Court Opinion

ID: 6321541
Source: CourtListenerOpinion
Date Created: 2022-03-09 18:02:35.325001+00
Date Added: 2024-06-11T09:11:05.344244
License: Public Domain

In the United States Court of Federal Claims
                                           No. 20-499C

                                 (Filed under seal: March 4, 2022)
                                    (Reissued: March 9, 2022)

 ___________________________________
                                                 )            Contract case related to private
 GILEAD SCIENCES, INC.,                          )            support for governmental research
                                                 )            agreements; proper scope of
                        Plaintiff,               )            discovery under RCFC 30(b)(6);
                                                 )            limitations imposed; RCFC
           v.                                    )            26(b)(2)(c)
                                                 )
 UNITED STATES,                                  )
                                                 )
                   Defendant.                    )
 ___________________________________             )

        Ronald C. Machen, Jr., Wilmer Cutler Pickering Hale and Dorr LLP, Washington, D.C.
for plaintiff Gilead Sciences, Inc. With him on the briefs were David B. Bassett, Wilmer Cutler
Pickering Hale and Dorr LLP, New York, NY, as well as Vinita Ferrera, Emily R. Whelan,
George P. Varghese, Timothy A. Cook, and Stephanie Lin, Wilmer Cutler Pickering Hale and
Dorr LLP, Boston, MA.

       Walter W. Brown, Senior Litigation Counsel, Commercial Litigation Branch, Civil
Division, United States Department of Justice, Washington, D.C. for the United States. With
him on the briefs were Michael Granston, Deputy Assistant Attorney General, Gary L. Hausken,
Director, and Philip Charles Sternhell, Assistant Director, and of counsel were Amanda K. Kelly,
Carrie E. Rosato, Patrick C. Holvey, Matthew D. Tanner, and Lucy Grace D. Noyola,
Commercial Litigation Branch, Civil Division, United States Department of Justice, Washington,
D.C.

                                     OPINION AND ORDER1

       LETTOW, Senior Judge.

       Pending before the court in this contract dispute is plaintiff Gilead Sciences, Inc.’s
(“Gilead”) motion to compel the designation of a witness under Rule 30(b)(6) of the Rules of the
Court of Federal Claims (“RCFC”). Pl.’s Mot. to Compel (“Pl.’s Mot.”), ECF No. 51. Gilead
has sued defendant United States (“the government”) for breach of contract, alleging that the
Centers for Disease Control and Prevention (“CDC”) violated the terms of four Material Transfer

       1
         Because of the protective order entered in this case, this opinion was initially filed under
seal. The parties were requested to review the decision and provide proposed redactions of any
confidential or proprietary information. No redactions were requested.
Agreements (“MTAs”) and two Clinical Trial Agreements (“CTAs”). See First Am. Compl.,
ECF No. 33.

       This action is closely tied to a patent infringement case pending in the district of
Delaware styled United States v. Gilead Sciences Inc., No. 19-2103MN (D. Del., filed Nov. 5,
2019). Discovery in that action and this one has been coordinated by the parties,2 except that the
pending motion has been filed only in this court, Hr’g Tr. 22:21-22, 24:20-25.3 The results
however, would be applicable also to the district court case. 4 The motion seeks to compel the
government to designate a witness or witnesses to testify regarding the topic of Gilead’s Rule
30(b)(6) Notice which concerns the government’s policies and procedures for tracking
government obligations under MTAs, CTAs, and other similar agreements. Pl.’s Mot. at 2. The
government counters that the notice was overly broad. Def.’s Opp’n to Pl.’s Mot. to Compel at 2
(“Def.’s Opp’n”), ECF No. 54. After briefing was completed, see Pl.’s Reply, ECF No. 58, the
court held a hearing on February 10, 2022. The motion is ready for disposition.

