Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-casd-3_11-cv-02214/USCOURTS-casd-3_11-cv-02214-2/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 35:271 Patent Infringement

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I';! I' II - 5 p. : 11 J v...1 __ 

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UNITED STATES DISTRICT COURT 

SOUTHERN DISTRICT OF CALIFORNIA 

ISIS PHARMACEUTICALS, INC., CASE NO. 11 cv2214-GPC (KSC) 

vs. 

Plaintiff, ORDER DETERMINING 

DISCOVERY DISPUTE RE: 

DEFENDANTS' FIRST SET 

OF INTERROGATORIES: 

NOS. 1,4,7 SANTARIS PHARMA AlS CORP. et aI., 

Defendant. [Doc. Nos. 145, 161] 

Before the Court is the parties' Joint Motion for Detemlination of Discovery 

Dispute [Doc. No. 145 (unsealed), Doc. No. 161 (sealed)] regarding plaintiffs 

responses to defendants' First Set ofInterrogatories. Specifically, defendants contend 

that plaintiff failed to provide adequate responses to Interrogatory Nos. 1,4, and 7, and 

seek an order from the Court compelling plaintiff to provide additional responses. For 

the reasons outlined below, defendants' request for additional responses from plaintiff 

is GRANTED in part and DENIED in part. 

I. BACKGROUND 

On September 22,2011, plaintifflsis Pharmaceuticals ("Isis" or "plaintiff') filed 

a Complaint [Doc. No.1] alleging that defendants Santaris Pharma A/S Corp. and 

Santaris Pharma AlS (collectively, "Santaris" or "defendants") have infringed upon two 

of plaintiffs patents. The two patents at issue in this litigation involve a form of 

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biotechnology called antisense molecules. Antisense molecules are generally used to 

interrupt the overproduction or abnormal production ofcertain proteins that can cause 

disease. On January 30, 2012, defendants filed a Motion for Summary Judgment 

arguing that their allegedly infringing activities were protected by the "Safe Harbor" 

provisionof35 U.S.C. § 271(e)(I). [Doc. No. ] 7] On July 26, 2012, the Court entered 

a Case Management Conference Order Regulating Discovery and Other Pretrial 

Proceedings in a Patent Case. [Doc. No. 42] The case progressed until September 

2012, when the normal flow of discovery was interrupted by an intervening Court 

Order. 

Specifically, on September 18,2012, Judge Moskowitz issued an Order Denying 

Defendants' January 30, 2012 Motion for Summary Judgment ("MSJ") without 

prejUdice [Doc. No. 53], finding that (1) defendants could fall within the Safe Harbor 

but that it is a fact-intensive inquiry and more substantial fact discovery was required; 

and, (2) the Safe Harbor issue could potentially dispense of the entire case. Judge 

Moskowitz established a 120-day period of limited discovery related solely to 

defendants' Safe Harbor defense, and gave defendants leave to re-file their MSJ (on the 

issue ofSafe Harbor only) within 30 days ofthe close ofthis limited discovery period. 

: t ~::~:: ::~:i~~l:::td::~~:=t~~:=:::~~e:n~~~:l::~: :~:o;:;. 20 Harbor related discovery to occur during the 120-day period. [Doc. No. 54] The 120­

21 day period oflimited discovery contemplated by the Judge Moskowitz was September 

22 18, 2012 to January 16, 2013. Further, the original30-day leave granted for defendants 

23 to re-file their Safe Harbor MSJ expired on February 15,2013. 

24 This matter was transferred from District Judge Moskowitz to District Judge 

25 Curiel on October 12, 2012. [Doc. No. 57] On November 30,2012, plaintiff filed an 

26 ex parte Motion [Doc. No. 62] asking the Court to vacate the remaining period of 

27 limited discovery so that discovery on all issues could re-commence, and to extend the 

28 filing deadline for defendants' renewed MSJ on the Safe Harbor issue. Plaintiff 

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claimed that, contrary to the representations made to Judge Moskowitz, discovery on 

the Safe Harbor issue was not narrow or isolated from the other issues and was much 

more complicated and fact-intensive than represented. On December 10, 2012, 

defendants filed an Opposition [Doc. No. 67], explaining that the Safe Harbor issue 

was more discrete than represented by plaintiff and that defendants' voluminous (and 

reluctant) discovery production (exceeding the scope ofSafe Harbor) was at plaintiffs 

request and stemmed from defendants' desire to avoid future costly discovery disputes. 

