UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`In the Matter of
`
`CERTAIN STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION SYSTEMS, AND
`COMPONENTS THEREOF INCLUDING
`GENERATORS
`
`INV. NO. 337-TA-1110
`
`INITIAL DETERMINATION ON VIOLATION OF SECTION 337 AND
`RECOMMENDED DETERMINATION ON REMEDY AND BOND
`
`Administrative Law Judge Clark S. Cheney
`
`(August 1, 2019)
`
`Appearances:
`
`For the Complainant Bracco Diagnostics, Inc.:
`
`Mark G. Davis, Esq., and Patrick J. McCarthy, Esq. of Goodwin Procter LLP of Washington, DC
`
`Scott Bornstein, Esq., and Brian J. Prew, Esq. of Greenberg Traurig, LLP of New York, NY
`
`For the Respondents Jubilant Draximage, Inc., Jubilant Pharma Limited, and Jubilant Life
`Sciences.:
`
`T. Cy Walker, Esq., Robert L. Hails, Esq., Jason F. Hoffman, Esq., and Michael E. Anderson,
`Esq. of Baker & Hostetler LLP of Washington, DC
`
`Jared A. Brandyberry, Esq. of Baker & Hostetler LLP of Denver, CO
`
`Kevin P. Flynn, Esq. of Baker & Hostetler LLP of Cincinnati, OH
`
`Lesley Grossberg, Esq. of Baker & Hostetler LLP of Philadelphia, PA
`
`Andrew E. Samuels, Esq. of Baker & Hostetler LLP of Columbus, OH
`
`Katrina Quicker, Esq. and Theresa M. Weisenberger, Esq. of Baker & Hostetler LLP of Atlanta,
`GA
`
`PUBLIC VERSION
`
`JUBILANT EXHIBIT 1035
`Jubliant v. Bracco, IPR2018-01449
`
`

`

`John T. Gallagher, Esq. and James F. Harrington, Esq. of Hoffman & Baron, LLP of Syosset,
`NY
`
`
`
`II
`
`PUBLIC VERSION
`
`

`

`
`
`Table of Contents
`
`I.
`
`Introduction ......................................................................................................................... 2
`
`A.
`
`B.
`
`1.
`
`2.
`
`Procedural History ........................................................................................................... 2
`
`The Parties ....................................................................................................................... 3
`
`Complainant Bracco Diagnostics Inc. .......................................................................... 3
`
`The Jubilant Respondents ............................................................................................. 3
`
`C.
`
`The Asserted Patents ........................................................................................................ 4
`
`1.
`
`2.
`
`3.
`
`D.
`
`E.
`
`F.
`
`U.S. Patent No. 9,814,826 (JX-0001) ........................................................................... 5
`
`U.S. Patent No. 9,750,869 (JX-0002) ........................................................................... 5
`
`U.S. Patent No. 9,750,870 (JX-0003) ........................................................................... 5
`
`The Technology at Issue .................................................................................................. 5
`
`The Accused Products...................................................................................................... 7
`
`The Domestic Industry Products ...................................................................................... 8
`
`II.
`
`Jurisdiction & Importation .................................................................................................. 9
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`Subject Matter Jurisdiction .............................................................................................. 9
`
`Personal Jurisdiction ........................................................................................................ 9
`
`In Rem Jurisdiction .......................................................................................................... 9
`
`Importation ....................................................................................................................... 9
`
`Standing ......................................................................................................................... 10
`
`III.
`
`Legal Principles ................................................................................................................ 10
`
`A.
`
`B.
`
`1.
`
`2.
`
`C.
`
`D.
`
`1.
`
`2.
`
`3.
`
`Claim Construction ........................................................................................................ 10
`
`Validity .......................................................................................................................... 12
`
`Anticipation ................................................................................................................ 12
`
`Obviousness ................................................................................................................ 13
`
`Assignor Estoppel .......................................................................................................... 14
`
`Infringement ................................................................................................................... 15
`
`Direct Infringement ................................................................................................... 16
`
`Inducement of Infringement ..................................................................................... 16
`
`Contributory Infringement .......................................................................................... 17
`
`E.
`
`Domestic Industry .......................................................................................................... 17
`
`1.
`
`2.
`
`Economic Prong ......................................................................................................... 18
`
`Technical Prong .......................................................................................................... 18
`
`IV.
`
`Level of Ordinary Skill in the Art ..................................................................................... 19
`
`III
`
`PUBLIC VERSION
`
`

