Court Opinion

ID: 4571261
Source: CourtListenerOpinion
Date Created: 2020-09-30 17:00:56.742842+00
Date Added: 2024-06-11T13:30:10.154900
License: Public Domain

UNITED STATES DISTRICT COURT
                              FOR THE DISTRICT OF COLUMBIA

 JUBILANT DRAXIMAGE INC.,

                Plaintiff,

        v.
                                                     Civil Action No. 19-1494 (RDM)
 UNITED STATES INTERNATIONAL
 TRADE COMMISSION,

                Defendant.

                             MEMORANDUM OPINION AND ORDER

       Plaintiff Jubilant DraxImage Inc. (“JDI”) is one of only two companies that manufacture

medical devices used for Cardiac Positron Emission Tomography, a noninvasive imaging

procedure that helps doctors evaluate patients for coronary artery disease. JDI’s competitor,

Bracco Diagnostics Inc. (“Bracco”), previously held a monopoly in the production of these

devices and has engaged in a long-running effort to exclude JDI, which is based in Canada, from

the U.S. market. During the pendency of proceedings before the United States International

Trade Commission (the “Commission”) to determine whether JDI’s products infringe Bracco’s

patents, the Commission ordered JDI to disclose publicly portions of its brief, which JDI had

redacted. JDI objected to making public parts of its brief that cite or reference Bracco’s patents

based on a concern that Bracco could use JDI’s references to specific portions of Bracco’s

lengthy patent claims, which are public, to infer the manner in which JDI has attempted to

engineer around Bracco’s patents, which is not public. Although JDI has now prevailed before

the Commission on the merits of the patent claims, the dispute over the redactions continues.

                                                 1
       The Court granted JDI’s previous motion for a preliminary injunction on the ground that

the Commission’s initial order was internally inconsistent, with no coherent basis for which

redactions it approved and which it rejected. Jubilant Draximage Inc. v. U.S. ITC, 396 F. Supp.

3d 113 (D.D.C. 2019) (“Jubilant I”). On voluntary remand, the Commission resolved those

inconsistencies by requiring JDI to disclose all of the references or citations to specific portions

of Bracco’s patent claims, although the Commission did not require disclosure of direct

references to JDI’s own, confidential design features. JDI now seeks a second preliminary

injunction, this time to prevent the Commission from enforcing the disclosure order entered on

remand. As explained below, JDI has not shown that it is entitled to preliminary relief.

       The Court will, accordingly, DENY JDI’s motion for a preliminary injunction.

                                       I. BACKGROUND

       The Court’s prior opinion—granting JDI’s first motion for a preliminary injunction—

detailed the litigation’s origins. Jubilant I, 396 F. Supp. 3d at 117–19. The Court repeats and

expands upon the key facts here insofar as they are relevant to the current motion. Based in

Canada, JDI is a radiopharmaceutical company, which means that it makes medicines and

medical devices that utilize nuclear technology. Dkt. 18 at 4–5 (Amd. Compl. ¶ 12). Among

JDI’s products is the RUBY, a Rubidium Elution System that generates rubidium-82 chloride,

“which is used for Cardiac Positron Emission Tomography (‘PET’), a non-invasive imaging

procedure . . . to evaluate regional myocardial perfusion in adult patients with suspected or

existing coronary artery disease.” Id. at 6 (Amd. Compl. ¶ 16). In layman’s terms, the RUBY is

a medical device that produces a substance used in PET scans of the heart.

       For many years, JDI’s competitor, Bracco, was the only supplier of such devices to the

U.S. market. Id. at 10 (Amd. Compl. ¶ 26). Then in 2007, JDI licensed technology, developed

                                                  2
at the Ottawa Heart Institute, for what it believed would be a superior product to Bracco’s, a

computerized model that could deliver both better performance and increased safety. Id. at 7–10

(Amd. Compl. ¶¶ 19–24). Thus began JDI’s long-running effort to turn Bracco’s monopoly into

a duopoly. After nine years developing a rubidium-82 elution system based on the Ottawa Heart

technology, JDI obtained approval from the Food and Drug Administration (“FDA”) in 2016 to

market the RUBY Version 3 in the United States and began doing so the following year. Id. at 9

(Amd. Compl. ¶¶ 22–23).

       Not to be outdone, Bracco began developing a successor computerized design that it

called the “Next-Gen.” Id. at 10 (Amd. Compl. ¶ 27). In 2008, just one year after JDI licensed

the Ottawa Heart technology, Bracco filed a patent application for the Next-Gen design. Id.

Although Bracco’s Next-Gen product has not obtained regulatory approval or gone to market,

the 2008 patent gained strategic importance.

       JDI alleges that when the FDA announced its approval of the RUBY Version 3 in 2016,

Bracco submitted a Freedom of Information Act (“FOIA”) request to the FDA and thereby

acquired a RUBY product manual from the agency. Id. at 11 (Amd. Compl. ¶ 29). Bracco then

used that information to draft and file three continuation patent applications that claimed the

technology found in the RUBY Version 3. Id. Bracco’s continuation patents, although copied

from JDI’s product, could claim priority based on Bracco’s earlier patent from 2008. Id. Sure

enough, as soon as the continuation patents issued, Bracco filed a complaint with the

Commission alleging that the RUBY Version 3 infringed Bracco’s three patents and asserting

violations of Section 337 of the Tariff Act of 1930. Id. (Amd. Compl. ¶ 30). The Commission

instituted an investigation in May 2018. Id.

                                                 3
       JDI made the next move. In response to Bracco’s complaint with the Commission, JDI

developed two new versions of the RUBY—Versions 3.1 and 4—that were “specifically

designed to avoid infringement of the three Bracco patents asserted in the investigation.” Id. at

12 (Amd. Compl. ¶ 32). And in a preemptive strike, JDI then filed a motion for summary

determination—the equivalent of a motion for summary judgment—in the underlying

Commission proceeding, seeking a ruling that the redesigned RUBY Versions 3.1 and 4 did not

infringe Bracco’s patents. Id. at 13 (Amd. Compl. ¶ 36); see also Dkt. 21-6 (Ex. F).

       The public version of JDI’s motion was heavily redacted. Id. The Commission’s

regulations permit parties to redact portions of their filings that would reveal confidential

business information. The Commission’s rules define “[c]onfidential business information” as:

       [1] information which concerns or relates to the trade secrets, processes,
       operations, style of works, or apparatus, or to the production, sales, shipments,
       purchases, transfers, identification of customers, inventories, or amount or
       source of any income, profits, losses, or expenditures of any person, firm,
       partnership, corporation, or other organization, or other information of
       commercial value, [2] the disclosure of which is likely to have the effect of either
       impairing the Commission’s ability to obtain such information as is necessary to
       perform its statutory functions, or causing substantial harm to the competitive
       position of the person, firm, partnership, corporation, or other organization from
       which the information was obtained . . . .

