Court Opinion

ID: 4684715
Source: CourtListenerOpinion
Date Created: 2021-05-06 20:01:53.695868+00
Date Added: 2024-06-11T08:04:23.489376
License: Public Domain

UNITED STATES DISTRICT COURT
                           FOR THE DISTRICT OF COLUMBIA

 VANDA PHARMACEUTICALS, INC.,
 et al.,
         Plaintiffs,
                 v.                                        Civil Action No. 19-301 (JDB)
 FOOD & DRUG ADMINISTRATION,
 et al.,

          Defendants.

                                 MEMORANDUM OPINION

       The underlying dispute in this case involved plaintiff Vanda Pharmaceuticals, Inc.’s

(“Vanda”) challenge under the Administrative Procedure Act (“APA”) to the Food and Drug

Administration’s (“FDA”) partial clinical hold on Vanda’s human testing of the as-yet unapproved

digestive drug tradipitant. In that litigation, as is required in any action brought under the APA,

the FDA filed an index to the administrative record, and the parties filed a joint appendix

containing copies of the record documents they cited to or relied upon in their briefing. One

volume of the joint appendix was filed under seal with this Court’s permission. The underlying

litigation between Vanda and FDA concluded when this Court granted FDA’s cross-motion for

summary judgment over a year ago, but now non-party law firm Robbins Geller Rudman & Dowd

LLP (“RGRD”) has moved to intervene for the limited purpose of unsealing much of the

administrative record. Both Vanda and FDA oppose unsealing the records, and Vanda also

opposes intervention. For the following reasons, the Court will permit RGRD to intervene and

will partially grant its motion to unseal, while also allowing Vanda to redact or withhold its

proprietary information to avoid any competitive harm from disclosure.

                                                1
                                             Background

        The factual background underlying the dispute between Vanda and FDA is laid out in full

in this Court’s January 2020 decision granting FDA’s cross-motion for summary judgment, see

Vanda Pharms., Inc. v. FDA, 436 F. Supp. 3d 256, 262–63 (D.D.C. 2020), but some recapitulation

is appropriate to provide relevant context here.          In September 2016, Vanda submitted an

Investigational New Drug Application (“IND”) to FDA to begin clinical trials on tradipitant—an

experimental drug that has not yet been approved by FDA—for the treatment of the digestive

disorder gastroparesis. Id. at 262. After conducting a six-month animal toxicity study of the drug

on rats and a three-month study on dogs, Vanda filed an IND to conduct a four-week clinical trial

on human subjects, which FDA granted. Id. In 2018, Vanda proposed extending its four-week

trial by twelve months, but FDA denied that request because the drug had not undergone the

requisite nine-month nonrodent toxicity study to prove to FDA that the drug was safe for long-

term human experimentation. Id. Vanda continued pressing for approval to extend its human trial,

but FDA refused to authorize any human testing in excess of three months and ultimately placed

a partial clinical hold on Vanda’s proposed twelve-month trial. Id. at 263.

        Vanda filed suit under the APA in February 2019, alleging that FDA’s decision to halt

Vanda’s trial lacked “an adequate scientific basis” and impermissibly applied “non-binding . . .

guidance as a binding regulation.” Id. Pursuant to Local Civil Rule 7(n), which governs the

submission of the administrative record in APA cases filed in this District, FDA filed an index

listing all of “the contents of the administrative record” it relied upon in reaching its partial clinical

hold decision. See Local Civ. R. 7(n); Admin. R. Certified Index [ECF No. 38]. After summary

judgment briefing concluded, and again in compliance with Local Civil Rule 7(n), the parties

jointly filed a two-volume appendix “containing copies of those portions of the administrative

                                                    2
record that [they] cited or otherwise relied upon” in their briefs. See Local Civ. R. 7(n). Vanda

submitted a motion to file Volume One of the appendix—“contain[ing] extremely sensitive

proprietary information about tradipitant’s development and therapeutic characteristics”—under

seal, see Pls.’ Sealed Mot. for Leave to File Vol. 1 of the Admin. R. App. Under Seal [ECF No.

42], which the Court granted, see Min. Order (Oct. 16, 2019). Volume Two was filed on the public

docket. See Admin. R. App. [ECF No. 43]. The Court held a hearing on the parties’ cross-motions

for summary judgment and ruled in favor of FDA in January 2020. See Vanda, 436 F. Supp. 3d

at 262–64. Vanda did not timely appeal, and the case was closed.

         Meanwhile, RGRD represents a putative class of Vanda shareholders in a securities-fraud

action in the Eastern District of New York. See Gordon v. Vanda Pharms. Inc., Case No. 1:19-cv-

01108-FB-LB, 2021 WL 911755 (E.D.N.Y. Mar. 10, 2021). Vanda’s motion to dismiss that case

was recently denied in relevant part, advancing the litigation to discovery. See id. at *4. As part

of its representation in that case, RGRD filed a Freedom of Information Act (“FOIA”) request with

FDA in July 2019 for fifteen documents that formed part of the sealed Volume One of the joint

appendix in this case. See Mem. of Law in Supp. of Mot. for Leave to Intervene & Unseal Jud.

