Case 3:11-cv-02214-GPC-KSC Document 283 Filed 10/17/14 Page 1 of 30 1 MCDERMOTT WILL & EMERY LLP WILLIAM G. GAEDE, III (136184) 2 [email protected] SHANE G. SMITH (272630) 3 [email protected] 275 Middlefield Road, Suite 100 4 Menlo Park, CA 94025 5 Telephone: (650) 815-7400 Facsimile: (650) 815-7401 6 MCDERMOTT WILL & EMERY LLP 7 DEREK J. MEYER (278346) [email protected] 8 JASON D. STRABO (246426) [email protected] 9 2049 Century Park East, Suite 3800 Los Angeles, CA 90067 10 Telephone: (310) 277-4110 11 Facsimile: (310) 277-4730 LLP 12 MCDERMOTT WILL & EMERY LLP MERY AW E L JOHN C. LOW (pro hac vice) T & ALLEY A V 13 [email protected] ILL ILL W 1000 Louisiana, Suite 3900 ILICON ILICON S TTORNEYS A 14 Houston, TX 77002 ERMOTT Telephone: (713) 653-1781 D C 15 Facsimile: (713) 739-7592 M 16 Attorneys for Isis Pharmaceuticals, Inc. 17 IN THE UNITED STATES DISTRICT COURT 18 IN AND FOR THE SOUTHERN DISTRICT OF CALIFORNIA 19 SAN DIEGO DIVISION 20 ISIS PHARMACEUTICALS, INC., Case No. 11-CV-02214 GPC (KSC) 21 a Delaware Corporation, SECOND AMENDED COMPLAINT 22 Plaintiff, FOR PATENT INFRINGEMENT 23 v. DEMAND FOR JURY TRIAL 24 SANTARIS PHARMA A/S CORP., a Delaware corporation, and 25 SANTARIS PHARMA A/S, a Danish Corporation, 26 Defendants. 27 28 2ND AMENDED COMPLAINT FOR PATENT INFRINGEMENT DM_US 55841402-5.058823.0336 CASE NO. 11-CV-02214 GPC (KSC) Case 3:11-cv-02214-GPC-KSC Document 283 Filed 10/17/14 Page 2 of 30 1 Plaintiff Isis Pharmaceuticals, Inc., complains against Defendants Santaris 2 Pharma A/S Corp. and Santaris Pharma A/S (collectively “Santaris”) as follows: 3 THE PARTIES 4 1. Plaintiff Isis Pharmaceuticals, Inc. (“Isis”), is a corporation organized 5 under the laws of Delaware, having its principal place of business at 2855 Gazelle 6 Court, Carlsbad, California 92010. 7 2. On information and belief, Defendant Santaris Pharma A/S Corp. is a 8 privately held company, incorporated in the State of Delaware, having a principal 9 place of business at 12626 High Bluff Drive, Suite 440, San Diego, California 10 92130. On information and belief, Santaris Pharma A/S Corp. is registered to do 11 business in the State of California. On information and belief, and as further LLP 12 MERY explained below, Santaris Pharma A/S Corp., itself and as the agent and wholly AW E L T & ALLEY A V 13 owned subsidiary of Santaris Pharma A/S, is in the business of discovering and ILL ILL W ILICON ILICON S TTORNEYS A 14 commercializing RNA-targeted therapies through third parties in the State of ERMOTT D C 15 California and throughout the United States. M 16 3. On information and belief, Santaris Pharma A/S is a privately held 17 biopharmaceutical company organized and existing under the laws of Denmark, 18 having a principal place of business at Kogle Allé 6, DK-2970 Hørsholm, 19 Denmark. On information and belief, and as further explained below, Santaris 20 Pharma A/S, itself and through its wholly owned subsidiary and agent, Santaris 21 Pharma A/S Corp., is in the business of discovering and commercializing RNA- 22 targeted therapies through third parties in the State of California and throughout the 23 United States. Santaris Pharma A/S Corp. is the alter ego of Santaris Pharma A/S, 24 where a unity of interest and ownership exists between Santaris Pharma A/S and 25 Santaris Pharma A/S Corp, such that separate personalities of the two do not in 26 reality exist. Isis is informed and believes, and on that basis alleges, that 27 Defendants were at all times relevant the partners, officers, agents, assignees, 28 successors-in-interest, co-conspirators, principals, alter egos, or employees of each 2ND AMENDED COMPLAINT FOR -1- PATENT INFRINGEMENT DM_US 55841402-5.058823.0336 CASE NO. 11-CV-02214 GPC (KSC) Case 3:11-cv-02214-GPC-KSC Document 283 Filed 10/17/14 Page 3 of 30 1 other, or were otherwise responsible for, contributed to, or participated in the acts 2 and omissions alleged herein, and thereby incurred liability therefore. 3 JURISDICTION AND VENUE 4 4. This is an action for patent infringement arising under the patent laws 5 of the United States (Title 35 of the United States Code) and arising from Santaris’s 6 sale, offer to sell, use or importation of Isis’s patented methods and/or compositions 7 prior to the expiration of U.S. Patent Nos. 6,326,199, 6,066,500, and 6,440,739. 8 The Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. §§ 9 1331, 1338(a) and Section 2201. 