19 C.F.R. § 201.6(a)(1). The Commission applies this Rule in a two-part test that mirrors the

language of the Rule itself: first asking whether the proposed redactions concern or relate to

trade secrets or other sensitive commercial information, and, second asking whether disclosure

would either harm the Commission’s ability to obtain such information from parties in the future

or cause substantial harm to the competitive position of the disclosing entity. See Certain

Network Devices, Related Software & Components Thereof, Inv. No. 337-TA-944, Comm’n

Declassification Op., 2017 WL 11261370, at *4 (Apr. 19, 2017). The Commission’s

confidential business information (“CBI”) Rule implements a provision of the Tariff Act, which

                                                  4
prohibits the disclosure of information that is properly redacted pursuant to the Commission’s

regulations. The statute provides in relevant part:

       Information submitted to the Commission or exchanged among the parties in
       connection with [Section 337] proceedings . . . which is properly designated as
       confidential pursuant to Commission rules may not be disclosed . . . to any
       person . . . without the consent of the person submitting it.

19 U.S.C. § 1337(n)(1).

       Throughout its motion for summary determination, JDI redacted direct references to its

trade secret designs of Versions 3.1 and 4. Dkt. 21-6 (Ex. F). No one contests that those

redactions were proper, and the Commission affirmed the propriety of those redactions on

remand. JDI also designated for redaction references or citations to specific elements of

Bracco’s patent claims. Id. Bracco’s patents are publicly available. But the infringement

analysis in JDI’s motion made direct comparisons between Bracco’s patent claims and the

designs of RUBY Versions 3.1 and 4, including by adding bold and italic emphases to portions

of Bracco’s patent claims that JDI argued its designs did not match. Dkt. 18 at 13 (Amd. Compl.

¶¶ 38–39). JDI therefore feared that a savvy reader—and, presumably, Bracco in particular—

could infer or ascertain aspects of JDI’s trade secret designs based on how JDI distinguished its

proposed products from elements of Bracco’s patent claims. Dkt. 18 at 13–14 (Amd. Compl.

¶¶ 40–41). Put differently, a reader could deduce what RUBY Versions 3.1 and 4 are, based on

what JDI argued they are not. JDI worried that Bracco might use “the specific claim limitations

that JDI has designed out of its products” to amend its still-pending patent applications or file

new continuation applications aimed at excluding RUBY Versions 3.1 and 4 from the market.

Id. at 14 (Amd. Compl. ¶ 41). JDI therefore “designated for redaction the portions of its motion

that discussed, quoted, and/or emphasized the specific claim elements that no longer mapped to

                                                 5
its Version 3.1 and Version 4 systems in the proposed public version” of its brief. Id. at 13

(Amd. Compl. ¶ 40).

        The Commission’s investigative staff filed a motion challenging JDI’s redactions of the

references to Bracco’s patents. Dkt. 4-1 (Confidential Ex. A). The staff argued that “passages

quoting from patents or descriptions of the scope of patents and claims do not fall within the

Commission’s definition of confidential business information.” Id. at 4. JDI opposed the

motion, arguing that the public release of “the passages that Staff seeks to reclassify . . . would

make obvious the specific redesigned features of the Version 3.1 and Version 4 systems.” Dkt.

4-2 at 4 (Confidential Ex. B). As an example, JDI noted that one claim limitation involved “a

binary design option,” and it would therefore be “obvious to anyone reading” that if JDI’s design

did not make the same choice as Bracco’s patent, it must have made the only other possible

choice. Id. at 11. To use a simple analogy, if a product could be only blue or red, saying that a

design is not red is the same as saying that it is blue.

        On March 21, 2019, a Commission Administrative Law Judge (“ALJ”) issued Order No.

31, “Initial Determination Granting-in-Part Commission Investigative Staff’s Motion to

Declassify Portions of Respondents’ Motion for Summary Determination.” Dkt. 4-3

(Confidential Ex. C). Applying the Commission’s two-part test for determining whether

proposed redactions fit the definition of “confidential business information” under 19 C.F.R.

§ 201.6(a)(1), the ALJ addressed JDI’s claim that “portions of its motion that merely recite text

and figures from the asserted patents should be given the same protection as the details of its

products” on the ground that “by identifying specific claim limitations that are not practiced by

[JDI]’s revised products, a reader may deduce the operation of those products.” Dkt. 4-3 at 4.

                                                   6
        First, the ALJ determined that the redactions of public patent language with respect to

Version 3.1 were proper. Id. at 4–5. Because those redactions concerned an either/or “binary

design decision,” the ALJ agreed that declassification “would reveal a confidential design feature

of [JDI]’s product.” Id. But the ALJ rejected JDI’s proposed redactions of public patent

language as it related to Version 4. Id. at 5–6. With respect to those redactions, the ALJ

determined that “it is not true, as a factual matter, that a reader can deduce the configuration of

[JDI’s] product from [those specific Bracco patent claim] statements” because “[m]ultiple

possibilities exist . . . that avoid[ ] the limitation in question.” Id. at 5–6. The ALJ, accordingly,

concluded that specific references to Bracco’s patents related to RUBY Version 4 “do not

constitute [JDI’s] confidential business information” and ordered JDI “to file a replacement

public version of its motion for summary determination with the improper redactions removed.”

Id. at 6.

        JDI appealed to the Commission. Dkt. 4-4 (Confidential Ex. D). Arguing that the ALJ’s

focus on whether the specific design choices “involve[d] a binary, either-one-or-the-other choice

. . . misses the point,” JDI stressed “that early identification of the emphasized claim limitations

will reveal to Bracco the specific limitations that [JDI’s] Version 4 products omit, which would

allow Bracco to file new applications containing claims that simply omit the designed-around

limitations.” Id. at 15. On May 6, 2019, the Commission issued a Notice of Commission

Decision to Review in Part an Initial Determination Granting-in-Part a Motion to Declassify.

Dkt. 1-1 (Compl. Ex. A). In a single sentence, the Commission announced its decision to review

in part the ALJ’s order and to affirm with one slight modification—adding one redaction to a

section heading. Id. at 3. The Commission did not specify which portions of the ALJ’s decision

it did or did not review. Id.

                                                  7
       The Commission stayed its determination to provide JDI time to seek judicial review. Id.

JDI filed this lawsuit on May 22, 2019, asserting claims under the Administrative Procedure Act

(“APA”), 5 U.S.C. § 701 et seq. Dkt. 1. JDI also sought a preliminary injunction, Dkt. 3, and,

on July 10, 2019, the Court granted that motion, Jubilant I, 396 F. Supp. 3d at 126. The Court

noted that JDI raised a “host” of APA challenges to the Commission’s decision to permit

redaction of Bracco patent claim elements relating to the “binary” design choices of Version 3.1

but not elements concerning the “non-binary” possibilities of Version 4. Id. at 120. The Court

focused on just one contention—that the Commission’s decisions were internally inconsistent,

rendering the agency’s action arbitrary and capricious under 5 U.S.C. § 706(2)(A). Id. at 121.

As the Court observed, “on multiple occasions, the Commission reached inconsistent results as

to identical or equivalent language.” Id. JDI was likely to succeed on the merits of that claim,

the Court concluded, because “the specific redactions proposed by the Commission are internally

inconsistent and run counter to the reasons given by the agency.” Id. at 123.