Records (“RGRD’s Mot.”) [ECF No. 51-1] at 5. Some sixteen months later, FDA issued a

response refusing to release any of the requested documents, stating it “lacks authority to consider

the releasability” of any records sealed under this Court’s Order. Id. Ex. 4, RGRD’s Mot. [ECF

No. 51-6] at 2. 1

         1
           FDA’s stated interpretation of its FOIA obligations is incorrect. An agency may only withhold sealed
documents from a FOIA requester if it meets its burden to prove that “the seal, like an injunction, prohibits the agency
from disclosing the records.” Judicial Watch, Inc. v. Dep’t of Just., 813 F.3d 380, 383 (D.C. Cir. 2016) (quoting
Morgan v. U.S. Dep’t of Just., 923 F.2d 195, 197 (D.C. Cir. 1991)). If it is unclear from the court’s sealing order
whether it intended to prohibit the agency from disclosing the sealed documents outside of the litigation, the agency
may be required to obtain clarification from the issuing court to meet its burden. Id. at 384 (citing Morgan, 923 F.2d
at 198).

                                                           3
        RGRD then filed the present motion to intervene in this case to unseal fifty-nine documents

from the administrative record “for the benefit of the public interest.” RGRD’s Mot. at 1. The set

of “Challenged Documents” in dispute has since evolved over the course of briefing on the motion.

First, FDA and Vanda pointed out that twenty-seven of the fifty-nine documents RGRD initially

sought to unseal were “listed on the corrected certified index of the administrative record but not

contained in the joint appendix submitted to the Court,” and are therefore not “judicial records”

subject to unsealing. See Defs.’ Opp’n to RGRD’s Mot. to Unseal Jud. Records (“Defs.’ Opp’n”)

[ECF No. 57] at 5 & n.2, 7–8; Vanda’s Opp’n to RGRD’s Mot. for Leave to Intervene & Unseal

Docs. (“Vanda’s Opp’n”) [ECF No. 58] at 11–12. 2 Upon becoming aware of that fact, in its reply

brief RGRD withdrew its motion as to any document “not included in the joint appendix.” Reply

Mem. of Law in Further Supp. of Mot. for Leave to Intervene & Unseal Jud. Records (“Reply”)

[ECF No. 60] at 15.

        In the same reply brief, RGRD also sought to add one more document to the thirty-two

remaining Challenged Documents—namely, the FDA’s “Remand Response,” which appears in

the sealed volume of the joint appendix as Item 82. Id. at 24. Even though FDA and Vanda did

not have an opportunity specifically to oppose unsealing the Remand Response, they conceded

that the thirty-three Challenged Documents listed in RGRD’s initial motion that are included in

the joint appendix are judicial records, and the same logic applies to the Remand Response. See

Defs.’ Opp’n at 7; Vanda’s Opp’n at 12. The Court will thus consider the Remand Response

        2
          The documents identified in RGRD’s motion that do not appear in the joint appendix are items 3–12, 14–
16, 21, 23–25, 28–31, 33, 34, 43, 64, 73, and 78.

                                                       4
among the Challenged Documents in dispute—bringing the total number to thirty-three—for the

sake of judicial efficiency in avoiding further litigation over this single document. 3

        Both Vanda and FDA oppose RGRD’s motion. Vanda asks this Court to reject RGRD’s

request at the gate and deny the motion to intervene as untimely. Vanda’s Opp’n at 1. FDA, for

its part, “take[s] no position on RGRD’s motion to intervene.” Defs.’ Opp’n at 1. But both FDA

and Vanda assert that the balance of interests weighs against unsealing and, in the alternative, that

the Court should permit Vanda to review and redact any documents the Court decides to unseal.

See Vanda’s Opp’n at 23; Defs.’ Opp’n at 12. RGRD agrees that Vanda should have the

opportunity to redact confidential information prior to unsealing. See Reply at 16. RGRD’s

motion has now been fully briefed and is ripe for decision. For the following reasons, the Court

will grant RGRD’s motion to intervene and will grant its motion to unseal with respect to certain

documents. Given Vanda’s commercial interest in the Challenged Documents, however, and with

the apparent consent of RGRD, the Court will permit Vanda to review and redact all documents

prior to their unsealing.

                                       RGRD’s Motion to Intervene

        Before proceeding to the merits of RGRD’s motion to unseal, the Court will address the

dispute over whether RGRD should be permitted to intervene in this matter. Federal Rule of Civil

Procedure 24(b) provides that a district “court may permit anyone to intervene who . . . has a claim

or defense that shares with the main action a common question of law or fact.” Fed. R. Civ. P.

24(b)(1)(B). However, the D.C. Circuit has “eschewed strict readings of the phrase ‘claim or

defense’” and embraced “a flexible reading of Rule 24(b)” when the proposed third-party

        3
           The documents that appear in the joint appendix are items 1, 2, 13, 17–20, 22, 26, 27, 32, 35–42, 65–72,
74–77, 79, and 82. For the purposes of this Memorandum Opinion, these thirty-three documents will be collectively
referred to as the “Challenged Documents.”