`

`
`
`V.
`
`Validity ............................................................................................................................. 21
`
`A.
`
`Assignor Estoppel .......................................................................................................... 21
`
`1.
`
`Staff Is Not Estopped .................................................................................................. 25
`
`B.
`
`Obviousness ................................................................................................................... 25
`
`1.
`
`2.
`
`3.
`
`4.
`
`The Prior Art ............................................................................................................... 26
`
`Comparing the Claims to the Prior Art ....................................................................... 39
`
`Secondary Considerations Bearing on Obviousness ................................................ 112
`
`Conclusion ................................................................................................................ 122
`
`C.
`
`Anticipation.................................................................................................................. 122
`
`VI.
`
`Infringement .................................................................................................................... 125
`
`1.
`
`2.
`
`Inducement of Infringement ..................................................................................... 127
`
`Contributory Infringement ........................................................................................ 128
`
`VII. Domestic Industry ........................................................................................................... 128
`
`A.
`
`B.
`
`Technical Prong ........................................................................................................... 128
`
`Economic Prong ........................................................................................................... 129
`
`1.
`
`The History of Bracco’s Rubidium Infusion Systems .............................................. 129
`
`2. Whether FDA Approval Is Required for a Domestic Industry ................................. 132
`
`3.
`
`4.
`
`5.
`
`Plant and Equipment ................................................................................................. 136
`
`Labor and Capital ..................................................................................................... 140
`
`Engineering, Research, and Development ................................................................ 145
`
`C.
`
`Status of the Industry ................................................................................................... 147
`
`1.
`
`A Domestic Industry Exists ...................................................................................... 147
`
`2. Whether the Domestic Industry Will Persist ............................................................ 148
`
`VIII. Conclusions of Law ........................................................................................................ 149
`
`IX.
`
`Recommended Determination on Remedy & Bond ....................................................... 150
`
`A.
`
`Background Facts......................................................................................................... 151
`
`1.
`
`2.
`
`The CardioGen-82 Model 510 .................................................................................. 154
`
`The RUBY Version 3 System .................................................................................. 157
`
`B.
`
`The Public Interest Factors .......................................................................................... 160
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Public Health and Welfare ........................................................................................ 160
`
`Competitive Conditions in the United States Economy ........................................... 166
`
`Production of Like or Directly Competitive Products in the United States ............. 168
`
`United States Consumers .......................................................................................... 169
`
`Conclusion ................................................................................................................ 170
`
`IV
`
`PUBLIC VERSION
`
`

`

`
`
`C.
`
`D.
`
`E.
`
`Limited Exclusion Order.............................................................................................. 170
`
`Cease and Desist Order ................................................................................................ 173
`
`Bond During Presidential Review ............................................................................... 175
`
`X.
`
`Initial Determination ....................................................................................................... 177
`
`
`
`V
`
`PUBLIC VERSION
`
`

