UNITED STATES INTERNATIONAL TRADE COMMISSION
`Washington, D.C.
`
`Before the Honorable David Shaw
`Administrative Law Judge
`
`In the Matter of
`
`CERTAIN STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION SYSTEMS,
`AND COMPONENTS THEREOF
`INCLUDING GENERATORS
`
`Inv. No. 337-TA-1110
`
`COMPLAINANT BRACCO DIAGNOSTICS INC.’S RESPONSES TO
`RESPONDENTS JUBILANT DRAXIMAGE, INC.’S, JUBILANT
`PHARMA LIMITED’S, AND JUBILANT LIFE SCIENCES’
`FOURTH SET OF INTERROGATORIES (No. 68)
`
`Pursuant to the United States International Trade Commission’s Rule of Practice and
`
`Procedure, 19 C.F.R. §§ 210.27 and 210.29 Complainant Bracco Diagnostics Inc. (“Bracco”), by
`
`its attorneys, hereby objects and responds to Respondents Jubilant DraxImage, Inc.’s, Jubilant
`
`Pharma Limited’s, and Jubilant Life Sciences’ (collectively “Respondents” or “Jubilant”) Third
`
`Set of Interrogatories (No. 68) (the “Interrogatories” or, individually, the “Interrogatory”) to
`
`Bracco as follows:
`
`PRELIMINARY STATEMENT
`
`All Responses are submitted as presently advised, and without prejudice to Bracco’s right
`
`to modify, amend, revise, correct, supplement, add to or clarify such Responses at the
`
`appropriate time.
`
`Bracco has not completed its discovery, investigation, research, and trial preparation.
`
`The following Responses are based solely on the information that is presently available and
`
`specifically known to Bracco. The following Responses are given without prejudice to Bracco’s
`
`JUBILANT EXHIBIT 1031
`Jubilant v. Bracco, IPR2018-01449
`
`
`Washington, D.C.
`
`Before the Honorable David Shaw
`Administrative Law Judge
`
`In the Matter of
`
`CERTAIN STRONTIUM-RUBIDIUM
`RADIOISOTOPE INFUSION SYSTEMS,
`AND COMPONENTS THEREOF
`INCLUDING GENERATORS
`
`Inv. No. 337-TA-1110
`
`COMPLAINANT BRACCO DIAGNOSTICS INC.’S RESPONSES TO
`RESPONDENTS JUBILANT DRAXIMAGE, INC.’S, JUBILANT
`PHARMA LIMITED’S, AND JUBILANT LIFE SCIENCES’
`FOURTH SET OF INTERROGATORIES (No. 68)
`
`Pursuant to the United States International Trade Commission’s Rule of Practice and
`
`Procedure, 19 C.F.R. §§ 210.27 and 210.29 Complainant Bracco Diagnostics Inc. (“Bracco”), by
`
`its attorneys, hereby objects and responds to Respondents Jubilant DraxImage, Inc.’s, Jubilant
`
`Pharma Limited’s, and Jubilant Life Sciences’ (collectively “Respondents” or “Jubilant”) Third
`
`Set of Interrogatories (No. 68) (the “Interrogatories” or, individually, the “Interrogatory”) to
`
`Bracco as follows:
`
`PRELIMINARY STATEMENT
`
`All Responses are submitted as presently advised, and without prejudice to Bracco’s right
`
`to modify, amend, revise, correct, supplement, add to or clarify such Responses at the
`
`appropriate time.
`
`Bracco has not completed its discovery, investigation, research, and trial preparation.
`
`The following Responses are based solely on the information that is presently available and
`
`specifically known to Bracco. The following Responses are given without prejudice to Bracco’s
`
`JUBILANT EXHIBIT 1031
`Jubilant v. Bracco, IPR2018-01449
`
`
`
`right to produce evidence of any subsequently-discovered facts. Bracco reserves the right to
`
`supplement the following Responses and to change any and all Responses therein as additional
`
`facts are ascertained, analyses are made, legal research is completed and contentions are made.
`
`Bracco’s Responses are subject to the Protective Order (Order No. 1).
