck's rights under the `868 patent; k. `868 patent; f. Judgment be entered that Defendants have willfully infringed the
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l.
g. Judgment be entered that this case is an exceptional one and that
Merck should be awarded its reasonable attorneys' fees pursuant to 35 U.S.C. § 285; and m. h. Such other and further relief as the Court may deem just and
proper under the circumstances.
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MORRIS, NICHOLS, ARSHT & TUNNELL LLP
OF COUNSEL: Raymond N. Nimrod Gregory D. Bonifield JENNER & BLOCK LLP 919 N. Third Avenue 37th Floor New York, NY 10022-3908 212.891.1600 Aaron A. Barlow Gregory D. Bonifield JENNER & BLOCK LLP 330 N. Wabash Avenue Chicago, IL 60611-7603 312.222.9350 Paul D. Matukaitis Charles M. Caruso MERCK & CO., INC. One Merck Drive Whitehouse Station, NJ 08889-0100 Edward W. Murray MERCK & CO., INC. 126 E. Lincoln Avenue Rahway, NJ 07065-0907
Mary B. Graham (#2256) James W. Parrett, Jr. (#4292) 1201 N. Market Street P.O. Box 1347 Wilmington, DE 19899-1347 302.658.9200 Attorneys for Merck & Co., Inc.
Dated: April 30, 2007January 11, 2008
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