Accordingly, defendants requested a hearing before Magistrate Judge Crawford to 

address plaintiff s requests. 

On January 15,2013, the Court held a Discovery Hearing to address the issues 

raised. [Doc. No. 101] Specifically, the Court heard oral argument regarding the 

deadline for filing a renewed MSJ on the Safe Harbor issue and the appropriate scope 

of discovery leading up to said filing. On January 31,2013, based on the arguments 

presented at the January 15, 2013 Discovery Hearing, the Court ordered, inter alia, 

"The current discovery stay limiting discovery to the Safe Harborissue only (35 U.S.C. 

§ 271(e)(1)) will remain in place until April 5, 2013. Parties are not authorized to 

engage in discovery related to any other areas, including 35 U.S.C. § 271(a), before 

April 5,2013. No discovery encompassing a broader range of issues is to commence 

absent further order of Court." [Doc. No. 94, p. 2 (emphasis in original)] 

On March 8, 2013, the parties submitted a Joint Motion for Resolution of 

Dispute [Doc. No. 113] concerning plaintiff s proposed testifying expert, Dr. Nicholas 

M. Dean. Defendants notified the Court that this pending dispute was impacting their 

ability to file their renewed MSJ on the Safe Harbor issue. Accordingly, on April 26, 

2013, District Judge Curiel set a telephonic status hearing for May 3, 2013 "to discuss 

an appropriate hearing date and briefing schedule for [d]efendants' renewed summary 

judgment motion." [Doc. No. 131, p. 2] As a result of the May 3, 2013 telephonic 

hearing, Judge Curiel amended the filing deadline and briefing schedule for 

defendants' renewed MSJ. [Doc. No. 132] 

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On May 6, 2013, a Discovery Hearing was held [Doc. No. 134] before 

Magistrate Judge Crawford to hear argument regarding the parties' dispute over 

plaintiffs expert, Dr. Dean. After considering the arguments, on May 17,2013, the 

Court ordered plaintiff to disclose certain information about Dr. Dean's consulting 

practice and further instructed the parties to timely contact the Court ifthey remained 

unable to resolve their conflict after the required information was disclosed. [Doc. No. 

140] After the production by plaintiff of the required information, defendants' 

objections remained and, on June 10, 2013, the parties filed a Supplemental Joint 

Motion for Resolution ofDispute over Dr. Dean. [Doc. No. 149 (unsealed), Doc. No. 

162 (sealed)] In addition, on June 7, 2013, the parties filed the instant Joint Motion for 

Determination ofDiscovery Dispute [Doc. No. 145 (unsealed), Doc. No. 161 (sealed)] 

regarding plaintiffs responses to defendants' First Set ofInterrogatories. The parties 

again notified the Court that these pending discovery disputes were impacting their 

ability to proceed with the renewed MSJ. [Doc. No. 155, Joint Motion seeking 

expedited review ofdiscovery disputes] 

II. DISCUSSION 

The scope ofdiscovery under Rule 26(b) is broad: "[p ]arties may obtain 

discovery regarding any matter, not privileged, which is relevant to the claim or 

defense of any party involved in the pending action. Relevant information need not 

be admissible at trial ifthe discovery appears reasonably calculated to lead to the 

discovery of admissible evidence." FED.R.CIV.P.26(b). However, a court may 

limit discovery ofrelevant material ifit determines that the discovery sought is 

unreasonably cumulative or duplicative, or obtainable from some other source that 

is more convenient, less burdensome, or less expensive, or the burden or expense of 

responding to the proposed discovery outweighs the likely benefit. The party 

resisting discovery generally bears the burden ofshowing that the discovery 

requested is irrelevant to the issues in the case or is overly broad, unduly 

burdensome, unreasonable, or oppressive. Ifthe resisting party meets its burden, 

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the burden shifts to the moving party to show the information is relevant and 

necessary. Henderson v. Holiday CVS, L.L.c., 269 F.R.D. 682, 686 (2010). 

