CII GreenbergTraurig
`
`DOC~~T
`NUMBER
`
`Patrick J. McCarthy
`Tel 202.533.2386
`Fax 202.331.3101
`mccarthyp@gtlaw.com
`
`March 27, 2018
`
`VIA HAND DELIVERY
`The Honorable Lisa Barton
`Secretary
`U.S. INTERNATIONAL TRADE COMMISSION
`500 E Street, S.W., Room 112
`Washington, D.C. 20436
`
`. --- . --· .-----··---------------------
`
`Ottice of the
`Secretary
`lnt'I rrade Commission
`
`Re:
`
`In the Matter of Certain Strontium-Rubidium Radioisotope Infusion Systems,
`and Components Thereof Including Generators
`U.S. ITC Inv. No. 337-TA-
`
`Dear Secretary Barton,
`
`Enclosed for filing on behalf of Complainant Bracco Diagnostics Inc. ("Bracco" or
`"Complainant") against the proposed Respondents Jubilant Draximage Inc., Jubilant
`Pharma Limited, and Jubilant Life Sciences (collectively, the "Proposed Respondents") are
`documents in support of Bracco's request that the Commission commence an investigation
`pursuant to Section 337 of the Tariff Act of 1930, as amended. A request for confidential
`treatment of Confidential Exhibit 22 and the Complaint is included with this letter.:
`
`Accordingly, Complainant submits the following documents for filing:
`
`1. An" original and eight (8) paper copies of the verified Non-Confidential Complaint
`and the Public Interest Statement. (19 CPR§§ 210.8(a)(l)(i), 210.8(b).)
`
`2. An original and eight (8) paper copies of the verified Confidential Complaint and
`the Public Interest Statement. (19 CPR§§ 210.8(a)(l)(i), 210.8(b).)
`
`3. One (1) copy, on CD of the accompanying Non-Confidential exhibits 1-21 and 23-
`28 and public version of Confidential Exhibit 22. (19 CPR §210.8(a)(l)(i).)
`
`4. One (1) copy, on CD with Confidential Exhibit 22. (19 CPR§§ 201.6(c).)
`
`5. One (1) copy, on CD of Physical Exhibit 1. (19 CPR §210.8(a)(l)(i).)
`
`6. Six (6) additional copies of the verified Non-Confidential Complaint and the Public
`Interest Statement and three (3) CDs of the Non-Confidential exhibits, one (1) of
`each for service upon each of the Proposed Respondents. (19 CPR§§
`210.8(a)(l)(iii) and 210.1 l(a).)
`
`GREENBERG TRAURIG, LLP • ATTORNEYS AT LAW • WWW.GTLAW.COM
`2101 L Street, N.W., Suite 1000 • Washington, D.C. 20037 • Tel 202.331.3100 • Fax 202.331.3101
`
`ALBANY
`
`AMSTERDAM
`
`ATLANTA
`
`AUSTIN
`
`BOSTON
`
`CHICAGO
`
`DALLAS
`
`DELAWARE
`
`DENVER
`
`FORT LAUDERDALE
`
`HOUSTON
`
`LAS VEGAS
`
`LONDON·
`
`LOS ANGELES
`
`MEXICO CITY•
`
`MIAMI
`
`MILAN•
`
`NEW JERSEY
`
`NEW YORK
`
`ORANGE COUNTY
`
`ORLANDO
`
`PALM BEACH COUNTY
`
`PHILADELPHIA
`
`PHOENIX
`
`ROME·
`
`SACRAMENTO
`
`SAN FRANCISCO
`
`SEOUL•
`
`SHANGHAI
`
`SILICON VALLEY
`
`TALLAHASSEE
`
`TAMPA
`
`TEL AVIV'
`
`TYSONS CORNl:R
`
`WARSAW·
`
`WASHINGTON, D.C.
`
`WHITE PLAINS
`' OPERATES AS GREENBERG
`TRAURIG f.'AHER LLP
`+ OPERATES AS
`GREENBERGTRAURIG, ac.
`"ABRANCHOF
`GREENBERG TRAURIG, PA
`FLCRIDI\USA
`• OPERATES AS
`GFIE~~RJGCF.ZESIAK~k
`• OPERATES AS
`GREENBERG TRAURIG liP
`FOREIGN UEGAL CONSULTANT
`OFFCE
`•• STRATEGIC ALLIANCE
`
`JUBILANT EXHIBIT 1003
`Jubilant v. Bracco, IPR2018-01449
`
`1 of 1085
`
`