`
`By providing responses to these Interrogatories, Bracco does not waive any objections it
`
`may have on the grounds of relevance, authenticity, admissibility, attorney-client privilege,
`
`attorney work product, and/or any other privilege or immunity. Bracco expressly reserves the
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`right, at any time, to object to the wording, implication, and/or characterization of any response
`
`to an Interrogatory. Finally, Bracco’s objections as set forth herein are made without prejudice
`
`to Bracco’s right to assert any additional or supplemental objections should Bracco discover
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`additional grounds for such objections.
`
`GENERAL OBJECTIONS
`
`Bracco responds and objects to Jubilant’s Interrogatories as set forth below. The
`
`following General Objections shall be applicable to, and shall be incorporated by reference in,
`
`Bracco’s response to each Interrogatory, whether or not mentioned expressly in any particular
`
`response. Bracco does not waive any of its General Objections by stating specific responses and
`
`objections to any particular Interrogatory or by failing to repeat a General Objection.
`
`1.
`
`Bracco objects to Jubilant’s Instructions and Definitions to the extent that they
`
`attempt to impose upon Bracco any obligations different from or in addition to those imposed by
`
`the United States International Trade Commission’s Rules of Practice and Procedure or the
`
`Ground Rules in this Investigation. Bracco further objects to Jubilant’s Instructions and
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`Definitions to the extent that they seek to embrace information and/or documentation outside of
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`the possession, custody or control of Bracco.
`
`2
`
`
`
`2.
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`Bracco objects to Jubilant’s Interrogatories to the extent they seek disclosure of
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`information protected by the attorney-client privilege, work-product doctrine or any other
`
`applicable privileges. Bracco hereby asserts such privileges and immunities to the extent that
`
`they are implicated by each Interrogatory, and excludes privileged and protected information
`
`from its responses. Any disclosure of such information is inadvertent and is not intended to
`
`waive privilege. An objection asserting that an Interrogatory seeks privileged information
`
`should not be construed as a representation that such information exists or existed. Such
`
`objection indicates only that the Interrogatory is of such a scope that it could embrace privileged
`
`subject matter.
`
`3.
`
`Bracco objects to Jubilant’s Interrogatories to the extent that they require the
`
`premature disclosure of expert testimony and/or expert analysis in advance of their respective
`
`deadlines governing this Investigation.
`
`4.
`
`Bracco objects to Jubilant’s Interrogatories to the extent that they seek
`
`information beyond the scope of the United States International Trade Commission’s Rules of
`
`Practice and Procedure; seek discovery that is unreasonably cumulative or duplicative; are
`
`unduly burdensome and oppressive; and may otherwise be construed to require responses
`
`beyond those required by the United States International Trade Commission’s Rules of Practice
`
`and Procedure.
`
`5.
`
`Bracco objects to Jubilant’s Interrogatories to the extent that they seek
`
`information and/or documents that are: (i) obtainable by Jubilant from other sources that are
`
`more convenient, less burdensome, less expensive; (ii) publicly available or otherwise is readily
`
`available to Jubilant; and/or (iii) already in Jubilant’s knowledge, possession and/or control
`
`because such information has been produced, or will be produced by Bracco.
`
`3
`
`
`
`6.
`
`Bracco objects to Jubilant’s Interrogatories to the extent they seek information
`
`not relevant to the issues raised in this Investigation, proportional to the needs of this
`
`Investigation, or relevant to the subject matter of this action. Nothing herein shall be construed
`
`as an admission by Bracco respecting the admissibility or relevance of any fact, or as an
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`admission of the truth or accuracy of any characterization, description or definition of any kind
`
`contained in Jubilant’s Interrogatories.
`
`7.
`
`Bracco objects to Jubilant’s Interrogatories to the extent that they are vague,
`
`ambiguous, overly broad, and/or unduly burdensome.
`
`8.
`
`Bracco objects to Jubilant’s Interrogatories to the extent the burden or expense of
`
`the proposed discovery outweighs its likely benefit, considering the needs of this Investigation,
`
`and the importance of the discovery in resolving the issues to be decided by the Commission.