A. Defendants' First Set of Interrogatories 

Defendants contend that plaintiff failed to provide adequate responses to 

Interrogatory Nos. 1,4, and 7. For the reasons articulated below, the Court finds 

plaintiff is not required to supplement its responses to Interrogatory No.1, but must 

provide additional responses to Interrogatory Nos. 4 and 7. 

1. Interrogatory No.1 

Interrogatory No. 1 asked plaintiff to identify and describe all ofdefendants' 

allegedly infringing acts, including the identification ofthe country where those acts 

occurred. [Doc. No. 161, p. 6] The description was to include the date, geographic 

location, and a statement labeling the infringing act as a sale, offer to sell, use, or 

importation. Id. Plaintiff objected to this interrogatory, arguing this request seeks 

information outside the scope ofthe Safe Harbor provision and potentially seeks 

information protected from disclosure by the attorney work product doctrine. Id. at 

6-7. Subject to these objections, plaintiff responded by referring defendants to the 

description of events contained in plaintiffs Complaint and Preliminary 

Infringement Contentions. Id. In a supplemental response, plaintiff stated that one 

or more ofthese acts occurred in the United States, citing specific, Bates-numbered 

contracts as examples of unauthorized "sales" and, as an example of unauthorized 

"use," that defendants, "at a minimum," performed patented methods at the Seattle, 

Washington facility of one of defendants' partners. Id. at 8-9. 

Plaintiff contends that ''these infringing offers for sale and resulting sales 

occurred 'in the United States,' as evidenced by at least (i) the terms ofthe various 

contracts, (ii) the physical location ofthe personnel and entities involved in the 

business negotiations in the Untied States, (iii) the physical location of 

[defendants'] contract negotiations over a period oftime in the United States, and 

(iv) the physical location ofthe resulting performance ofthe contracting parties ... 

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pursuant to commercial sales embodied in the contracts and their associated 

amendments, modifications, and addenda." Id. at 9-10. As support for these 

contentions, plaintiff lists hundreds ofBates-numbered documents. Id. at 10-25. 

To the extent "place ofperformance" is relevant, plaintiff contends that the 

thousands ofpages of details cited provide defendants with the information sought. 

Id. at 31. 

Defendants argue that plaintiff should be compelled to provide further 

responses as to specific geographic locations because a "significant fact related to 

'use' is where the allegedly infringing compounds, methods, and processes were 

used." Id. at 25. Defendants contend that the plain language ofthe Safe Harbor 

provision itself exempts acts only "within the United States." Id. Further, 

defendants argue that plaintiffs own actions, i.e. asking defendants and witnesses in 

discovery requests and depositions to identify "where" certain work was performed, 

demonstrate the geographical relevance. Id. Defendants state that plaintiff has only 

revealed the exact geographic location of one alleged act of infringement and asks 

the Court to compel plaintiff to do so with regard to all alleged acts. For the reasons 

set forth below, the Court DENIES defendants' request to compel plaintiff to 

provide additional responses to Interrogatory No.1. 

Since opening a period oflimited discovery on the Safe Harbor issue and 

staying discovery on all other issues, the Court has repeatedly made clear its 

intention ofkeeping discovery limited solely to the issues raised by 35 U.S.C. § 

271(e)(1), not 271(a), pending resolution ofdefendants' renewed summary 

judgment motion on the Safe Harbor issue.l The parties' dispute over the specific 

I Section 271(a) states in pertinent part,"Except as otherwise provided in this 

title, whoever without authoriry makes, uses, offers to sell, or sens any patented invention, within the United States or imports into the United States any patented invention, during the term of the patent therefor) infringes the patent." 35 U.S.C. §

271(a). Section 271(e)(1) (the Safe Harbor PrOVIsion), a proviSIOn contained "within 

the same title," states in pertinent -pat;:f "It shall not be an act of infringement to make, 

use, offer to sell, or selI within Hie united States or import into the-United States a 

patented invention . . . solely for uses reasonably related to the development and 

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geographical information sought in defendants' Interrogatory No.1 is not essential 

for defendants to prepare their renewed Safe Harbor MSJ. Plaintiff asserts in its 

