IPC Ltd., IPC Corp., and IPC International: Jurisdiction and Patent Infringement, Schemes and Mind Maps of Business

Download IPC Ltd., IPC Corp., and IPC International: Jurisdiction and Patent Infringement and more Schemes and Mind Maps Business in PDF only on Docsity! IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PURDUE PHARMA L.P., PURDUE PHARMACEUTICALS L.P., THE P.F. LABORATORIES, INC., and GRÜNENTHAL GMBH, Plaintiffs, v. INTELLIPHARMACEUTICS INTERNATIONAL INC., INTELLIPHARMACEUTICS CORPORATION, and INTELLIPHARMACEUTICS LTD., Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) C.A. No. 18-404 (RGA) AMENDED AND SUPPLEMENTAL COMPLAINT Plaintiffs Purdue Pharma L.P., Purdue Pharmaceuticals L.P., and The P.F. Laboratories, Inc. (collectively, “Purdue”) and Grünenthal GmbH (“Grünenthal”) (Purdue and Grünenthal, collectively, Plaintiffs), for their Amended and Supplemental Complaint against Intellipharmaceutics International Inc., Intellipharmaceutics Corporation, and Intellipharmaceutics Ltd. (collectively, “Intellipharmaceutics” or “Defendants”), aver as follows.1 NATURE OF THE ACTION 1. This is an action for patent infringement arising under the patent laws of the United States, Title 35, United States Code, for infringement of United States Patent Nos. 9,775,808 (the “’808 patent”); 9,763,886 (the “’886 patent”); 9,763,933 (the “Mannion ’933 1 Pursuant to the August 17, 2018 Scheduling Order (D.I. 46 ¶ 2), Plaintiffs are filing this Amended and Supplemental Complaint to assert a newly issued Purdue patent from U.S. Patent Application No. 15/015,763, and as a result, The P.F. Laboratories, Inc. is being added as a plaintiff to the action. Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 1 of 22 PageID #: 3116 2 patent”); 9,675,610 (the “’610 patent”); and 10,076,497 (the “’497 patent”) (collectively, “the patents-in-suit”). This action relates to New Drug Application (“NDA”) No. 209653 (“Defendants’ NDA”) submitted upon information and belief in the name of Intellipharmaceutics to the United States Food and Drug Administration (“FDA”). 2. Plaintiffs seek judgment that Defendants have infringed the ’808, ’886, Mannion ’933, ’610, and ’497 patents. The ’808, Mannion ’933, and ’610 patents are listed in the FDA Approved Drug Products With Therapeutic Equivalence Evaluations (“Orange Book”) as covering Purdue’s OxyContin® (oxycodone hydrochloride) (“OxyContin®”), an extended- release pain medication. Defendants have infringed the ’808, ’886, Mannion ’933, ’610, and ’497 patents under 35 U.S.C. § 271(e)(2)(A) by filing NDA No. 209653, submitted upon information and belief in the name of Intellipharmaceutics to the FDA. Defendants’ NDA seeks approval to market extended-release oxycodone-hydrochloride tablets in the 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg dosage strengths (“Defendants’ NDA Products”) and designates Purdue’s OxyContin®, which is the subject of approved NDA No. 022272, as the Reference Listed Drug. THE PARTIES 3. Plaintiff Purdue Pharma L.P. (“Purdue Pharma”) is a limited partnership organized and existing under the laws of the State of Delaware, having a place of business at One Stamford Forum, 201 Tresser Boulevard, Stamford, Connecticut 06901-3431. Purdue Pharma is an owner of the ’808, ’886, Mannion ’933, and ’497 patents, identified in paragraphs 38-40 and 42 below, and Purdue Pharma is an exclusive licensee of the ’610 patent, identified in paragraph 41 below. Purdue Pharma is also the holder of approved NDA No. 022272 for OxyContin®, indicated for pain severe enough to require daily, around-the-clock, long-term Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 2 of 22 PageID #: 3117 5 13. On information and belief, the acts of IPC Ltd. complained of herein were done at the direction of, with the authorization of, and/or with the cooperation, participation, and assistance of, and at least in part for the benefit of, IPC Corp. and/or IPC International. 14. On information and belief, the acts of IPC International complained of herein were done at the direction of, with the authorization of, and/or with the cooperation, participation, and assistance of, and at least in part for the benefit of, IPC Corp. and/or IPC Ltd. SUBJECT MATTER JURISDICTION AND VENUE 15. This action arises under the patent laws of the United States, including 35 U.S.C. § 271. 16. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and 1338(a). 17. Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391(b), 1391(c), and 1400(b). 