       As for irreparable harm, the Court determined that, by permitting JDI to redact Bracco’s

patent information related to Version 3.1, the Commission had conceded that, at least in some

instances, publicly available patent claims could constitute CBI under the Commission’s rules—

a determination that included, by definition, a finding of potential harm. Id. at 124 (observing

that “the Commission has already conceded its core premise”). Because permitting the

Commission to release the disputed material at the outset of the litigation would destroy the very

right that JDI sought to protect, the Court had “little trouble concluding that the injury would be

irreparable.” Id. at 125. Finally, the Court also found that the balance of equities and the public

interest tipped in JDI’s favor. Id. at 125–26. The Court, accordingly, enjoined the Commission

                                                 8
from disclosing any portion of JDI’s motion for summary determination. Id. at 126. On July 25,

2019, the Court granted the Commission’s motion for voluntary remand. Dkt. 17.

       In parallel with the dispute over redactions, JDI prevailed on the merits in the

Commission proceedings as to all three of its designs. On February 8, 2019, the ALJ issued an

initial determination that RUBY Version 3 infringed Bracco’s patents but also held that neither

Version 3.1 nor Version 4 infringed the patents. See Dkt. 12-2 at 3 (Ex. 2). The Commission

declined to review that decision. Id. Then, on August 1, 2019, after the Court had remanded the

redaction question, the ALJ ruled in favor of JDI on Bracco’s challenge to RUBY Version 3 as

well, and on December 11, 2019, the Commission affirmed. Dkt. 27-3 (Ex. B). The

Commission determined that the disputed claims in Bracco’s three continuation patents were

invalid because they were obvious given the Ottawa Heart technology. Id. at 12–13. That

decision is on appeal to the Federal Circuit. 1 See Bracco Diagnostics Inc. v. ITC, No. 20-1358

(Fed. Cir.). At least for now, JDI has won before the Commission across the board.

       On remand from this Court, the Commission sought further briefing from the parties and

on March 6, 2020 issued a “declassification” opinion in which it devoted far more than one

sentence to the propriety of JDI’s proposed redactions. Dkt. 21-5 (Ex. E). To JDI’s detriment,

the Commission resolved the inconsistencies in its previous decision by declassifying all

quotations from or references to public patent language, regardless whether the information

related to Version 3.1 or Version 4, along with any “bare legal conclusions of infringement or

1
  In parallel litigation, JDI filed petitions for inter partes review with the United States Patent
and Trademark Office, challenging Bracco’s three continuation patents. On February 6, 2020, in
three lengthy written decisions, the Patent Trial and Appeal Board held the disputed claims in all
three patents invalid. See Jubilant DraxImage Inc. v. Bracco Diagnostics Inc., Nos. IPR 2018-
01448, IPR 2018-01449, IPR 2018-01450 (P.T.A.B. Feb. 6, 2020). Bracco has appealed those
decisions to the Federal Circuit as well. See Bracco Diagnostics Inc. v. Jubilant DraxImage Inc.,
No. 20-1696 (Fed. Cir.).
                                                9
non-infringement” comparing JDI’s products to Bracco’s patents. Id. at 2. The Commission

also clarified that it had not reviewed the ALJ’s “binary distinction” in its previous ruling, id. at

2, and now rejected it as “inconsistent with the present determination as well as with other

Commission and district court precedent,” id. at 8.

       To determine whether JDI’s proposed redactions met the definition of “confidential

business information” in Rule 201.6, the Commission applied its two-part test. Id. at 6–7. Both

prongs must be satisfied for information to qualify as CBI under the regulation. The

Commission concluded that “public patent information and bare legal conclusions of

infringement or non-infringement do not satisfy the definition of ‘confidential business

information’ under Commission Rule 201.6.” Id. at 7.

       First, the Commission asked whether the information at issue is “information which

concerns or relates to . . . trade secrets . . . or other information of commercial value.” Id. at 6–7

(internal quotations and citations omitted). The Commission rejected JDI’s broad reading of

“concerns or relates to” in Rule 201.6 as “quite literally, unprecedented.” Id. at 10. The

Commission found it “highly probative” that JDI could point to no administrative or judicial

precedent “that has accepted a theory in which patent claim language can be redacted as

protected CBI.” Id. at 9–10. Relying on its own precedents, citations to district court opinions,

and references to the redaction practices of the Federal Circuit, the Commission concluded that

“[p]ublic information is not transformed into CBI simply because it coincides with a feature of

[JDI’s] Version 3.1 and Version 4 products.” Id. at 9–12.

       Likewise, the Commission rejected the premise that bare legal conclusions constitute

confidential business information. “We disagree with [JDI]’s argument that the absence of

claimed features can be CBI . . . .” Id. at 10. The Commission reasoned that JDI’s competitors

                                                  10
could just as easily infer aspects of its product designs from public information, including

Bracco’s patents and the Ottawa Heart designs, as from the references to public information in its

brief. Id. at 10–11. The references that JDI sought to redact were “nothing more than the typical

analysis performed by parties in patent litigation; it does not reveal information that is

proprietary, confidential, or worthy of trade secret protection.” Id. at 12.

       Second, the Commission asked whether “the disclosure of such information [is] likely to

have the effect of either (1) impairing the Commission’s ability to obtain such information as is

necessary to perform its statutory functions, or (2) causing substantial harm to the competitive

position of the person, firm, partnership, corporation, or other organization from which the

information was obtained.” Id. at 7 (internal quotations and citations omitted). The Commission

addressed JDI’s argument that “Bracco can use the non-infringement contentions to draft claims

that read on [JDI]’s Version 3[.1] and Version 4 products and then initiate patent litigation based

on such claims.” Id. at 13. But the Commission found that this theory of harm was

“speculative,” especially given the Commission’s holding that Bracco’s contested patent claims

were invalid based on prior art. Id.

       The Commission therefore ordered declassified all references to Bracco’s patent claims

in JDI’s brief. Id. at 17. But it again affirmed the redaction of direct references to the designs of

JDI’s Versions 3.1 and 4. Id. On March 19, 2020, JDI returned to this Court, filing an amended

complaint alleging that the Commission’s remand decision violated the APA. Dkt. 18. On April

17, JDI filed a second motion for preliminary injunction. Dkt. 24. The motion is now fully

briefed and ripe for decision.

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                                           II. ANALYSIS

        “A preliminary injunction is an extraordinary remedy never awarded as of right,” Winter

v. Nat. Res. Def. Council, 555 U.S. 7, 24 (2008), but “only when the party seeking the relief, by a

clear showing, carries the burden of persuasion,” Cobell v. Norton, 391 F.3d 251, 258 (D.C. Cir.

2004). To secure a preliminary injunction, a plaintiff “must establish [1] that he is likely to

succeed on the merits, [2] that he is likely to suffer irreparable harm in the absence of

preliminary relief, [3] that the balance of equities tips in his favor, and [4] that an injunction is in

the public interest.” Winter, 555 U.S. at 20. The first factor is the “most important.” Aamer v.

Obama, 742 F.3d 1023, 1038 (D.C. Cir. 2014). “The last two factors,” moreover, “‘merge when

the Government is the opposing party.’” Guedes v. Bureau of Alcohol, Tobacco, Firearms &

Explosives, 920 F.3d 1, 10 (D.C. Cir. 2019) (quoting Nken v. Holder, 556 U.S. 418, 435 (2009)).

        Before the Supreme Court’s decision in Winter, the D.C. Circuit applied a “sliding-scale”

approach to the preliminary injunction analysis under which “a strong showing on one factor

could make up for a weaker showing on another.” Sherley v. Sebelius, 644 F.3d 388, 392 (D.C.