Complaint that defendants committed infringing acts under Section 271 ( a) within 

the United States, and responded to Interrogatory No. 1 with pages of documents 

"identiflying] ... contract documents showing where the place of performance 

occurred ..." [Doc. No. 162, p. 32] The Safe Harbor is an affirmative defense that 

only excuses otherwise infringing activities that occurred in the United States. To 

avail themselves of this defense, defendants must implicitly admit that they "ma[ d]e, 

use[d], offer[ed] to sell, or so[ld]" one ofplaintiffs patented compounds or methods 

within the United States. 35 U.S.C. § 271(e)(1). Otherwise, there would be no 

conduct to be excused by the affirmative defense. While a Section 271 (a) 

infringement claim requires a prima facie showing that an infringing act occurred in 

the United States, the assertion ofthe Safe Harbor defense assumes that the conduct 

at issue occurred in the United States, but focuses on whether an otherwise unlawful 

or infringing use of plaintiffs patented technology falls within 271(e)(1)'s Safe 

Harbor, namely whether the use is "reasonably related to the development and 

submission of information under a F ederallaw which regulates the manufacture, 

use, or sale" of a drug. Accordingly, defendants' request seeking a Court order 

compelling plaintiff to provide supplemental responses to Interrogatory No. 1 is 

DENIED. 

2. Interrogatory No.4 

Interrogatory No.4 asked plaintiff to identify and describe all positions 

advanced by or on behalf ofplaintiff, or an entity related to plaintiff, regarding the 

scope or application ofthe Safe Harbor provision as it relates to the '199 Patent 

(one ofthe two patents at issue in this litigation). [Doc. No. 161, p. 33-34] The 

description was to identify all communications with entities other than plaintiff or 

submission ofinformation under a F ederallaw which regulates the manufacture, use, 

or sale of drugs or veterinary biological products." 35 U.S.C. § 271(e)(1). 

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defendants where any party asserted that the activities alleged to come within the 

scope ofthe '199 Patent fell under the Safe Harbor provision. Id. Plaintiff objected 

to this interrogatory, arguing the request was vague, overbroad, duplicative, and 

sought information protected from disclosure by the attorney-client privilege and 

work product doctrine. Id. at 34. Subject to these objections, and pursuant to 

Federal Rule ofCivil Procedure 33(d), plaintiff responded by referring defendants 

to numerous, already-produced Bates-numbered documents based on the results 

yielded from the following mutually-agreeable search terms: "Safe Harbor", 

"271(e)(1)", and "271el ". Id. at 34-45. In a supplemental response, plaintiff 

directed defendants to numerous additional papers filed in this litigation, including 

the declarations ofDr. Nicholas Dean and Dr. Elizabeth Gordon. Id. at 45. 

In a further supplemental response, plaintiff explained the extent of its 

involvement in two legal actions of interest to defendants, namely the 2012 

Alnylam2 case and the 2001-2002 Sequitu,-'J litigation. Regarding Alnylam, plaintiff 

states that it was not the lead party in the litigation, the case was filed in January 

2012 and dismissed in November 2012, and that plaintiff did not correspond 

directly with Tekmira regarding the Safe Harbor provision. Id. at 46. Thus, 

plaintiff is unaware of the existence of any non-privileged communications on the 

topic, and claims that all other responsive documents are either publically available 

or already in defendants' possession. Id. With respect to the Sequitur cases, 

plaintiff claims it conducted extensive investigations regarding any correspondence 

within the 2000-2001 time frame with Oasis, Hybridon, Genta, and other entities 

involved in the litigation and did not find any additional responsive, non-privileged 

information. Id. 