`

`Honorable Secretary Barton
`March 27, 2018
`Page2
`
`7. Three (3) CDs of Confidential Exhibit 22, one (1) of each for service upon each of the
`Proposed Respondents. (19 CPR§§ 210.8(a)(l)(iii) and 210.1 l(a).)
`
`8. Three (3) CDs of Physical Exhibit 1, one (1) of each for service upon each of the
`Proposed Respondents. (19 CPR§§ 210.8(a)(l)(iii) and 210.1 l(a).)
`
`9. Certified copies of United States Patent Nos. 9,814,826 ("the '826 Patent"); 9,750,869
`("the '869 Patent"); and 9,750,870 ("the '870 Patent), included in the Complaint as
`Exhibits, 1, 3, and 5. (19 CPR§§ 2}0.8(a)(l)(iii) and 210.12(a)(9)(i).)
`
`10. Certified copies of the assignments for the '826, '869, and '870 patents included in the
`Complaint as Exhibits 2, 4, and 6. (19 CFR §§ 210.8(a)(l)(iii) and 210.12(a)(9)(ii).)
`
`11. Certified copies of the prosecution histories of the '826, '869, and '870 patents,
`included in the Complaint as Appendices 1, 3, and 5, and three (3) additional copies of
`each on separate CDs. (19 CPR §210.12(c)(l)).
`
`12. Four (4) copies on separate CDs of patent and technical reference documents
`identified in the each of the prosecution histories of the '826, '869, and '870 patents,
`included in the Complaint as Appendices 2, 4, and 6. (19 CPR §210.12(c)(2)).
`
`Thank you for your attention to this matter. Please contact me if you have any questions.
`
`Respectfully submitted,
`
`Patrick J. McCarthy
`
`2 of 1085
`
`

`

`Ii GreenbergTraurig
`
`Patrick J. McCarthy
`Tel 202.533.2386
`Fax 202.331.3101
`mccarthyp@gtlaw.com
`
`March 27, 2018
`
`VIA HAND DELIVERY
`
`The Honorable Lisa Barton
`Secretary
`U.S. INTERNATIONAL TRADE COMMISSION
`500 E Street, S.W., Room 112
`Washington, D.C. 20436
`
`Re:
`
`In the Matter of Certain Strontium-Rubidium Radioisotope Infusion Systems,
`and Components Thereoflncluding Generators
`U.S. ITC Inv. No. 337-TA-
`
`Dear Secretary Barton,
`
`In accordance with Commission Rules 201.6 and 210.5, Complainant Bracco Diagnostics
`Inc. ("Bracco") requests confidential treatment of the business information contained in the
`Complaint and Confidential Exhibit 22.
`
`The information for which confidential treatment is sought is proprietary commercial
`information not otherwise publicly available. Specifically, these exhibits contain
`proprietary commercial information concerning Bracco's business records, trade secrets,
`processes, sales, licenses, expenditures and/or other information of commercial value.
`
`The information described above qualifies as confidential business information pursuant to
`Commission Rule 201.6(a) because:
`
`1.
`
`It is not available to the public;
`
`2. unauthorized disclosure of such information could cause substantial harm to the
`competitive position of Bracco and/or a third party;
`
`3. Its disclosure could impair the Commission's ability to obtain information necessary
`to perform its statutory function.
`
`GREENBERG TRAURIG, LLP • ATTORNEYS AT LAW • WWW.GTLAW.COM
`2101 L Street, N.W., Suite 1000 • Washington, D.C. 20037 • Tel 202.331.3100 • Fax 202.331.3101
`
`ALBANY
`
`AMSTERDAM
`
`ATLANTA
`
`AUSTIN
`
`BOSTON
`
`CHICAGO.
`
`DALLAS
`
`DELAWARE
`
`DENVER
`
`FORT LAUDERDALE
`
`HOUSTON
`
`LAS VEGAS
`
`LONDON·
`
`LOS ANGELES
`
`MEXICO CITY+
`
`MIAMI
`
`MILAN·
`
`NEW JERSEY
`
`NEW YORK
`
`ORANGE COUNTY
`
`ORLANDO
`
`PALM BEACH COUNTY
`
`PHILADELPHIA
`
`PHOENIX
`
`ROME·
`
`SACRAMENTO
`
`SAN FRANCISCO
`
`sEouL·
`SHANGHAI
`
`SILICON VALLEY
`
`TALLAHASSEE
`
`TAMPA
`
`TEL AVIV•
`
`TYSONS CORNER
`
`WARSAW(cid:173)
`
`WASHINGTON, D.C.
`
`WHITE PLAINS
`• OPERATES AS GREENBERG
`TRAURIG MAHER UP
`
`+ CPERATES AS
`GREENBERG TRAURIG, S.C.
`~ A BRANCH OF
`GREENBERG TRAURJG, PA
`FLORl!l'I, USA
`• OPERATESAS
`rnEEl'-SEffi TRAUPK> GRZESU\K ">J.k.
`
`"OPERATES AS
`GREENBERGTRAURJGUP
`FOREIGN LEGAL CONSUL TANT
`OFRCE
`"STRATEGICAf.LIANCE
`
`3 of 1085
`
`