`

`TABLE OF ABBREVIATIONS
`
`
`
`CDX
`
`Complainant’s demonstrative exhibit
`
`CIB
`
`CPB
`
`CPX
`
`CRB
`
`CX
`
`Complainant’s initial post-hearing brief
`
`Complainant’s pre-hearing brief
`
`Complainant’s physical exhibit
`
`Complainant’s reply post-hearing brief
`
`Complainant’s exhibit
`
`Dep.
`
`Deposition
`
`JX
`
`Joint Exhibit
`
`RDX
`
`Respondent’s demonstrative exhibit
`
`RIB
`
`RPX
`
`RPB
`
`RRB
`
`RRX
`
`RX
`
`SIB
`
`SPB
`
`SRB
`
`Stip.
`
`Tr.
`
`Respondent’s initial post-hearing brief
`
`Respondent’s physical exhibit
`
`Respondent’s Pre-hearing brief
`
`Respondent’s reply post-hearing brief
`
`Respondent’s rebuttal exhibit
`
`Respondent’s exhibit
`
`Staff’s initial post-hearing brief
`
`Staff’s Pre-hearing brief
`
`Staff’s reply post-hearing brief
`
`Stipulation of the parties
`
`Transcript
`
`VI
`
`PUBLIC VERSION
`
`

`

`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`Washington, D.C.
`
`
`In the Matter of
`
`CERTAIN STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION SYSTEMS, AND
`COMPONENTS THEREOF INCLUDING
`GENERATORS
`
`INV. NO. 337-TA-1110
`
`
`
`
`
`INITIAL DETERMINATION ON VIOLATION OF SECTION 337 AND
`RECOMMENDED DETERMINATION ON REMEDY AND BOND
`
`Administrative Law Judge Clark S. Cheney
`
`(August 1, 2019)
`
`Pursuant to the Notice of Investigation, 83 Fed. Reg. 19112 (May 1, 2018), this is the final
`
`Initial Determination in the matter of Certain Strontium-Rubidium Radioisotope Infusion Systems,
`
`and Components Thereof Including Generators, Investigation No. 337-TA-1110. 19 C.F.R.
`
`§§ 210.10(b), 210.42(a)(1)(i).
`
`For the reasons stated herein, I have determined that no violation of section 337 of the
`
`Tariff Act of 1930, as amended (19 U.S.C. § 1330 or “section 337”), has occurred in the
`
`importation into the United States, the sale for importation, or the sale within the United States
`
`after importation of certain strontium-rubidium radioisotope infusion systems, and components
`
`thereof, including generators, alleged to infringe U.S. Patent Nos. 9,814,826 (“the ’826 patent”),
`
`9,750,869 (“the ’869 patent”), and 9,750,870 (“the ’870 patent”).
`
`1
`
`PUBLIC VERSION
`
`

`

`
`
`I.
`
`INTRODUCTION
`
`A.
`
`Procedural History
`
`On April 3, 2018, complainant Bracco Diagnostics Inc. (“Bracco”) filed a complaint
`
`alleging violations of 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 one or more of U.S. Patent No. 9,814,826 (JX-0001, hereinafter “the ’826 patent”);
`
`U.S. Patent No. 9,750,869 (JX-0002, hereinafter “the ’869 patent”); and U.S. Patent No. 9,750,870
`
`(JX-0003, hereinafter “the ’870 patent”). 83 Fed. Reg. 14294 (April 3, 2018).
`
`On May 1, 2018, the Commission instituted this investigation to determine:
`
`whether there is a violation of subsection (a)(1)(b) of section 337 in the importation
`into the United States, the sale for importation, or 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 one or more
`claims 1-3, 5, 9-14, 17-19, 26, and 28 of the ’826 patent; claims 1-5, 8, 14, 24 and
`27-30 of the ’869 patent; and claims 1, 2, 8-13, 16, 17, 22, and 27 of the ’870 patent;
`and whether an industry in the United States exists, or is in the process of being
`established, as required by subsection (a)(2) of section 337.
`
`83 Fed. Reg. 19112 (May 1, 2018).
`
`The named respondents were Jubilant DraxImage Inc. of Quebec, Canada, Jubilant Pharma
`
`Limited of Singapore, and Jubilant Life Sciences of Uttar Pradesh, India (collectively “Jubilant”).
`
`See id. at 19113.
`
`The Commission investigative staff (“Staff”) is a party to this investigation. Id. at 19112.
`
`On August 8, 2018, Administrative Law Judge Shaw granted Bracco’s unopposed motion
`
`for termination of the investigation with respect to claims 10 and 26 of the ’826 patent, claims 27
`
`and 28 of the ’869 patent, and claims 9 and 22 of the ’870 patent. Order No. 15; see also Notice
`
`of a Comm’n Det. not to Review an Initial Det. Granting an Unopposed Mot. for Partial Term. of
`
`2
`
`PUBLIC VERSION
`
`