                                          BACKGROUND5

         Gilead’s lawsuit “arises out of a specific series of interactions and two sets of contracts”
in its ongoing collaboration with the CDC. First Am. Compl. ¶ 5. From 2004 to 2014, Gilead
and the government entered into four MTAs (and issued several amendments to those
agreements during that time span) that stipulated that Gilead would provide the CDC “with
significant quantities of Gilead compounds free of charge.” First Am. Compl. ¶¶ 6, 45; see also
First Am. Compl., Exs. 4-7, ECF Nos. 34-4 to 34-7. In exchange, the government agreed to
“promptly notify” Gilead of “any Inventions” derived from work performed under the
agreements. First Am. Compl., Ex. 4 at 3. “Inventions” were defined in each MTA as “any
inventions, discoveries and ideas that are made, conceived or reduced to practice.” First Am.
Compl., Ex. 4 at 3. Per the agreements, the CDC was “to put the results of the Trial[s],
patentable or otherwise, in the public domain for all to use without obligation or compensation to
[the] CDC.” First Am. Compl., Ex. 27 at 2, ECF No. 34-27.

       2
           See Hr’g Tr. 6:14 to 7:5 (Feb. 10, 2022).

           The date will be omitted from further citations to the hearing transcript.
       3
         The parties reportedly used the same numbering system for discovery in both courts.
Hr’g Tr. 24:21-23.
       4
          The parties previously agreed that “[d]eposition testimony given in the Delaware action
shall be deemed given in this action as well.” Joint Status Report of March 17, 2021 at 26, ECF
No. 24. The reverse is also true; any response the government makes to discovery in this action
will be applicable in the District of Delaware. Hr’g Tr. 6:22 to 7:2.

       5
          The recitations that follow do not constitute findings of fact but rather are recitals
attendant to the pending motions and reflect matters drawn from the complaint, the parties’
briefs, and records and documents appended to the complaint and briefs.

                                                   2
        Additionally, Gilead and CDC entered into two CTAs in 2004. First Am. Compl. ¶¶ 50,
57. The first CTA was amended in 2007, and the second was amended three times between
2006-2012. First Am. Compl. ¶¶ 54, 60. The CTAs specified that the CDC would “not . . . seek
patent protection in connection with any inventions that derive from the use of the Study Drug[s]
in the Trial[s].” First Am. Compl., Ex. 27 at 2.

        In February 2006, the CDC first took steps to patent inventions “related to purported
inventions that CDC made in the course of the research conducted under the MTAs, . . . using the
compounds that Gilead provided under the MTAs.” First. Am. Compl. ¶ 11. It was not until
years later that the Patent and Trademark Office issued several patents.6 Having previously
received approval from the Food and Drug Administration on July 16, 2012 for the use of the
drug Truvada for HIV-1 pre-exposure prophylaxis and begun doing so, see First Am. Compl. ¶
15, the government notified Gilead on March 11, 2016—some years later—that Truvada “may
be covered” by a patent “recently obtained” by the CDC. First Am. Compl., Ex. 26 at 1, ECF
No. 34-26. Gilead countered that the government had breached their agreements and that the
patents were not valid. First Am. Compl. ¶ 110.

        On November 6, 2019, the government filed suit against Gilead in the United States
District Court for the District of Delaware. See United States v. Gilead Sciences, Inc., No 19-
2103MN (D. Del., filed Nov. 6, 2019). The government alleges in the Delaware lawsuit that
Gilead infringed its patents by selling and promoting Truvada and a related drug, Descovy, for
HIV PrEP. First Am. Compl. ¶ 115. On April 24, 2020, Gilead filed suit in this court, alleging
breach of the MTAs and CTAs. See Compl., ECF No. 1. Since that time, the court has held that
it possessed jurisdiction over the case and declined to dismiss the action. See Gilead Sciences,
Inc. v. United States, 151 Fed. Cl. 742 (2020); Gilead Sciences, Inc. v. United States, 155 Fed.
Cl. 336 (2021). Coordinated discovery has proceeded simultaneously in both this case and the
related case before the district court in Delaware. During the course of discovery, the parties
took over 100 hours of deposition testimony, see Def.’s Opp’n at 2, in which Gilead received
conflicting testimony from various government employees about how or who tracked the
government’s obligations under the agreements. Pl.’s Mot. at 8-9.7