                                                        5
intervention does not fit the mold of a non-litigant seeking to stake a claim in an ongoing civil

action. See EEOC v. Nat’l Children’s Ctr., Inc., 146 F.3d 1042, 1046 (D.C. Cir. 1998) (citing

Nuesse v. Camp, 385 F.2d 694, 704 (D.C. Cir. 1967)). Specifically, “third parties may be allowed

to permissively intervene under Rule 24(b) for the limited purpose of seeking access to materials

that have been shielded from public view . . . by seal.” Id. The only statutory requirement for the

court’s exercise of discretion over a motion to permissively intervene is that “the court must

consider whether the intervention will unduly delay or prejudice the adjudication of the original

parties’ rights.” Fed. R. Civ. P. 24(b)(3).

       Where intervention is sought only for a collateral purpose like unsealing documents, the

ordinary requirements for permissive intervention are relaxed.        For one, “[a]n independent

jurisdictional basis is . . . unnecessary when the movant seeks to intervene only for the limited

purpose of obtaining access to documents covered by seal, . . . because the third party does not ask

the court to rule on the merits of a claim or defense.” EEOC, 146 F.3d at 1047. Moreover, “Rule

24(b)’s timeliness requirement,” the purpose of which “is to prevent prejudice in the adjudication

of the rights of the existing parties,” need not apply “when the existing parties have settled their

dispute and intervention is for a collateral purpose.” Id. (quoting United Nuclear Corp. v. Cranford

Ins. Co., 905 F.2d 1424, 1427 (10th Cir. 1990)). Accordingly, there is “consensus among the

courts of appeals that intervention to challenge confidentiality orders may take place long after a

case has been terminated.” Id. (quoting Pansy v. Borough of Stroudsburg, 23 F.3d 772, 779 (3rd

Cir. 1994)). And finally, unlike in an ordinary motion for permissive intervention, “no particularly

strong nexus of fact or law need exist between” the underlying litigation and the case for which

the intervenor is seeking to access the sealed documents. Id. at 1048.

                                                 6
       Vanda advances two arguments against RGRD’s motion to intervene. First, Vanda asserts

that “RGRD’s intervention motion—filed fourteen months after the documents in question were

sealed and ten months after this case was closed . . . —fails the ‘threshold question of timeliness.’”

Vanda’s Opp’n at 5 (quoting United States v. British Am. Tobacco Australia Servs., Ltd., 437 F.3d

1235, 1239 (D.C. Cir. 2006)). But as noted above, that “threshold” is low—to the extent it exists

at all—when a third party only seeks to intervene for the narrow purpose of unsealing judicial

records. See, e.g., EEOC, 146 F.3d at 1047. Not one of the litany of cases Vanda cites in support

of its timeliness argument against intervention arose in the same context as RGRD’s motion.

Indeed, Vanda plainly states that the “key factor” in evaluating the timeliness of a motion to

intervene “is ‘whether any delay in seeking intervention unfairly disadvantage[s] the original

parties.’” Vanda’s Opp’n at 5 (quoting Roane v. Leonhart, 741 F.3d 147, 151 (D.C. Cir. 2014)).

Where, as here, the original parties’ dispute has already been resolved “and intervention is for a

collateral purpose,” that “concern [is] not present.” EEOC, 146 F.3d at 1047 (quoting United

Nuclear Corp., 905 F.2d at 1427).

       Next, Vanda urges the Court to exercise its discretion to reject RGRD’s proposed

intervention “because it is an attempt to shift a discovery dispute in Gordon to this Court.” Vanda’s

Opp’n at 8. Part of Vanda’s argument on this score relies on the automatic stay of discovery in

Gordon pursuant to the Private Securities Litigation Reform Act, which was in effect at the time

RGRD filed its motion. See id. at 9 (citing 15 U.S.C. § 78u-4(b)(3)(B)). That stay was

subsequently lifted when the Gordon court denied in relevant part Vanda’s motion to dismiss on

March 10, 2021, allowing RGRD’s client’s claims to proceed to discovery. See Non-Party

RGRD’s Notice of Supp. Auth. (“Notice of Supp. Auth.”) [ECF No. 62] at 1 & n.2. Accordingly,

the now-lifted stay has no bearing on this Court’s consideration of RGRD’s motion.

                                                  7
       Still, Vanda insists that “RGRD is attempting an end-run around the Gordon court” and

should not be permitted to intervene “to seek records here that it has alternative avenues to obtain”

there. Pls.’ Resp. to Non-Party Law Firm RGRD’s Notice of Supp. Auth. (“Resp. to Notice”)

[ECF No. 63] at 3. But the docket in Gordon does not indicate any ongoing discovery dispute or

restrictions in that case, so permitting intervention here would not be “evad[ing] restrictions on

discovery in” Gordon as Vanda suggests. See Vanda’s Opp’n at 9. Conversely, the cases Vanda

cites against permissive intervention to evade discovery restrictions all involve some material

roadblocks to discovery in parallel lawsuits which are simply not present in this case now that the

stay has been lifted. See, e.g., AT&T Corp. v. Sprint Corp., 407 F.3d 560, 562 (2d Cir. 2005)

