ISIS Pharmaceuticals, Inc. v. Santaris Pharma A/S Corp. et al, No. 3:2011cv02214 - Document 128 (S.D. Cal. 2013)
Court Description: ORDER Granting 95 Plaintiff's Motion for Leave to File First Amended Complaint. The April 26, 2013 hearing is Vacated. All discovery and disclosure obligations are Stayed pending this Court's decision on Defendant's renewed motion fo r summary judgment on the safe harbor issue. Defendants' counsel is directed to contact this Court's chambers on or before April 26, 2013, to obtain a hearing date for renewed motion for summary judgment. Signed by Judge Gonzalo P. Curiel on 4/23/2013. (srm)
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ISIS Pharmaceuticals, Inc. v. Santaris Pharma A/S Corp. et al Doc. 128 1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 SOUTHERN DISTRICT OF CALIFORNIA 10 11 12 13 14 15 16 17 18 19 ISIS PHARMACEUTICALS, INC., a Delaware Corporation, ) ) ) Plaintiff, ) v. ) ) SANTARIS PHARMA A/S CORP., a ) Delaware Corporation, and ) SANTARIS PHARMA A/S, a Danish ) Corporation, ) ) Defendants. ) ) ) ) AND RELATED COUNTERCLAIMS. ) ) Case No. 3:11-cv-2214-GPC-KSC ORDER GRANTING PLAINTIFF’S MOTION FOR LEAVE TO FILE FIRST AMENDED COMPLAINT (ECF NO. 95) 20 INTRODUCTION 21 22 Before the Court is Plaintiff’s Motion for Leave to File a First Amended 23 Complaint, (ECF No. 95), which has been fully briefed, (ECF Nos. 104, 109), and 24 which the Court finds suitable for disposition without oral argument, see CivLR 25 7.1.d.1. After considering the parties’ submissions and the record in this matter, and 26 for the reasons that follow, the Court hereby GRANTS Plaintiff’s Motion for Leave 27 to File a First Amended Complaint. 28 /// 3:11-cv-2214-GPC-KSC Dockets.Justia.com BACKGROUND 1 2 Plaintiff filed suit on September 22, 2011, alleging infringement of two of its 3 patents: U.S. Patent No. 6,326,199, “Gapped 2' Modified Oligonucleotides” (“‘199 4 Patent”) and U.S. Patent No. 6,066,500 “Antisense Modulation of Beta Catenin 5 Expression” (“‘500 Patent”). (ECF No. 1.) Both the ‘199 Patent and the ‘500 Patent 6 cover methods and compounds related to the modification of genetic material. 7 Ribonucleic acid, or RNA, is a single-stranded molecule that carries genetic 8 instructions. Messenger RNA, or mRNA, carries genetic instructions from a cell’s 9 nucleus to the cell’s cytoplasm, where it provides instructions for the production of 10 proteins. Nucleotides from the basic structural unit of nucleic acids like mRNA. 11 The ‘199 Patent covers the synthesis and use of short strands of nucleotides 12 called oligonucleotides, antisense molecules, or – very broadly – macromolecules. The 13 ‘199 Patent claims a method whereby antisense molecules are hybridized with 14 complimentary strands of mRNA in a target cell to modify the target cell’s behavior in 15 some way. 16 To ensure successful hybridization, the antisense molecules covered by the ‘199 17 Patent possess features that make degradation of the molecule less likely and that make 18 binding with the complimentary strand more likely. 19 If successfully hybridized, the antisense molecule modifies the target cell to, for 20 example, decrease production of a certain protein. Indeed, the ‘500 Patent covers the 21 synthesis and use of an antisense molecule that specifically reduces production of the 22 protein Beta catenin – a protein whose overproduction has been tied to certain cancers. 23 Plaintiff alleges in its Complaint that Defendants have used the molecules 24 claimed by the ‘199 Patent, and the method of contacting cells with those molecules 25 also claimed in the ‘199 Patent, to “identify [gene] targets and/or to screen gapmer ... 26 antisense molecules for activity inhibiting a target.” Plaintiff alleges Defendants sell 27 and offer for sale in the U.S. the patented methods of the ‘199 Patent. Plaintiff further 28 alleges that Defendants have infringed the ‘500 Patent by offering for sale and selling 2 3:11-cv-2214-GPC-KSC 1 antisense compounds that inhibit Beta catenin production. 2 Plaintiff bases its infringement contentions on four agreements between 3 Defendants and various U.S. pharmaceutical companies: a January 4, 2011 agreement 4 with Pfizer, Inc.; a July 27, 2006 agreement with Enzon Pharmaceuticals, Inc.; an 5 August 24, 2009 agreement with Shire PLC; and a December 19, 2007 agreement with 6 GlaxoSmithKline. Plaintiff alleges each of the agreements infringe the ‘199 Patent 7 (and that the Enzon agreement also infringes the ‘500 Patent) because the agreements 8 require Defendants to supply the above pharmaceutical companies with antisense 9 molecules that are covered by the ‘199 and ‘500 Patents for use in connection with 10 therapeutic targets identified by the pharmaceutical companies. 11 On December 8, 2011, Defendants filed an answer and counterclaims against 12 Plaintiff. (ECF No. 12.) On December 12, 2011, Plaintiff filed a reply to Defendants’ 13 counterclaims. (ECF NO. 14.) 