MEMORANDUM OPINION AND ORDER
RANDOLPH D. MOSS, UNITED STATES DISTRICT JUDGE
Plaintiff
Jubilant DraxImage Inc. (“JDI”) manufactures a
Rubidium Elution System (“RUBY”), one of only two
medical devices used for Cardiac Positron Emission
Tomography, a non-invasive imaging procedure designed to
evaluate patients for coronary artery disease. JDI's
principal-indeed only-competitor in this specialized field is
Bracco Diagnostics Inc. (“Bracco”), a company
manufacturing a similar device. JDI is currently in
proceedings before the United States International Trade
Commission (“the Commission”) addressing whether
JDI's RUBY technology infringes on a series of
Bracco's patents. In the course of those proceedings, the
Commission ordered JDI publicly to disclose portions of its
briefs, all of which were filed under seal. JDI objects to
making public those portions of its briefs that cite or
reference Bracco's patent claims. The reason? Revealing
the specific Bracco claim elements at issue would, according
to JDI, allow Bracco to modify or remove the very claim
elements that make JDI's products non-infringing. In
other words, Bracco could use JDI's references to
particular 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. JDI seeks a preliminary injunction to prohibit
the Commission from enforcing its disclosure order. As
explained below, JDI has demonstrated that it is entitled to
preliminary relief. The Court will therefore
GRANT the motion for a preliminary
injunction.
I.
BACKGROUND
JDI is
a radiopharmaceutical company based in Kirkland, Canada. Dkt.
1 at 3 (Compl. ¶ 7). Among other things, JDI markets a
medical device named RUBY, an elution system that generates
Rubidium-82 Chloride, a chemical used for Cardiac Positron
Emission Tomography, a non-invasive imaging procedure used to
evaluate regional myocardial perfusion in adult patients with
suspected or existing coronary artery disease. Id.
at 4 (Compl. ¶ 11). The Food and Drug Administration
(“FDA”) first approved RUBY in 2016. Id.
(Compl. ¶ 12). As soon as the FDA approved JDI's
device, Bracco submitted a FOIA request to the FDA and
obtained a RUBY product manual from the agency. Id.
(Compl. ¶ 13). Bracco was able to claim priority to
earlier-filed patent applications and, between September and
November 2017, Bracco used information in the product manual
to seek and to obtain three continuation patents crafted to
claim the technology found in the RUBY product. Id.
at 4-5 (Compl. ¶ 13). As soon as those patents issued,
Bracco filed a complaint with the Commission, alleging
violations of Section 337 of the Tariff Act of 1930, 19
U.S.C. § 1337. Id. at 5 (Compl. ¶ 14). The
Commission instituted the current investigation in May 2018.
Id.
In
response to Bracco's complaint with the Commission, JDI
created two new versions of RUBY “specifically designed
to avoid infringement of Bracco's three
patents”-Versions 3.1 and 4. Id. (Compl.
¶ 17). In proceedings before the Commission, JDI
attempted to show that these new versions did not infringe
Bracco's existing patents. JDI filed a motion for summary
determination (“MSD”)-the equivalent of a summary
judgment motion-which compared the technology behind Versions
3.1 and 4 against Bracco's patent claims. Id. at
6 (Compl. ¶ 21); see also Dkt. 4-5 at 15-56
(Ex. 1 to Confidential Ex. E). To show that the new versions
did not infringe Bracco's patents, JDI quoted specific
portions of-and highlighted key terms in- Bracco's
lengthy patent claims. Dkt. 4-5 at 24-27. “Because the
emphasized claim limitations identif[ied] the specific
features of the RUBY product that were redesigned, ”
JDI feared that, if made aware of the precise claim elements
that JDI had designed around, Bracco would file yet another
set of continuation patents in an effort to exclude the new
designs utilized in Versions 3.1 and 4. Dkt. 1 at 6-7 (Compl.
¶¶ 23-24). JDI, accordingly, treated all references
to Bracco's claim elements as “confidential
business information” pursuant to Commission
regulations and “redacted the portions of its [briefs]
discussing, quoting, and emphasizing these limitations of
Bracco's patent claims in the public version of its
brief.” Dkt. 1 at 6 (Compl. ¶ 23). JDI did this in
four portions of its brief: the background sections for
Versions 3.1 and 4, which list the particular claim elements
at issue, and in the merits sections for Versions 3.1 and 4,
which argue that the new designs do not infringe the
identified claim elements.
Commission
staff attorneys objected to a number of JDI's redactions
and filed a motion to declassify portions of JDI's brief.