Defendants argue that further responses should be compelled because the 

2 Alnylam et al. v. Tekmira, 12cvl0087 (D. Mass. 2012). 

3 Isis v. Sequitur, Inc., 01cv1223, 01cv2286, 02cv842 (C.D. Cal. 2001, 2002). 

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communications sought are relevant to the Safe Harbor issue. ld. at 47. Defendants 

claim plaintiff has a history of aggressively enforcing its patents; thus, what plaintiff 

has said and done in other cases involving the '199 Patent and the Safe Harbor 

provision is relevant to this action because it may undermine or contradict 

plaintiff's current contentions. ld. Specifically, defendants believe plaintiff sent 

cease-and-desist letters to Oasis, Hybridon, Genta, and other entities involved in the 

Sequitur cases. ld. at 48. These letters have not been produced. Furthermore, 

defendants are not satisfied with plaintiff's application ofthe 3 search terms to the 

electronically stored information, arguing that a key document4 was not produced 

and many documents that were produced were irrelevant to this action. 

Accordingly, defendants seek a Court order compelling plaintiff to conduct a 

thorough search for such communications not limited by plaintiff's 2001-2001 time 

frame. ld. Further, defendants seek assurances that no additional responsive 

documents exist. ld. 

Plaintiff argues it already provided detailed responses, that it has now twice 

conducted "substantial" investigations at great time and expense regarding 

communications in the Sequitur cases, that the communications, if any, are now 

over 11 years old, and that defendants' demand for additional responses rests solely 

upon defense counsel's speculation that such communications exist. ld. at 48-49. 

Furthermore, plaintiff contends that defendants have already deposed 5 witnesses on 

the topic and there is nothing left to discover. ld. at 49. According to plaintiff, "[I]t 

is not that [plaintiff] has not complied; it is that Santaris does not like the answer." 

ld. 

Based on the arguments presented in the Joint Motion, the Court GRANTS 

4 They key item cited by: defendants which was not initially produced by plaintiff in this case is a document written by plaintiff's CEO, Dr. Stanley Crooke, where Dr. 

Crooke alluded to defendants' actiVIties beiqg protected by the Safe Harbor provision. 

[Doc. No. 161, p. 47] Defendants argue tliat the absence of this document from 

Qlaintiff's initial production both undercuts p'laintiff' s position in this lawsuit and casts 

ooubt upon the completeness ofplaintiff's oiscovery responses in this litigation. 

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defendants' request to compel plaintiff to provide additional responses to 

Interrogatory No.4. Interrogatory No.4 contains no language limiting its request to 

the 2000-2001 time period. Accordingly, plaintiffs unilateral imposition of a 

temporal limitation on defendants' request was improper. Thus, to the extent 

responsive, non-privileged information exists from the time period of 2000 to 

present, it should be produced. Accordingly, within 30 days ofissuance ofthis 

Order, plaintiff must conduct a thorough search and produce any non-privileged 

communications regarding the scope or application ofthe Safe Harbor provision as 

it relates to the' 199 Patent. Also within 30 days ofissuance ofthis Order, plaintiff 

must provide defendants with a certification in a sworn discovery response that the 

production represents the entire universe ofresponsive documents in plaintiffs 

custody. Specifically, plaintitrs representative must provide defendants with a 

written declaration under penalty ofperjury detailing their efforts to locate the 

sought-after items and stating that ''to the best of [his or her] knowledge, 

information, and belief formed after a reasonable inquiry," the responses to these 

requests are "complete and correct." FED.R.eIV.p. 26(g)(1 )(A). 

3. Interrogatory No.7 

Interrogatory No.7 asked plaintiff to identifY and describe each 

Investigational New Drug Application ("IND") and New Drug Application 

("NDA") for an antisense oligonucleotide drug candidate submitted to the FDA by 

plaintiff or by one ofplaintiffs "third party pharmaceutical partners" pursuant to 

"an agreement with [plaintiff]." [Doc. No. 161, p. 49] The description was to 

include the identities ofplaintiff's employees most knowledgeable about the 

submissions ofthe INDs or NDAs, as well as communications with the FDA 

regarding the same. Id. Furthermore, the Interrogatory sought a statement as to 

"whether the IND or NDA contained any discussions or reports of in vitro tests of 

an antisense oligonucleotide and the purpose of any such tests." Id. 

Plaintiff objected to this Interrogatory, claiming it seeks information outside 

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the scope the Safe Harbor provision, is vague, overbroad, and that the burden of 

ascertaining the answer to all parts ofthe request will be substantially the same for 

either party based on the documents already produced by plaintiff in this litigation. 

