GILEAD SCIENCES, INC.’S MOTION TO COMPEL Case No. 5:13-cv-04057-BLF/PSG 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 John M. Farrell (CA Bar No. #99649) [email protected]FISH & RICHARDSON P.C. 500 Arguello Street, Suite 500 Redwood City, CA 94063 Telephone: (650) 839-5070 Facsimile: (650) 839-5071 Jonathan E. Singer (CA Bar No. #187908) [email protected]FISH & RICHARDSON P.C. 3200 RBC Plaza 60 South Sixth Street Minneapolis, MN 55402 Telephone: (612) 335-5070 Juanita R. Brooks (CA Bar No. #75934) [email protected]FISH & RICHARDSON P.C. 12390 El Camino Real San Diego, CA 92130 Telephone: (858) 678-5070 Douglas E. McCann (Pro Hac Vice) [email protected]Gregory R. Booker (Pro Hac Vice) [email protected]Robert M. Oakes (Pro Hac Vice) [email protected]Elizabeth M. Flanagan (Pro Hac Vice) [email protected]FISH & RICHARDSON P.C. 222 Delaware Avenue, 17th Floor Wilmington, DE 19801 Telephone: (302) 652-5070 Attorneys for Plaintiff GILEAD SCIENCES, INC. UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA SAN JOSE DIVISION GILEAD SCIENCES, INC., Plaintiff, v. MERCK & CO, INC., MERCK SHARP & DOHME CORP. and ISIS PHARMACEUTICALS, INC. Defendants. Case No. 5:13-cv-04057-BLF/PSG GILEAD SCIENCES, INC.’S MOTION TO COMPEL DEFENDANTS TO RESPOND TO DISCOVERY REQUESTS Date: April 21, 2015 Time: 10:00 A.M. Case5:13-cv-04057-BLF Document114 Filed03/24/15 Page1 of 27
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GILEAD SCIENCES, INC.’S MOTION TO COMPEL
Case No. 5:13-cv-04057-BLF/PSG
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John M. Farrell (CA Bar No. #99649) [email protected] FISH & RICHARDSON P.C. 500 Arguello Street, Suite 500 Redwood City, CA 94063 Telephone: (650) 839-5070 Facsimile: (650) 839-5071 Jonathan E. Singer (CA Bar No. #187908) [email protected] FISH & RICHARDSON P.C. 3200 RBC Plaza 60 South Sixth Street Minneapolis, MN 55402 Telephone: (612) 335-5070 Juanita R. Brooks (CA Bar No. #75934) [email protected] FISH & RICHARDSON P.C. 12390 El Camino Real San Diego, CA 92130 Telephone: (858) 678-5070 Douglas E. McCann (Pro Hac Vice) [email protected] Gregory R. Booker (Pro Hac Vice) [email protected] Robert M. Oakes (Pro Hac Vice) [email protected] Elizabeth M. Flanagan (Pro Hac Vice) [email protected] FISH & RICHARDSON P.C. 222 Delaware Avenue, 17th Floor Wilmington, DE 19801 Telephone: (302) 652-5070 Attorneys for Plaintiff GILEAD SCIENCES, INC.
UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA
SAN JOSE DIVISION
GILEAD SCIENCES, INC., Plaintiff,
v.
MERCK & CO, INC., MERCK SHARP & DOHME CORP. and ISIS PHARMACEUTICALS, INC. Defendants.
Case No. 5:13-cv-04057-BLF/PSG GILEAD SCIENCES, INC.’S MOTION TO COMPEL DEFENDANTS TO RESPOND TO DISCOVERY REQUESTS
Date: April 21, 2015
Time: 10:00 A.M.
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GILEAD SCIENCES, INC.’S MOTION TO COMPEL Case No. 5:13-cv-04057-BLF/PSG
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TABLE OF CONTENTS
NOTICE OF MOTION ..................................................................................................................1
POINTS AND AUTHORITIES IN SUPPORT OF THE MOTION .............................................2
I. STATEMENT OF ISSUES TO BE DECIDED ................................................................2
II. STATEMENT OF RELEVANT FACTS ..........................................................................2
A. Case Background ...................................................................................................2
B. Gilead’s Deposition Scheduling Requests .............................................................4
C. Gilead’s Interrogatory Nos. 1, 4 and 5 ...................................................................5
D. Gilead’s Interrogatory Nos. 2, 7, 8, 10 and 11 .......................................................8
E. Defendants’ Document Production ........................................................................9
III. ARGUMENT ...................................................................................................................13
A. Legal Standards ....................................................................................................13
B. Defendants Should Be Compelled To Respond To Gilead’s Deposition Requests.............................................................................................14
C. Defendants Should Be Compelled To Provide Complete Responses To All Interrogatories.........................................................................15
1. Gilead’s Interrogatory Nos. 1, 4, And 5 Seek Relevant Information That Defendants Currently Possess .....................................15
2. Defendants’ Responses To Gilead’s Interrogatory Nos. 2, 7, 8, 10 And 11 Are Deficient Under Rule 33(d) .................................17
D. Defendants Should Be Compelled To Produce All Documents Requested by Gilead ............................................................................................18
1. Defendants Document Production Delays Must Be Cured To Avoid Continued Prejudice To Gilead ....................................19
2. Documents Related To Defendants’ Post-2003 Efforts At Developing Nucleosides For Treatment Of HCV Are Relevant To Gilead’s Defenses ................................................................22
IV. CONCLUSION ................................................................................................................22
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TABLE OF AUTHORITIES
CASES PAGE
Bercut-Vandervoort & Co. v. Maison Tarride Ledroit & Cie,
Fed. R. Civ. P. 30(b)(1)..................................................................................................................13
Fed. R. Civ. P. 33 ...........................................................................................................................13
Fed. R. Civ. P. 33(d) .............................................................................................................. passim
Fed. R. Civ. P. 34(a) ......................................................................................................................14
Fed. R. Civ. P. 34(a)(1)(A) ............................................................................................................14
