The opinion
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4 UNITED STATES DISTRICT COURT
5 NORTHERN DISTRICT OF CALIFORNIA
6
7 IN RE DEXILANT Case No. 3:25-cv-02785-JSC
(DEXLANSOPRAZOLE) ANTITRUST
8 LITIGATION
ORDER RE: MOTIONS TO SEAL
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Re: Dkt. Nos. 194, 197, 200, 201
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12 Currently pending before the Court are four motions to seal documents related to a motion
13 for sanctions brought by Defendants TWi Pharmaceuticals, Inc. and TWi Pharmaceuticals USA,
14 Inc. (“TWi”). (See Dkt. Nos. 194, 197, 200, and 201.)1
15 LEGAL STANDARD
16 There is a right of public access to judicial records and documents. See Nixon v. Warner
17 Commc’ns, Inc., 435 U.S. 589, 597 (1978). In considering motions to seal, “a strong presumption
18 in favor of access is the starting point.” Kamakana v. City & Cnty. of Honolulu, 447 F.3d 1172,
19 1178 (9th Cir. 2006) (cleaned up). So, parties seeking to seal judicial records relating to motions
20 that are “more than tangentially related to the underlying cause of action,” Ctr. for Auto Safety v.
21 Chrysler Grp., LLC, 809 F.3d 1092, 1099 (9th Cir. 2016), bear the burden of overcoming the
22 presumption of access with “compelling reasons supported by specific factual findings . . . that
23 outweigh the general history of access and the public policies favoring disclosure,” Kamakana,
24 447 F.3d at 1178-79 (cleaned up). However, records attached to “nondispositive motions” which
25 are “not related, or only tangentially related, to the merits of a case,” are not subject to the strong
26 presumption of access and must instead meet a lower “good cause” standard. See Ctr. for Auto
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1 Safety, 809 F.3d at 1098-99.
2 In addition, under Civil Local Rule 79-5, sealing is only permitted when the parties have
3 established “the applicable legal standard and the reasons for keeping a document under seal,
4 including an explanation of: (i) the legitimate private or public interests that warrant sealing; (ii)
5 the injury that will result if sealing is denied; and (iii) why a less restrictive alternative to sealing is
6 not sufficient.” N.D. Cal. Civ. L.R. 79-5(c)(1); see also FTC v. Microsoft Corp., No. 23-cv-
7 02880-JSC, 2023 WL 5186252, at * 2 (N.D. Cal. Aug. 11, 2023) (“[Rule 79-5] supplements the
8 ‘compelling reasons’ standard.”). Civil Local Rule 79-5 also requires the parties to “narrowly
9 tailor[]” their requests only to the sealable material. N.D. Cal. Civ. L.R. at 79-5(c)(3). Thus,
10 although sometimes it may be appropriate to seal a document in its entirety, whenever possible a
11 party must redact. See Kamakana, 447 F.3d at 1183 (noting a preference for redactions so long as
12 they “have the virtue of being limited and clear”).
13 DISCUSSION
14 I. DEFENDANTS’ MOTIONS
15 TWi seeks to seal portions of both its motion for sanctions and the exhibits supporting the
16 motion. (See Dkt. 200 at 1-2.)2 The “compelling reasons” standard applies to these sealing
17 motions. The briefing at issue in these motions is more than tangentially related to the merits of
18 the case for two reasons. First, the briefing involves core merits arguments about whether the
19 challenged settlement agreement caused an antitrust injury. (See Dkt. No 193 at 7-8; Dkt. No. 203
20 at 7 (“The question now is what evidence ‘central to the case’ exists for Plaintiffs to maintain their
21 core allegation. . . .”).) Second, TWi treats it as a dispositive motion. (See Dkt. No 193 at 8
22 (“[S]tanding on their current pleadings is not an option.”); id. (“Plaintiffs should be sanctioned and
23 this case should be brought to an end”); id. at 24 (“Plaintiffs should withdraw their complaint
24 against TWi in their entirety”)); see also Folz v. State Farm Mut. Auto. Ins. Co., 331 F.3d 1122,
25 1136 (9th Cir. 2003) (“[O]nce the sealed discovery documents are made part of a dispositive
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2 TWi filed three motions to file under seal. (See Dkt. Nos. 194, 200, and 201.) Docket No. 200
1 motion [,] e.g., a summary judgment motion ruled upon by the court[,] they lose their status of
2 being raw fruits of discovery.” (cleaned up)). TWi thus appropriately moves for sealing under the
3 “compelling reasons” standard. (See Dkt. 200 at 1-2.)