Id. at 49-50. Subject to these objections, plaintiff responded by referring defendants 

to certain Bates-numbered documents already produced, pursuant to Federal Rule of 

Civil Procedure 33(d). Id. In a supplemental response, plaintiff identified 

additional, already-produced documents, "which are the INDs and communications 

thereon that [plaintiffJ has produced in this action," and cited that defendants have 

already deposed the two Isis employees identified as signing these INDs. Id. In 

addition, plaintiff described the two NDAs in its possession, custody, or control, 

namely antisense drug compounds marketed under the brand names Vitravene and 

Kynamro. Id. at 50-51. Vitravene, the lone NDA filed by plaintiff since its 

inception, was approved by the FDA in 1998. Id. at 50. Kynamro was developed 

by plaintiffs partner, Genzyme, and was approved by the FDA in 2012. Id. at 51. 

Plaintiff identified former Isis employee Mark Lotz as being the employee most 

knowledgeable about the Vitravene NDA, and, to the extent plaintiff was consulted 

by Genzyme regarding the Kynamro NDA, the Isis employees most directly 

involved are Joseph Johnston and Dr. Brandt. Id. 

Defendants argue that the information sought in this Interrogatory is directly 

relevant to the Safe Harbor issue because these "INDs and NDAs provide examples 

of the type information that [plaintiffJ or others believe may be provided to the 

FDA, and thus sheds light on whether [defendants'] allegedly infringing activities 

include research that 'if successful, would be appropriate to include in a submission 

to the FDA.'" Id. at 52, citing Merck KgaA v. Integra LifeSciences 1, Ltd., 545 U.S. 

193,207 (2005). To that end, defendants seek a Court order compelling plaintiff to 

produce the NDAs and to provide additional, sworn statements in formal discovery 

responses regarding the completeness of the production ofINDs and NDAs. 

Regarding the INDs, it appears any substantive dispute has already been 

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resolved. However, defendants seek an unequivocal and binding statement from 

plaintiff (in a sworn discovery response, not in a discovery motion) that it has 

produced to defendants all of the INDs in plaintiffs possession, custody, or control. 

ld. at 52. Under Rule 26(g)(1 )(A), defendants are entitled to such a certification.5 

Plaintiff appears willing to give such formal assurances. With respect to the NDAs, 

defendants seek an order compelling plaintiff to produce the Vitravene and 

Kynamro NDAs, as well as any other NDAs similarly linked to plaintiff, or, if none, 

a statement in a sworn discovery response unambiguously confirming such. ld. at 

52-53. Plaintiff contends that further response is not necessary, as it has already 

identified the 2 NDAs in its possession or control, that such documents are 

publically available, that defendants' request for production of the NDAs was 

untimely under the Chamber Rules ofMagistrate Judge Crawford, and that the 

portion of defendants' request requiring plaintiff to "describe" the documents is 

vague and unduly burdensome, as each document totals over 175,000 pages. ld. at 

53-55. Notwithstanding, plaintiff concedes its willingness to produce the NDAs. 

ld. at 54-55 (representing to the Court: "[H]ad [defendants] actually requested the 

two NDAs, [plaintiff] would also have produced the two NDA documents (each 

exceeding 175,000 pages) in its possession, custody, or control.") For the reasons 

set forth below, the Court GRANTS defendants' request to compel plaintiff to 

provide additional responses to Interrogatory No.7. 

Based on the arguments presented in the Joint Motion, the content contained 

within the INDs and NDAs seems reasonably likely to lead to the discovery of 

information relevant to the Safe Harbor issue. Further, the disputes over the INDAs 

and NDAs appear to be a matter of form, not substance. As to the INDs, defendants 

5 Under Rule 26(g)(1)(A), discovery responses must be accompanied by a 

certification "after a reasonable inquiJ}''' indicating that the disclosure is "complete and 

correct as of the time it is made. . .. While plamtiff provided substantially similar 

assurances in the parties' jointly submitted DlscoveryMotion this is not a binding discovery response, and tlius, is insufficient to satisfy the certification required under 

Rule 26. 