(intervention “to circumvent the close of discovery” in a parallel action was improper); United

Nuclear Corp., 905 F.2d at 1428 (“[A] collateral litigant has no right to obtain discovery materials

that are privileged or otherwise immune from eventual involuntary discovery in the collateral

litigation.” (quoting Wilk v. Am. Med. Ass’n, 635 F.2d 1295, 1298 (7th Cir. 1980))). Finally, as

discussed at length below, the meritorious grounds for unsealing cited in RGRD’s motion do not

arise out of its client’s particularized interest in accessing the Challenged Documents for use in

Gordon at all. Even if RGRD is ultimately seeking the Challenged Documents to advance the

interests of the Gordon plaintiffs, its motion asserts the public’s “common law right of access to

judicial records,” which exists independent of RGRD’s representation in Gordon. RGRD’s Mot.

at 10 (citing Nixon v. Warner Commc’ns, 435 U.S. 589, 597–98 (1978)). Hence, the Court will

exercise its discretion to permit intervention in order to reach the merits of whether that public

right favors unsealing.

                                                 8
                       RGRD’s Motion to Unseal the Challenged Documents

          In the federal courts of the United States, “there is a ‘strong presumption in favor of public

access to judicial proceedings” and the records thereof in order to “ensur[e] the integrity of judicial

proceedings in particular and of the law enforcement process more generally.” Metlife, Inc. v.

Fin. Stability Oversight Council, 865 F.3d 661, 665 (D.C. Cir. 2017) (quoting United States v.

Hubbard, 650 F.2d 293, 315, 317 (D.C. Cir. 1980)). However, “the right of public access . . . is

not absolute.” Id. at 663. In United States v. Hubbard, the D.C. Circuit developed a “six-factor

test to balance” the litigants’ interests in sealing documents against the presumption of public

access:

                 [W]hen a court is presented with a motion to seal or unseal, it should weigh: “(1)
                 the need for public access to the documents at issue; (2) the extent of previous
                 public access to the documents; (3) the fact that someone has objected to disclosure,
                 and the identity of that person; (4) the strength of any property and privacy interests
                 asserted; (5) the possibility of prejudice to those opposing disclosure; and (6) the
                 purposes for which the documents were introduced during the judicial
                 proceedings.”

Id. at 665 (quoting EEOC, 98 F.3d at 1409); see also Hubbard, 650 F.2d at 317–22. After

considering these six “Hubbard factors,” a court may only place or keep judicial records under seal

if it “concludes that justice so requires.” Metlife, 865 F.3d at 666 (quoting In re Nat’l Broad. Co.,

653 F.2d 609, 613 (D.C. Cir. 1981)).

   I.        Need for Public Access

          RGRD advances a number of reasons why the Challenged Documents should be publicly

accessible. Only one of those reasons—the inherent public interest in access to judicial records—

is persuasive, and it weighs substantially in favor of unsealing.

          At bottom, “[p]ublic access to judicial records is ‘fundamental to a democratic state’ and

‘serves the important function[] of ensuring the integrity of judicial proceedings.’” Guttenberg v.

                                                    9
Emery, 26 F. Supp. 3d 88, 92 (D.D.C. 2014) (quoting Hubbard, 650 F.2d at 315 & n.79). Indeed,

the “strong public interest in the openness of judicial proceedings . . . exists irrespective of whether

the proceedings at issue relate to disputes among private litigants.” In re McCormick & Co., No.

MC 15-1825 (ESH), 2017 WL 2560911, at *1 (D.D.C. June 13, 2017) (quoting Upshaw v. United

States, 754 F. Supp. 2d 24, 28 (D.D.C. 2010)). Accordingly, “[i]t is not the [party seeking

unsealing’s] burden to proffer a need for public access; the burden is instead the respondent’s to

demonstrate the absence of a need for public access because the law presumes that the public is

entitled to access the contents of judicial proceedings.” United States v. ISS Marine Servs., Inc.,

905 F. Supp. 2d 121, 140–41 (D.D.C. 2012) (citing Hubbard, 650 F.2d at 314–15). The public has

an especially strong interest in reviewing documents “specifically referred to in the trial judge’s

public decision,” Guttenberg, 26 F. Supp. 3d at 94 (quoting Hubbard, 650 F.2d at 318), to further

the public interest in open access “as a check on the judiciary” that bolsters litigants’ “confiden[ce]

that they will be treated fairly and justly,” id. at 92. Reviewing the materials underlying a judge’s

decision enables the public to “understand[] what needs to be pleaded to satisfy the pleading

standard,” or in this case, what evidence needs to be put forward to satisfy the summary judgment

standard. See id. at 93. And in a democracy like ours, it is a “well-established principle that ‘in

cases where the government is a party . . . [t]he appropriateness of making court files accessible’

is enhanced” even further. United States v. Thomas, 840 F. Supp. 2d 1, 4 (D.D.C. 2011) (quoting

Friedman v. Sebelius, 672 F. Supp. 2d 54, 58 (D.D.C. 2009)).