       6
        Those patents are Nos. 9,044,509 (issued June 2, 2015); 9,579,333 (issued Feb. 28,
2017); 9,937,191 (issued Apr. 10, 2018); and 10,335,423 (issued July 2, 2019). See First Am.
Compl. ¶ 12.
       7
         The director of the CDC’s Technology Transfer office testified that she did not
determine whether the CDC had obligations under MTAs. Pl.’s Mot., Ex. 8 at 70:20 to 71:4,
ECF No. 51-8. In contrast, an employee of the National Institutes of Health stated that she
“presume[d]” that obligations associated with MTAs were tracked by the CDC’s Technology
Transfer Office. Id., Ex. 9 at 87:17 to 88:4, ECF No. 51-9. Further employees within the CDC
provided conflicting testimony regarding who bore the responsibility of ensuring compliance
with the CDC’s obligations. Compare id., Ex. 10 at 96:14 to 97:23, ECF No. 51-10 (“Q: Did you
ever have to notify any party to a material transfer agreement based on the discovery described in
a material transfer agreement? A. No. . . . Q: Would this type of notification have fallen on Lisa
[Blake-DiSpigna]’s plate? Would Lisa have been responsible for something like that? A.
Yes.”), with id., Ex. 11 at 41:11-20, ECF No. 51-11 (“Q: So, if Ms. Ghosh had suggested that it
was your office’s responsibility to notify Gilead, would you agree with that? A: No. . . . Q:
Why not? A: Because our role was administrative services. And our job was simply to put
                                                  3
        On October 21, 2021, Gilead served the government with a Rule 30(b)(6) notice.
Particular to this motion, Topic 130 of that notice sought testimony regarding:

       The policies, procedures, and persons involved in tracking the [g]overnment’s
       obligations under material transfer agreements, clinical trial agreements, or
       Cooperative Research and Development Agreements [(“CRADAs”)] that CDC
       and [Public Health Service (“PHS”)] enter into, including but not limited to
       procedures or guidance related to the persons responsible for providing
       disclosures or notice under any such agreements, what such disclosure or notice
       typically includes, and the timing of such disclosure or notice.

Pl.’s Mot., Ex. 2 at 2, ECF No. 51-2. The parties conferred about Topic 130 on November 8,
2021 before the government served formal responses to the Rule 30(b)(6) notice. Pl.’s Mot at. 3;
Def.’s Opp’n at 3-4. At that time, the government raised its concern that Topic 130 was overly
broad. Pl.’s Mot. at 3; Def.’s Opp’n at 4. Gilead avers that it clarified that the topic sought
“testimony only with respect to the policies and procedures governing agreements involving
CDC and PHS and that it was willing to further limit the scope of the topic to CDC’s policies
and procedures related to its obligations in MTAs and CTAs.” Pl.’s Mot. at 3. Thereafter,
Gilead did not serve an amended version of Topic 130, and the government objected to the topic
as overly broad in its responses served on November 18, 2021. Def.’s Opp’n at 4.

         The parties conferred again on December 21, 2021. Pl.’s Mot. at 4; Def.’s Opp’n. at 4.
At that time, Gilead offered to limit the scope of the topic “to specific groups at CDC or to a
specific time period.” Pl.’s Mot. at 5. The government responded that those limitations would
not rectify the burden on the government since Topic 130—in the government’s view—seeks
testimony “concerning every MTA, CTA, or CRADA that unnamed groups at CDC entered
into.” Def.’s Opp’n at 5. The government offered that it would be willing to provide a witness
to testify regarding the specific agreements at issue in the case due to the “unique obligations”
created in individual MTAs and CTAs. Id.8 Gilead rejected that compromise, maintaining that
Topic 130 “seeks testimony on general policies related to the types of agreements at issue in this
case, and not testimony on each and every government collaboration.” Pl.’s Mot. 4-5. The
parties did not reach an agreement concerning the scope of Topic 130, and the government did
not designate a witness to testify to it.