Fed. R. Civ. P. 37(a)(4) ..................................................................................................................13
Fed. R. Civ. P. 37 ...........................................................................................................................13
Fed. R. Civ. P. 37(a) ........................................................................................................................1
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Fed. R. Civ. P. 37(a)(1) ....................................................................................................................1
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GILEAD SCIENCES, INC.’S MOTION TO COMPEL
Case No. 5:13-cv-04057-BLF-PSG
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NOTICE OF MOTION
PLEASE TAKE NOTICE THAT on April 21, 2015, at 10:00 A.M., or as soon thereafter
as counsel may be heard by the Honorable Paul S. Grewal in Courtroom 5, United States District
Court for the Northern District of California, Robert F. Peckham Federal Building, 280 South 1st
Street, San Jose, California 95113, Plaintiff Gilead Sciences, Inc. (“Gilead”) will, and hereby
does, move to compel Defendants Merck & Co., Inc. (“Merck & Co.”), Merck Sharp & Dohme
Corp. (“MSD Corp.”) and Isis Pharmaceuticals, Inc. (“Isis”) (collectively “Defendants”) to 1)
provide witnesses for depositions; 2) provide supplemental responses to Gilead’s Interrogatory
Nos. 1, 2, 4, 5, 7, 8, 10, and 11; and 3) produce all documents requested in Gilead’s Requests for
Production and in particular Nos. 28, 39, 46, 49, and 60-62.1
Pursuant to Federal Rule of Civil Procedure 37(a), Gilead seeks an order compelling
Defendants to 1) provide witnesses for depositions, including offering multiple dates for
witnesses that fit within Gilead’s schedule; 2) provide complete supplemental responses to
Gilead’s Interrogatory Nos. 1, 2, 4, 5, 7, 8, 10, and 11, including complete information related to
actual reduction to practice and complete responses without imparting date limitations, by April
24, 2015; and 3) produce all documents requested in Gilead’s Requests for Production and in
particular Nos. 28, 39, 46, 49, and 60-62 by April 24, 2015. Pursuant to Federal Rule of Civil
Procedure 37(a)(1), Gilead hereby certifies that it has in good faith met and conferred with
Defendants in an effort to obtain these responses without court action.2
GILEAD’S CIVIL LOCAL RULE 37-2 STATEMENT
Pursuant to Civil Local Rule 37-2, the relevant discovery requests and the Defendants’
objections and/or responses thereto are provided herewith as Exhibit A to the Declaration of
Joseph B. Warden in Support of Gilead Sciences, Inc.’s Motion to Compel Defendants to
Respond to Discovery Requests (hereinafter “Warden Decl.”).
1 “Merck” refers to Merck & Co., Inc. or Merck Sharpe & Dohme Corp., whichever is the relevant corporate entity, or both. 2 See Warden Decl., ¶¶ 3-16.
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POINTS AND AUTHORITIES IN SUPPORT OF THE MOTION
I. STATEMENT OF ISSUES TO BE DECIDED
Plaintiff Gilead respectfully requests that the Court order Defendants to 1) schedule
depositions; 2) provide full and complete responses to Interrogatory Nos. 1, 2, 4, 5, 7, 8, 10, and
11; and 3) produce all documents requested in Gilead’s Requests for Production and in particular
Nos. 28, 39, 46, 49, and 60-62, and in related letters regarding Merck’s production deficiencies.
This motion is needed because of Defendants’ pattern of evading its discovery
obligations and refusing to engage in discovery. Defendants have thwarted Gilead’s attempts to
take depositions by ignoring Gilead’s repeated requests—beginning in early February—to
schedule depositions. And despite Gilead’s persistent attempts to obtain written and document
discovery from Defendants—discovery that has been outstanding for a year—Defendants refuse
to meaningfully participate. Rather, they have delayed their responses, ignored Gilead’s
attempts to discuss the status of their discovery, and not followed through on the few discovery
commitments they have made.
The May 22, 2015 fact discovery deadline is fast approaching, and Defendants’
evasiveness and refusal to cooperate in meaningful discovery has prejudiced and continues to
prejudice Gilead. Without a court order, Defendants will continue to skirt their discovery
obligations, will refuse to produce witnesses for depositions, and will fail to fulfill their written
and document discovery obligations. Defendants should be compelled to engage in discovery
and provide this outstanding discovery immediately.
II. STATEMENT OF RELEVANT FACTS
A. Case Background
This case concerns Gilead’s drug sofosbuvir, a nucleotide analog that has permanently
changed the treatment of hepatitis C virus (HCV) from a debilitating course of therapy that only
sometimes worked to a cure for most patients in a short period of time with few side effects.
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Sofosbuvir has a fluorine atom (F) oriented down, and a methyl group (Me) oriented up,
at a particular place (the 2’ position) on the sugar ring of the molecule,3 as shown below:
It is very difficult to synthesize this 2’ F-Me configuration on this type of compound; so far as
Gilead has been able to learn, it had never been successfully done before Gilead’s predecessor
Pharmasset did it in 2003 and then subsequently published that method in 2005. Before
Pharmasset’s synthesis method published—and under a confidentiality agreement—Pharmasset
disclosed its 2’ F-Me compound to Merck. After learning of Pharmasset’s work and the
tremendous promise that certain compounds with the 2’ F-Me configuration possessed for
treating HCV, Merck cancelled all the claims of a pending patent application and drafted new
claims intended to target those compounds. The claims as finally issued in Defendants’ ’499
patent-in-suit include compounds having the 2’ F-Me configuration.
Gilead believes that Merck made this change in claim scope because of what it learned
from Pharmasset, and further believes that Merck never conducted meaningful research on
compounds having a 2’ F-Me configuration, or any compounds falling within the scope of the
issued claims, before filing its patent applications and amending its claims.