10 5. This Court has personal jurisdiction over Santaris by virtue of the fact 11 that Santaris conducts business in the State of California, and has availed itself of LLP 12 MERY the rights and benefits under California law, and has engaged in substantial and AW E L T & ALLEY A V 13 continuous contacts in the State of California. ILL ILL W ILICON ILICON S TTORNEYS A 14 6. To the extent that Santaris Pharma A/S (Denmark) successfully ERMOTT D C 15 contends that it is not doing business in California, personal jurisdiction over M 16 Santaris Pharma A/S is proper under Federal Rule of Civil Procedure 4(k)(2). 17 7. Venue is proper in this district pursuant to 28 U.S.C. §§ 1391(b) and 18 1400. 19 THE PATENTS-IN-SUIT 20 8. On December 4, 2001, United States Patent No. 6,326,199 (the “‘199 21 Patent”) entitled “Gapped 2' Modified Oligonucleotides” issued to Isis 22 Pharmaceuticals, Inc., as assignee of the inventors. (A copy of the ‘199 Patent is 23 attached as Exhibit 1.) 24 9. On May 23, 2000, United States Patent No. 6,066,500 (the “‘500 25 Patent”) entitled “Antisense Modulation of Beta Catenin Expression” issued to Isis 26 Pharmaceuticals, Inc., as assignee of the inventors. (A copy of the ‘500 Patent is 27 attached as Exhibit 2.) 28 2ND AMENDED COMPLAINT FOR -2- PATENT INFRINGEMENT DM_US 55841402-5.058823.0336 CASE NO. 11-CV-02214 GPC (KSC) Case 3:11-cv-02214-GPC-KSC Document 283 Filed 10/17/14 Page 4 of 30 1 10. On August 27, 2002, United States Patent No. 6,440,739 (the “‘739 2 Patent”) entitled “Antisense Modulation of Glioma-Associated Oncogene-2 3 Expression” issued to Isis Pharmaceuticals, Inc., as assignee of the inventors. (A 4 copy of the ‘739 Patent is attached as Exhibit 3.) 5 11. The ‘199, ‘500 and ‘739 Patents (collectively the “patents-in-suit”) 6 have been owned by Isis at all times, are fully maintained, and are valid and 7 enforceable. 8 DRUG DISCOVERY AND DEVELOPMENT 9 12. In the fields of medicine and biotechnology, drug discovery is the 10 process by which drugs are designed and/or identified. The process of drug 11 discovery involves target validation and drug candidate identification. During the LLP 12 MERY target validation phase, pharmaceutical researchers test a hypothesis that, for AW E L T & ALLEY A V 13 example, the reduction of a given protein target will yield a biochemical change ILL ILL W ILICON ILICON S TTORNEYS A 14 potentially relevant for treating disease. Candidate identification commences after ERMOTT D C 15 a target has been validated in relevant disease models and often involves screening M 16 numbers of compounds for their biological activity. Once a compound has been 17 identified through the foregoing process and shown to have the specific desired 18 activity, it will enter the process of drug development. 19 13. Drug development refers to activities undertaken after a compound has 20 been identified as a potential drug that seek to establish its suitability as a 21 medication. This process determines appropriate formulation and dosing, as well as 22 establishes safety. Research in these areas generally includes a number of required 23 in vivo studies and clinical trials in healthy volunteers to assess safety, and 24 ultimately in patients to assess therapeutic value as a medication. Certain pre- 25 clinical and clinical data generated during the drug discovery phase may ultimately 26 form the basis for a filing with the Food and Drug Administration (FDA) for 27 regulatory approval to market the drug in the United States. 28 2ND AMENDED COMPLAINT FOR -3- PATENT INFRINGEMENT DM_US 55841402-5.058823.0336 CASE NO. 11-CV-02214 GPC (KSC) Case 3:11-cv-02214-GPC-KSC Document 283 Filed 10/17/14 Page 5 of 30 1 ANTISENSE TECHNOLOGY 2 14. Proteins are fundamental components of all living cells, and include 3 many types of molecules necessary for carrying out cellular functions. The 4 overproduction or abnormal production of proteins is implicated or associated with 5 many diseases. Genes are DNA chemical entities within the nuclei of cells that 6 hold the information necessary to make proteins. This information is converted 7 into proteins in two steps called transcription and translation. At the transcription 8 step, the genetic information for a given protein is copied to a molecule called 9 messenger RNA (mRNA). During translation, cellular machinery converts the 10 information embodied in the mRNA into proteins. 11 15. Most drugs produced by the pharmaceutical and biotechnology LLP 12 MERY industries, such as small molecules (e.g., Lipitor) or monoclonal antibodies (e.g., AW E L T & ALLEY A V 13 Enbrel) are designed to bind to and interfere with the function of disease-causing ILL ILL W ILICON ILICON S TTORNEYS A 14 proteins.