`

`
`
`the Inv. As to Certain Patent Claims (Sept. 6, 2018) (EDIS Doc. ID 655032). On September 20,
`
`2018, Administrative Law Judge Shaw granted Bracco’s unopposed motion for termination of the
`
`investigation with respect to claim 13 of the ’870 patent. Order No. 18; see also Notice of a
`
`Comm’n Det. not to Review an Initial Det. Granting an Unopposed Mot. for Partial Term. of the
`
`Inv. As to a Patent Claim (Sept. 26, 2018) (EDIS Doc. ID 656868).
`
`On February 8, 2019, I granted Bracco and Jubilant’s cross motions for summary
`
`determination with respect to whether certain accused products and proposed products practiced
`
`the asserted patent claims. Order No. 27, not reviewedNotice of a Comm’n Det. not to Review an
`
`Initial Det. Granting Summary Det. as to Certain Patent Infringement Issues (March 12, 2019)
`
`(EDIS Doc. ID 669522).
`
`I convened an evidentiary hearing on February 11-12 and 15-17, 2019, to determine
`
`whether section 337 has been violated by reason of the importation into the United States, the sale
`
`for importation, or the sale within the United States after importation of the infringing strontium-
`
`rubidium radioisotope infusion systems and components thereof.
`
`B.
`
`The Parties
`
`1.
`
`Complainant Bracco Diagnostics Inc.
`
`
`
`Bracco is a corporation organized and existing under the laws of Indiana, with its
`
`headquarters and principal place of business located at 259 Prospect Plains Road, Building H,
`
`Monroe Township, NJ, 08831. Compl. at ¶ 5. Bracco is the owner by assignment of the asserted
`
`patents in this investigation. See ’862 patent at Cover; ’869 patent at Cover; ’870 patent at Cover.
`
`2.
`
`The Jubilant Respondents
`
`
`
`Respondents Jubilant DraxImage Inc., Jubilant Pharma Limited, and Jubilant Life Sciences
`
`are related corporations. Response at ¶¶ 17-18. The companies sell a range of medical products,
`
`3
`
`PUBLIC VERSION
`
`

`

`
`
`including the radiopharmaceutical infusion and generation products at issue in this investigation.
`
`RPB at 2-3.
`
`a)
`
`Jubilant DraxImage Inc.
`
`Jubilant DraxImage Inc. is a Canadian corporation with its principal place of business at
`
`16751 TransCanada Highway Kirkland, Quebec, Canada, H9H 4J4. Amended Response at ¶ 13.
`
`Jubilant DraxImage Inc. is a subsidiary of Jubilant Pharma Limited. Id. at 17.
`
`b)
`
`Jubilant Pharma Limited
`
`Jubilant Pharma Limited is a Singaporean corporation with its principal place of business
`
`at 6 Temasek Boulevard, #20-06 Suntec City Tower Four, Singapore, 038986. Id. at ¶ 15. Jubilant
`
`Pharma Limited is a subsidiary of Jubilant Life Sciences Limited. Id. at 18.
`
`c)
`
`Jubilant Life Sciences
`
`Jubilant Life Sciences Limited is an Indian company with its principal place of business at
`
`Plot 1-A Sector 16-A Institutional Area Noida, Uttar Pradesh, 201301, India. Id. at ¶ 16.
`
`C.
`
`The Asserted Patents
`
`Bracco asserts claims of three related patents in this investigation: the ’826 patent, the ’869
`
`patent, and the ’870 patent. The appropriate priority date for the claimed inventions is disputed.
`
`On their face, all three patents claim priority to June 11, 2008. The parties agree that the earliest
`
`relevant priority date for all three patents is no earlier than June 11, 2009, the date Application No.
`
`PCT/US2009/047031 was filed. See CPB at 438; RPB at 91; SIB at 6. Jubilant alone asserts the
`
`priority date is later. RIB at 2-8. The named inventors on all three patents are Stephen E. Hidem,
`
`Aaron M. Fontaine, Janet L. Gelbach, Patrick M. McDonald, Kathryn M. Hunter, Rolf E. Swenson,
`
`and Julius P. Zodda. ’826 patent at Cover; ’869 patent at Cover; ’870 patent at Cover. All three
`
`4
`
`PUBLIC VERSION
`
`