`
`9.
`
`Bracco objects to each of Jubilant’s Interrogatories as unduly burdensome,
`
`insofar as any Interrogatory is cumulative or duplicative of other Interrogatories.
`
`10.
`
`Bracco objects to Jubilant’s Interrogatories to the extent that they request
`
`disclosure of Bracco’s trade secrets or other confidential or proprietary business information.
`
`11.
`
`Bracco objects to Jubilant’s Interrogatories as being premature to the extent it
`
`seeks Bracco’s electronically stored information (ESI) before the parties have negotiated a
`
`schedule for the exchange, if any, of ESI.
`
`12.
`
`Bracco objects to Jubilant’s Interrogatories to the extent that they seek
`
`production of information and/or documents in the possession of a third party or otherwise
`
`outside of Bracco’s possession, custody or control.
`
`
`
`4
`
`
`
`13.
`
`Bracco objects to Jubilant’s Interrogatories to the extent that they include terms
`
`that have not been appropriately defined. The use of such terms renders these Interrogatories
`
`unduly vague, ambiguous, and not reasonably susceptible to responses.
`
`14.
`
`Bracco objects to Jubilant’s Interrogatories to the extent they call for information
`
`that is subject to the privacy and/or confidentiality rights of third parties, either in the United
`
`States or any foreign country. Bracco will not disclose such information in responding to these
`
`Interrogatories, including, for example, clinical and individual patient level data and private
`
`information subject to the Health Insurance Portability and Accountability Act (“HIPAA”), or
`
`any other applicable privacy laws.
`
`15.
`
`Bracco objects to Jubilant’s Interrogatories to the extent they are not reasonably
`
`limited in time.
`
`16.
`
`Bracco objects to Jubilant’s Definition of “Bracco Domestic Industry Product(s)”
`
`on the grounds overly broad and unduly burdensome to the extent it purports to include any
`
`products other than the domestic industry product identified by Bracco. Bracco will construe
`
`the term “Bracco Domestic Industry Product” to mean the CardioGen-82® Infusion System,
`
`Model 1700 (hereinafter “Model 1700”).
`
`17.
`
`Bracco objects to each interrogatory, definition, and instruction to the extent that
`
`it contains multiple subparts or the definition or instruction renders an interrogatory compound.
`
`Such interrogatories constitute separate interrogatories that count toward the limit on
`
`interrogatories that Jubilant is permitted to propound. Bracco objects to each and every
`
`interrogatory that would exceed such limit.
`
`18.
`
`Bracco objects to the definitions of “Complainant,” “Bracco,” “you,” and “your”
`
`on the grounds that they are overly broad and unduly burdensome to the extent it purports to
`
`
`
`5
`
`
`
`include any entity other than the Bracco entity named in this action. Bracco will respond to the
`
`Jubilant’s Interrogatories only on behalf of the named Complainant Bracco Diagnostics Inc.
`
`19.
`
`Bracco objects to the definition of “Bracco Group” on the grounds that it is
`
`overly broad and unduly burdensome to the extent it purports to include any entity other than
`
`the Bracco entity named in this action. Bracco will respond to the Jubilant’s Interrogatories
`
`only on behalf of the named Complainant Bracco Diagnostics Inc.
`
`20.
`
`Bracco objects to the definition of “Related Patents” on the grounds that it is
`
`overly broad and unduly burdensome. Bracco further objects to the definition of “Related
`
`Patents” to the extent it purports to include “all issued patents and abandoned or pending patent
`
`applications related to the Patents-in-Suit” and “any other U.S. or non-U.S. foreign patents and
`
`patent applications that disclose, describe, or claim any invention disclosed, described, or
`
`claimed in Patents-in-Suit, or that claim priority from the Patents-in-Suit,” on the grounds that
`
`incorporating such terms is neither relevant to the issues raised in this Investigation nor
`
`proportional to the needs of this Investigation, and are contrary to the United States International
`
`Trade Commission’s Rules of Practice and Procedure.
`
`21.