Cir. 2011). Since Winter, however, the court of appeals has hinted on several occasions ‘“that a

likelihood of success is an independent, free-standing requirement for a preliminary injunction.’”

Id. at 393 (quoting Davis v. Pension Benefit Guar. Corp., 571 F.3d 1288, 1296 (D.C. Cir. 2009)

(Kavanaugh, J., concurring)); see also Archdiocese of Wash. v. Wash. Metro. Area Transit Auth.,

897 F.3d 314, 334 (D.C. Cir. 2018) (observing that Winter may be “properly read to suggest a

‘sliding scale’ approach to weighing the four factors be abandoned”). But it has repeatedly

declined to decide the issue. See, e.g., League of Women Voters of U.S. v. Newby, 838 F.3d 1, 7

(D.C. Cir. 2016); see also Am. Meat Inst. v. U.S. Dep’t of Agric., 746 F.3d 1065, 1074 (D.C. Cir.

                                                   12
2014), reinstated in relevant part by 760 F.3d 18 (D.C. Cir. 2014) (en banc); Sherley,

644 F.3d at 393.

       As explained below, the Court concludes that each of the four factors weighs against

granting JDI’s motion for a preliminary injunction.

A.     Likelihood of Success on the Merits

       In its previous opinion, the Court concluded that JDI was likely to succeed on the merits

because the Commission’s prior decision did not apply a consistent rule or reach consistent

results in its treatment of like requests for redactions. Jubilant I, 396 F. Supp. 3d at 121–22. On

remand, the Commission eliminated those inconsistencies by uniformly rejecting all of JDI’s

proposed redactions of citations to and quotations from Bracco’s patents. Dkt. 18-1 (Ex. 1); Dkt.

21-5 (Ex. E). No longer able to attack the Commission’s decision on the ground of

inconsistency, JDI now presses a variety of other APA claims, both procedural and substantive.

Dkt. 24-1 at 18–31.

       Most substantially, JDI argues that the Commission’s determination that JDI’s proposed

redactions did not satisfy the definition of CBI in Rule 201.6 is arbitrary and capricious in

violation of the APA. Id. at 21–29. JDI correctly reads federal law as imposing on the

Commission a “non-discretionary duty not to disclose information” that is designated as

confidential under the Commission’s regulations. Id. at 17; see 19 U.S.C. § 1337(n)

(“Information submitted to the Commission . . . which is properly designated as confidential

pursuant to Commission rules may not be disclosed . . . .”). According to JDI, moreover, all of

its proposed redactions come within the plain meaning of the Commission’s definition of CBI—

both as to whether its references to Bracco’s patents relate to its trade secrets and whether

disclosure of those references is likely to cause substantial harm to its competitive position. Dkt.

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24-1 at 5, 17, 21–29 (citing 19 C.F.R. § 201.6(a)(1)). On the first prong, JDI argues that the

Commission’s myopic focus on the public nature of Bracco’s patent language prevented it from

adequately considering whether that language, when read in context, would give away JDI’s

trade secret designs of RUBY Versions 3.1 and 4. Id. at 23. As to the second prong, whether

disclosure is likely to cause substantial harm to its competitive position, JDI asserts that “[i]f the

[Commission] were to disclose the specific claim limitations that JDI applied to its new designs

to avoid Bracco’s copied claims, Bracco likely would . . . draft new claims using [Commission]-

published information as a blueprint, and restart new litigation against JDI’s redesigned

systems.” Id. at 27. For those reasons, JDI contends that the Commission’s action was arbitrary

and capricious under 5 U.S.C. § 706(2)(a). Id. at 19.

        1.      Likelihood that Disclosure Will Cause Substantial Competitive Harm

        In its briefs, JDI focused most of its fire on the Commission’s determination, at the first

step of the Rule 201.6 test, that public patent information does not become CBI even when that

public information, when read in context, might reveal aspects of a firm’s secret product designs.

See Dkt. 21-5 at 9–12 (Ex. E); Dkt. 24-1 at 21–25. But, as explained above, to qualify as CBI

under Rule 201.6, a party’s proposed redactions must satisfy both prongs of the test. See

Network Devices, 2017 WL 11261370, at *4. In order to demonstrate a likelihood of success on

the merits, therefore, JDI must show that the Commission’s reasoning was arbitrary and

capricious as to both prongs. And conversely, if the Commission’s decision was reasonable in

concluding that JDI’s proposed redactions failed to satisfy either prong, the decision must be

upheld. Because the analysis is more straightforward with respect to the second leg of the test—

which requires that “disclosure . . . is likely to have the effect of . . . causing substantial harm to

                                                   14
[JDI’s] competitive position,” 19 C.F.R. § 201.6(a)(1)—the Court will begin its review of the

Commission’s decision with the question of JDI’s likelihood of suffering substantial harm.

       The APA requires “reasoned decisionmaking.” Motor Vehicle Mfrs. Ass’n v. State Farm

Mut. Auto. Ins. Co., 463 U.S. 29, 52 (1983). The Court must, accordingly, assess whether the

agency considered “the relevant factors and whether there has been a clear error of judgment.”

Id. at 43 (quotation marks omitted); see also Judulang v. Holder, 565 U.S. 42, 53 (2011). “The

scope of review under the ‘arbitrary and capricious’ standard,” however, “is narrow,” and the

Court must not “substitute its judgment for that of the agency.” State Farm, 463 U.S. at 43.

Rather, the Court must “presume[] the validity of agency action.” AT&T Corp. v. FCC, 349 F.3d

692, 698 (D.C. Cir. 2003). All that the APA requires is that “the process by which [an agency]

reaches [its] result [is] logical and rational.” Allentown Mack Sales & Serv., Inc. v. NLRB, 522

U.S. 359, 374 (1998). The Court must uphold the Commission’s action so long as it “considered

the relevant factors and articulated a rational connection between the facts found and the choice

made.” Nat’l Ass’n of Clean Air Agencies v. EPA, 489 F.3d 1221, 1228 (D.C. Cir. 2007)

(quotation marks omitted).

       By this deferential standard, the Commission’s decision was lawful. With respect to

harm, the Commission addressed two arguments from JDI that disclosure would injure its

competitive position. Dkt. 21-5 at 13 (Ex. E). First, the Commission considered JDI’s primary

argument that “Bracco can use the non-infringement contentions to draft claims that read on

[JDI]’s Version 3[.1] and Version 4 products and then initiate patent litigation based on such

claims.” Id. (citing Dkt. 21-1 at 10–11 (Ex. A)). The Commission also acknowledged JDI’s

alternative argument that disclosure would permit other firms to “develop competitive strategies

                                                15
against the new designs earlier than they otherwise would be able to.” Id. (quotation marks

omitted) (citing Dkt. 21-1 at 11 (Ex. A)).