Gilead has examined the compounds described in the 154 examples in the Patents-in-
Suit, as well as the 126 compounds Merck has identified as the “representative compounds”
whose testing is reported in the Patents-in-Suit. None of those compounds fall within the scope
3 Hereinafter, this configuration at the 2’ position will be referred to as “2’ F-Me.”
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described by the issued claims. This is likely because the amended claims are not based off
Merck’s work, but rather were drafted based of what Merck derived from Pharmasset.
Gilead seeks to confirm these facts through deposition testimony, interrogatories, and
Defendants’ document production, but Defendants’ failure to meaningfully engage in discovery
is hamstringing Gilead’s ability to do so.
B. Gilead’s Deposition Scheduling Requests
Gilead has been attempting to work with Defendants on the scheduling of depositions,
but Defendants have refused to participate. Gilead first contacted Defendants about scheduling
depositions on February 6, 2015, including by naming 15 specific individuals Gilead intended to
depose and proposing multiple dates for those depositions.4 During a subsequent meet and
confer call on February 10, 2015, Defendants stated that they were not yet prepared to discuss
deposition scheduling.5 Gilead subsequently contacted Defendants several times to schedule
depositions, and further asked that Defendants tell Gilead which witnesses were no longer
employed by the Defendants so that Gilead could prepare subpoenas for any such witness.6
Defendants responded with silence, refusing to provide any deposition dates, and refusing to tell
Gilead who they needed to subpoena. With Defendants refusing to participate in the deposition
scheduling process, Gilead began serving deposition notices, and continued to press Defendants
for deposition dates.7 Defendants’ first communications on deposition scheduling occurred on
March 9, when Defendants merely represented that they were still determining the availability of
the witnesses.8 Only after Gilead told Defendants that Gilead would be filing a motion to
compel did Defendants provide a deposition date—Defendants offered a single witness, Mr.
Stephen de Laszlo, for a deposition on May 5, almost six weeks after Gilead’s requested
4 See Warden Decl., Ex. M. 5 See Warden Decl., ¶ 12. 6 Id. 7 Id. 8 See Warden Decl., Ex. T.
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deposition date.9 During a March 23 meet and confer, arranged after Gilead notified Defendants
it would be filing a motion to compel, Defendants refused to tell Gilead why the witnesses were
unavailable on the noticed dates and also refused to tell Gilead when Defendants first contacted
witnesses about scheduling depositions.10 Defendants further informed Gilead that the only day
Mr. de Laszlo was available for deposition was May 5.11 Again, Defendants refused to tell
Gilead why Mr. de Laszlo was only available for a single day during the entire discovery
period.12 During the meet and confer, Defendants offered a date for one more witness, also
during the last few weeks of discovery—April 30, 2015 for Mr. Carroll. Although Defendants
stated that they hoped to give more dates the next week, they would not commit to a date by
which they would provide dates for all witnesses.13 Gilead has no assurances that, absent a Court
order, Defendants will provide dates for all witnesses in sufficient time for all depositions to be
completed during the discovery period.
C. Gilead’s Interrogatory Nos. 1, 4 and 5
Gilead sought information regarding Defendants’ efforts at making or testing 2’ F-Me
nucleoside derivatives, or other compounds claimed or described by the Patents-in-Suit, through
Interrogatory Nos. 1, 4 and 5 served over a year ago on March 6, 2014, and through related
requests for admissions (RFAs) served beginning in July 2014.
Interrogatory No. 1 seeks the basis “for what Defendants contend to be the date of the
invention,” including “conception” and “actual and constructive reduction to practice.”14
Defendants’ initial response identified June 19, 2001 as the date of constructive reduction to
practice, and stated that their “investigation continues as to the earliest date of conception of the
claimed subject matter.”15 Interrogatory Nos. 4 and 5 seek a description of every embodiment of
9 See Warden Decl., Exs. V and W. 10 See Warden Decl. ¶ 13. 11 Id. 12 Id. 13 Id. 14 See Warden Decl., Ex. A. 15 Id.
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the Patents-in-Suit made, used, and/or tested (No. 4) and a description of any testing of
compounds that fall within the claims of the Patents-in-Suit (No. 5).16 Defendants’ initial
response stated that the information could be found in documents that had been or would be
produced pursuant to Rule 33(d).17
Gilead requested supplemental responses in June 2014 and multiple times thereafter.18
On December 5, 2014, Gilead finally informed Defendants that it was prepared to seek a court
order compelling responses to these interrogatories, related RFAs, and other discovery because
of Defendants’ continued refusal to supplement.19 In response, Defendants agreed to provide full
and complete responses to the related RFAs on or before January 30, 2015, and also to
Interrogatory Nos. 1, 4-6, and 13 at roughly the same time and, based on these assurances,
Gilead agreed to forego its motion to compel.20
Defendants responded to the RFAs on January 30, 2015, but failed to supplement any of
the interrogatories. At that time, Defendants committed to supplementing their interrogatories by
February 6, 2015.21 However, Defendants failed to supplement the responses by that date either.
During a February 10, 2015 meet and confer, when Gilead asked Defendants why they could not
supplement the responses to include at least the information on which Defendants based their
responses to Gilead’s RFAs, part of Defendants’ excuse was that, after serving the RFA
responses, they received significant new information that needed to be incorporated in the
interrogatory responses.22 Defendants committed, however, to supplement the interrogatory
responses by early in the week of February 16.23 Once again, Defendants did not abide by their
commitment, and no response was received during the week of February 16, 2015. After Gilead
16 Id. 17 Id. 18 See, e.g., Warden Decl., Exs. B and C; ¶ 3. 19 See Warden Decl., Ex. G. 20 See Warden Decl., ¶ 5. 21 See Warden Decl., ¶ 8. 22 Id. 23 Id.
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followed up again on February 22, 2015, Defendants committed to supplement their responses
by February 27 but, as had become the pattern, Defendants did not supplement their response by
the promised date.24 It was not until March 5, 2015 that Defendants finally supplemented their
responses to Interrogatory Nos. 1, 4 and 5.25 But the responses did not contain new information
nor any meaningful supplementation. Instead, Defendants imposed both new objections to the
interrogatories and limitations on the answers in a manner inconsistent with the parties’
agreement that Gilead would forego its motion to compel in return for Defendants actually
answering these interrogatories.