`

`
`
`patents are assigned to Bracco. The asserted patents relate to strontium-rubidium elution and
`
`infusion systems used in positron emission tomography (“PET”) for cardiac imaging.
`
`1.
`
`U.S. Patent No. 9,814,826 (JX-0001)
`
`U.S. Patent No. 9,814,826, titled “Integrated Strontium-Rubidium Radioisotope Infusion
`
`Systems,” was issued by the U.S. Patent and Trademark Office (“PTO”) on November 14, 2017,
`
`from U.S. Application No. 15/620,320, filed on June 12, 2017. Bracco asserts claims 1-3, 5, 9,
`
`11-14, 17-19, and 28 of the ’826 patent.
`
`2.
`
`U.S. Patent No. 9,750,869 (JX-0002)
`
`U.S. Patent No. 9,750,869, titled “Integrated Strontium-Rubidium Radioisotope Infusion
`
`Systems,” was issued by the PTO on September 5, 2017, from U.S. Application No. 15/389,200,
`
`filed on December 22, 2016. Bracco asserts claims 1-5, 8, 14, 24, and 29-30 of the ’869 patent.
`
`3.
`
`U.S. Patent No. 9,750,870 (JX-0003)
`
`U.S. Patent No. 9,750,870, titled “Integrated Strontium-Rubidium Radioisotope Infusion
`
`Systems,” was issued by the PTO on September 5, 2017, from U.S. Application No. 15/490,484,
`
`filed on April 18, 2017. Bracco asserts claims 1, 2, 8, 10-12, 16-17, and 27 of the ’870 patent.
`
`D.
`
`The Technology at Issue
`
`All three asserted patents are directed to the same technology and share the same
`
`specification. The patents describe a computer-controlled medical device that generates the
`
`radioisotope rubidium-82 (Rb-82) and safely infuses a patient with the isotope in conjunction with
`
`PET imaging of the patient’s heart. The asserted claims are apparatus claims directed to the
`
`structure of the generator and infusion device, method claims for making the device, and method
`
`claims for using the device.
`
`5
`
`PUBLIC VERSION
`
`