        As RGRD points out, several “of the Challenged Documents were affirmatively relied upon

by this Court, even though they remain sealed.” RGRD’s Mot. at 13 (citing Vanda, 436 F. Supp.

3d at 263–75). 4 Indeed, even though it opposes unsealing the Challenged Documents, “FDA

        4
         The nine Challenged Documents identified as having been cited by the Court are items 19, 20, 39, 66, 68,
70–72, and 82. See RGRD’s Mot. at 4–5; Defs.’ Opp’n at 9, 12 n.4; Reply at 24.

                                                       10
acknowledges . . . D.C. Circuit precedent recogniz[ing] a particular need for public access” to

sealed documents cited in a judicial opinion. See Defs.’ Opp’n at 9 (citing EEOC, 98 F.3d at

1409). At least with respect to the cited documents, then, this factor plainly favors unsealing.

       Although less strongly, the first Hubbard factor also favors unsealing the other Challenged

Documents submitted for the Court’s review in the joint appendix. Those documents also contain

“information with which the parties hope[d] to influence the court.” See Metlife, 865 F.3d at 667.

And the public also has a transparency interest in knowing what record evidence the Court saw fit

to exclude from its explanation of the reasons underlying its ultimate decision. See id. at 668

(“Without access to the sealed materials, it is impossible to know which parts of those materials

persuaded the court and which failed to do so (and why).”).

       The other arguments RGRD advances under the first Hubbard factor are too attenuated

from the public interest in “ensur[ing] the integrity of judicial proceedings” or “the law

enforcement process” to carry any additional persuasive weight, but nor do the private interests

RGRD asserts turn the first Hubbard factor against unsealing as Vanda would have it. See Metlife,

865 F.3d at 665. For one, the interest asserted by RGRD for “Vanda’s investors . . . to understand

how, why, and when Vanda decided not to conduct the required safety study” falls outside of the

public interest in open judicial proceedings. See RGRD’s Mot. at 14. As Vanda points out, there

is “an entire doctrinal framework of private corporate law” governing shareholders’ rights to

inspect a corporation’s books and records. See Vanda’s Opp’n at 14 (citing 8 Del. Code § 220(b)).

Moreover, now that Gordon will advance to discovery, Vanda’s investors that make up the putative

class of plaintiffs there have a separate path to assert their private interest in any documents in

Vanda’s custody and control, including the Challenged Documents. See Vanda’s Opp’n at 15–16.

And as a publicly traded company, Vanda is also required by the federal securities laws to

                                                11
accurately disclose relevant information to the public in order to inform current shareholders,

prospective investors, and other market actors of its business conduct. See 15 U.S.C. § 78m. 5

         At the same time, Vanda misinterprets the contours of the first Hubbard factor when it

asserts that “RGRD’s unsealing request here is completely divorced from any of” the interests

underlying the common-law right of public access. See Vanda’s Opp’n at 14; ISS Marine Servs.,

905 F. Supp. 2d at 140 (party seeking to maintain seal “misunderstands the meaning of the first

factor in arguing” that party seeking unsealing “has proffered no public need for access apart from

a generalized need for inspection” given strong presumption favoring public access). Indeed,

Vanda completely overlooks the fact that this Court cited and discussed at length several of the

Challenged Documents in its summary judgment ruling. Even if RGRD merely “seeks unsealing

for the express purpose of bolstering its client’s claims in private litigation against Vanda,”

Vanda’s Opp’n at 16, that does not undercut the public’s independent interest in accessing

documents relied upon in a published judicial opinion. See, e.g., Upshaw, 754 F. Supp. 2d at 28

(argument that there is no need for public to access court documents “because the case relates

solely to private matters, . . . quite simply[] misconstrues the relevant inquiry and completely

ignores the strong public interest in the openness of judicial proceedings, which exists irrespective

of whether the proceedings at issue relate to disputes among private litigants”).

         Separately, RGRD states “that any person or entity that is contemplating conducting human

clinical trials” would benefit from a review of the sealed correspondence between Vanda and FDA

in order to understand FDA’s prerequisite requirement for long-term nonrodent studies. RGRD’s

Mot. at 14. FDA retorts that “the parties’ unredacted filings and the Court’s opinion describe the

         5
           The Court recognizes the possibility that documents sealed or redacted under this Court’s sealing order may
not be discoverable without further order from this Court, but it is not this Court’s intention to curtail the authority of
the Eastern District of New York to manage discovery in Gordon.

                                                           12
scientific dispute at length” already, and that any presumptive drug-maker “may directly solicit

FDA’s views through normal regulatory channels. Defs.’ Opp’n at 9. The Court agrees with FDA.

The particularized interests of sophisticated pharmaceutical companies that may seek FDA

approval for human clinical trials is significantly narrower than the common-law public right to

access judicial records given the robust regulatory framework in place governing the IND process

and the prohibitions on disclosing data on experimental drugs submitted to FDA prior to approval.

See 21 C.F.R. § 314.430(d)(1). Importantly, though, the presence of FDA regulations prohibiting

public disclosure of IND information “does not displace the common-law right of public access to

judicial records, or the Hubbard test” absent any specific statutory or regulatory language

indicating an intent to do so. See Metlife, 865 F.3d at 674 (rejecting argument that similar statutory

confidentiality provision precludes unsealing of covered documents).