14 Thereafter, before a case management conference was held (and thus before 15 discovery commenced), Defendants filed a motion for summary judgment. (ECF No. 16 17.) Defendants asserted they are entitled to judgment as a matter of law pursuant to 17 the safe harbor provision set forth in 35 U.S.C. § 271(e)(1).1 Defendants claimed their 18 use of the antisense technology falls within the safe harbor provision because the only 19 purpose for Defendants’ use of the technology is to develop antisense drugs that target 20 conditions that have already been identified by Defendants’ pharmaceutical partners 21 22 23 24 25 26 27 28 1 Section 271(e)(1) provides: “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs[.]” The safe harbor provision applies “where a drugmaker has a reasonable basis for believing that a patented compound may work, through a particular biological process, to produce a physiological effect, and uses the compound in research that, if successful, would be appropriate to include in a submission to the FDA, the use is ‘reasonably related’ to the ‘development and submission for information . . . under federal law.’” Merck KGaA v. Integra Lifesciences I, Ltd, 545 U.S. 193, 207 (2005). The safe harbor provision does not apply when a biological compound is used to perform “basic scientific research” or as a “research tool.” Id. at 205-06. 3 3:11-cv-2214-GPC-KSC 1 in the U.S. That is, Defendants claimed their use of the antisense technology falls 2 within the safe harbor provision because Defendants’ pharmaceutical partners 3 ultimately use Defendants’ work in connection with seeking FDA approval of antisense 4 drugs. 5 On September 19, 2012, prior to the case’s transfer to this Court, Judge 6 Moskowitz denied Defendants’ Motion for Summary Judgment without prejudice. 7 (ECF No. 53.) Judge Moskowitz found Defendants had offered insufficient evidence 8 as to Defendants’ specific uses of the infringing compounds, methods, and processes. 9 Judge Moskowitz further found a dispute of material fact as to whether Defendants do 10 not perform any antisense technology work until a therapeutic target has already been 11 identified by a pharmaceutical partner. Judge Moskowitz concluded, stating, “To the 12 extent [Defendants] [are] selling and/or licensing infringing ‘platform’ technology so 13 that another company can ‘discover and develop’ drug candidates—rather than 14 developing and/or licensing/selling specific drug candidates itself—[Defendants] could 15 be using or selling patented technology to perform ‘basic scientific research.’” And 16 such use, of course, would not fall within the safe harbor. 17 In denying Defendants’ Motion for Summary Judgment, Judge Moskowitz 18 permitted the parties 120 days to conduct limited discovery related to the issues raised 19 by Defendants’ safe harbor defense. Judge Moskowitz further granted Defendants 20 leave to re-file a motion for summary judgment on the safe harbor issue within 30 days 21 following close of the limited discovery period. In a separate order, Judge Moskowitz 22 stayed all discovery and disclosure obligations unrelated to the Defendants’ safe harbor 23 defense until January 16, 2012. (ECF No. 54.) 24 Judge Crawford held a CMC on July 20, 2012, and issued a case management 25 conference order on July 26, 2012 (“First Scheduling Order”). (ECF Nos. 41, 42.) The 26 First Scheduling Order set a deadline of August 20, 2012, to file “[a]ny motion to join 27 other parties, to amend the pleadings, or to file additional pleadings.” (ECF No. 42.) 28 On October 12, 2012, the case was transferred to this Court. (ECF No. 57.) 4 3:11-cv-2214-GPC-KSC 1 On January 31, 2013, Judge Crawford found good cause to vacate the First 2 Scheduling Order. (ECF No. 94.) Judge Crawford gave Plaintiff until February 1, 3 2013 to file a motion for leave to file a first amended complaint, continued the stay 4 limiting discovery to the safe harbor issue until April 5, 2013, and informed the parties 5 that a new briefing scheduling on Defendants’ safe harbor summary judgment motion 6 would be set following this Court’s ruling on Plaintiff’s motion for leave to amend. 7 Plaintiff thereafter filed the instant motion. DISCUSSION 8 9 I. Legal Standard 10 Leave to amend a complaint after a responsive pleading has been filed “shall be 11 freely given when justice so requires.” Fed. R. Civ. P. 15(a). Granting leave to amend 12 rests in the sound discretion of the trial court. Int’l Ass’n of Machinists & Aerospace 13 Workers v. Republic Airlines, 761 F.2d 1386, 1390 (9th Cir. 1985). This discretion 14 must be guided by the strong federal policy favoring the disposition of cases on the 15 merits and permitting amendments with “extreme liberality.” DCD Programs Ltd. v. 16 Leighton, 833 F.2d 183, 186 (9th Cir. 1987). “Amendments seeking to add claims are 17 to be granted more freely than amendments adding parties.” Union Pacific R.R. Co. 18 v. Nevada Power Co., 950 F.2d 1429, 1432 (9th Cir. 1991). 