18. Defendants have agreed not to contest venue in the District of Delaware in this action and will not move to change the venue of this action. 19. On information and belief, IPC International, IPC Corp., and IPC Ltd. have previously been sued in this district and have not challenged venue. See, e.g., Purdue Pharma L.P. et al. v. Intellipharmaceutics Corp. at al. (D. Del. C.A. No. 17-392-RGA). PERSONAL JURISDICTION 20. Defendants have agreed not to contest personal jurisdiction for purposes of this action, and will not move to dismiss this action on grounds that the District of Delaware lacks personal jurisdiction over Defendants for purposes of the action. Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 5 of 22 PageID #: 3120 6 21. On information and belief, IPC International, IPC Corp. and IPC Ltd. are in the business of formulating, manufacturing and commercializing pharmaceutical products. 22. On information and belief, IPC International, either directly or through one or more of its wholly owned subsidiaries and/or agents, develops drug products for sale and use throughout the United States, including within this judicial district. 23. On information and belief, IPC Corp., with the assistance and/or at the direction of IPC Ltd. and/or IPC International, develops drug products for sale and use throughout the United States, including within this judicial district. 24. On information and belief, IPC Ltd., with the assistance and/or at the direction of IPC Corp. and/or IPC International, develops drug products for sale and use throughout the United States, including within this judicial district. 25. On information and belief, IPC International, IPC Corp. and IPC Ltd. operate as an integrated, unitary business. 26. On information and belief, IPC Ltd., through IPC Corp., develops both branded and generic controlled-release pharmaceutical products, and licenses these developed products for commercialization. 27. On information and belief, IPC International, IPC Corp. and IPC Ltd. acted in concert to develop Defendants’ NDA Products and to prepare and file Defendants’ NDA, an application pursuant to § 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 355(b)(2)) (“§ 505(b)(2)”) that references Purdue’s OxyContin® NDA No. 022272 and seeks approval from the FDA to sell Defendants’ NDA Products throughout the United States and in this judicial district. Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 6 of 22 PageID #: 3121 7 28. On information and belief, IPC International and/or IPC Ltd., through their authorized agent and subsidiary, IPC Corp., submitted NDA No. 209653 to the FDA. On information and belief, IPC International and IPC Ltd. have attributed the acts of IPC Corp. to themselves. On information and belief, IPC International, IPC Ltd. and IPC Corp. thus acted as a single entity in connection with preparing and submission of NDA No. 209653. On further information and belief, IPC Corp. acted as an agent of IPC International and/or IPC Ltd. 29. On information and belief, and as previously noted, IPC Ltd. is a corporation organized and existing under the laws of Delaware. By virtue of its incorporation in Delaware, this Court has personal jurisdiction over IPC Ltd. 30. On information and belief, by virtue of, inter alia, IPC Ltd.’s relationship with IPC International in connection with the preparation and/or filing of NDA No. 209653, and their systematic and continuous activities in Delaware, including but not limited to the development of generic drug products for sale to residents of Delaware, this Court has personal jurisdiction over IPC International. 31. On information and belief, by virtue of, inter alia, IPC Ltd.’s relationship with IPC Corp. in connection with the preparation and/or filing of NDA No. 209653, and their systematic and continuous activities in Delaware, including but not limited to the development of generic drug products for sale to residents of Delaware, this Court has personal jurisdiction over IPC Corp. 32. On information and belief, separate and apart from its relationship with IPC Ltd., IPC International has availed itself of the laws of the State of Delaware and engaged in a course of conduct in the State of Delaware, at least by incorporating and/or maintaining the incorporation of its subsidiary and/or agent IPC Ltd. under Delaware law, and identifying the Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 7 of 22 PageID #: 3122 10 including the right to sue and to recover for past infringement