First, Defendants refused to answer Interrogatory Nos. 4 and 5 with respect to the ’499
patent.26 Yet again, Gilead had to threaten a motion to compel to get Defendants to agree to
answer these interrogatories.27 Defendants did so, but their responses remain incomplete because
they are improperly limited to the time period “prior January 18, 2002.” Specifically, their
responses state that “prior to January 18, 2002, [Defendants] did not make, use or test any
operable embodiment of the subject matter defined by the asserted claims” of the ‘499 and ‘712
patents and that “prior to January 18, 2002, [Defendants] did not test any compounds within the
classes defined by the structural formulas set forth in the ‘499 and ‘712 patents.”28 Notably,
neither interrogatory as served by Gilead contained any date limitation; Defendants’
supplemental responses unilaterally implemented this January 18, 2002 cut-off.
Second, the supplemental response to Interrogatory No. 1 is deficient because it lacks any
information regarding actual reduction to practice, even though the interrogatory expressly calls
for that information. The response merely states that “each and every claim asserted in this
action was constructively reduced to practice” by filing patent applications on “June 19, 2001 . . .
24 See Warden Decl., Exs. Q and R. 25 See Warden Decl., Ex. A. 26 Id. 27 See Warden Decl., Ex. T. 28 See Warden Decl., Ex. A.
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and . . . January 18, 2002,” and that Defendants are not relying on any other reduction to practice
dates.29
Gilead promptly informed Defendants that these supplemental responses were deficient
and required further supplementation to 1) account for the time period after January 18, 2002
(Nos. 4-5), and 2) identify dates of actual reduction to practice (No. 1).30 During the March 23,
2015 meet and confer, Defendants said they would discuss the responses with their client again,
but refused to commit to any further supplements to these interrogatories and stated that this was
an area where agreement was unlikely to be reached.31
D. Gilead’s Interrogatory Nos. 2, 7, 8, 10 and 11
Gilead served Interrogatory Nos. 2, 7, 8, 10, and 11 over a year ago, on March 6, 2014.32
These interrogatories specifically seek information related to Isis’ role in the development of any
compounds described or claimed in the Patents-in-suit (No. 2), Defendants’ communications
with Pharmasset (inventor of the product accused by Defendants of infringement) or knowledge
of Pharmasset’s nucleoside drug development efforts (No. 7), Merck’s efforts to acquire
Pharmasset (No. 8), Defendants’ interests (including Defendants’ alleged ownership and
licensing and financial interests) in the Patents-in-Suit (No. 10), and the factual and legal basis
and supporting evidence for Defendants’ contention that Sofosbuvir (the product accused of
infringement) was not invented by Pharmasset (No. 11).33
Defendants’ responses invoke Fed. R. Civ. P. 33(d) but state only that “responsive
information may be obtained from documents that have been produced or will be produced in
this litigation. Fed. R. Civ. P. 33(d).”34 Gilead expressed concerns over the sufficiency of these
responses on as early as June 7, 2014.35 In response, Defendants represented that they expected
29 Id. 30 See Warden Decl., Ex. V. 31 See Warden Decl., ¶ 14. 32 See Warden Decl., Ex. A. 33 Id. 34 Id. 35 See Warden Decl., Ex. B.
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to produce more documents and identify them under Rule 33(d).36 To date, Defendants have not
supplemented their responses to identify any documents from which the answers could be
obtained, despite having committed to identify documents for at least some of these
interrogatories in November 2014.37 During the March 23, 2015 meet and confer, again
arranged after Gilead told Defendants it would be filing a motion to compel, Defendants
indicated that they would supplement their responses to these interrogatories, and stated that two
weeks was probably a reasonable time by which they would supplement.38 Based on Defendants
above-described pattern of failing to provide supplemental responses by the dates to which they
have committed, and failure to provide adequate responses when they have finally supplemented,
however, Gilead has no assurance that Defendants will actually provide a meaningful
supplementation within two weeks, absent a Court order requiring them to do so.
E. Defendants’ Document Production
Gilead served requests for production (RFPs) on Defendants in March and July 2014.39
Despite Gilead’s repeated requests that Defendants complete their document production and cure
their document production deficiencies,40 Defendants—one of which, Merck, is a large
pharmaceutical conglomerate—have produced less than 200,000 pages of documents to date.41
In fact, Defendants have not yet produced documents from several custodians, including Roger
Pomerantz, Douglas Pon, and Wallace Ashton, each of whom Gilead has requested to depose.42
And Gilead’s document review has uncovered few documents from numerous other custodians,
including Anne Eldrup and Phillip Cook, who are named inventors on the patents-in-suit, and
36 See Warden Decl., ¶ 4. 37 See Warden Decl., ¶ 3. 38 See Warden Decl., ¶ 14. 39 See Warden Decl., Ex. A. 40 From August 2014 to March 2015, Gilead sent Defendants at least 11 letters and met and conferred with them at least 5 times on the subject of Defendants’ document production deficiencies. See, e.g., Warden Decl., ¶¶ 3-15; Exs. B, D, E, F, H, J, O, P, Q, S, and W. 41 This page count is far lower than expected; indeed, Gilead’s document production to date exceeds 2,400,000 pages. 42 See Warden Decl., ¶ 9; Ex. M.
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Quanlai Song, who appears to be the chemist that attempted to synthesize some compounds with
a 2’ F-Me configuration.43
More specifically, some of Gilead’s RFPs seek information concerning synthesis (both
successful and failed) and testing of compounds with 2’ modified nucleoside compounds for
HCV treatment (Nos. 28, 39, 60 and 62), Defendants’ efforts to develop compounds for HCV
treatment from 2000-2011 (Nos. 46 and 49).44 Gilead has attempted to obtain documents from
Defendants for months but has not received satisfactory responses from Defendants.