       The Commission rejected these arguments for several reasons. First, the Commission

reasoned that JDI’s theory of harm was “speculative,” especially given that the Commission had

found Bracco’s patent claims invalid as obvious based on prior art. Id. JDI’s brief before the

Commission had argued that Bracco might “use the motion’s discussion of the elements to draft

new patent claims in continuation applications to cover the redesigned systems, which could

include simply eliminating the specific claim limitations that JDI designed around.” Dkt. 21-1 at

11 (Ex. A). The Commission found this unpersuasive. If Bracco could have patented claims

with broader scope, the Commission reasoned, it would have done so already, regardless of what

it might learn about JDI’s designs. Dkt. 21-5 at 13–14 (Ex. E). More to the point, because

Bracco’s narrower patent claims were found invalid as obvious, the Commission concluded that

it is unlikely that any broader—and therefore even more obvious—claims would be patentable.

Id. The Commission thus determined that “it is speculative to assume either that Bracco can or

will amend its claims at all, much less that it will do so as a result of the specific disclosures

here.” Id. at 14. Additionally, the Commission observed that JDI’s alleged harm was simply

permissible competitive activity on the part of Bracco. Id. at 14 n.12 (citing Kingsdown Med.

Consultants, Ltd. v. Hollister Inc., 863 F.2d 867, 874 (Fed. Cir. 1988) (“[T]here is nothing

improper, illegal or inequitable in filing a patent application for the purpose of obtaining a right

to exclude a known competitor’s product from the market[.]”)). Finally, the Commission noted

that, because JDI itself filed the motion for summary determination as to Versions 3.1 and 4, JDI

“should have reasonably expected that it would be required to disclose its non-infringement

contentions on a claim element-by-element basis.” Id. at 14–15.

                                                  16
       In its preliminary injunction motion, JDI repeats its argument that disclosure of the public

patent claims and non-infringement contentions it sought to redact would cause competitive

harm because revealing that information would increase the risk of Bracco initiating further

patent litigation. Dkt. 24-1 at 27. Bracco has crafted continuation patents based on JDI’s

designs once before, and “[i]f the [Commission] were to disclose the specific claim limitations

that JDI applied to its new designs to avoid Bracco’s copied claims, Bracco likely would employ

th[at] tactic again, draft[ing] new claims using [Commission]-published information as a

blueprint, and restart[ing] new litigation against JDI’s redesigned systems.” Id. To explain why

this theory of harm is not unprecedented, JDI draws an analogy to patent prosecution bars, which

prevent lawyers who gain access to another party’s confidential product designs in patent

litigation from prosecuting patent claims in a related field. Id. at 26. In JDI’s telling, the

existence of such bars shows that “the risk of harm in the current case is routinely recognized.”

Id. at 27. JDI also objects to the Commission’s statement that JDI’s alleged harm is just

permissible competitive activity by Bracco. Id. at 28. Although “it certainly is permissible for

companies to draft patent claims against their competitors’ products using publicly available

information,” JDI argues that does not support the Commission disclosing “non-public, properly

designated, confidential business information.” Id. Likewise, JDI contends that the Commission

erred in holding that JDI brought disclosure on itself by seeking summary determination as to

Versions 3.1 and 4, because JDI filed its motion with the Commission on the understanding that

its CBI would be protected. Id. at 28–29.

       Although the Court may not agree with every point in the Commission’s analysis, the

Commission reasonably concluded that JDI’s theory of harm was speculative. JDI’s principal

                                                  17
argument for why disclosure will likely lead to substantial harm depends on a chain of potential

future events. As explained in its brief before the Commission, JDI fears that Bracco will:

       (1) obtain a copy of the motion with the disallowed redactions,

       (2) identify from the declassified redactions the specific claim elements that
       JDI designed around in developing the Version 3.1 and Version 4,

       (3) use the motion’s discussion of the elements to draft new patent claims in
       continuation applications to cover the redesigned systems, which could
       include simply eliminating the specific claim limitations that JDI designed
       around, and

       (4) use the new patents to initiate patent infringement litigation against
       Respondents based on the Version 3.1 and Version 4 systems.

Dkt. 21-1 at 11 (Ex. A). Even if JDI is correct about the first two links in that chain, the

Commission reasonably concluded that its theories as to the third and fourth are speculative,

especially given the Commission’s merits determination that the disputed claims in Bracco’s

three continuation patents are invalid. And even accepting that JDI is correct that Bracco has

tried this gambit before—obtaining the design of the RUBY Version 3 through a FOIA request

and then drafting continuation patents based on that design in an attempt to exclude the RUBY

Version 3 from the market—that first attempt failed. The Commission held that the disputed

claims in Bracco’s continuation patents were invalid as obvious based on prior art. Dkt. 27-3

(Ex. B). With that premise in mind, the Commission reasonably concluded that any patent

claims Bracco might try to assert by “simply eliminating the specific claim limitations that JDI

designed around” would be even more general and obvious—and therefore would likely be

invalid too. Dkt. 21-1 at 11 (Ex. A). (Of course, it is possible that the Federal Circuit will

reverse the Commission and hold that Bracco’s patents are valid, but insofar as JDI’s theory of

harm relies on that possibility, it is even more speculative.) Further, if Bracco could have

patented broader claims, it had plenty of incentive to do so in the first place, namely to increase

                                                 18
the scope of its protection. Dkt. 21-5 at 13–14 (Ex. E). Bracco’s attempt to patent only the

narrower claims in its three continuation patents signals its recognition that broader claims were

not patentable.

       In its briefs, JDI does not even acknowledge, much less address, the Commission’s

determination that the failure of Bracco’s first attempt to draft continuation patents based on

JDI’s designs might reduce the probability that Bracco might try the same strategy again. By

failing to grapple with what impact its victory on the underlying patent claims might have on its

theory of harm, JDI has not provided the Court with any non-speculative reason to believe that

Bracco could—or would—seek to amend its patents to cover the technology that Bracco might

infer JDI has now deployed. The Commission’s decision that JDI did not face a substantial

likelihood of harm from further patent litigation was neither arbitrary nor capricious.

       JDI briefly hints at an alternative theory of harm. In its submissions to the Commission

on remand, JDI argued in a single sentence that irrespective of Bracco’s potential patent

strategies, “the disclosure of information about the technical details of the products before they

become public would enable Bracco to develop competitive strategies against the new designs

earlier than they otherwise would be able to, which will likely cause substantial harm to JDI.”

Dkt. 21-1 at 11 (Ex. A). The Commission’s conclusion that JDI’s risk of facing substantial

competitive harm was speculative is sufficient to address this single sentence in JDI’s remand

brief. “[A]n agency’s decision” need not “be a model of analytic precision to survive a

challenge;” rather, “[a] reviewing court will ‘uphold a decision of less than ideal clarity if the

agency’s path may reasonably be discerned.’” Dickson v. Sec’y of Def., 68 F.3d 1396, 1404

(D.C. Cir. 1995) (quoting Bowman Transp., Inc. v. Arkansas-Best Freight Sys., Inc., 419 U.S.

281, 285–86 (1974)). Here, the Commission acknowledged JDI’s contention that disclosure of

                                                 19
the asserted patent dissimilarities would allow Bracco to develop competitive strategies that

would likely harm JDI and rejected that contention as unduly speculative.

       The Commission’s conclusion was reasonable. Indeed, by JDI’s own admission,

Versions 3.1 and 4 were “specifically designed to avoid infringement of the three Bracco patents

asserted in the investigation.” Dkt. 18 at 12 (Amd. Compl. ¶ 32). JDI did not argue that these

updated products included better technology or that they were superior designs in any other way.