19 Courts should consider five factors in determining whether a plaintiff ought to 20 be granted leave to amend: undue delay, bad faith or dilatory motive, failure to cure 21 deficiencies by amendments previously allowed, prejudice to the opposing party, and 22 futility of amendment. Foman v. Davis, 371 U.S. 178, 182 (1962). “Absent prejudice, 23 or a strong showing of any of the remaining Foman factors, there exists a presumption 24 under Rule 15(a) in favor of granting leave to amend.” Eminence Capital, LLC v. 25 Aspeon, Inc., 316 F.3d 1048, 1052 (9th Cir. 2003) (emphasis added). 26 II. Analysis 27 Plaintiff seeks to amend its Complaint by: (1) adding an allegation of direct 28 infringement under 35 U.S.C. § 271(b); (2) expand the factual allegation of direct 5 3:11-cv-2214-GPC-KSC 1 infringement to include new information on Defendants’ previously undisclosed 2 relationship with a third party; and (3) add a third cause of action for Defendants’ 3 infringement of U.S. Patent No. 6,440,739 (“‘739 Patent”). 4 Plaintiff argues it should be granted leave to amend because all of the Foman 5 factors tip in its favor. Plaintiff asserts it has not unduly delayed in seeking leave to 6 amend because Plaintiff was not aware of the facts underlying its proposed 7 amendments until November 2012. Plaintiff further asserts it is seeking leave to amend 8 in good faith and that its amendments are not futile. Plaintiff argues its amendments 9 will not prejudice Defendants because of the relatively early stage of these 10 proceedings: discovery has only proceeded on a limited basis, no full scheduling order 11 has issued, and the parties have not yet begun complying with the many requirements 12 found in the Patent Local Rules. Plaintiff lastly argues that Judge Crawford’s January 13 31, 2013 order vacating the First Scheduling Order provides further support for 14 Plaintiff’s request for leave to amend. 15 Defendants argue in response that Plaintiff has unduly delayed in seeking leave 16 to amend because Plaintiff had knowledge of the facts underlying its proposed 17 amendments at the time Plaintiff filed its initial complaint and because Plaintiff was not 18 diligent with respect to adding its proposed claim for infringement of the ‘739 Patent. 19 Defendants argue Plaintiff’s amendments would prejudice Defendants by (1) 20 potentially delaying the end of this litigation, as Defendants’ safe harbor summary 21 judgment motion will be dispositive of the entire case; and (2) expanding discovery 22 into the activities of several third parties. Defendants argue that, at a minimum, 23 Plaintiff should be denied leave to amend without prejudice and allowed to re-file the 24 motion after this Court’s ruling on Defendants’ renewed summary judgment motion. 25 The Court first notes that Defendants do not argue Plaintiff’s proposed 26 amendments are futile or sought in bad faith; thus, the Court does not consider those 27 factors. As to delay, the Court finds Plaintiff did not unduly delay in seeking leave to 28 file a first amended complaint. Given the complexity of this case and the number of 6 3:11-cv-2214-GPC-KSC 1 documents produced in the limited discovery that has occurred thus far, the Court finds 2 any delay by Plaintiff was reasonable. The Court further finds Defendants have not 3 demonstrated they would be significantly prejudiced by Plaintiff’s proposed 4 amendments given the relatively early stage of these proceedings. The Court therefore 5 concludes that Defendants have not made a showing sufficient to overcome the 6 “presumption under Rule 15(a) in favor of granting leave to amend.” See Eminence 7 Capital, 316 F.3d at 1052. CONCLUSION 8 9 10 11 After a careful review of the parties’ submissions and the records in this matter, and for the foregoing reasons, IT IS HEREBY ORDERED that: 1. No. 95), is GRANTED; 12 13 2. 3. Plaintiff shall file its First Amended Complaint on or before April 26, 2013; 16 17 The hearing on Plaintiff’s Motion for Leave to File a First Amended Complaint, currently set for April 26, 2013, is VACATED; 14 15 Plaintiff’s Motion for Leave to File a First Amended Complaint, (ECF 4. The limited discovery period having concluded on April 5, 2013, all 18 discovery and disclosure obligations are STAYED pending this Court’s 19 decision on Defendant’s renewed motion for summary judgment on the 20 safe harbor issue; 21 5. Notwithstanding Judge Crawford’s instructions to contact her chambers 22 to set a status conference, (see ECF No. 94 at ¶ 5), Defendants’ counsel 23 is instead directed to contact this Court’s chambers on or before April 26, 24 2013, to obtain a hearing date for Defendants’ renewed motion for 25 summary judgment on the safe harbor issue. 26 27 28 DATED: April 23, 2013 HON. GONZALO P. CURIEL United States District Judge 7 3:11-cv-2214-GPC-KSC
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