         On the whole, then, the first Hubbard factor strongly favors unsealing the nine Challenged

Documents cited in the Court’s opinion and, to a somewhat lesser extent, favors unsealing the rest

as well.

   II.      Extent of Previous Public Access

         The second Hubbard factor looks to “whether, when and under what conditions the public

has already had access to court records.” Hubbard, 650 F.2d at 318. If members of the public

already have had access to the Challenged Documents, there would presumably be less

justification to keep them under seal. See id. at 318 n.97. However, “the second Hubbard factor

is neutral where there has been no previous access.” Grynberg v. BP P.L.C., 205 F. Supp. 3d 1, 3

(D.D.C. 2016) (quoting Am. Prof’l Agency v. NASW Assurance Servs., 121 F. Supp. 3d 21, 24

(D.D.C. 2013)).

                                                 13
          Claiming this factor in its favor, RGRD asserts that “the sum and substance of the

Challenged Documents has been in the public domain for some time.” RGRD’s Mot. at 14. To

put it mildly, this is an overstatement. The only evidence RGRD cites in support of its factually

unmoored averment is a one-page press release from Vanda’s CEO broadly outlining Vanda’s

lawsuit against FDA and the limited references to the Challenged Documents in this Court’s

summary judgment ruling. See id. “A district court weighing the second factor should consider

the public’s previous access to the sealed information, not its previous access to the information

available in the overall lawsuit.” Cable News Network, Inc. v. FBI, 984 F.3d 114, 119 (D.C. Cir.

2021) (emphasis added). RGRD does not allege that any of the Challenged Documents—beyond

the already publicly available portions quoted in the Court’s published opinion—have ever been

accessible to or accessed by the public. Hence, this factor is neutral.

   III.      Objections to Disclosure

          Both FDA and Vanda oppose unsealing the Challenged Documents. For its part, “RGRD

acknowledges that the parties’ opposition means that the third Hubbard factor does not favor

unsealing.” RGRD’s Mot. at 14. Although this factor weighs somewhat against unsealing, it is

not by itself dispositive. See, e.g., EEOC, 98 F.3d at 1410 (reversing district court’s decision to

seal consent decree when objection to unsealing was only factor weighing in favor of maintaining

seal). And FDA does not assert any special governmental interest that should give its objection

added weight, as would exist, for example, when law enforcement agencies object to unsealing

documents with national security implications. See Cable News Network, 984 F.3d at 119–20.

   IV.       Strength of Property and Privacy Interests in Sealing

          The fourth Hubbard factor corresponds to the exception to public access that “protect[s]

trade secrets” and “business information that might harm a litigant’s competitive standing.”

                                                 14
Hubbard, 650 F.2d at 315 (quoting Nixon, 435 U.S. at 598). Importantly, this factor does not serve

as a blanket excuse to keep the public from accessing entire judicial records—rather, it may justify

only “keep[ing] under seal those documents or portions of documents which would result in an

unwarranted invasion of privacy” or business confidentiality. Id. at 324 (emphasis added).

       Vanda stakes its strongest claim against unsealing the Challenged Documents under this

factor based on its purportedly “very strong property and privacy interests” in the “extremely

sensitive documents containing proprietary information about tradipitant’s development and

therapeutic characteristics.” See Vanda’s Opp’n at 3, 18. For its part, “FDA does not assert any

confidentiality interest . . . independent of Vanda’s,” but acknowledges that “[a] sponsor like

Vanda generally possesses strong privacy interests in IND information.” Defs.’ Opp’n at 11.

       According to Vanda, the Challenged Documents “are comprised of: (1) Vanda’s IND

submissions, attached documents, and related correspondence (Item Nos. 1-35); (2) FDA’s return

correspondence discussing Vanda’s INDs (Item Nos. 36-43); and (3) FDA’s internal scientific

evaluations of the information contained in Vanda’s INDs (Item Nos. 64-81).” Vanda’s Opp’n at

19. All of these categories of documents relate directly to Vanda’s IND submission. As both

Vanda and FDA note, see id. at 20; Defs.’ Opp’n at 3–4, 11, the statutory and regulatory framework

governing the IND process generally prohibits the public disclosure of “data or information

contained in the application . . . before the agency sends an approval letter,” see 21 C.F.R. §

314.430(d)(1); see also 21 U.S.C. § 331(j) (prohibiting public disclosure of information from, inter

alia, an IND application “concerning any method or process which as a trade secret is entitled to

protection”). Likewise, in conducting similar (though not identical) inquiries into withholding

IND materials under FOIA Exemption 4—protecting confidential commercial or financial

information from disclosure, see 5 U.S.C. § 552(b)(4)—the D.C. Circuit has recognized a property

                                                15
interest where “other companies ‘could make use of the information in the INDs in order to

eliminate much of the time and effort that would otherwise be required to bring to market a product

competitive with the product for which’ the submitting company filed the IND.” Judicial Watch,

Inc. v. FDA, 449 F.3d 141, 148–49 (D.C. Cir. 2006) (quoting Pub. Citizen Health Research Grp.

v. FDA, 185 F.3d 898, 905 (D.C. Cir. 1999)). However, “all information in INDs” cannot be

“categorically exempt” from public disclosure absent a particularized interest in keeping protected

information under seal. See id. at 149.