Versions 3.1 and 4 are creatures of patent litigation, and nothing in the record suggests that those

designs have any competitive value aside from not infringing Bracco’s patents or that JDI’s

competitors would have any interest in the designs of Versions 3.1 and 4 or in developing

competitive strategies against them. Nor will the Commission’s order reveal the designs of

RUBY Versions 3.1 and 4 in their entirety; at most, removing the redactions will disclose the

ways in which certain aspects of JDI’s designs differ from Bracco’s patents. Absent more

substantiation for this argument, JDI has not carried its burden to show that the Commission’s

decision was arbitrary and capricious for failing adequately to consider potential competitive

harms other than the risk that JDI may be subjected to further patent litigation.

       Finally, in its reply brief, JDI asserts that it was inconsistent for the Commission to rule

that its theory of harm is invalid as to the redactions the Commission rejected, while at the same

time affirming that same theory of harm with respect to the redactions that the Commission

approved. Dkt. 29 at 13–14. Although the Court in its prior opinion found that JDI had a

likelihood of success on the merits based on internal inconsistencies in the Commission’s

redaction rulings, JDI did not argue on remand or in its opening brief in support of its pending

motion for preliminary injunction that the Commission’s updated redactions remained

inconsistent. Because JDI presented this argument for the first time in its reply, the Court need

                                                 20
not consider it. See United States v. Apodaca, 251 F. Supp. 3d 1, 5 (D.D.C. 2017). But even if

JDI had timely raised this argument, the Court would be unpersuaded. It was reasonable for the

Commission to draw a distinction between the risk of harm from direct disclosure of JDI’s trade

secret designs and the lesser risk associated with the inferences that competitors might draw

based on how JDI presents public patent information and non-infringement contentions in the

context of its brief.

        The Court thus holds that the Commission acted rationally in deciding that JDI’s

proposed redactions did not satisfy the definition of CBI in Rule 201.6 because JDI had not

shown a likelihood that disclosure would lead to substantial harm to its competitive position.2

Because the Rule’s definition of CBI is a two-key system—that is, information qualifies as CBI

only if it both concerns or relates to trade secrets and is likely to cause substantial harm if

disclosed—affirming the Commission’s decision on the harm prong alone is sufficient to

demonstrate that JDI does not have a likelihood of success on the merits. The Court therefore

need not reach JDI’s arguments on the first prong that the Commission erred, both procedurally

and substantively, in its analysis of whether the information JDI seeks to redact “concerns or

relates to [JDI’s] trade secrets.” See 19 C.F.R. § 201.6(a)(1). Any such error would necessarily

be harmless. See 5 U.S.C. § 706 (requiring courts reviewing agency action to take “due account

. . . of the rule of prejudicial error”); Jicarilla Apache Nation v. U.S. Dep’t of Interior, 613 F.3d

2
  Given that the Court concludes, at the end of its merits analysis, that the Commission acted
rationally in deciding that JDI was not likely to suffer competitive harm from disclosure, one
might wonder whether JDI has alleged an injury in fact sufficient to establish its standing to
bring this lawsuit in the first place. But when assessing standing, courts generally presume that
the plaintiff will succeed on the merits of their claim. See U.S. House of Reps. v. Mnuchin, No.
19-5176, slip op. at 3, 7–8 (D.C. Cir. Sept. 25, 2020); Schnitzler v. United States, 761 F.3d 33, 40
(D.C. Cir. 2014). And the Court should “avoid resolving issues contested on the merits under the
banner of standing.” Pietrangelo v. Refresh Club, Inc., No. 18-cv-1943, 2019 WL 2357379, at
*4 (D.D.C. June 4, 2019).
                                                  21
1112, 1121 (D.C. Cir. 2010) (“The harmless error rule applies to agency action because if the

agency’s mistake did not affect the outcome, if it did not prejudice the petitioner, it would be

senseless to vacate and remand for reconsideration.” (citation, internal brackets, and internal

quotation marks omitted)).

       To be sure, even if the Court were to reach JDI’s arguments with respect to the first

prong, the Court is unpersuaded that the Commission’s action was either procedurally invalid or

arbitrary and capricious with respect to that prong.

       2.      Public Information Concerning or Relating to Trade Secrets

       JDI first contends that the Commission’s “broad, categorical pronouncement” that

publicly available patent claim language and legal conclusions of non-infringement do not

constitute CBI “effectively amends,” rather than interprets, the agency’s definition of CBI in

Rule 201.6. JDI argues that, as an amendment to a regulation, this new policy is unlawful

because the Commission did not promulgate it in accordance with the APA’s notice and

comment requirements. Dkt. 24-1 at 20; see 5 U.S.C. § 553. The Commission responds that it

has discretion to make policy through either rulemaking or adjudication and that proceeding by

“adjudication makes reasonable sense under the present circumstances: applying a general rule to

a specific context.” Dkt. 27 at 29. The Commission further maintains that it was merely

interpreting, rather than amending, Rule 201.6. Id.

       The Commission is correct that agencies have discretion to make policy through either

rulemaking or adjudication. See SEC v. Chenery Corp. (Chenery II), 332 U.S. 194, 201–03

(1947). The Commission is also correct that one mechanism is usually just as good as the other:

“Most norms that emerge from a rulemaking are equally capable of emerging (legitimately) from

an adjudication, and accordingly agencies have very broad discretion whether to proceed by way

                                                 22
of adjudication or rulemaking.” Qwest Servs. Corp. v. FCC, 509 F.3d 531, 536 (D.C. Cir. 2007)

(internal quotation marks and citations omitted). But that does not answer JDI’s argument,

because here the agency was not writing on a blank slate. Cf. NLRB v. Bell Aerospace Co., 416

U.S. 267, 294(1974) (explaining that “the choice between rulemaking and adjudication lies in the

first instance within the [agency]’s discretion” (emphasis added)). Rather, the Commission had

already promulgated Rule 201.6 pursuant to the APA’s notice and comment procedures. Once

promulgated, that Rule carried the force of law, and the Commission was required to follow it in

subsequent adjudications. The Commission could change the Rule, as JDI argues, only in the

same way it created the Rule: through notice and comment rulemaking. See Perez v. Mortg.

Bankers Ass’n, 575 U.S. 92, 101 (2015) (holding that the APA “mandate[s] that agencies use the

same procedures when they amend or repeal a rule as they used to issue the rule in the first

instance”).

       As a result, the question is whether the Commission’s pronouncement that “patent

language and legal conclusions of infringement or non-infringement are not CBI,” Dkt. 21-5 at

10 (Ex. E), constitutes a legislative amendment to Rule 201.6 or an interpretative application of

the Rule. The distinction between legislative and interpretive rules is a subject “of much

scholarly and judicial debate,” Perez, 575 U.S. at 97, and the D.C. Circuit has not yet announced

a bright-line rule for distinguishing between them. It has, however, provided several guiding

principles for navigating through the “smog.” Am. Mining Cong. v. Mine Safety & Health

Admin., 995 F.2d 1106, 1108 (D.C. Cir. 1993) (quotation marks omitted). Most notably, a

legislative rule “purports to impose legally binding obligations or prohibitions on regulated

parties,” while an interpretative rule “merely interprets a prior statute or regulation, and does not

itself purport to impose new obligations or prohibitions or requirements on regulated parties.”