`

`Honorable Secretary Barton
`March 27, 2018
`Page2
`
`If you have any questions, please do not hesitate to contact me at (202) 533-2386.
`
`Sincerely,
`
`Patrick J. McCarthy
`
`4 of 1085
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
`
`In the Matter of
`
`CERTAIN STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION
`SYSTEMS, AND COMPONENTS
`THEREOF INCLUDING
`GENERATORS
`
`Investigation No. 337-TA-__
`
`STATEMENT REGARDING THE PUBLIC INTEREST
`
`Complainant Bracco Diagnostics Inc. ("Bracco" or "Complainant") submits this public-
`
`interest statement pursuant to Commission Rule 210.8(b ), 19 C.F .R. § 210.8(b ). As discussed
`
`below, the remedies sought against Jubilant Draximage Inc., Jubilant Pharma Limited, and
`
`Jubilant Life Sciences (collectively, the "Proposed Respondents" or "Jubilant") will not have an
`
`adverse effect on public health and welfare in the United States, competitive conditions in the
`
`United States economy, the production of competitive articles in the United States, or U.S.
`
`consumers.
`
`The products at issue in this Investigation are strontium-rubidium radioisotope infusion
`
`systems and component thereof that infringe one or more claims of the Asserted Patents: U.S.
`
`Patent No. 9,814,826 ("the '826 patent"); U.S. Patent No. 9,750,869 ("the '869 patent"); and
`
`U.S. Patent No. 9,750,870 ("the '870 patent"). Bracco seeks a limited exclusion order barring
`
`from entry into the United States all infringing strontium-rubidium radioisotope infusion systems
`-,
`
`and components thereof sold for importation, imported, or sold within the United States after
`
`importation by the Proposed Respondents. Bracco also seeks a cease and desist order prohibiting
`
`the Proposed Respondents from engaging in the unlawful sale for importation into the United
`
`5 of 1085
`
`

`

`States, importation into the United States, and/or the sale within 'the United States after
`
`importation of infringing strontium-rubidium radioisotope infusion systems and components
`
`thereof. These requested remedies do not and will not adversely affect the public interest.
`
`I. HOW THE ARTICLES SUBJECT TO THE PROPOSED REMEDIAL ORDERS
`ARE USED IN THE UNITED STATES
`
`The Accused Product is a strontium-rubidium radioisotope infusion system, including
`
`rubidium generator, sold under the · tradename Ruby-Fill®. Ruby-Fill® and/or components
`
`thereof are imported into the United States and/or sold in the United States after importation, at
`
`least, by the Proposed Respondents. The Ruby-Fill® system is used in the medical field to
`
`produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82
`
`chloride injection is indicated by the U.S. Food and Drug Administration ("FDA") for Positron
`
`Emission Tomography ("PET") imaging of the myocardium under rest or pharmacologic stress
`
`conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing
`
`coronary artery disease. The resulting images allow a physician to evaluate the blood flow
`
`(perfusion) through the coronary arteries to the heart muscle, and thus diagnose whether any
`
`heart disease exists.
`
`II.
`
`IDENTIFY AND PUBLIC HEALTH, SAFETY, OR WELFARE CONCERNS
`RELATING TO THE REQUESTED REMEDIAL ORDERS
`
`The ITC has made clear that the public interest rests in the protection of intellectual
`
`property rights. 1 The question with respect to public interest, then, is not whether a "balancing"
`
`of factors merely favors a remedy, but rather whether competing interests exist of so great a
`
`significance with regard to only the Accused Products that the strong public policy of protecting
`
`1 See, e.g., Certain Digital Television Prods. & Certain Prods. Containing Same & Methods of Using Same, Inv. No.
`337-TA-617, Comm'n Op., at 9 (Aug. 23, 2009) ("Digital TV Products").
`
`2
`
`6 of 1085
`
`