        Gilead filed its motion to compel on January 10, 2022. Fact discovery in the case closed
on January 21, 2022. See Order of April 6, 2021, ECF No. 26. In its motion, Gilead argues that
the topic is relevant and not overly broad as it seeks information about the government’s
monitoring practices generally and that a witness is necessary to address the issue because other
government witnesses have given inconsistent answers. See generally Pl.’s Mot. The

together the agreement and get it executed. And we did our part. And that was the
responsibility.”).
       8
         The government contends that a restriction in time is necessary in part because there
was a change in structure of the offices responsible for the agreements. Def.’s Opp’n at 7. Prior
to 2013, the Office of Technology Transfer essentially handled prosecuting patents while the
Office of Administrative Services drafted and negotiated the types of agreements at issue here.
Hr’g Tr. 19:24 to 20:18. In 2013, those offices merged. Hr’g Tr. 20:18-23.
                                                 4
government counters that the wording of Topic 130 encompasses every policy and agreement
entered into by CDC and PHS and is therefore overly broad. Def.’s Opp’n at 6. Further, the
government contends that any inconsistency in testimony is a result of Gilead asking broad
questions to the wrong witnesses. Id. at 11. Subsequent to the filing of Gilead’s motion and the
government’s opposition brief, the government served a supplemental interrogatory response on
January 28, 2022, which stated in part that “CDC and PHS as agencies do not (and did not) track
‘the [g]overnment’s obligations under [MTAs, CTAs, or CRADAs] that CDC and PHS enter
into,’ including the MTAs and CTAs at issue in this litigation.” Pl.’s Reply, Ex. 1 at 15, ECF
No. 58-1.

        In its opposition and at the hearing, the government argued that Topic 130 should be
limited to the CDC, a specific time period, and to the agreements at issue in this case. See Def.’s
Opp’n at 8-10; Hr’g Tr. 19:6-23; 22:19 to 23:5. At the hearing, Gilead suggested limiting
discovery under the topic to “policies from the CDC and the PHS for these types of agreements,
MTAs and CTAs.” Hr’g Tr. 26:14-24.

                                STANDARDS FOR DECISION

        “Questions of the scope and conduct of discovery are, of course, committed to the
discretion of the trial court.” Florsheim Shoe Co. v. United States, 744 F.2d 787, 797 (Fed. Cir.
1984). “Accordingly, resolution of a motion to compel discovery is committed to that
discretion.” 3rd Eye Surveillance, LLC v. United States, 143 Fed. Cl. 103, 109 (2019) (citing
Heat & Control, Inc. v. Hester Indus., Inc., 785 F.2d 1017, 1022 (Fed. Cir. 1986)). When
deciding motions to compel, the “court must balance potentially conflicting goals,” Petro-Hunt,
L.L.C. v. United States, 114 Fed. Cl. 143, 144 (2013), with the understanding that “[m]utual
knowledge of all the relevant facts gathered by both parties is essential to proper litigation,”
Hickman v. Taylor, 329 U.S. 495, 507 (1947).

                                           ANALYSIS

        Rule 30(b)(6) requires that a party serving a notice under this rule “must describe with
reasonable particularity the matters for examination.” In turn, the named organization “must
then designate one or more . . . persons who consent to testify on its behalf.” Id. Rule 30(b)(6) is
subject to the limitations of Rule 26(b)(2), and the court must limit the scope of a Rule 30(b)(6)
topic to the extent it is unreasonably cumulative or is unduly burdensome. See RCFC
26(b)(2)(C)(1)-(3). Therefore, “Rule 30(b)(6) call[s] on the court[] to ensure that both sides are
adhering to the rule’s objective of fair access to corporate information and, at the same time, to
guard against overreaching by the party seeking discovery and failure of the [organizational]
party to satisfy its obligations.” 8A Richard L. Marcus, Federal Practice & Procedure § 2103 (3d
ed. 2021) (discussing Fed. R. Civ. P. 30); see Ierardi v. Lorillard, Inc., Civ. A. No. 90-7049,
1991 WL 66799, at *2 (E.D. Pa. Apr. 15, 1991) (“The purpose of Rule 30(b)(6) is to ensure that
corporations supply relevant information to opposing counsel relating to corporate practices,
policies, procedures and actions.”) (discussing Fed. R. Civ. P. 30(b)(6)).9