                                                 23
Nat’l Mining Ass’n v. McCarthy, 758 F.3d 243, 251–252 (2014); see also Perez, 575 U.S. at 97

(explaining that “the critical feature of interpretive rules is that they are issued by an agency to

advise the public of the agency’s construction of the statutes and rules which it administers”

(internal quotations and citations omitted)). Several factors help operationalize this distinction,

including whether there is any basis for enforcement in the absence of the new rule, whether the

agency invoked “general legislative authority” in issuing the new rule rather than refining an

already-specific statute or legislative rule, and whether “the rule effectively amends a prior

legislative rule.” Am. Mining Cong., 995 F.2d at 1112. The D.C. Circuit has also opined that the

distinction “turns on how tightly the agency’s interpretation is drawn linguistically from the

actual language of the statute or rule.” Paralyzed Veterans of Am. v. D.C. Arena L.P., 117 F.3d

579, 588 (D.C. Cir. 1997), abrogated on other grounds by Perez, 575 U.S. at 100.

       Applying those standards here, the Court concludes that the Commission was entitled to

decide without notice and comment whether Rule 201.6’s definition of CBI covers public patent

claims and legal conclusions. The regulatory definition of CBI is, to be sure, detailed in many

respects. It lists more than a dozen types of records that qualify as CBI, including “information

which concerns or relates to the trade secrets, processes, operations, style of works, or apparatus,

or to the production, sales, shipments, purchases, transfers, identification of customers,

inventories, or amount or source of any income, profits, losses, or expenditures of any person,

firm, partnership, corporation, or other organization.” 19 C.F.R. § 201.6(a)(1). But the Rule also

applies more generally to “other information of commercial value.” Id. That open-ended

definition requires interpretation, as does the Rule’s indefinite inclusion of not only information

that constitutes “trade secrets” but also information that merely “concerns or relates to . . . trade

secrets.” 19 C.F.R. § 201.6(a)(1) (emphasis added). Although JDI argues that the information it

                                                  24
seeks to redact “concerns or relates to” its trade secrets, just how closely related the information

must be is precisely the sort of gap in the meaning of a regulation that an interpretive rule can

fill. The Commission’s interpretation clarifies the reach of an existing rule, rather than

establishing a new, legislative rule. The Commission did not purport to establish new

restrictions or obligations; to the contrary, it asserted that its interpretation of the Rule is

consistent with decades of its own precedent. Dkt. 27 at 28. And the Commission’s analysis is

tied to the language of the Rule itself, showing a “linguistic” connection between the existing

legislative rule and the Commission’s interpretation of it. Paralyzed Veterans, 117 F.3d at 588.

        JDI also contends that the Commission’s interpretation effectively amends the Rule as to

the second prong as well, by announcing that public patent information and legal conclusions are

not CBI “no matter how much ‘harm to the competitive position of the [party]’ the disclosure is

likely to cause.” Dkt. 24-1 at 19–20 (quoting 19 C.F.R. § 201.6(a)(1)). But this misapprehends

the nature of the Commission’s interpretation. All of the Commission’s interpretive work

occurred in its analysis of the first prong, where it decided that public patent claims cannot ever

concern or relate to trade secrets. The result of that decision is that public patent claims will not

qualify as CBI regardless of the likely harm. It does not mean, however, that the Commission

interpreted the second prong itself. (And, as explained above, the Commission’s application,

rather than interpretation, of the second prong is alone sufficient to sustain the Commission’s

action.)

        The APA thus did not require the Commission to go through notice and comment

rulemaking in order to interpret whether public patent information and legal conclusions

“concern or relate to” trade secrets within the meaning of its regulation. Whether the

Commission’s substantive answer to that question was permissible under the APA is a closer

                                                   25
question. The Commission recognized and recited JDI’s central claim that the redactions in its

summary determination motion were needed because the “motion compares new features of the

systems with avoided claim limitations, which if not redacted, would make obvious the specific

design changes that [JDI] has implemented in the new Version 3.1 and Version 4 systems and

alert Bracco to the specific claim elements that need to be changed or deleted from its pending

patent applications in order to read on these new systems.” Dkt. 21-5 at 8–9 (Ex. E) (quotation

marks omitted). In rejecting that contention, the Commission placed substantial weight on JDI’s

inability to cite to any precedent for its claim that public patent elements could become

confidential information just because the public patent elements, when read in context, might

allow a reader to deduce the confidential information. Id. at 9–10. Weighing against JDI’s

position, the Commission cited its own precedents, district court opinions, and the redaction rules

of the Federal Circuit. Id. at 9–12. Of particular relevance, the Commission relied on its

previous decision in In re Certain X-Ray Breast Imaging Devices & Components Thereof, Inv.

No. 337-TA-1063, Comm’n Notice, 2018 WL 6411405, at *2 (Dec. 4, 2018). In that case, an

ALJ rejected a party’s request to redact the phrase “post-acquisition processing” on the ground

that, “when read in context[,] . . . particular instances of the phrase” would give away aspects of

the company’s designs. See In re Certain X-Ray Breast Imaging Devices & Components

Thereof, Inv. No. 337-TA-1063, Order No. 33, 2018 WL 6837930, at *2–4 (Nov. 2, 2018). The

ALJ was “not persuaded that public information, such as the scope of an asserted claim, can

nonetheless be withheld from the public simply because an infringement finding necessarily

indicates that the accused product falls within that scope. Id. at *4. Based on that authority, the

Commission concluded that JDI’s “claims of confidentiality are, quite literally, unprecedented,

and that [JDI] failed to establish a basis for confidentiality for patent language and legal

                                                 26
conclusions of infringement or noninfringement.” Dkt. 21-5 at 10 (Ex. E). The Commission

also relied on its own policy judgment and experience adjudicating similar claims, observing that

the passages JDI sought to protect were “nothing more than the typical analysis performed by

parties in patent litigation; it does not reveal information that is proprietary, confidential, or

worthy of trade secret protection.” Id. at 12.

        JDI attacks the Commission’s reasoning on several grounds. It first argues that “the

Commission misreads its own regulation” by focusing on literal trade secrets, when the Rule also

encompasses information that “concerns or relates” to those trade secrets, and by ignoring other

classes of information covered by the Rule, such as sales, shipments, and purchases. Dkt. 24-1 at

21. Second, JDI argues that the Commission’s remand decision is contradicted by the ALJ’s

earlier findings, at least as to the binary design elements of Version 3.1. Id. at 21–22. Third, JDI

asserts, in various formulations, that the Commission ignored the thrust of its argument by

focusing on the public character of the information in a vacuum without recognizing what that

public information might reveal about JDI’s trade secrets in context. Id. at 22–23.

        JDI’s substantive challenge to the Commission’s decision that public patent information

and bare legal contentions cannot constitute information concerning or related to trade secrets

presents a close question. The Commission’s analysis on the first prong is thin and conclusory,

and, at least for binary design decisions, JDI presents a substantial argument that public

information relates to trade secrets when reading the public information in context would give

away those trade secrets. But ultimately, under the deferential standard that applies to judicial

review of administrative decisions, the Court concludes that the Commission’s reasoning was not

arbitrary and capricious for much the same reason that its interpretation of the Rule was

procedurally valid. The meaning of the phrase “concerns or relates to” is not so obvious as to

                                                  27
render unreasonable the Commission’s conclusion that the definition does not encompass public

patent information or bare legal conclusions. And the Commission is due an additional level of

deference in interpreting its own genuinely ambiguous regulation. See Kisor v. Wilkie, 139 S. Ct.

