UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
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`In the Matter of
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`CERTAIN STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION SYSTEMS,
`AND COMPONENTS THEREOF
`INCLUDING GENERATORS
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`Investigation No. 337-TA-1110
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`NOTICE OF COMMISSION FINAL DETERMINATION OF NO VIOLATION
`OF SECTION 337; TERMINATION OF THE INVESTIGATION
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` U.S. International Trade Commission.
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`Notice.
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`AGENCY:
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`ACTION:
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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.
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`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, D.C. 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.
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`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, Québec, Canada; Jubilant Pharma Limited of Singapore; and Jubilant Life Sciences of
`Noida, Uttar Pradesh, India (collectively, “Respondents” or “Jubilant”) as respondents in this
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`1
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`JUBILANT EXHIBIT 1039
`Jubilant v. Bracco, IPR2018-01449
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`

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`investigation. See id. The Office of Unfair Import Investigations is also a party to this
`investigation. See id.
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`On February 8, 2019, the ALJ issued an initial determination (“ID”) (Order No. 27)
`finding by summary determination that Jubilant’s RUBY 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.
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`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.
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`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.
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`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.
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`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.
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`2
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`JUBILANT EXHIBIT 1039
`Jubilant v. Bracco, IPR2018-01449
`
`

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`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).
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`By order of the Commission.
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`Issued: December 2, 2019
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`Lisa R. Barton
`Secretary to the Commission
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`3
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`JUBILANT EXHIBIT 1039
`Jubilant v. Bracco, IPR2018-01449
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