       To be sure, RGRD overstates its case for unsealing when it asserts that “the Challenged

Documents cannot possibly contain confidential business information that could negatively impact

Vanda by . . . disclosing sensitive information to its competitors.” RGRD’s Mot. at 15. But

RGRD’s hyperbolic framing does not relieve “the party seeking to avoid disclosure” from its

burden to “identify specific privacy interests in the documents at issue.” Guttenberg, 26 F. Supp.

3d at 94 (emphasis added). It is insufficient for Vanda to simply “mak[e] broad reference to

‘confidential and sensitive information’” even if the Challenged Documents comprise voluminous

materials. See Friedman, 672 F. Supp. 2d at 60.

       Here, Vanda has provided two examples of documents it claims would “put Vanda at an

unfair competitive disadvantage were [they] made public to pharmaceutical companies developing

their own gastroparesis drugs.” Vanda’s Opp’n at 20. It states that “Item No. 13 . . . consists of

the reports from ten separate toxicology studies of tradipitant in various animals for various

durations, amounting to thousands of pages.” Id. RGRD appears to concede, see Reply at 23, and

the Court agrees, that such reports constitute precisely the type of sensitive business information a

competitor “could make use of.” Moreover, the public interest in Item 13 is somewhat diminished

because it was not affirmatively relied on in the Court’s ruling. But Vanda’s other example, Item

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68, was cited by the Court and contains non-proprietary information about Vanda’s arguments

against conducting long-term nonrodent studies alongside “FDA’s internal evaluation and analysis

of tradipitant’s safety and efficacy results and other underlying data” that could presumably be

redacted to shield trade secrets. See Vanda’s Opp’n at 20; Item 68 [ECF No. 42-5] at 141.

       As for the rest of the Challenged Documents, the descriptions in the Table of Contents to

the sealed volume of the administrative record appendix provide some limited insight into whether,

and to what extent, they consist fully or partially of confidential business information that could

cause Vanda competitive harm. See Admin. R. App. Vol. 1 – Table of Contents [ECF No. 42-1].

For example, documents consisting entirely of clinical studies, protocols, and results are likely to

comprise confidential proprietary data necessitating continued protection under seal. On the other

hand, materials regarding the dispute over Vanda’s human trial proposal, including large portions

of the Remand Response, appear less susceptible to unfair or improper use by competitors.

       This Court “declines to sift through the record to attempt to divine” which documents ought

to be fully or partially redacted, see Friedman, 672 F. Supp. 2d at 60, but it hopes the above

discussion will guide Vanda in making sound and reasonably narrow determinations over which

documents to redact or keep under seal. The Court is cognizant of the administrative burden of

reviewing the thousands of pages of records at issue here, but the D.C. Circuit has expressly held

that “the burden of producing judicial records may not permanently foreclose their unsealing.”

See In re Leopold to Unseal Certain Elec. Surveillance Applications & Orders, 964 F.3d 1121,

1134 (D.C. Cir. 2020). Moreover, removing Item 13 from the equation in its entirety reduces the

page count of the Challenged Documents by more than 4,000.

       In sum, the fourth Hubbard factor weighs strongly in favor of keeping confidential trade

secrets and proprietary information under seal, but more work is required of Vanda to specifically

                                                17
identify which documents or portions thereof among the Challenged Documents—other than Item

13—must be withheld or redacted to protect it from competitive harm. As Vanda appears to

acknowledge, its risk of competitive harm would be mitigated by giving Vanda the “opportunity

to either challenge disclosure” of entire documents “or provide document-by-document redactions

to protect its confidential business information.” Vanda’s Opp’n at 23. And RGRD has agreed

that Vanda should be permitted to redact confidential information prior to unsealing. See Reply

at 16.

    V.      Prejudice

         The fifth Hubbard factor looks to “whether disclosure of the documents will lead to

prejudice in future litigation to the party seeking the seal.” Friedman, 672 F. Supp. 2d at 60. FDA

concedes that “it cannot identify any specific prejudice in future litigation that would result from

unsealing.” Defs.’ Opp’n at 11. Vanda insists that “[t]he D.C. Circuit recently clarified that

prejudice in this context encompasses real-world ‘consequences’ from the publication of

information, not just prejudice that may occur within the litigation itself.” Vanda’s Opp’n at 21

n.11 (citing Cable News Network, 984 F.3d at 120). But the D.C. Circuit’s discussion of the fifth

factor in Cable News Network consists of a single sentence advising district courts simply to

“consider the dire consequences that may occur if an agency discloses its intelligence sources and

methods.” 984 F.3d at 120. That direction is in the uniquely sensitive context of national security

litigation. But even if that sentence were meant to expand the meaning of “prejudice” for the

purposes of the fifth Hubbard factor more generally, Vanda has not identified any prejudice it

would suffer from disclosure apart from the competitive harm discussed at length under factor

four. Importantly, Vanda does not allege that unsealing would prejudice its position in the Gordon

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litigation. Therefore, the fifth Hubbard factor does not move the needle in favor of maintaining

the seal.