thereof. A copy of the ’886 patent is attached hereto as Exhibit B, which was duly and legally issued on September 19, 2017, naming William H. McKenna, Richard O. Mannion, Edward P. O’Donnell, and Haiyong H. Huang as the inventors. THE MANNION ’933 PATENT 40. Purdue Pharma and Purdue Pharmaceuticals are the lawful owners of all right, title and interest in the Mannion ’933 patent, titled “TAMPER RESISTANT DOSAGE FORMS,” including the right to sue and to recover for past infringement thereof. The Mannion ’933 patent is listed in the Orange Book as covering OxyContin®, which is the subject of approved NDA No. 022272. A copy of the Mannion ’933 patent is attached hereto as Exhibit C, which was duly and legally issued on September 19, 2017, naming William H. McKenna, Richard O. Mannion, Edward P. O’Donnell, and Haiyong H. Huang as the inventors. THE ’610 PATENT 41. Grünenthal is the lawful owner of all right, title, and interest in the ’610 patent, titled “ABUSE-PROOFED DOSAGE FORM,” including the right to sue and to recover for past infringement thereof. Purdue Pharma is an exclusive licensee of the ’610 patent from Grünenthal, with the right to enforce the ’610 patent. The ’610 patent is listed in the Orange Book as covering OxyContin®, which is the subject of approved NDA No. 022272. A copy of the ’610 patent, attached hereto as Exhibit D, was duly and legally issued on June 13, 2017, naming Johannes Bartholomäus and Heinrich Kugelmann as the inventors. THE ’497 PATENT 42. Purdue Pharma, Purdue Pharmaceuticals, and P.F. Labs are the lawful owners of all right, title, and interest in the ’497 patent, titled “PHARMACEUTICAL Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 10 of 22 PageID #: 3125 11 FORMULATION CONTAINING GELLING AGENT,” including the right to sue and to recover for past infringement thereof. A copy of the ’497 patent is attached hereto as Exhibit E, which was duly and legally issued on September 18, 2018, naming Curtis Wright, Benjamin Oshlack, and Christopher Breder as the inventors. DEFENDANTS’ NDA 43. On information and belief, on or about November 22, 2016, and after November 16, 2016, Defendants filed Defendants’ NDA No. 209653, which they have periodically supplemented and/or amended, under § 505(b)(2), seeking approval to engage in the commercial manufacture, use, or sale of Defendants’ NDA Products, generic products based on the Reference Listed Drug OxyContin®, which is the subject of approved NDA No. 022272. 44. In a letter dated March 5, 2018, addressed to Plaintiffs and received by Purdue Pharma on or about March 6, 2018, Defendants provided a “Notice of Paragraph IV Certification” with respect to Defendants’ NDA and Defendants’ NDA Products and, inter alia, the ’808, Mannion ’933, and ’610 patents, under § 505(b)(2) (“March 2018 Notice Letter”). 45. Plaintiffs commenced this action with the filing of their original complaint on April 7, 2018, asserting, inter alia, the ’808, Mannion ’933, and ’610 patents (D.I. 2) within the 45-day period after receiving the March 2018 Notice Letter as described in 21 U.S.C. § 355(c)(3)(C)(iii). FIRST CLAIM FOR RELIEF (PATENT INFRINGEMENT OF U.S. PATENT NO. 9,775,808) 46. Purdue Pharma and Purdue Pharmaceuticals incorporate by reference and reallege paragraphs 1 through 45 above as though fully restated herein. Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 11 of 22 PageID #: 3126 12 47. Pursuant to 35 U.S.C. § 271(e)(2), Defendants’ submission of NDA No. 209653 to the FDA seeking approval of Defendants’ NDA Products was an act of infringement of the ’808 patent by Defendants. 48. Defendants’ NDA Products, or the use thereof, are covered by one or more claims of the ’808 patent, including but not limited to independent claim 1, which recites, inter alia, a pharmaceutical composition comprising: at least one active agent comprising oxycodone or a pharmaceutically acceptable salt thereof; and at least one high molecular weight polyethylene oxide (PEO), having an approximate molecular weight of from 1 million to 15 million; at least one of an additive and a film coating; wherein (a) the active agent and high molecular weight PEO are combined in a solid oral extended release dosage form that is (i) compression shaped, (ii) air cured by heated air, without compression, for at least about 5 minutes at a temperature above the softening temperature of the high molecular weight PEO, (iii) cooled, and (iv) hardened; (b) the high molecular weight PEO comprises at least about 30% (by weight) of the dosage form; (c) the molecular weight of each PEO is based on rheological measurements; and (d) the total weight of the dosage form is calculated by excluding the combined weight of said film coatings. 