`

`intellectual property rights must give way. As shown below, any public interest concerns
`
`invoked by this Investigation pales in comparison to this countervailing interest.
`
`Issuance of the requested relief, a limited exclusion order and/or a cease and desist order
`
`will have no adverse effect on the public health, safety or welfare in the United States. Bracco's
`
`CardioGen-82® is the first FDA-approved radioimaging agent dedicated to cardiac PET, and is
`
`available today for patients in need of cardiac PET exams, including patients in the United
`
`States. Proposed Respondents submitted an abbreviated new drug application ("ANDA") to the
`
`U.S. Food and Drug Administration on June 18, 2010 to market a system Proposed Respondents
`
`described as the equivalent of Bracco's CardioGen-82®. Due to variations in administration
`
`rates, the FDA reclassified the ANDA application as a 505(b )(2) NOA application. However,
`
`Proposed Respondents still stated that since "both generators are systems for the production of
`
`rubidium 82, equal utility is expected from Ruby-Fill." Thus, an alternative system, which
`
`Proposed Respondents represented to the FDA is equivalent to the Ruby-Fill® system, is readily
`
`available to the public.
`
`III.
`
`IDENTIFY LIKE OR DIRECTLY COMPETITIVE ARTICLES THAT
`COMPLAINANTS, THEIR LICENSEES, OR THIRD PARTIES MAKE WHICH
`COULD REPLACE THE SUBJECT ARTICLE IF THEY WERE TO BE
`EXCLUDED
`
`As set out in the Complaint, Bracco manufactures CardioGen-82® which is like or
`
`directly competitive with the Ruby-Fill® system and could seamlessly replace it. Thus, any U.S.
`
`consumer with a desire to purchase or use a strontium-rubidium radioisotope infusion system can
`
`purchase or use the existing CardioGen-82® immediately. Proposed Respondents have a
`
`relatively small portion of the U.S. market for strontium-rubidium radioisotope infusion systems.
`
`Accordingly, Bracco would easily be able to fill the demand gap, if any, felt by the requested
`
`remedies.
`
`3
`
`7 of 1085
`
`

`

`IV.
`
`IDENTIFY WHETHER COMPLAINANTS, COMPLAINANTS' LICENSEES,
`AND/OR THIRD PARTY SUPPLIERS HA VE THE CAPACITY TO REPLACE
`THE VOLUME OF ARTICLES SUBJECT TO THE REQUESTED REMEDIAL
`ORDERS IN A COMMERCIALLY REASONABLE TIME
`
`There is no question that Bracco has the capacity to replace the volume of Accused
`
`Products subject to the requested remedial orders within a commercially reasonable time. As
`
`stated above, Proposed Respondents have a relatively low market share. Thus, there is no
`
`indication that excluding the Accused Products will harm the public interest via unmet demand.
`
`V.
`
`STATE HOW THE REQUESTED REMEDIAL ORDER WOULD IMPACT
`CONSUMERS
`
`As discussed above, even after the requested remedy is issued, customers may purchase
`
`and consumers will have access to strontium-rubidium radioisotope infusion systems, namely
`
`CardioGen-82®. Proposed Respondents represented to the FDA that the Accused Product
`
`(Ruby-Fill®) is equivalent to CardioGen-82®. Accordingly, the issuance of such relief will have
`
`no relevant public interest impact on U.S. consumers.
`
`For the foregoing reasons, no public-interest concerns preclude the issuance of the
`
`proposed remedies against the Proposed Respondents in this matter.
`
`4
`
`8 of 1085
`
`

`

`Dated: March 27, 2018
`
`By:
`
`GREENBERG TRAURIG, LLP
`Mark Davis
`Patrick J. McCarthy
`2101 L Street, NW
`Washington, DC 20037
`Tel: (202) 331-3100
`Email: davisma@gtlaw.com
`Email: mccarthyp@gtlaw.com
`
`Scott Bornstein
`Brian J. Prew
`MetLife Building
`200 Park A venue
`New York, NY 10166
`Tel: (212) 801-9200
`Email: bornsteins@gtlaw.com
`Email: prewb@gtlaw.com
`
`Attorneys for Complainant
`
`5
`
`9 of 1085
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
`
`In the Matter of
`
`CERTAIN STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION
`SYSTEMS, AND COMPONENTS
`THEREOF INCLUDING
`GENERATORS
`
`Investigation No. 337-TA-__
`
`COMPLAINT UNDER SECTION 337
`OF THE TARRIF ACT OF 1930, AS AMENDED
`
`PROPOSED RESPONDENTS:
`Jubilant Draximage Inc.
`16751 TransCanada Highway
`Kirkland, Quebec, Canada
`H9H4J4
`
`Jubilant Pharma Limited
`6 Temasek Boulevard, #20-06 Suntec City
`Tower Four,
`Singapore 038986
`
`Jubilant Life Sciences
`Plot 1-A Sector 16-A Institutional Area
`Noida, Uttar Pradesh, 201301 India
`
`COMPLAINANT:
`Bracco Diagnostics Inc.
`259 Prospect Plains Road
`Building H,
`Monroe Township, NJ 08831
`Telephone: (800) 631-5245
`
`COUNSEL FOR COMPLAINANT:
`GREENBERG TRAURIG, LLP
`Scott J. Bornstein
`Brian J. Prew
`MetLife Building
`200 Park A venue
`New York, NY 10166
`Telephone: (212) 801-9200
`
`Mark G. Davis
`Patrick J. McCarthy
`2101 L Street, N.W., Suite 1000
`Washington, D.C. 20037
`Telephone: (202) 331-3100
`
`10 of 1085
`
`