Indeed, twice in August 2014, and again in October, Gilead pointed out specific
categories of documents missing from Defendants’ production.45 In November, Defendants
acknowledged issues on their part in reviewing and producing documents and promised that
Gilead would be getting more productions soon.46 When those productions were not received by
early January, Gilead again raised these issues, including by identifying 13 custodians whose
documents appeared missing or substantially deficient.47 On January 23, 2015 Defendants
committed to collect and produce documents from all of the custodians Gilead had identified and
to provide an update on the status of those collections and other production deficiencies,
including, for example, documents concerning structure-activity-relationship (“SAR”) studies
and Merck’s nucleoside development programs, by January 30.48 Defendants also agreed to let
Gilead know at that time whether they would produce documents concerning attempts at making
and/or testing any 2’ fluorinated nucleoside beyond 2004.49
Defendants failed, however, to timely provide this updated information promised to
Gilead. Rather, on January 29 Defendants told Gilead they would need until February 4 to
43 See Warden Decl., ¶ 9. 44 See Warden Decl., Ex. A. 45 See Warden Decl., Exs. D, E, and F. 46 See Warden Decl., ¶ 4. 47 See Warden Decl., ¶ 7; Ex. J. 48 See Warden Decl., Ex. J. 49 Id.
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respond.50 Then, on February 4, Defendants said they needed until February 9.51 Then, on
February 9, instead of providing the promised information, Defendants requested a meet and
confer.52 When the parties met on February 10, Defendants represented that document collection
from key custodians was ongoing, but could not provide a timetable for completion for all of the
requested custodians.53 Defendants also represented that all documents concerning SAR studies
had been collected and would be produced “soon.”54 But Defendants refused to produce any
documents beyond January 2005 about their efforts at making any 2’F-Me nucleosides, or
documents beyond 2003 showing efforts at developing nucleosides for treatment of HCV.55
Gilead thereafter explained the relevance of this information,56 and followed up to continue
discussing Defendants’ document production.57
Defendants finally responded on February 25, 2015 and agreed to produce documents
concerning synthesis of 2’F-Me nucleosides before December 31, 2006.58 Defendants still
refused, however, to provide information related to post-2003 efforts at developing nucleosides
for treatment of HCV, contending that their post-2003 efforts “do not address the ease or
difficulty of actually making the compounds claimed in the Patent-in-Suit.”59
Dissatisfied with Defendants’ position, on March 4, 2015, Gilead again explained the
relevance of Defendants’ post-2003 efforts at developing nucleosides for treatment of HCV.60
Gilead offered to work with Defendants to narrow down the scope of this production and
requested that Defendants provide a date by which their document production would be
50 See Warden Decl., Ex. K. 51 See Warden Decl., Ex. L. 52 See Warden Decl., Ex. N. 53 See Warden Decl., ¶ 9. 54 See Warden Decl., ¶ 11. 55 See Warden Decl., ¶ 10. 56 See Warden Decl., Ex. O. 57 See Warden Decl., Exs. P and Q. 58 See Warden Decl., Ex. R. 59 Id. 60 See Warden Decl., Ex. S.
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completed.61 Defendants responded on March 9, 2015, stating that they would consider Gilead’s
position and “respond within a week, once we have had an opportunity to discuss this issue
further with our clients.”62 But again, Defendants did not provide any date for completing their
document production.63
On March 12, 2015, Gilead reiterated its request for Defendants to address deficiencies in
their document production and informed Defendants that Gilead would be filing a motion to
compel if no response is received by March 16, 2015.64 Upon receiving Gilead’s letter stating it
would be moving to compel, Defendants offered to meet and confer again on March 23, 2015.
On the March 23 meet and confer, Defendants indicated that they hoped to produce
documents related to the synthesis of 2’F-Me nucleosides by the end of the week or the
following week.65 In light of Defendants previous failures to follow through on discovery
commitments, Gilead questions both the timing and the completeness of this production,
particularly because Defendants indicated that the production would only consist of laboratory
notebooks and suggested that Gilead should identify any holes in the production after reviewing
it.66 Likewise, Defendants further indicated that they hoped to produce documents, again by the
end of the week or the following week, related to Defendants’ post-2003 efforts at developing
nucleosides, in particular documents showing why MK-608 was selected as the lead compound
for development and why development was discontinued.67 Defendants further represented that
MK-608 was the only lead compound, and there were no back-up compounds or other
compounds selected for further development.68 Gilead advised Defendants that in light of
Defendants previous failures to fulfill their discovery obligations, including previous failures to
61 Id. 62 See Warden Decl., Ex. U. 63 Id. 64 See Warden Decl., Ex. W. 65 See Warden Decl., ¶ 15. 66 Id. 67 Id. 68 Id.
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follow through on discovery they committed to providing, that Gilead would be including in this
motion to compel document production related to 2’F-Me nucleosides and Defendants lead
compounds.69
Finally, Gilead has uncovered substantial deficiencies with respect to Defendants’
production of SAR studies and production from key custodians. Defendants were unable to
confirm whether their document production on these issues was complete.70
III. ARGUMENT
A. Legal Standards
“Federal Rule of Civil Procedure 37 grants judicial authority to compel disclosure where
a party has failed to provide authorized discovery in a timely fashion.” Torres v. Peninsula
2011). Such authorized discovery includes depositions, answers to interrogatories, and responses
to requests for production. See Fed. R. Civ. P. 37. “An evasive or incomplete disclosure, answer,
or response must be treated as a failure to disclose, answer, or respond.” Fed. R. Civ. P. 37(a)(4).