       9
        RCFC 30(b)(6) mirrors Fed. R. Cir. P. 30(b)(6), and the rules should be interpreted in
pari materia.
                                              5
        The government does not contest the relevancy of Gilead’s inquiry generally but does
contend that Gilead has failed to meet its obligation under Rule 30(b)(6) to describe the inquiry
with particularity. See Def.’s Opp’n at 12. Ultimately, the party seeking discovery bears the
burden of showing it has defined its deposition notice with particularity. See 8A Richard L.
Marcus, Federal Practice & Procedure § 2103 (3d ed. 2021) (discussing Fed. R. Civ. P. 30).
Both parties have offered potential limitations for the topic. The government would limit the
topic according to time, agency, and the specific agreements in this case, Def.’s Opp’n 7-8, while
Gilead would limit the topic to CDC and PHS policies regarding MTAs and CTAs generally.
Hr’g Tr. 26:14-24. The parties are correct to offer limitations to the inquiry because it is overly
broad as written in that it seeks information about all of the CDC’s and PHS’s MTAs, CTAs, and
CRADAs without a time limitation. While Gilead contends that it seeks information related only
to “general policies and procedures that [CDC and PHS] follow to track their obligations under
the specific types of agreements,” Pl.’s Reply at 3, the language of the notice does not
necessarily reflect that focus.

        Pursuant to Rule 26(b)(2)(C), the court will limit Topic 130 of Gilead’s Rule 30(b)(6)
notice by time, agency, and type of agreement. The court will address the parties’ suggested
limitations in turn, beginning with whether the topic should be limited to the CDC alone or
should also include PHS. The government argues that PHS is irrelevant to the claim because “all
the agreements in this case were between Gilead and the CDC.” Def.’s Opp’n at 8. In response,
Gilead argues that the MTAs at issue are titled “Public Health Service Material Transfer
Agreement,” Pl.’s Reply at 3 n.2 (citing First Am. Compl., Ex. 4 at 1), and those agreements
create obligations for PHS because it agreed to “give serious and reasonable consideration to
[p]rovider’s request for a non-exclusive or exclusive license on commercially reasonable terms
under PHS’s intellectual property rights in or to any [i]nventions.” Id. (citing First Am. Compl.,
Ex. 4 at ¶ 8).

        Eight of the eleven agencies of the Department of Health and Human Services make up
PHS. In effect, PHS is a sprawling entity whose policies and procedures encompass agencies
and agreements that are unrelated to this case. Further while Gilead is correct that the MTAs
state obligations for “PHS,” each MTA also states that the National Institutes of Health, the Food
and Drug Administration, and the CDC are collectively referred to as PHS and the “recipient”
under each agreement is listed solely as CDC. First Am. Compl., Ex. 4 at 1; Ex. 5 at 1, ECF No.
34-5; Ex. 6 at 1, ECF No. 34-6; Ex. 7. at 1, ECF No. 34-7. Gilead does contend that CDC, as a
sub-agency of PHS, may be subject to general PHS policies that would not be considered CDC
policies. Hr’g Tr. 25:21 to 26:13. In light of the breadth of PHS, the lack of other PHS
agencies’ involvement, and the predominance of CDC’s role in this case, the court will limit the
scope of Topic 130 to agreements concerning the CDC specifically and any general policies that
PHS has implemented that pertain to the CDC. Policies specific to other agencies within PHS
and their MTAs and CTAs will be beyond the scope of the now limited topic.