`

`I.
`
`II.
`
`TABLE OF CONTENTS
`Introduction ......................................................................................................................... 1
`A.
`Complainant ............................................................................................................ 2
`B.
`Proposed Respondents ............................................................................................ 4
`Technology and Products-At-Issue ..................................................................................... 6
`Bracco's Products ................................................................................................... 6
`A.
`B.
`Jubilant's Ruby-Fill Is Manufactured And/Or Imported by Jubilant.. .................... 9
`The Asserted Patents and Non-Technical Description ..................................................... 11
`A.
`The '826 Patent ..................................................................................................... 11
`B.
`The '869 Patent ..................................................................................................... 12
`C.
`The '870 Patent ..................................................................................................... 13
`D.
`Foreign Patents and Applications Corresponding to the Asserted Patents ........... 14
`E.
`Licensees to the Asserted Patents ......................................................................... 14
`Unlawful and Unfair Acts of the Proposed Respondents ................................................. 14
`IV.
`Specific Acts of Unfair Importation and Sale ................................................................... 16
`V.
`Harmonized Tariff Schedule Information ......................................................................... 19
`VI.
`VII. Related Litigation .............................................................................................................. 19
`VIII. Domestic Industry ............................................................................................................. 19
`A.
`The Economic Prong ............................................................................................. 19
`
`III.
`
`The Technical Prong············································································.··~·············· 21
`B.
`Request for Relief ............................................................................................................. 22
`
`IX.
`
`11
`
`11 of 1085
`
`

`

`Exhibit Number
`Exhibit No. 1
`Exhibit No. 2
`Exhibit No. 3
`Exhibit No. 4
`Exhibit No. 5
`Exhibit No. 6
`Exhibit No. 7
`Exhibit No. 8
`Exhibit No. 9
`Exhibit No. 10
`Exhibit No. 11
`Exhibit No. 12
`Exhibit No. 13
`Exhibit No. 14
`Exhibit No. 15
`Exhibit No. 16
`Exhibit No. 17
`Exhibit No. 18
`Exhibit No. 19
`Exhibit No. 20
`Exhibit No. 21
`Exhibit No. 22
`Exhibit No. 23
`Exhibit No. 24
`Exhibit No. 25
`Exhibit No. 26
`Exhibit No. 27
`Exhibit No. 28
`
`EXHIBIT LIST
`
`Description
`Certified Copy of U.S. Patent No. 9,814,826
`Certified Copy of the assignment for U.S. Patent No. 9,814,826
`Certified Copy of U.S. Patent No. 9,750,869
`Certified Copy of the assignment for U.S. Patent No. 9,750,869
`Certified Copy of U.S. Patent No. 9,750,870
`Certified Copy of the assignment for U.S. Patent No. 9,750,870
`Westlaw Company Investigator Report for Jubilant Draximage Inc.
`Westlaw Company Investigator Report for Jubilant Pharma Limited
`Jubilant Draxlmage website
`Jubilant Draximage Oct. 3, 2016 press release
`May 28, 2005 Bracco Press Release
`Prescribing Information for Ruby-Fill®
`January 18, 2018 Earnings Call summary by Prabhudas Lilladher
`ASNC 2017 Final Program
`List of Foreign Counterparts to the Asserted Patents
`Mo-99 2017 Technical Program, Sept. 10-13, 2017
`Claim Chart showing infringement of U.S. Patent No. 9,814,826
`Claim Chart showing infringement of U.S. Patent No. 9,750,869
`Claim Chart showing infringement of U.S. Patent No. 9,750,870
`FDA Approval Package for Application No. 202153
`Ruby-Fill® User Manual
`Declaration of Ken Troger (Confidential)
`Domestic Industry chart regarding U.S. Patent No. 9,814,826
`Domestic Industry chart regarding U.S. Patent No. 9, 750,869
`Domestic Industry chart regarding U.S. Patent No. 9,750,870
`INTENTIONALLY LEFT BLANK
`INTENTIONALLY LEFT BLANK
`Westlaw Company Investigator Report for Jubilant Life Sciences
`
`,
`
`Physical Exhibit
`Number
`Physical Exhibit No.
`1
`
`PHYSICAL EXHIBIT LIST
`
`Description
`
`Ruby-Fill® video file, previously available at
`http://www.draximage.com/
`
`iii
`
`12 of 1085
`
`