`

`
`
`
`
`Rubidium-82 has been used as a radiation source for cardiac PET imaging for many
`
`decades, well before the invention in the patents at issue. See, e.g., RX-0207 (CardioGen-82
`
`Model 510 user manual); Tr. at 137:15-24, 589:18-590:8. Rubidium-82 is useful because of its
`
`relatively short half-life of 76 seconds and because it is absorbed by cardiac tissue proportionally
`
`to coronary-artery blood flow. RX-106.000017. Although the short half-life minimizes the
`
`patient’s radiation exposure, it requires that rubidium-82 be generated on-demand for each patient
`
`infusion. Id. at .0017-0018.
`
`For several decades, the medical imaging field has been generating rubidium-82 by passing
`
`.9% NaCl saline over another radioactive isotope, strontium-82 (Sr-82), in a device called a
`
`generator, a process called elution. RX-106.000018. The saline picks up rubidium atoms
`
`generated by the strontium as it decays and the resulting fluid, called an eluate, is infused into the
`
`patient.
`
`Some additional details about strontium will be helpful to understand the risks of rubidium
`
`infusion and the field of the claimed inventions. Strontium-82 is created in a very large, very
`
`expensive piece of equipment called a cyclotron particle accelerator. Ideally, the product of the
`
`cyclotron would be pure strontium-82, but the resultant material may have strontium-85 (Sr-85)
`
`impurities. Id. Strontium-82 has a half-life of 25.5 days, and strontium-85 has a substantially
`
`longer 65-day half-life. Id. Because strontium shares chemical properties with calcium, the human
`
`body readily absorbs it and binds it to bones and teeth. Id. at .000019. Consequently, if either
`
`Sr-82 or Sr-85 is accidentally administered to a patient during infusion, the patient will have a
`
`radiation source in his or her body emitting radiation for months. Id. Bone marrow is also
`
`particularly susceptible to damage from radiation exposure, rendering strontium exposure
`
`particularly dangerous for patient health. Id.
`
`6
`
`PUBLIC VERSION
`
`

`

`
`
`Inside a strontium-rubidium generator, strontium-82 is affixed to a tin oxide (SnO2)
`
`column. RX-106.000018. As the generator ages, strontium eventually starts to detach from the
`
`column and contaminate the eluate, posing a risk to patient health. Id. Such an occurrence is
`
`known as strontium “breakthrough.” Id. Strontium breakthrough can also be caused by a user
`
`putting the wrong solution into the generator. For example, one solution regularly used in medical
`
`settings, called ringer’s lactate, can displace substantial amounts of strontium from the core.
`
`Tr. at 451:9-452:1. On at least six occasions, operators have mistakenly run ringer’s lactate
`
`through a strontium-rubidium infusion system and injected a patient with strontium. Tr. at
`
`433:18-24.
`
`To prevent inadvertent patient exposure to strontium resulting from strontium
`
`breakthrough, operators must perform daily quality-control checks on the generator. RX-106 at
`
`.0019-.0020. In the prior art, such as with Bracco’s CardioGen-82 device, operators performed
`
`breakthrough tests manually. The test involved the operator manually transporting the radioactive
`
`eluate for testing and required the operator to accurately perform complex calculations.
`
`Tr. at 428:23-431:14.
`
`The asserted patents describe a strontium-rubidium infusion system “on-board” a cart. See,
`
`e.g., ’869 patent at claim 1. The system is configured to determine a strontium breakthrough test
`
`result from a sample on the cart and “not allow a patient infusion if the strontium breakthrough
`
`test result is greater than or equal to an allowed limit,” such as would occur in a strontium
`
`breakthrough event. See id.
`
`E.
`
`The Accused Products
`
`The accused products in this investigation are Jubilant’s RUBY Rubidium Elution
`
`Systems, the generators used in those systems, and the tubing sets used for the systems. Jubilant
`
`currently markets and sells the RUBY Rubidium Elution System Version 3 (“RUBY Version 3”)
`
`7
`
`PUBLIC VERSION
`
`

