[Federal Register Volume 84, Number 235 (Friday, December 6, 2019)]
[Notices]
[Pages 66933-66934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26317]


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INTERNATIONAL TRADE COMMISSION

[Investigation No. 337-TA-1110]


Certain Strontium-Rubidium Radioisotope Infusion Systems, and 
Components Thereof Including Generators; Notice of Commission Final 
Determination of No Violation of Section 337; Termination of the 
Investigation

AGENCY: U.S. International Trade Commission.

ACTION: Notice.

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SUMMARY: Notice is hereby given that the U.S. International Trade 
Commission has determined to affirm with modification a final initial 
determination (``FID'') of the presiding administrative law judge 
(``ALJ'') finding no violation of section 337 of the Tariff Act of 
1930, as amended. The investigation is terminated.

FOR FURTHER INFORMATION CONTACT: Houda Morad, Office of the General 
Counsel, U.S. International Trade Commission, 500 E Street SW, 
Washington, DC 20436, telephone (202) 708-4716. Copies of non-
confidential documents filed in connection with this investigation are 
or will be available for inspection during official business hours 
(8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. 
International Trade Commission, 500 E Street SW, Washington, DC 20436, 
telephone (202) 205-2000. General information concerning the Commission 
may also be obtained by accessing its internet server at https://www.usitc.gov. The public record for this investigation may be viewed 
on the Commission's electronic docket (EDIS) at https://edis.usitc.gov. 
Hearing-impaired persons are advised that information on this matter 
can be obtained by contacting the Commission's TDD terminal on (202) 
205-1810.

SUPPLEMENTARY INFORMATION: The Commission instituted this investigation 
on May 1, 2018, based on a complaint, as amended, filed by Bracco 
Diagnostics Inc. of Monroe Township, New Jersey (``Bracco''). See 83 FR 
19112 (May 1, 2018). The complaint, as amended, alleges violations of 
section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337) 
(``section 337''), based upon the importation into the United States, 
the sale for importation, and the sale within the United States after 
importation of certain strontium-rubidium radioisotope infusion 
systems, and components thereof including generators, by reason of 
infringement of U.S. Patent Nos. 9,814,826; 9,750,869; and 9,750,870 
(collectively, ``the asserted patents''). See id. The notice of 
investigation names Jubilant DraxImage Inc. of Kirkland, Qu[eacute]bec, 
Canada; Jubilant Pharma Limited of Singapore; and Jubilant Life 
Sciences of Noida, Uttar Pradesh, India (collectively, ``Respondents'' 
or ``Jubilant'') as respondents in this investigation. See id. The 
Office of Unfair Import Investigations is also a party to this 
investigation. See id.
    On February 8, 2019, the ALJ issued an initial determination 
(``ID'') (Order No. 27) finding by summary determination that 
Jubilant's RUBY

[[Page 66934]]

Rubidium Elution System Version 3.0 directly infringes the asserted 
patents. See Order No. 27 (Feb. 8, 2019), unreviewed, Comm'n Notice 
(Mar. 8, 2019). In addition, the ID determines that Jubilant's RUBY 
Rubidium Elution System Version 3.1 and the RUBY Rubidium Elution 
System Version 4 do not directly infringe the asserted patents. See id. 
The ID (Order No. 27) declines to reach indirect infringement on 
summary determination. See id.
    The ALJ conducted an evidentiary hearing on February 11-12 and 15-
17, 2019, and on August 1, 2019, issued the FID finding no violation of 
section 337. Specifically, the FID finds that the domestic industry 
requirement is satisfied and that all the asserted claims are infringed 
but invalid as obvious over the prior art. The FID also contains the 
ALJ's Recommended Determination (``RD'') recommending, should the 
Commission find a section 337 violation, that the Commission issue a 
limited exclusion order (``LEO'') barring entry of articles that 
infringe the asserted claims. The RD does not recommend that the 
Commission issue a cease and desist order or impose a bond during the 
period of Presidential review. Furthermore, as directed by the 
Commission, the RD provides findings with respect to the public 
interest and recommends a determination that the public interest 
factors do not preclude entry of the proposed LEO.
    On August 14, 2019, both Bracco and the Commission's Investigative 
Attorney (``IA'') filed petitions for review of the FID. Bracco 
petitioned for review of the FID's findings with respect to invalidity, 
while the IA petitioned for review of the FID's findings with respect 
to domestic industry. On August 22, 2019, the parties filed responses 
to the respective petitions.
    On September 30, 2019, the Commission determined to review the FID 
in part with respect to invalidity and domestic industry. See 84 FR 
53177 (Oct. 4, 2019). The Commission determined not to review the 
remainder of the FID. See id.
    Having considered the FID, the parties' petitions, responses 
thereto, and the record in this investigation, the Commission has 
determined to affirm with modification the FID's findings and 
conclusion of no violation of section 337. Specifically, as explained 
in the Commission Opinion issued concurrently herewith, the Commission 
has determined to affirm with modification and to supplement the FID's 
findings with respect to the invalidity of the asserted patent claims. 
The Commission has further determined to affirm in part and vacate in 
part the FID's findings with respect to the domestic industry 
requirement. All findings in the FID that are not inconsistent with the 
Commission's final determination are affirmed. The investigation is 
terminated except with respect to the declassification proceeding 
presently before the Commission.
    The authority for the Commission's determination is contained in 
section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and 
in part 210 of the Commission's Rules of Practice and Procedure (19 CFR 
part 210).

    By order of the Commission.

    Issued: December 2, 2019.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2019-26317 Filed 12-5-19; 8:45 am]
 BILLING CODE 7020-02-P