`

`APPENDICES
`
`endix Number
`endix No. 1
`A endix No. 2
`A endix No. 3
`A endix No. 4
`A endix No. 5
`A endix No. 6
`
`Descri tion
`Certified co of Prosecution Histo of U.S. Patent No. 9,814,826
`Cited references for Prosecution Histo of U.S. Patent No. 9,814,826
`Certified co y of Prosecution Histo of U.S. Patent No. 9,750,869
`Cited references for Prosecution Histo of U.S. Patent No. 9,750,869
`Certified co of Prosecution Histo of U.S. Patent No. 9,750,870
`Cited references for Prosecution Histo of U.S. Patent No. 9,750,870
`
`iv
`
`13 of 1085
`
`

`

`I.
`
`Introduction
`
`1.
`
`This Complaint is filed by Bracco Diagnostics Inc. ("Bracco" or "Complainant"),
`
`pursuant to Section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337 ("Section
`
`1337"), against the proposed Respondents Jubilant Draxhnage Inc., Jubilant Phaima Limited,
`'
`and Jubilant Life Sciences (collectively, the "Proposed Respondents" or "Jubilant"). Bracco
`
`respectfully requests that the United States International Trade Commission (the "Commission")
`
`institute an investigation relating to the unlawful sale for imp01tation into the United States,
`
`imp01tation into the United States, and/or the sale within the United States after impoliation of
`
`certain strnntium-mbidium radioisotope infusion systems and/or components thereof, including
`
`but not limited to rnbidium-82 generators.
`
`2.
`
`The Proposed Respondents have engaged in m1fair acts in violation of Section
`
`337(a)(l)(B) through and in connection with the unlicensed impo1tation into the United States,
`
`sale for impoliation, and/or sale within the United States after impoliation of the Proposed
`
`Respondent's strontium-rnbidium radioisotope infusion systems and components thereof, that
`
`infringe one or more of the following U.S. patents owned by Bracco (collectively, "the Asse1ted
`
`Patents"): 9,814,826 ("the '826 patent") (Exhibit No. 1).; 9,750,869 ("the '869 patent.")
`
`(Exhibit No. 3); and 9,750,870 ("the '870 patent") (Exhibit No. 5). The non-exclusive list of
`
`claims that the Proposed Respondents infringe, and/or induce or contribute to the infringement of
`
`is as follows:
`
`t
`p d
`.
`.
`I f
`n rmgmg ro uc
`
`Asserted Claims of Asserted Claims of Asserted Claims of
`the '869 Patent
`the '870 Patents
`the '826 Patent
`
`Ruby-Fill®
`
`1, 2, 3, 5, 9, 10, 11, 1, 2, 3, 4, 5, 8, 14, 1 2 8 9 10 11 12
`
`12, 13, 14, 17, 18, 24, 27, 28, 29, and 13 i6 'ri 2i d 27'
`
`19, 26, and 28
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`30
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`3.
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`The Proposed Respondents have violated and continue to violate Section 337 to
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`the detriment of the domestic industry of Bracco that exists or is in the process of being
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`established in the United States relating to the Asserted Patents.
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`4.
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`To remedy the Proposed Respondents' continuing and unlawful violation of
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`Section 337, Bracco hereby states pursuant to Commission Rule 210.12(a)(ll) that it seeks, as
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`permanent relief, a limited exclusion order, pursuant to 19 U.S.C. § 1337(d), barring from entry
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`into the United States all infringing strontium-rubidium radioisotope infusion systems and
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`components thereof sold for importation, imported, or sold within the United States after
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`importation by the Proposed Respondents. Bracco also seeks cease and desist orders, pursuant to
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`19 U.S.C. § 1337(f), prohibiting the Proposed Respondents from engaging in the unlawful sale
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`for importation into the United States, importation into the United States, and/or the sale within
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`the United States after importation of infringing strontium-rubidium radioisotope infusion
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`systems and components thereof that infringe, induce or contribute to the infringement of one or
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`more claims of the Asserted Patents. Further, Bracco requests that the Commission impose a
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`bond upon Proposed Respondents' importation of infringing strontium-rubidium radioisotope
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`infusion systems and components thereof during the 60-day Presidential review period, pursuant
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`to 19 U.S.C. § 1337(j), to prevent further injury to the domestic industry that exists or is in the
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`process of being established in the United States relating to the Asserted Patents.
`
`A.
`
`5.
`
`Complainant
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`Bracco Diagnostics Inc. is a corporation organized and existing under the laws of
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`the State of Delaware, with a principal place of business at 259 Prospect Plains Road, Monroe
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`Township, New Jersey 08831.