`

`
`
`in the United States, and the Commission has already found that the RUBY Version 3 practices all
`
`asserted patent claims. See Order No. 27, not reviewed Comm’n Det. not to Review an Initial Det.
`
`Granting Summary Det. (March 12, 2019) (EDIS Doc. ID 669522). Jubilant is also seeking
`
`approval of the U.S. Food and Drug Administration (“FDA”) to market the RUBY Rubidium
`
`Elution System Version 3.1 (“RUBY Version 3.1”) and RUBY Rubidium Elution System Version
`
`4 (“RUBY Version 4”) in the United States. See Tr. at 323:9-11. The Commission has found the
`
`designs of those two devices do not practice any claim of the asserted patents. Comm’n Det. not
`
`to Review an Initial Det. Granting Summary Det. (March 12, 2019) (EDIS Doc. ID 669522).
`
`All three RUBY Versions use the same generator, called the RUBY-FILL rubidium-82
`
`generator. The generators have a one or two month life before they must be replaced. Tr. at
`
`319:16-320:2. The eluate tubing for a rubidium infusion system must also be replaced regularly.
`
`Id. All three RUBY Versions use the same set of tubing called the RUBY Set. Tr. at 323:3-8.
`
`Typically, both Jubilant and Bracco sell their own branded tubing sets and generators, which are
`
`not interchangeable between the two manufacturer’s systems. See CX-0033C (“RUBY-FILL
`
`‘Family’ of Products”); CX-0566C (Gentilcore Dep. Tr.) at 149:3-150:1; RX-0411C (Troger Dep.
`
`Tr.) at 121:3-10; Tr. at 381:17-382:4; 876:20-25.
`
`F.
`
`The Domestic Industry Products
`
`Bracco’s CardioGen 1700 rubidium infusion system is the only potential domestic industry
`
`product at issue in this investigation. There is no dispute that the CardioGen1700 practices at least
`
`one claim of each of the asserted patents. Tr. at 28:7-10. Because the CardioGen 1700 is not FDA
`
`approved, however, the parties dispute whether a domestic industry exists or is in the process of
`
`being established for products that practice the asserted patents.
`
`8
`
`PUBLIC VERSION
`
`

`

`
`
`II.
`
`JURISDICTION & IMPORTATION
`
`A.
`
`Subject Matter Jurisdiction
`
`Section 337 confers subject matter jurisdiction on the Commission to investigate, and if
`
`appropriate, to provide a remedy for, unfair acts and unfair methods of competition in the
`
`importation of articles into the United States and the sale of such articles. See 19 U.S.C.
`
`§§ 1337(a)(1)(B) and (a)(2). Bracco filed a complaint alleging a violation of section 337, and the
`
`Commission has subject matter jurisdiction over the complaint. See Amgen, Inc. v. Int’l. Trade
`
`Comm’n, 902 F.2d 1532, 1536 (Fed. Cir. 1990).
`
`B.
`
`Personal Jurisdiction
`
`Jubilant has appeared and participated in this investigation. The Commission therefore has
`
`personal jurisdiction over Jubilant. See, e.g., Certain Magnetic Tape Cartridges and Components
`
`Thereof, Inv. No. 337-TA-1058, ID at 12 (Aug. 17, 2018) (EDIS Doc. No. 653306) (unreviewed
`
`in relevant part).
`
`C.
`
`In Rem Jurisdiction
`
`The parties have stipulated that Jubilant Labs has imported the RUBY Version 3.1 and
`
`Version 4, as well as the generators and tubing used for all three RUBY Versions (3, 3.1, and 4).
`
`RPB at 40; Stip. at ¶ 2 (EDIS Doc. ID 664016, at Ex. H). Accordingly, the Commission has in
`
`rem jurisdiction over the accused products. See Sealed Air Corp. v. Int’l Trade Comm’n, 645 F.2d
`
`976, 985-86 (C.C.P.A. 1981) (noting that the Commission has jurisdiction over imported goods).
`
`
`
`D.
`
`Importation
`
`The RUBY Version 3 infusion device is made in the United States; it is not imported.
`
`But the generator and tubing sets used with Jubilant’s products are imported. Specifically, the
`
`parties have stipulated that Jubilant DraxImage Inc. has imported the RUBY-FILL rubidium
`
`9
`
`PUBLIC VERSION
`
`

