Jubilant Draximage Inc. v. U.S. Int'l Trade Comm'n

490 F.Supp.3d 169

JUBILANT DRAXIMAGE INC., Plaintiff,

v.UNITED STATES INTERNATIONAL TRADE COMMISSION, Defendant.

Civil Action No. 19-1494 (RDM)

United States District Court, District of Columbia.

Signed September 30, 2020

Jason F. Hoffman, Baker & Hostetler LLP, Washington, DC, for Plaintiff.

Houda Morad, Sidney A. Rosenzweig, United States International Trade Commission, Washington, DC, for Defendant.

MEMORANDUM OPINION AND ORDER

RANDOLPH D. MOSS, United States District Judge

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.

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 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.

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 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 its Version 3.1 and Version 4 systems in the proposed public version" of its brief. Id. at 13 (Amd. Compl. ...