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`6.
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`Bracco Diagnostics Inc., the U.S.-based subsidiary of Bracco Imaging SpA, was
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`established in 1994 and has since become a leader in the U.S. in innovative contrast imaging
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`agents. Bracco Diagnostics Inc., with headquarters and research offices in Monroe Township,
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`New Jersey, offers a product and solution portfolio for all key diagnostic imaging modalities: X(cid:173)
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`Ray Imaging (including Computed Tomography, Interventional Radiology, and Cardiac
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`Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS),
`
`and Nuclear Medicine through radioactive tracers.
`
`7.
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`Bracco Diagnostics
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`Inc.
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`is committed
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`to
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`the discovery, development,
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`manufacturing and marketing of imaging agents and solutions aimed at providing quality
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`solutions in terms of diagnostic efficacy, patient safety and cost effectiveness.
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`8.
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`Bracco's innovative and impressive product portfolio includes Bracco's nuclear
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`medicine and radiopharmaceuticals, such as strontium-rubidium radioisotope infusion systems
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`and rubidium-82 generators that are used with such systems. Bracco's strontium-rubidium
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`radioisotope infusion system is sold under the trade name CardioGen-82®.
`
`9.
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`CardioGen-82® is a closed system used to produce rubidium Rb 82 chloride
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`injection for intravenous administration. Rubidium Rb 82 chloride injection is indicated by the
`
`U.S. Food and Drug Administration ("FDA") for Positron Emission Tomography ("PET")
`
`imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional
`
`myocardial perfusion in adult patients with suspected or existing coronary artery disease. The
`
`resulting images allow a physician to evaluate the blood flow (perfusion) through the coronary
`
`arteries to the heart muscle, and thus diagnose whether any heart disease exists.
`
`10.
`
`PET is an imaging technique that uses small amounts of a radioactive tracer to
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`help in the diagnosis of heart disease. The tracer is introduced into the body, by IV injection
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`directly from a small and portable generator (e.g., CardioGen-82®), and a PET scanner is used to ·
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`produce an image showing the distribution of the tracer in the heart.
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`11.
`
`In 1989, Bracco's CardioGen-82® became the first FDA-approved radioimaging
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`agent dedicated to cardiac PET, and it is available today for patients in need of cardiac PET
`
`exams, including patients in the United States.
`
`12.
`
`As a pioneer in the field of cardiac PET imaging, Bracco has enjoyed tremendous
`
`success based on its innovative strontium-rubidium radioisotope infusion system. Bracco's
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`initial and continued success is based on extensive domestic research and development efforts.
`
`B.
`
`Proposed Respondents
`
`13.
`
`Jubilant Draxlmage lnc. is a corporation organized and existing under the laws of
`
`Canada with its principal place of business at 16751 TransCanada Highway Kirkland, Quebec,
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`Canada H9H 4J4. 1 See Exhibit No. 7.
`
`14.
`
`Jubilant Draxlmage Inc. received FDA approval for Ruby-Fill® rubidium-82
`
`generator and elution system on September 30, 2016. See Exhibit No. 20.
`
`15.
`
`Jubilant Pharma Limited is a corporation organized and existing under the laws of
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`Singapore with its principal of place of business at 6 Temasek Boulevard, #20-06 Suntec City
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`Tower Four, Singapore 038986. See Exhibit No. 8.
`
`16.
`
`Jubilant Life Sciences is a corporation existing under the laws of India with its
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`principal place of business at Plot 1-A Sector 16-A Institutional Area Noida, Uttar Pradesh,
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`201301 India. See Exhibit No. 28.
`
`17.
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`Jubilant Draxlmage Inc. is a subsidiary of Jubilant Pharma Limited. See Exhibit
`
`No.9.
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`1 http://www.draximage.com/
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`18.
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`19.
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`Jubilant Pharma Limited is a subsidiary of Jubilant Life Sciences.