         The government next advocates that the topic should be limited to the specific MTAs and
CTAs at issue in this case. Def.’s Opp’n at 7; Hr’g Tr. 22:23 to 23:5. While Gilead’s original
request encompassed all MTAs, CTAs, and CRADAs, it has since expressed a willingness to
limit its request to MTAs and CTAs as categories. Hr’g Tr. 26:20-24. It maintains, however,
that Topic 130 must extend to all MTAs and CTAs, not just the ones at issue here, to accomplish
its goal of determining what CDC’s general policies and procedures are in regard to tracking its
obligations under these types of agreements. Pl.’s Mot. at 7. The government maintains that a
                                                6
non-specific discussion of MTAs and CTAs is not possible due to each agreements’ unique
terms. Def.’s Opp’n at 7; Hr’g Tr. 29:24 to 30:8.

         As an initial matter, in light of the distinct nature of CRADAs and Gilead’s own
willingness to limit its request in that regard, CRADAs are removed from the scope of Topic
130. The court, however, will not limit the topic to the specific MTAs and CTAs involved in
this case. The purpose of Rule 30(b)(6) is in part to give parties the opportunity to obtain
information about the general policies and procedures of its opponent. See 8A Richard L.
Marcus, Federal Practice & Procedure § 2103 (3d ed. 2021) (discussing Fed. R. Civ. P. 30).
Limiting Gilead’s discovery to only the six agreements at issue here would deprive them of the
relevant knowledge of whether CDC (and PHS as a whole) have general policies that were not
followed in this case. While the government stated in its supplemental interrogatory response
that CDC and PHS “do not (and did not) track ‘the government’s obligations’” under these types
of agreements, it still must designate a witness to testify whether that failure was proper under
applicable policies, and whether the failure had a reasonable basis in law and fact. Pl.’s Reply,
Ex. 1 at 15. In that same vein, where the government contends that it was the role of the
principal investigators to track the obligations under CTAs, see Hr’g Tr. 17:23 to 18:24; 21:16 to
22:2, it again must produce a witness to testify to the CDC’s procedures in that regard.

        The court, however, will limit the scope of Topic 130 to MTAs and CTAs entered into by
CDC between the relevant time of 2004 and 2014 when the agreements and amendments here
were made. While this time period does encompass the years before the technology transfer
office and the office of administrative services were merged, see supra n.8, Rule 30(b)(6)
contemplates that “one or more” individuals may be designated to address the issues raised. See
RCF 30(b)(6).

       Topic 130 should now be read as:

       The policies, procedures, and persons involved in tracking the government’s
       obligations under material transfer agreements and clinical trial agreements that
       the CDC entered into between 2004 and 2014.10

These limitations bring the topic within the confines of Rule 30(b)(6) as explicated by this court
in Ehren-Haus Indus., Inc. v. United States, 150 Fed. Cl. 513 (2020), by limiting it to policies at
issue during the relevant time of the contracts at issue.

                                         CONCLUSION

     For the reasons set forth above, the government’s motion to compel is GRANTED IN
PART AND DENIED IN PART. Fact discovery is reopened for this purpose until April 5, 2022,

       10
          The government argues that the entire notice was made impermissible by Gilead’s use
of the language “including, but not limited to . . .” pursuant to Reed v. Bennett, 193 F.R.D. 689,
692 (D. Kan. 2000). Rather than strike the entire notice, the court has stricken the impermissible
language consistent with a ruling by the District Court of the District of Columbia. See Tri-State
Hosp. Supply Corp. v. United States, 226 F.R.D. 118, 125 (D. D.C. 2005) (striking “but not
limited to” language from a Rule 30(b)(6) notice).
                                                   7
and the government is instructed to designate a witness or witnesses to respond to the modified
Topic 130 by March 18, 2022.

       It is so ORDERED.

                                            s/ Charles F. Lettow
                                            Charles F. Lettow
                                            Senior Judge

                                                8