Rule 30(b)(1) allows a party to “depose a person by oral questions” upon “[giving]
reasonable written notice to every other party.” Fed. R. Civ. P. 30(b)(1). Civil Local Rule 30-1
additionally requires that “before noticing a deposition of a party or witness affiliated with a
party, the noticing party must confer about the scheduling of the deposition with opposing
counsel.” N.D. Cal. Civ. L.R. 30-1. But when promptly served requests by a deposing party are
“met only with lengthy silence, followed by a blanket objection,” this Court has found that the
deposing party cannot be accused of insufficient efforts to meet and confer. M.H. v. County of
Alameda, No. 11-cv-02868-JST, 2013 WL 5497176, at *1 (N.D. Cal. October 3, 2013).
Rule 33 provides that a party may serve interrogatories “relat[ing] to any matter that may
be inquired into under Rule 26(b).” Fed. R. Civ. P. 33. “Each interrogatory must, to the extent it
69 Id. 70 Id.
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is not objected to, be answered separately and fully in writing under oath.” Id. “If the answer to
an interrogatory may be determined by examining, auditing, compiling, abstracting, or
summarizing a party’s business records (including electronically stored information), and if the
burden of deriving or ascertaining the answer will be substantially the same for either party, the
responding party may answer by: (1) specifying the records that must be reviewed, in sufficient
detail to enable the interrogating party to locate and identify them as readily as the responding
party could . . . .” Fed. R. Civ. P. 33(d).
Rule 34(a) requires a responding party to produce requested documents “within the scope
of Rule 26(b)” that are “in the responding party’s possession, custody, or control.” Fed. R. Civ.
P. 34(a)(1)(A). “If a party facing a discovery deadline is waiting for documents in response to a
document request, the party may immediately move to compel production of the documents.”
Integrated Global Concepts, Inc. v. j2 Global, Inc., No. C-12-03434-RMW, 2013 WL 6576124,
at *1 (N.D. Cal. Dec. 13, 2013).
B. Defendants Should Be Compelled To Respond To Gilead’s Deposition Requests
As stated above, despite repeated requests by Gilead for over six weeks, Defendants so
far have not meaningfully engaged in the deposition process. Defendants’ delay in responding to
Gilead’s deposition scheduling requests and failure to identify workable deposition dates is
prejudicing Gilead. It is unacceptable to Gilead for Defendants to refuse to produce witnesses on
the dates noticed by Gilead, and to not offer multiple dates for its witnesses. It would be unduly
burdensome on Gilead to have all depositions in the last few weeks of discovery, but
Defendants’ failure to engage and their control over the witnesses have tied Gilead’s hands. And
it appears that Defendants stall tactics may pay off for them to Gilead’s detriment—the only date
they have offered for Mr. de Laszlo is May 5, 2015, almost seven weeks after the date noticed by
Gilead. The only other date they have offered—April 30, 2015 for Mr. Carroll—is also within
the last few weeks of discovery.
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Defendants refusal to tell Gilead why the witnesses were unavailable on the noticed
dates, refusal to tell Gilead when Defendants’ first contacted witnesses about scheduling
depositions, and refusal to give any explanation for why Mr. de Laszlo was only available for a
single day during the entire discovery period are all further evidence of Defendants’ failure to
engage in the deposition process. As a result, Gilead respectfully requests that the Court compel
Defendants to engage in the deposition process by timely scheduling depositions beginning
immediately. Because of Defendants’ refusal thus far to provide witnesses for depositions, in
order for Gilead to have sufficient time to schedule and complete these depositions, Defendants
should be required to provide multiple dates for its witnesses such that the dates will work with
Gilead’s schedule.
In addition, to date Defendants have not identified a single witness they intend to depose.
Gilead requested Defendants provide that list so scheduling could commence. Gilead took those
steps to prevent a log jam of depositions in the last remaining weeks of fact discovery. Any
failure of Defendants to complete its depositions, therefore, is a consequence of their own lack of
diligence in pursuing deposition dates of Gilead witnesses.
C. Defendants Should Be Compelled To Provide Complete Responses To All Interrogatories
1. Gilead’s Interrogatory Nos. 1, 4, And 5 Seek Relevant Information That Defendants Currently Possess
Defendants’ responses to Interrogatories Nos. 1, 4 and 5 are incomplete. This was an
issue that Gilead was prepared to bring to the Court’s attention in December, but did not do so
because of Defendants’ agreement to respond to these interrogatories. Defendants, however,
failed to live up to their side of the agreement.
With respect to Interrogatory No. 1, Defendants have not identified any actual reduction
to practice date, and instead seek to avoid that subject by opting to rely solely on a constructive
reduction to practice date. But whether Defendants actually reduced their claimed inventions to
practice is relevant notwithstanding Defendants’ choice to hinge their conception date on a
constructive, rather than actual, reduction to practice. As stated in above, Gilead seeks to prove
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that the asserted claims are invalid because they are not supported by the written description, are
not enabled, and were derived from Pharmasset’s work. If Defendants were attempting to
actually reduce their claimed inventions to practice, but could not, or did not, do so until after
their chosen constructive reduction to practice date, Gilead should be able to learn those facts
because they bear directly on the issue of whether skilled artisans could have made and used the
claimed inventions without undue experimentation as of the patents’ priority dates. See, e.g.,
Plant Genetic Sys., N.V. v. Dekalb Genetics Corp., 315 F. 3d 1335, 1343-44 (Fed. Cir. 2003)
(approving the district court’s use of post-filing evidence in its non-enablement determination).
And the timing of any actual reduction to practice will shed light on whether Defendants used
Pharmasset’s published synthetic methods instead of their own.
With respect to Interrogatory Nos. 4 and 5 concerning the compounds described in the
patents-in-suit and asserted claims and their biological testing, Defendants’ failure to provide
substantive responses for the time period after January 18, 2002 is inappropriate. Any
embodiment made, used, or tested by Defendants, even if after the date of constructive reduction
to practice, is relevant to Gilead’s invalidity defenses. For example, if Defendants’ tests show
that the claimed compounds do not function as HCV inhibitors, that bears on whether
Defendants in fact enabled and possessed the claimed inventions as of their priority date, or
instead merely set out a plan for future research in their patent. Id. Interrogatory Nos. 4 and 5
do not include any date limitations, and Defendants cannot unilaterally and artificially implement
such a limitation, even if Defendants are not relying on dates other than the dates of constructive
reduction to practice.