`

`
`
`generator and the RUBY Set. Stip. at ¶¶ 2, 4. The parties have also stipulated that Jubilant has
`
`imported other components of the system, including the RUBY Saline Line, the RUBY IN Line,
`
`and RUBY Connectors. Id. It is undisputed that Jubilant also imported prototypes of the RUBY
`
`Version 3.1 and Version 4 designs. Order No. 27 at 18. I find that the importation requirement
`
`of section 337 has been satisfied.
`
`E.
`
`Standing
`
`
`
`The evidence of record demonstrates that Bracco, as assignee of the asserted patents, has
`
`standing to bring its complaint. See ’826 patent at Cover; ’869 patent at Cover; ’870 patent at
`
`Cover. Accordingly, I find that Bracco has standing in this investigation.
`
`III. LEGAL PRINCIPLES
`
`A.
`
`Claim Construction
`
`“An infringement analysis entails two steps. The first step is determining the meaning and
`
`scope of the patent claims asserted to be infringed. The second step is comparing the properly
`
`construed claims to the device accused of infringing.” Markman v. Westview Instruments, Inc., 52
`
`F.3d 967, 976 (Fed. Cir. 1995) (en banc) (internal citations omitted), aff’d, 517 U.S. 370 (1996).
`
`Claim construction resolves legal disputes between the parties regarding claim scope. See Eon
`
`Corp. IP Holdings v. Silver Spring Networks, 815 F.3d at 1314, 1319 (Fed. Cir. 2016).
`
`Evidence intrinsic to the application, prosecution, and issuance of a patent is the most
`
`significant source of the legally operative meaning of disputed claim language. See Bell Atl.
`
`Network Servs., Inc. v. Covad Commc’ns Grp., Inc., 262 F.3d 1258, 1267 (Fed. Cir. 2001). The
`
`intrinsic evidence includes the claims themselves, the specification, and the prosecution history.
`
`See Phillips v. AWH Corp, 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc); see also
`
`Markman, 52 F.3d at 979. As the Federal Circuit explained in Phillips, courts must analyze each
`
`10
`
`PUBLIC VERSION
`
`

`

`
`
`of these components to determine the “ordinary and customary meaning of a claim term” as
`
`understood by a person of ordinary skill in the art at the time of the invention. 415 F.3d at 1313.
`
`“It is a ‘bedrock principle’ of patent law that ‘the claims of a patent define the invention to
`
`which the patentee is entitled the right to exclude.’” Phillips, 415 F.3d at 1312 (quoting
`
`Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir.
`
`2004)). “Quite apart from the written description and the prosecution history, the claims
`
`themselves provide substantial guidance as to the meaning of particular claims terms.” Id. at 1314;
`
`see Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001) (“In
`
`construing claims, the analytical focus must begin and remain centered on the language of the
`
`claims themselves, for it is that language that the patentee chose to use to ‘particularly point[ ] out
`
`and distinctly claim[ ] the subject matter which the patentee regards as his invention.”’). The
`
`context in which a term is used in an asserted claim can be “highly instructive.” Phillips, 415 F.3d
`
`at 1314. Additionally, other claims in the same patent, asserted or unasserted, may also provide
`
`guidance as to the meaning of a claim term. Id.
`
`The specification “is always highly relevant to the claim construction analysis. Usually, it
`
`is dispositive; it is the single best guide to the meaning of a disputed term.” Id. at 1315 (quoting
`
`Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). “[T]he specification
`
`may reveal a special definition given to a claim term by the patentee that differs from the meaning
`
`it would otherwise possess. In such cases, the inventor’s lexicography governs.” Id. at 1316. “In
`
`other cases, the specification may reveal an intentional disclaimer, or disavowal, of claim scope
`
`by the inventor.” Id. As a general rule, however, the particular examples or embodiments
`
`discussed in the specification are not to be read into the claims as limitations. Id. at 1323. In the
`
`end, “[t]he construction that stays true to the claim language and most naturally aligns with the
`
`11
`
`PUBLIC VERSION
`
`

`

`
`
`patent’s description of the invention will be . . . the correct construction.” Id. at 1316 (quoting
`
`Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998)).
`
`When the intrinsic evidence does not establish the meaning of a claim, then extrinsic
`
`evidence (i.e., all evidence external to the patent and the pro