49. If approved by the FDA, Defendants’ commercial manufacture, use, importation, sale, and/or offer for sale of Defendants’ NDA Products will infringe, contribute to the infringement of, and/or induce the infringement of one or more claims of the ’808 patent under 35 U.S.C. § 271(a)-(c). 50. Defendants’ NDA Products constitute a material part of the inventions covered by the claims of the ’808 patent. Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 12 of 22 PageID #: 3127 15 60. Unless Defendants are enjoined by the Court, Purdue Pharma and Purdue Pharmaceuticals will be substantially and irreparably harmed by Defendants’ infringement of the ’886 patent. Purdue Pharma and Purdue Pharmaceuticals do not have an adequate remedy at law. THIRD CLAIM FOR RELIEF (PATENT INFRINGEMENT OF U.S. PATENT NO. 9,763,933) 61. Purdue Pharma and Purdue Pharmaceuticals incorporate by reference and reallege paragraphs 1 through 60 above as though fully restated herein. 62. Pursuant to 35 U.S.C. § 271(e)(2), Defendants’ submission of NDA No. 209653 to the FDA seeking approval of Defendants’ NDA Products was an act of infringement of the Mannion ’933 patent by Defendants. 63. Defendants’ NDA Products, or the use thereof, are covered by one or more claims of the Mannion ’933 patent, including but not limited to independent claim 1, which recites, inter alia, a pharmaceutical composition comprising: at least one active agent; at least one high molecular weight polyethylene oxide (PEO) having an approximate molecular weight of from 1 million to 15 million; optionally at least one film coating; wherein (a) the active agent and high molecular weight PEO are combined in a solid oral extended release dosage form that is (i) compression shaped, (ii) air cured by heated air, without compression, for at least about 5 minutes at a temperature above the softening temperature of the high molecular weight PEO, (iii) cooled, and (iv) hardened; (b) the high molecular weight PEO comprises at least about 30% (by weight) of the dosage form; (c) the molecular weight of each PEO is based on rheological measurements; and (d) the total weight of the dosage form is calculated by excluding the combined weight of said film coatings. Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 15 of 22 PageID #: 3130 16 64. If approved by the FDA, Defendants’ commercial manufacture, use, importation, sale, and/or offer for sale of Defendants’ NDA Products will infringe, contribute to the infringement of, and/or induce the infringement of one or more claims of the Mannion ’933 patent under 35 U.S.C. § 271(a)-(c). 65. Defendants’ NDA Products constitute a material part of the inventions covered by the claims of the Mannion ’933 patent. 66. Upon information and belief, Defendants been aware of the existence of the Mannion ’933 patent and have no reasonable basis for believing that Defendants’ NDA Products will not infringe the Mannion ’933 patent, thus rendering the case “exceptional,” as that term is used in 35 U.S.C. § 285. 67. Unless Defendants are enjoined by the Court, Purdue Pharma and Purdue Pharmaceuticals will be substantially and irreparably harmed by Defendants’ infringement of the Mannion ’933 patent. Purdue Pharma and Purdue Pharmaceuticals do not have an adequate remedy at law. FOURTH CLAIM FOR RELIEF (PATENT INFRINGEMENT OF U.S. PATENT NO. 9,675,610) 68. Grünenthal and Purdue Pharma incorporate by reference and reallege paragraphs 1 through 67 above as though fully restated herein. 69. Pursuant to 35 U.S.C. § 271(e)(2), Defendants’ submission of NDA No. 209653 to the FDA seeking approval of Defendants’ NDA Products was an act of infringement of the ’610 patent by Defendants. 