4 TWi seeks to seal “information concerning TWi’s ANDA product characteristics, testing
5 of the same, and development and efforts to receive FDA approval of the same.” (Dkt. No. 200 at
6 3.) TWi asserts this information is “competitively-sensitive confidential information” that, if
7 released, “would cause TWi substantial competitive harm.” (Id. at 3-4.)
8 A request to seal may be supported by compelling reasons if the documents or portions of
9 documents at issue are “sources of business information that might harm a litigant's competitive
10 standing.” Ctr. for Auto Safety, 809 F.3d at 1097 (citing Nixon, 435 U.S. at 598-99). However,
11 “[a]n unsupported assertion of ‘unfair advantage’ to competitors without explaining how a
12 competitor would use the information to obtain an unfair advantage is insufficient.” Ochoa v.
13 McDonald’s Corp., No. 14–cv–02098–JD, 2015 WL 3545921, at * 1 (N.D. Cal. June 5, 2015)
14 (cleaned up). Moreover, under Civil Local Rule 79–5, sealing is only appropriate where the
15 requesting party has “establishe[d] that the document or portions thereof is privileged or
16 protectable as a trade secret or otherwise entitled to protection under the law.” Civ. L.R. 79–5(b).
17 FDA regulations guide what information surrounding an Abbreviated New Drug
18 Application (“ANDA”) submitted to the agency will be made public. See 21 C.F.R. § 314.430.
19 Most information about an approved product and its application is available to the public absent
20 “extraordinary circumstances.” See id. at § 314.430(e)-(f). However, under § 314.430(g), three
21 types of information can be held back even after an ANDA is approved: (1) “[m]anufacturing
22 methods or processes,” (2) “production, sales distribution, and similar data and information,” and
23 (3) “[q]uanitative or semiquanitative formulas.” Id. at § 314.430(g). Since TWi’s ANDA was
24 approved by the FDA in 2022, (see Dkt. No. 160 at 30), most information from the ANDA is
25 largely already publicly available under the FDA’s disclosure regime.
26 Nevertheless, as TWi points out, some courts have sealed information relating to ANDAs.
27 See, e.g., Citizens Comm’n on Human Rights v. FDA, No. 92-CV-5313, 1993 WL 1610471, at *7
1 the extent it “contain[ed] significant information about how a pioneer drug product is formulated,
2 chemically composed, manufactured, and quality controlled.”); Appleton v. FDA, 451 F.Supp.2d
3 129, 141 (D.D.C. 2006) (granting the withholding of “documents [that] contain information
4 consisting of drug product manufacturing information, including manufacturing processes or drug
5 chemical composition and specifications”). But, the decisions TWi cites relate to pending or
6 rejected applications, not approved ones. See Biovail Lab’ys, Inc. v. Anchen Pharms. Inc., 463 F.
7 Supp.2d 1073, 1084 (C.D. Cal. 2006) (“[S]ince the FDA is now considering Anchen's generic
8 ANDA. . . .”); Spectrum Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2:12–cv–00111–GMN–NJK,
9 2014 WL 3546293, at *1-2 (D. Nev. Jul. 1, 2014) (“[T]he FDA does not disclose the existence of
10 a proposed ANDA product until it has been approved.”); Citizens Comm’n on Human Rights,
11 1993 WL 1610471, at * 10 (“The Court therefore finds that information pertaining to unapproved
12 supplements was properly withheld under Exemption 4 of the FOIA.” (emphasis added)); In re
13 Gabapentin Litigation, 312 F.Supp.2d 653, 667 n.7 (D. N.J. 2004) (citing “21 C.F.R. §
14 314.430(b)-(d),” the portion of FDA regulations pertaining to unapproved ANDAs).