See Dkt. 4-1 (Confidential Ex. A). Specifically, the
Commission staff argued that “passages quoting from
[Bracco's] patents or descriptions of the scope of
patents and claims do not fall within the Commission's
definition of confidential business information” and
that, “unless the sentence explicitly describes the
specific aspects of the RUBY Version 3.1 and Version 4
systems, any quotation from or discussion of the asserted
[Bracco] patents should not be redacted.” Id.
at 4-5. JDI opposed the motion, arguing that “[a]ny
patent attorney reading a brief seeking a determination of
noninfringement that provides a background overview of
specific claim limitations would readily recognize that those
claim limitations form the basis for why the confidential
products do not infringe” and that, “for example,
” one of Bracco's limitations “concerns a
binary design option.” Dkt. 4-2 at 11 (Confidential Ex.
B). Reviewing a proposed, redacted brief provided by
Commission staff, moreover, JDI compared redactions approved
by the Commission staff to those rejected and argued that
“there is no real difference between the redacted
passages reproduced below that the Staff seeks to reclassify.
. . and those it has approved.” Id. at 12-13.
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). The Order explained that
“confidentiality determinations . . . are governed by
the definition given in 19 C.F.R. § 201.6(a).”
Id. at 4. That definition, according to the ALJ,
mandates a “two-part test.” Id. First,
the ALJ “asks whether the contested information
‘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.'”
Id. at 3 (citation omitted) (quoting 19 C.F.R.
§ 201.6(a)). Second, the ALJ determines whether
“the disclosure of such information [would] be 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 3-4 (alteration in
original) (citation omitted) (quoting 19 C.F.R. §
201.6(a)).
The ALJ
acknowledged JDI's argument that, “by identifying
specific claim limitations that are not practiced by
[JDI's] revised products, a reader may deduce the
operation of those products.” Id. at 4. With
respect to Version 3.1, for example, the ALJ noted JDI's
argument that the relevant claim element concerned “a
binary design decision” and “that language in its
brief stating that it does not practice the [specific]
limitation necessarily reveals . . . the [RUBY] elements in
question . . . and that is competitive information not
available to the public.” Id. at 4-5. Applying
the two-part test, the ALJ “agree[d] that
declassification of those redactions [i.e., those that
revealed a “binary design decision”] from the
public version of the [JDI] MSD would reveal a confidential
design feature of [JDI's] product, ” and,
accordingly, rejected the Commission staff's motion with
respect to those redactions. Id. at 5. Turning to
the Version 4 patents, however, 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 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 (“Notice”). Dkt. 1-1 (Compl. Ex. A).
In a single sentence, the Commission affirmed the ALJ's
Order No. 31.[1] Id. at 3. The Commission also
attached a version of JDI's brief, edited by Commission
staff, showing which redactions the Commission approved and
which redactions JDI would have to forgo. See Id. at
2; see also Dkt. 4-5 at 11-56 (Ex. 1 to Confidential
Ex. E). The Commission stayed its order for 21 days to allow
JDI to seek judicial review of its disclosure order. Dkt. 1-1
at 3 (Compl. Ex. A). The Commission later extended that stay
until July 12, 2019. June 21, 2019 Hrg. Tr. (Rough at
20:17-19).
JDI
filed the instant suit on May 22, 2019, seeking relief under
the Administrative Procedure Act (“APA”), 5
U.S.C. § 701 et seq. and a writ of mandamus, 28
U.S.C. § 1361. Among other things, JDI alleges that the
Notice is “arbitrary, capricious, and contrary to law,
” Dkt. 1 at 11 (Compl. ¶ 44), and that the
Commission “owes a non-discretionary duty not to
disclose information properly designated as confidential
under Commission rules, ” id. at 12 (Compl.
¶ 56). JDI filed a motion for a preliminary injunction
that same day, Dkt. 3, as well as a motion to seal portions
of the administrative record, Dkt. 4.[2] After setting a schedule
with the parties' consent, the Court held oral argument
on June 21, 2019, and those motions are now ripe for
decision.
II.
ANALYSIS
“A
preliminary injunction is an extraordinary remedy never
awarded as of right, ” Winter v. Nat. Res. Def.
Council, Inc., 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
last two factors ‘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, courts
in this 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, the D.C. Circuit 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)), but it has
repeatedly declined to decide that issue, see Am. Meat
Inst. v. U.S. Dep't of Agric., 746 F.3d 1065, 1074
(D.C. Cir. 2014), reinstated in relevant part by 760
F.3d 18 (D.C. Cir. 2014) (en banc); see also League of
Women Voters of United States v. Newby, 838 F.3d 1, 7
(D.C. Cir. 2016); Sherley, 644 F.3d at 393 (reading
“Winter at least to suggest if not to hold
‘that a likelihood of success is an independent,
free-standing requirement for a preliminary injunction,
'” but declining to decide the issue (quoting
Davis, 571 F.3d at 1296)).
Here,
because all four factors weigh in favor of granting a
preliminary injunction, JDI is entitled to preliminary relief
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