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`Jubilant Draximage Inc. is the manufacturer of the infringing strontium-rubidium
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`radioisotope infusion system, which it sells under the tradename Ruby-Fill®. See, e.g., Exhibit
`
`Nos. 12 and 21. Jubilant Draximage Inc. also filed 505(b)(2) New Drug Application (NDA or
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`505(b)(2) NDA) to market and sell the infringing strontium-rubidium radioisotope infusion
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`system (Ruby-Fill®) in the United States. Exhibit No. 20.
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`20.
`
`At
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`least Jubilant Pharma Limited and Jubilant Draximage Inc. actively
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`participated in the development and regulatory approval process for the infringing strontium(cid:173)
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`rubidium radioisotope infusion system (Ruby-Fill®). Exhibit No. 20 at 436-38, 449-50, 461-62,
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`4 73-7 4 (identifying employees from each company that participated in meetings with the FDA to
`
`discuss NDA No. 202153).
`
`21.
`
`On October 3, 2016, after the 505(b)(2) NDA was approved by the FDA, Jubilant
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`Pharma Limited's CEO (GP Singh) commented "we are proud to bring to the US market" the
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`Ruby-Fill® system. Exhibit No. 10 (emphasis added).
`
`22.
`
`In recent earnings calls, Jubilant Life Sciences stated that it had completed
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`installation of Ruby-Fill® systems in the United States. Exhibit No. 13.
`
`23.
`
`Thus, upon information and belief, Jubilant Pharma Limited, Jubilant Life
`
`Sciences, a~d Jubilant Draximage Inc. direct the manufacture and development of the Ruby-Fill®
`
`system that is the subject of NDA No. 202153, and directly or indirectly, derive substantial
`
`revenue from the sale of the Ruby-Fill® system and its components thereof.
`
`24.
`
`Furthermore, upon information and belief, Jubilant Pharma Limited, Jubilant Life
`
`Sciences, and Jubilant Draximage Inc. are agents of each other and/or work in concert with each
`
`other with respect to the development, regulatory approval, marketing, sale, importation, and
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`distribution of the infringing strontium-rubidium radioisotope infusion system (Ruby-Fill®)
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`and/or components thereof throughout the Un.ited States.
`
`II.
`
`Technology and Products-At-Issue
`
`A.
`
`Bracco's Products
`
`25.
`
`Heart disease
`
`is
`
`the number one killer of American men and women.
`
`Approximately 650,000 Americans die each year from heart disease related illness. Early
`
`detection is critical to effectively treat the disease. Tools for evaluating heart disease include
`
`treadmill evaluation, stress echocardiogram, perfusion imaging, coronary calcium screening, and
`
`coronary angiography.
`
`26.
`
`As a pioneer in the strontium-rubidium radioisotope infusion systems market,
`
`Bracco is an industry leader for such devices. The existing CardioGen-82® system was the first
`
`FDA approved generator-based PET perfusion agent reimbursed for the evaluation of coronary
`
`artery disease. See Exhibit No. 11.
`
`27.
`
`The existing CardioGen-82® system infuses a radioactive nuclear medicine agent,
`
`rubidium-82 which is produced from its precursor strontium-82, for the purpose of imaging the
`
`heart to determine if the heart's blood supply is normal or not. By way of example, the existing
`
`CardioGen-82® system can be seen below (the actual generator is housed underneath in lead
`
`shielding):
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`•
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`28.
`
`Contained inside this cart is the rubidium generator:
`
`t!tJ
`~~ ~~~
`\.·--·~ ... ·
`\:,
`·'j
`·'
`
`\ .
`
`l
`
`...
`
`~ ~ ----
`
`---
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`7
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`29.
`
`Continuing with its strong tradition of providing strontium-rubidium radioisotope
`
`infusion systems for the U.S. Market, Bracco has developed the next generation CardioGen-82®
`
`Infusion System, Model 1700 (hereinafter "Model 1700") for the U.S. Market.
`
`30.
`
`The development of the Model 1700 system
`
`Confidential Exhibit No. 22.
`
`31.
`
`The Model 1700 system is and will be manufactured using Bracco's proprietary
`
`processes and equipment, and practices one or more claims of the Asserted Patents. Likewise,
`
`See
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`8
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`the Model 1700 system and the use thereof also practices one or more of the Asserted Patents, as
`
`explained below.
`
`B.
`
`Jubilant's Ruby-Fill Is Manufactured And/Or Imported by Jubilant.
`
`32.
`
`Jubilant Draxlmage Inc. manufactures and/or
`
`imports strontium-rubidium
`
`radioisotope infusion systems and/or components thereof, including but not limited to rubidium-
`
`82 generators, under the tradename Ruby-Fill®, which are sold in the United States. See Exhibit
`
`No. 12 (stating Ruby-Fill® system is manufactured by Jubilant Draximage Inc. with an address in
`
`Canada). The Ruby-Fill® system is pictured below:
`
`See http://www.draximage.com/products/us/ruby-fill/.
`
`33.
`
`The 2017 Mo-99 Topica