    VI.      Purpose of Challenged Documents During Judicial Proceedings

          The sixth Hubbard factor favors disclosure where “the parties explicitly intended the Court

to rely on [the sealed] materials in adjudicating their dispute.” Berliner Corcoran & Rowe LLP v.

Orian, 662 F. Supp. 2d 130, 135 (D.D.C. 2009). The interest in disclosure is especially strong for

documents relevant “to the central claims of the litigation.” Guttenberg, 26 F. Supp. 3d at 96. And

“[w]hen a sealed document is considered as part of judicial decisionmaking, the sixth factor will

oftentimes carry great weight.” Cable News Network, 984 F.3d at 120. At the same time, “when

the sixth factor highlights the fact that a sealed document didn’t affect a judicial decision, it can

be the ‘most important’ element cutting against disclosure.” Id.

          Not surprisingly, given the number and volume of Challenged Documents at issue here,

their significance in the underlying litigation is varied and so, therefore, is the weight of support

for unsealing provided by the sixth Hubbard factor. Obviously, this factor most strongly favors

unsealing the documents the Court cited in its Memorandum Opinion. See RGRD’s Mot. at 24.

Even FDA acknowledges as much, conceding that those documents, including the Remand

Response, are “the most relevant.” Defs.’ Opp’n at 12 & n.4. Vanda does not confront this

conclusion head-on, but rather asserts that the lengthy record documents included in the joint

appendix “were tangential at best” to the litigation. Vanda’s Opp’n at 22. FDA similarly argues

against disclosing “the thousands of pages in the other 24 Appendix Documents” not cited by the

Court, which it maintains were “unnecessary for the disposition of the case.” Defs.’ Opp’n at 12.

Even though, as RGRD notes, the non-cited documents were cited to or relied on in the parties’

summary judgment briefing, the Court is sympathetic to Vanda’s and FDA’s position, and this

                                                  19
APA case involving review of a massive administrative record is distinguishable from the cases

cited by RGRD involving unsealing a more discrete set of substantive exhibits. See, e.g., Berliner,

662 F. Supp. 2d at 132. So while the Court finds that the sixth factor strongly favors disclosing

the documents cited in the Court’s ruling, it only marginally supports unsealing the rest.

   VII.    Balancing the Hubbard Factors

       On balance, the Hubbard factors favor lifting the seal from the Challenged Documents

inasmuch as doing so will not expose Vanda to competitive harm. Most important to the equation

is the “fundamental” common-law right of “[p]ublic access to judicial records,” weighing strongly

in favor of unsealing pursuant to factor one. See Guttenberg, 26 F. Supp. 3d at 92 (quoting

Hubbard, 650 F.2d at 315 & n.79). The fact that the parties submitted the Challenged Documents

into the record “hop[ing] to influence the court” strengthens the public interest in accessing them

to better analyze and understand the Court’s ultimate decision. See Metlife, 865 F.3d at 667. This

public interest is strongest as to those nine documents cited in this Court’s summary judgment

ruling. See EEOC, 98 F.3d at 1409; Upshaw, 754 F. Supp. 2d at 30. Given the Court’s reliance

on those documents, factor six also weighs strongly in favor of unsealing them. See Cable News

Network, 984 F.3d at 120.

       Conversely, factors three and four weigh against lifting the seal. The parties’ objections to

unsealing carry limited weight under factor three and fall well short of outweighing the public

interest in access under factor one. See EEOC, 98 F.3d at 1410. But the stronger consideration

against unsealing stems from Vanda’s interest in shielding its proprietary information from

disclosure to avoid suffering competitive harm. However, that interest—while compelling—can

be served by granting Vanda the opportunity to review and redact the Challenged Documents

before unsealing. Hence, Vanda will be permitted to review and redact these documents prior to

                                                20
their unsealing, with the benefit of this Court’s expressed position on the confidentiality of clinical

trials and related sensitive information regarding still-unapproved tradipitant.

       The Court is not persuaded that RGRD’s ability to obtain some or all of the Challenged

Documents through discovery in Gordon diminishes or undermines the public interest in open

access. See In re McCormick & Co., 2017 WL 2560911, at *1. If anything, the necessity of

Vanda’s document-by-document review of the Challenged Documents pursuant to its discovery

obligations in Gordon reduce the administrative burden of effectuating this Court’s order to unseal

here. Presumably the Gordon plaintiffs will seek all of the Challenged Documents in discovery

anyway, so Vanda’s review for confidential information here need not result in duplicative efforts.

                                             Conclusion

       For the foregoing reasons, the Court will grant RGRD’s motion to intervene, and will grant

its motion to unseal in part. It will deny RGRD’s motion to unseal as to Item 13 and permit Vanda

to review and redact the remaining Challenged Documents prior to their unsealing. A separate

order will issue on this date.

                                                                                    /s/
                                                                              JOHN D. BATES
                                                                         United States District Judge
Dated: May 6, 2021

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