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seek a sworn statement in a discovery response that plaintiff s current production is 

complete - a statement plaintiff is willing to give. Regarding the NDAs, defendants 

are no longer demanding that plaintiff "describe" the voluminous NDAs; rather, the 

most recent demand contained in defendants' portion ofthe Joint Motion seeks 

plaintiff s production ofthe 2 NDAs, and, any other NDAs similarly linked to 

plaintiff in plaintiff s control, or, if none, a sworn statement unambiguously 

confirming such. Id. at 53, lines 11-13. Setting aside any arguments regarding the 

timeliness of defendants' request6

, plaintiff appears willing to produce the 2 NDAs, 

and, in the Joint Motion, represents that there are no other responsive NDAs in its 

possession or control. Id. at 54-55. 

Good cause appearing, and because plaintiff represents that it is willing to 

produce the Vitravene and Kynamro NDAs and provide the assurances defendants 

desire, plaintiff is ORDERED to provide additional responses to Interrogatory No. 

7. Accordingly, within 10 days of issuance of this Order, plaintiff must (1) produce 

the Vitravene and Kynamro NDAs; and, (2) provide a Rule 26(g)(1)(A) certification 

that the production ofINDs and NDAs in this case represents the entire universe of 

responsive documents in plaintiffs custody. Specifically, plaintiffs representative 

6 It is unclear to the Court whether defendants' request for Rroduction of the 

NDA was timely. Plaintiffs argue that defendants never specifically requested the 

production of the NDAs. In contrast to defendants specifically requesting and 

engagin,g in meet and conferrals about the INDs, defendants allegedly did not make 

similar mquiries regarding the NDAs. Rather, accordin~ to plaintift the "only clear 

reguest for informatIOn regarding [plaintiffsl two NDAs' was in derendants' last set 

ofmterrogatories, served VIa emaIl on March 0, 2013. [Doc. No. 161, p. 55] According 

to plaintifI and based on the FRCP, Rlaintiff s response to this March 6 request was due 

on April 8,2013, after the April 5, 2013 discovery cut-off established in this Court's 

Scheauling Order. Id. 

Conversely, defendants contend that production ofthe NDAs was responsive to 

a prior timely interrogatory served in March 2013 and that May 30, 2013 was the first 

time piaintiff had even identified these NDAs. Given that the parties have asked the 

Court to decide this (and another) discovery dispute on an exyedited basis in 

anticipation of filing a deadline-impacted renewed Safe Harbor MS [Doc. No. 155], 

as wen as defendants willingness to produce the requested items, the Court will assume 

that the objection was timely filed and refrain from analyzing the timeliness of 

defendants request. 

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must provide defendants with a written declaration under penalty ofperjury 

detailing their efforts to locate the sought-after items and stating that "to the best of 

[his or her] knowledge, information, and belief formed after a reasonable inquiry," 

the responses to these requests are "complete and correct." FED.R.Clv.P. 

26(g)(1)(A). However, the portion of the request seeking a description of the 

lengthy NDAs is unduly burdensome, and thus, it is DENIED. With the production 

of the NDAs themselves, the Court concludes that this information is equally 

accessible to both parties. 

III. CONCLUSION 

For the reasons stated above, plaintiff is not required to supplement its 

responses to Interrogatory No.1, but must provide additional responses to 

Interrogatory Nos. 4 and 7. Accordingly, IT IS HEREBY ORDERED THAT: 

1. Interro2atory No.4: Within 30 days of issuance ofthis Order, 

plaintiff must (1) conduct a thorough search and produce any responsive, nonprivileged communications from the time period of 2000 to present regarding the 

scope or application of the Safe Harbor provision as it relates to the' 199 Patent, and 

(2) provide a Rule 26(g)(1)(A) certification that the production represents the entire 

universe ofresponsive documents in plaintiffs custody or control. 

2. Interro2atory No.7: Within 10 days of issuance of this Order, 

plaintiffmust (1) produce the Vitravene and Kynamro NDAs; and, (2) provide a 

Rule 26(g)(1)(A) certification that the production ofINDs and NDAs represents the 

entire universe ofresponsive documents in plaintiff s custody or control. 

IT IS SO ORDERED. 

Date: July" , 2013 

S.CRAWFORD 

United States Magistrate Judge 

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