2400 (2019). In any event, even if the Commission erred in its analysis of the first prong, its

reasonable conclusion that JDI’s theory of harm was speculative is enough by itself to sustain the

Commission’s decision.

B.     Irreparable Harm

       The Court must also consider whether JDI “is likely to suffer irreparable harm in the

absence of preliminary relief.” Winter, 555 U.S. at 20. “[A] showing that irreparable injury is

‘likely’ is the sine qua non for obtaining a preliminary injunction—it is what justifies the

extraordinary remedy of granting relief before the parties have had the opportunity fully to

develop the evidence and fully to present their respective cases.” Achagzai v. Broad. Bd. of

Governors, No. 14-cv-768, 2016 WL 471274, at *3 (D.D.C. Feb. 8, 2016); see also Chaplaincy

of Full Gospel Churches v. England, 454 F.3d 290, 297 (D.C. Cir. 2006) (“A movant’s failure to

show any irreparable harm is therefore grounds for refusing to issue a preliminary injunction,

even if the other three factors entering the calculus merit such relief.”); Tex. Children’s Hosp. v.

Burwell, 76 F. Supp. 3d 224, 241–42 (D.D.C. 2014); Trudeau v. FTC, 384 F. Supp. 2d 281, 296

(D.D.C. 2005), aff’d, 456 F.3d 178 (D.C. Cir. 2006).

       With respect to irreparable harm, as with the other remaining preliminary injunction

factors, JDI largely rests on its laurels. It reasons that the Court “already found that the second,

third, and fourth requirements are met” and that “[n]othing has happened since then that merits

disturbing those findings.” Dkt. 24-1 at 18–19. JDI therefore presented no additional arguments

in its motion as to those factors. JDI addressed irreparable harm briefly in its reply, but again

                                                 28
emphasized the lack of “changed facts since the Court made its previous ruling.” Dkt. 29 at 19–

20. But as the Commission argues, and contrary to JDI’s assertions, the situation has changed in

at least one important respect since the Court’s previous opinion. See Dkt. 27 at 43–45.

       On December 11, 2019, the Commission held the contested claims in Bracco’s

continuation patents invalid. Dkt. 27-3 at 12–13, 43 (Ex. B). That holding undermines JDI’s

theory of harm, as explained above in the Court’s discussion of the harm prong of the

Commission’s CBI test. JDI fears that Bracco will figure out aspects of its trade secret designs

based on clues in its brief and then use that information to draft new patents claims aimed at

excluding RUBY Versions 3.1 and 4 from the market. But that risk is substantially reduced by

the Commission’s decision that the contested claims in Bracco’s previously issued continuation

patents are invalid as obvious in light of prior art. (And the fact that the Patent and Trademark

Appeals Board reached the same result only further undermines JDI’s theory of harm.) As the

record now stands, the Court must conclude that any further attempts by Bracco to employ the

same strategy would likely meet the same end—JDI certainly has not presented the Court with

any reason to believe that the Federal Circuit is unlikely to affirm the Commission’s invalidity

determination. The Commission is correct that JDI’s theory of harm is “wholly speculative.”

Dkt. 27 at 45.

       It is true that revealing the information in JDI’s brief will be irreversible. Once the

information has become public, the cat cannot be put back in the bag. But JDI’s theory is not

that harm will result directly from the disclosure of that information but rather from what Bracco

might do with the information, which may well be nothing at all. The Commission’s action in

removing the redactions from JDI’s brief will be irreversible, but JDI has not shown that it will

                                                29
cause the company irreparable harm. The Court is therefore unpersuaded that JDI will suffer any

irreparable injury from release of the references to Bracco’s patent claims in JDI’s brief.

C.     Balance of Equities and Public Interest

       Finally, JDI must show “that the balance of equities tips in [its] favor, and that an

injunction is in the public interest.” Winter, 555 U.S. at 20. “The[se] last two factors ‘merge

when the Government is the opposing party.’” Guedes, 920 F.3d at 10 (internal citation omitted)

(quoting Nken, 556 U.S. at 435). Here too, JDI argues that nothing has changed since the

Court’s previous opinion, in which it found that the final two factors “tip in JDI’s favor.” Dkt.

14 at 17. But upon reexamining the issues, the Court reaches the opposite conclusion on these

factors as well.

       The Commission asserts an interest in doing its work in public. Dkt. 27 at 45–47. The

Commission cited its transparency obligations under the Sunshine Act, 5 U.S.C. § 552b, as well

as the requirement that it make reasoned decisions under the APA. Dkt. 27 at 45–47. Dkt. 27 at

45–47. “The Commission must be able to explain its reasoning to the public at large by at least

providing bare legal conclusions of infringement and non-infringement, which includes a claim

element-by-element analysis under patent law.” Id. at 46. A ruling in favor of JDI in this case

would set a precedent that parties before the Commission could use to seek an increased number

of redactions in the Commission’s opinions themselves, making it more difficult for the

Commission to obtain the legitimating benefits of explaining its judgments in public.

       In reply, JDI argues that “the public has no right to information that identifies with

specificity which claim elements each of JDI’s trade secret designs has or does not have” and

that Rule 201.6 itself strikes “the appropriate balance between private and public rights.” Dkt.

                                                30
29 at 21. These arguments bleed back into the merits because, although the Commission agrees

that Rule 201.6 strikes an appropriate balance, the parties disagree on what that balance is.

        The Court credits both parties’ arguments. The Commission has an interest in doing its

work in public view, but only insofar as public disclosure of its records and proceedings does not

reveal trade secrets or other confidential information of the participating parties. Here, because

the Court finds that the Commission reasonably concluded that the information in question is not

CBI, and because JDI has not shown that substantial harm is likely to result from disclosure, the

balance of equities tips in the Commission’s favor. In its previous opinion, the Court held that

“relatively little harm to the Commission” would result from an injunction because, “[i]n the

event that the Commission ultimately prevails, JDI will be required to disclose the redacted

material in short order.” Dkt. 14 at 17. The reality is that although a preliminary injunction is

temporary relief in the life cycle of a lawsuit, it can still result in substantial delay. JDI filed its

motion for summary determination in October 2018, and now two years have passed with that

brief’s legal arguments shrouded from public view. In sum, the Commission’s interests in

promoting transparency, accountability, and legitimacy outweigh the potential competitive harm

to JDI, especially when the extent of that harm is so unclear.

        All four factors, accordingly, weigh against the extraordinary relief of a second

preliminary injunction in this case.

                                                   31
                                      CONCLUSION

       For the reasons stated above, it is hereby ORDERED that Plaintiff’s motion for

preliminary injunction, Dkt. 24, is DENIED.

       SO ORDERED.

                                                   /s/ Randolph D. Moss
                                                   RANDOLPH D. MOSS
                                                   United States District Judge

Date: September 30, 2019

                                              32