Despite Defendants’ nearly 13 months of investigation,71 Gilead has not received an
adequate substantive response to Interrogatory Nos. 1, 4 and 5. “The duty to supplement is not a
license to unduly delay production or get around discovery obligations when convenient.”
71 This 13-month period of course does not include whatever investigation Merck’s prosecutors undertook at the time it amended its claims in 2005 to make sure that the claims as amended had adequate support in both the specification and Merck’s research and development efforts.
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United States v. Cook, No. 2:11-CV-3422 WBS GGH, 2013 WL 79525, at *1 (E.D. Cal. Jan. 4,
2013) (internal quotation marks omitted). Without an order compelling Defendants to answer
Gilead’s interrogatories, both parties will waste countless hours and resources while Gilead
attempts to obtain the very same information from Defendants’ witnesses at depositions over the
next two months. And based on Defendants conduct to date, Gilead is also concerned that
Defendants may improperly try to prevent their witnesses from answering questions related to
post-2002 activity and actual reduction to practice. Defendants should provide answers to these
straightforward questions, and should not be allowed to prevent its witnesses from testifying
about these issues. With the close of fact discovery scheduled for May 22, 2015, it is imperative
that Defendants immediately respond to these interrogatories.
2. Defendants’ Responses To Gilead’s Interrogatory Nos. 2, 7, 8, 10 And 11 Are Deficient Under Rule 33(d)
Defendants have failed to respond to Nos. 2, 7, 8, 10, and 11. Rather, Defendants
invoked Rule 33(d) but have refused to identify a single document for any of these
interrogatories from which the answer could be ascertained. Defendants are obligated under the
Rule to “specify[] the records that must be reviewed, in sufficient detail to enable the
interrogating party to locate and identify them as readily as the responding party could.” Fed. R.
Civ. P. 33(d); see also Bercut-Vandervoort & Co. v. Maison Tarride Ledroit & Cie, No. C-05-
5122-JF (RS), 2006 WL 3699548, at *2 (N.D. Cal. Dec. 13, 2006) (providing that, in invoking
Rule 33(d), “it is not sufficient for [a responding party] to say only, in effect, ‘just look through
the entire production for anything that appears to be [the information sought]’”).
Despite the narrow scope of these interrogatories, Defendants responded with overly
broad statements that refer to all “documents that have been produced or will be produced in this
litigation” as sources from which “responsive information may be obtained.” In other words, to
date Defendants have effectively told Gilead to “look through the entire production for anything
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that appears to be [the information sought].” Id. Forcing Gilead to look for answers to its
interrogatories within Defendants’ entire document production without direction is improper
under Rule 33(d). Bowoto v. Chevron Corp., No. C-99-02506 SI, 2006 WL 2507454, at *3
(N.D. Cal. Aug. 29, 2006) (providing that a responding party “must explicitly describe the
content of the relatively few documents that contain the requested information, and must
describe the content of the remaining documents”); Sun Microsys. Inc. v. Hynix Semiconductor
Inc., No. C-06-01665 PJH (JCS), 2007 WL 1514876, at *2 (N.D. Cal. May 21, 2007) (requiring
responses invoking Rule 33(d) to include BATES number). Defendants should be held to their
obligation to actually identify responsive documents consistent with Rule 33(d) and to provide
meaningful narrative responses where appropriate. Although Defendants have said they would
supplement these interrogatories, after Gilead informed Defendants it would be moving to
compel, given Defendants past unfulfilled commitments to supplement interrogatories—
including some of these very same interrogatories—Gilead has no assurances that these
interrogatory responses will be supplemented without a Court order.
D. Defendants Should Be Compelled To Produce All Documents Requested by Gilead
Gilead seeks to obtain documents from Defendants that bear on Gilead’s enablement,
written description, and derivation defense. Gilead has requested these documents repeatedly,
and made multiple attempts to resolve the issue with Defendants amicably, but so far those
request have been met with diversion and undue delay. Defendants should be required to
produce these documents so that Gilead can meaningfully prepare for depositions and discover
all facts related to its defenses.
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1. Defendants Document Production Delays Must Be Cured To Avoid Continued Prejudice To Gilead
As with their interrogatory responses, Defendants have also engaged in a pattern of delay
with their document productions. Gilead noticed the deficiencies in Defendants’ document
production early in the discovery process72 and discussed the issue with Defendants on multiple
occasions73 in efforts to get Defendants to correct the problem and engage in meaningful
discovery. Unfortunately, those efforts to move the discovery process forward have been met
only by lengthy silence, empty “commitments”, and other delay tactics of Defendants to avoid
substantive responses.
As an example, Gilead’s first set of RFPs, served almost a year ago, encompasses
requests for information related to structure-activity-relationship studies.74 By mid-October,
2014, seven months after serving its first set of RFPs and having contacted Defendants at least
twice about of their lack of production,75 Gilead received an incomplete production on that
topic.76 That forced Gilead to write to Defendants again on October 17, 2014 about the
deficiencies in their document production.77 During the next three months, Gilead raised the
same issue multiple times through both written communications and meet and confers,78 but
Defendants still failed to act. Frustrated, yet still trying to resolve the issue amicably, Gilead
reasserted its concerns on a February 10, 2015 meet and confer call.79 Counsel for Defendants
responded by stating that many of the documents on this subject had not yet been produced, but
would be “soon.”80 Yet Gilead’s document review to date has uncovered only a handful of
72 See, e.g., Warden Decl., Ex. D. 73 From August 2014 to March 2015, Gilead sent Defendants at least 11 letters and met and conferred with them at least 5 times on the subject of Defendants’ document production deficiencies. See, e.g., Warden Decl., ¶¶ 3-15; Exs. B, D, E, F, H, J, O, P, Q, S, and W. 74 See Warden Decl., Ex. A. 75 See Warden Decl., Exs. D and E. 76 See Warden Decl., Ex. F. 77 Id. 78 See Warden Decl., Exs. H and I; ¶¶ 4 and 7. 79 See Warden Decl. ¶ 11. 80 Id.