70. Defendants’ NDA Products, or the use or manufacture thereof, are covered by one or more claims of the ’610 patent, including but not limited to independent claim 1, which recites, inter alia, a solid dosage form for oral administration with reduced potential for Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 16 of 22 PageID #: 3131 17 parenteral abuse, said dosage form comprising: (a) one or more active ingredients having potential for abuse selected from the group consisting of (among others) oxycodone and a pharmaceutically acceptable salt thereof; and (b) one or more viscosity-increasing agents in a quantity such that an aqueous extract of a total content of the dosage form when comminuted and combined with 10 ml of water at 25° C forms a gel that can be drawn up into and injected back out of a hypodermic needle having a diameter of 0.9 mm, into a further quantity of water, wherein threads of the gel injected from said needle remain visible to the naked eye in said further quantity of water at 37° C. 71. If approved by the FDA, Defendants’ commercial manufacture, use, importation, sale, and/or offer for sale of Defendants’ NDA Products will infringe, contribute to the infringement of, and/or induce the infringement of one or more claims of the ’610 patent under 35 U.S.C. § 271(a)-(c). 72. Defendants’ NDA Products constitute a material part of the inventions covered by the claims of the ’610 patent. 73. Upon information and belief, Defendants been aware of the existence of the ’610 patent and have no reasonable basis for believing that Defendants’ NDA Products will not infringe the ’610 patent, thus rendering the case “exceptional,” as that term is used in 35 U.S.C. § 285. 74. Unless Defendants are enjoined by the Court, Grünenthal and Purdue Pharma will be substantially and irreparably harmed by Defendants’ infringement of the ’610 patent. Grünenthal and Purdue Pharma do not have an adequate remedy at law. Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 17 of 22 PageID #: 3132 20 C. Preliminarily and permanently enjoining, pursuant to 35 U.S.C. §§ 271(e)(4)(B) and 283 and Rule 65, Fed. R. Civ. P., Defendants, their officers, partners, agents, servants, employees, parents, subsidiaries, divisions, affiliate corporations, other related business entities, and all other persons acting in concert, participation, or in privity with them, and their successors and assigns, from any commercial manufacture, use, offer to sell, or sale within the United States, or importation into the United States, of any drug product that is the subject of NDA No. 209653, including Defendants’ NDA Products or any other drug product that infringes the ’808, ’886, Mannion ’933, ’610, and ’497 patents; D. Declaring this an exceptional case and awarding Plaintiffs their attorneys’ fees and costs, as provided by 35 U.S.C. §§ 271(e)(4) and 285; and E. Awarding Plaintiffs such other and further relief as this Court may deem just and proper. OF COUNSEL: John J. Normile Pablo D. Hendler Kelsey I. Nix Gasper J. LaRosa Kenneth S. Canfield Christopher J. Harnett Sarah A. Geers Lisamarie LoGuidice JONES DAY 250 Vesey Street New York, NY 10281 (212) 326-3939 MORRIS, NICHOLS, ARSHT & TUNNELL LLP /s/ Rodger D. Smith II Jack B. Blumenfeld (#1014) Rodger D. Smith II (#3778) Megan E. Dellinger (#5739) 1201 North Market Street P.O. Box 1347 Wilmington, DE 19899 (302) 658-9200 jblumenfeld@mnat.com rsmith@mnat.com mdellinger@mnat.com Attorneys for Plaintiffs Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 20 of 22 PageID #: 3135 21 Jason G. Winchester JONES DAY 77 West Wacker Drive Chicago, IL 60601 (312) 269-4373 Attorneys for Plaintiffs Purdue Pharma L.P. and Purdue Pharmaceuticals L.P., Jennifer H. Roscetti Matthew J. Luneack FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP 901 New York Avenue, NW Washington, DC 20001 (202) 408-4000 Anthony C. Tridico FINNEGAN EUROPE LLP 16 Old Bailey London EC4M 7EG United Kingdom 011 44 20 3178 7883 Attorneys for Plaintiff Grünenthal GmbH September 24, 2018 Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 21 of 22 PageID #: 3136 CERTIFICATE OF SERVICE I hereby certify that on September 24, 2018, I caused the foregoing to be electronically filed with the Clerk of the Court using CM/ECF, which will send notification of such filing to all registered participants. I further certify that I caused copies of the foregoing document to be served on September 24, 2018, upon the following in the manner indicated: Neal C. Belgam, Esquire Eve H. Ormerod, Esquire SMITH, KATZENSTEIN & JENKINS LLP 1000 West Street, Suite 1501 Wilmington, DE 19801 Attorneys for Defendants VIA ELECTRONIC MAIL Shashank Upadhye, Esquire Joseph E. Cwik, Esquire Yixin H. Tang, Esquire Brent Batzer, Esquire Adam D. Sussman, Esquire Samuel J. Ruggio, Esquire Erin R. Conway, Esquire AMIN TALATI UPADHYE LLP 100 S. Wacker Drive, Suite 2000 Chicago, IL 60606 Attorneys for Defendants VIA ELECTRONIC MAIL /s/ Rodger D. Smith II __________________________ Rodger D. Smith II (#3778) Case 1:18-cv-00404-RGA Document 54 Filed 09/24/18 Page 22 of 22 PageID #: 3137