15 Therefore, to the extent that information from the ANDA would be eligible for disclosure
16 under the FDA’s own regulations for approved applications, the Court DENIES the sealing
17 request. However, material—such as formulas or manufacturing processes—that the FDA does
18 not disclose for approved ANDAs can be sealed. With these principles in mind, the Court’s rulings
19 are organized in the below chart:
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Document Dkt. No. Portion(s) Requested Ruling
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TWi’s Motion 200-3 1:21 DENIED. Information has been
22 for Sanctions publicly discussed in the course
of these proceedings.
23 TWi’s Motion 200-3 13:14-15; 14:15-16; 14:23-25; DENIED. Per 21 C.F.R. §
for Sanctions 15:1-2 314.4(e)(7),
24 “all correspondence and written
summaries of oral discussions
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between FDA and the applicant
26 relating to the application” are
available to the public after
27 approval.
the “formulas” or
1
“manufacturing methods or
2 processes” are not automatically
available to the public.
3 Exhibit G 200-4 Highlighted portions of pages GRANTED. Per 21 C.F.R. §
3-6, 9-10 314.4(g), information relating to
4 the “formulas” or
“manufacturing methods or
5
processes” are not automatically
6 available to the public.
Exhibit H 200-5 Highlighted portions of pages GRANTED. Per 21 C.F.R. §
7 of pages 2-18; 21-24 314.4(g), information relating to
the “formulas” or
8 “manufacturing methods or
processes” are not automatically
9
available to the public.
10 Exhibit I 200-6 Entire document GRANTED. Per 21 C.F.R. §
314.4(g), information relating to
11 the “formulas” or
“manufacturing methods or
12
processes” are not automatically
13 available to the public.
Exhibit J 200-7 Highlighted portions of pages GRANTED. Per 21 C.F.R. §
14 2-4, 6, 7 314.4(g), information relating to
the “formulas” or
15 “manufacturing methods or
processes” are not automatically
16
available to the public.
17 Exhibit K 200-8 Highlighted portions of pages GRANTED. Per 21 C.F.R. §
2-7, 9-11 314.4(g), information relating to
18 the “formulas” or
“manufacturing methods or
19 processes” are not automatically
available to the public.
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So, TWi’s motions to file under seal are PARTIALLY GRANTED and PARTIALLY
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DENIED.
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II. PLAINTIFFS’ MOTION
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Plaintiffs seek provisional sealing on documents filed as part of their opposition to TWi’s
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motion for sanctions but designated as “confidential” or “highly confidential” by TWi. (See Dkt.
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No. 197.) Because TWi (“the Designating Party”) and not Plaintiffs (“the Filing Party”) are
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seeking to designate the documents as confidential, the Court reviews the request under Civil
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] Material Should be Sealed.” N.D. Cal. Civ. L.R. 79-5(f). Under LR 79-5(f), “the Designating
2 Party must file a statement and/or declaration” and “[a] failure to file a statement or declaration
3 may result in the unsealing of the provisionally sealed document without further notice to the
4 || Designating Party.” N.D. Cal. Civ. L.R. 79-5(f}(3). TWi filed no such statement. Therefore, the
5 Court DENIES Plaintiffs’ motion because the Designating Party has failed to provide reasons for
6 || keeping the material under seal. See N.D. Cal. Civ. L.R. 79-5(c)(1).
7 So, Plaintiffs’ motion to consider whether another party’s material should be sealed is
8 || DENIED.
9 This Order disposes of Docket Nos. 194, 197, 200, 201.
10 IT IS SO ORDERED.
11 Dated: September 8, 2026
nm
a ACQUELINE SCOTT CORLE
14 United States District Judge
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