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documents related to structure-activity-relationship studies.81 Even during the March 23, 2015
meet and confer, Defendants represented that they still were not certain of the status of the
production of those documents, and could not commit to a date by which they would be
produced.82
As another example, despite receiving multiple requests from Gilead, Defendants to date
still have not produced documents from several key custodians Gilead has identified.83 Gilead
informed Defendants about these custodians no later than January 7, 2015,84 and reminded
Defendants again about the request on January 14, 2015.85 When the parties met on January 23,
2015, Defendants committed to producing documents from all of the custodians identified by
Gilead and providing an update of the status by January 30, 2015.86 No update was ever
provided by the promised date.87 When the parties discussed the deficient production from these
individuals on February 10, 2015, less than 50 days before the scheduled discovery cut-off,88
counsel for Defendants stated that production had been completed for only about 25% of the
custodians and more productions were to be rolled out by January 20, 2015 and January 28,
2015.89 Defendants could not, however, provide a timetable for when production for all of the
custodians would be completed.90 To date, Gilead’s document review has found no documents
from at least three custodians.91 Collections from other custodians are also suspiciously sparse.92
During the parties’ March 23, 2015 meet and confer, Defendants still could not commit to a date
by which many of these additional documents would be produced.93
81 Id. 82 See Warden Decl., ¶ 15. 83 See Warden Decl., ¶ 9. 84 See Warden Decl., Ex. H. 85 See Warden Decl., Ex. I. 86 See Warden Decl., Ex. J. 87 See Warden Decl., ¶ 7. 88 The parties have since stipulated to an extension of the cut-off date. 89 See Warden Decl., ¶ 9. 90 Id. 91 Id. 92 Id. 93 See Warden Decl., ¶ 15.
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Last but not least, Gilead requested, almost a year ago in its first two sets of RFPs,
information related to synthesis and testing of nucleosides with the 2’ F-Me configuration.94
Defendants first objected to the request;95 then tried to unilaterally limit the production to until
2004;96 then extended the collection to January 200597 before finally agreeing in principle to
produce documents up to December 31, 2006.98 Defendants wasted almost a year before
committing to producing the requested information. And even after such a lengthy delay,
Defendants, to date, still have not made any meaningful production on this subject matter.
Although Defendants have now said they hope to produce documents this week, Defendants
have represented that the production will consist only of lab notebooks, and have told Gilead that
if it still believes there are holes in that production after reviewing those notebooks, it should
identify them at that time.99
Defendants’ delayed and deficient document production is prejudicing Gilead’s ability to
prepare its case. The document requests outlined here as examples as well as those contained in
Gilead’s RFPs seek important information relevant to Gilead’s defenses in this litigation. In fact,
Defendants do not dispute the relevance of most of these requests—they simply have not
fulfilled their obligations to produce. The pattern of evasiveness and delay in Defendants’
discovery-related conduct needs to be stopped.100
94 See Warden Decl., Ex. A. 95 Id. 96 See Warden Decl., Ex. J. 97 See Warden Decl., ¶ 10. 98 See Warden Decl., Ex. R. 99 See Warden Decl., ¶ 15. 100 As discussed above, during the March 23, 2015 meet and confer following Gilead’s notification to Defendants that it would be filing a motion to compel, Defendants agreed in principle to produce the documents referred to in this section. Defendants, however, have not committed to a firm date certain to produce all of these documents, and it will be some time before Gilead has the opportunity to assess the adequacy of Defendants’ production related to these issues.
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2. Documents Related To Defendants’ Post-2003 Efforts At Developing Nucleosides For Treatment Of HCV Are Relevant To Gilead’s Defenses
Documents related to Defendants’ post-2003 efforts at developing nucleosides for
treatment of HCV (including those related to MK-608 and other lead compounds described by
the Patents-in-Suit) are relevant to Gilead’s enablement and written description defenses,
including how and why these compounds may have failed. Furthermore, Defendants’post-2003
development efforts are also relevant to Gilead’s derivation defenses because they could show,
for example, how Defendants development efforts differed from their patent claiming strategy
after Pharmasset provided information to Defendants.
Defendants’ post-2003 efforts at developing nucleosides for treatment of HCV (including
those related to MK-608 and other lead compounds) are relevant to Gilead’s enablement, written
description, and derivation defenses. Gilead therefore respectfully requests that the Court
compel Defendants to produce documents concerning these efforts.101
IV. CONCLUSION
In view of the above, Gilead respectfully requests that the Court order Defendants to
begin scheduling depositions immediately, provide complete responses to Gilead’s
interrogatories, and timely complete their document production.
Dated: March 24, 2015 FISH & RICHARDSON P.C.
By: /s/ Gregory R. Booker
Gregory R. Booker
Attorney for Plaintiff
GILEAD SCIENCES, INC.
101 As discussed above, during the March 23, 2015 meet and confer Defendants agreed in principle to produce documents related to lead compounds, but indicated that there was only one lead compound, MK-608, and no other compounds selected for further development. Defendants, however, have not committed to a firm date certain to produce these documents, and it will be some time before Gilead has the opportunity to assess the adequacy of Defendants’ production.
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GILEAD SCIENCES, INC.’S MOTION TO COMPEL Case No. 5:13-cv-04057-BLF-PSG
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CERTIFICATE OF SERVICE
The undersigned hereby certifies that a true and correct copy of the above and foregoing
document has been served on March 24, 2015, to all counsel of record who are deemed to have
consented to electronic service via the Court’s CM/ECF system per Civil Local Rule 5-1(h)(1).
Cecilia Acosta
Cecilia Acosta
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