`
`Bracco objects to the Definitions Nos. 11–15 to the extent they purport to require
`
`Bracco to disclose identifying information beyond what is required by the Federal Rule of Civil
`
`Procedure, Commission’s Rules of Practice and Procedure, and Ground Rules issued in this
`
`Investigation, or purport to require information that is not within Bracco’s possession, custody,
`
`or control.
`
`22.
`
`Bracco objects to the Definitions Nos. 5, 7–8, and 18 as vague and ambiguous,
`
`overly broad, and unduly burdensome to the extent that the definitions (in combination with the
`
`individual Interrogatories): (i) seek to encompass information that is neither relevant nor
`
`
`
`6
`
`
`
`proportional to the needs of this Investigation; (ii) are not reasonably limited in time or scope;
`
`(iii) seek to encompass information not within Bracco’s possession, custody, or control; and/or
`
`(iv) seek to encompass information protected from disclosure by the attorney-client privilege,
`
`the work product doctrine the common interest privilege, or any other applicable privilege or
`
`immunity. Bracco also objects to these definitions to the extent they presume that Bracco has
`
`knowledge of each of the persons or entities within the scope of the definitions.
`
`23.
`
`Bracco gives the following objections and responses without waiving its right to
`
`produce evidence at any hearing, or in any other proceeding in this Investigation, of any
`
`subsequently-ascertained facts. Bracco provides these objections and responses without
`
`admitting or waiving objections to the materiality, relevance, or admissibility in evidence of the
`
`matters set forth.
`
`24.
`
`Bracco’s responses herein are based upon present knowledge, information and
`
`belief following its diligent search and reasonable inquiry. Discovery and investigation are
`
`ongoing and Bracco reserves its right to amend, correct, supplement, or clarify its answers upon,
`
`among other things: further investigation; discovery of additional facts; discovery of persons
`
`with knowledge or relevant information; or developments in this Investigation or any other
`
`proceeding. Bracco reserves the right to rely on any facts, documents or other evidence that
`
`may develop or come to its attention during discovery in this Investigation.
`
`SPECIFIC RESPONSES AND OBJECTIONS
`
`Without waiving the foregoing General Objections, Bracco further responds and objects
`
`to the Interrogatories as follows:
`
`INTERROGATORY NO. 68:
`
`Describe the level of education, training and experience that
`
`You contend was held by a person of ordinary skill in the art at the time of the invention of the
`
`subject matter disclosed and claimed in the Asserted Patents.
`
`
`
`7
`
`
`
`RESPONSE TO INTERROGATORY NO. 68:
`
`Bracco specifically incorporates its general
`
`objections herein as if fully set forth in response to this Interrogatory. In addition, Bracco
`
`objects to this Interrogatory to the extent that it seeks the premature disclosure of expert
`
`testimony and/or expert analysis in advance of the respective deadlines governing this
`
`Investigation. Bracco further objects to this Interrogatory to the extent it requires Bracco to
`
`perform a legal analysis or reach a legal conclusion. Bracco further objects to this Interrogatory
`
`to the extent it seeks information protected by the attorney-client privilege, the work-product
`
`doctrine, or any other applicable privilege or immunity. Bracco further objects to this
`
`Interrogatory to the extent it seeks information outside of Bracco’s possession, custody, or
`
`control. Subject to the aforementioned general and specific objections, Bracco responds as
`
`follows:
`
`
`
`A person of ordinary skill in the art (“POSITA”) at the time of the invention claimed in
`
`the Asserted Patents would generally have a graduate degree in medicine and/or in a medical
`
`related science, including physics, chemistry, biology, physiology, and/or biophysics, or a related
`
`field, and would generally have at least some clinical, research, and/or design experience with
`
`respect to Positron Emission Tomography (“PET”) imaging and/or PET imaging systems.
`
`Bracco reserves the right to amend or supplement this response as discovery in this
`
`matter is ongoing.
`
`
`
`
`
`Dated: August 6, 2018
`
`Respectfully Submitted,
`
`By: /s/ Mark G. Davis
`
`
`
`Mark Davis
`Patrick J. McCarthy
`GOODWIN PROCTER LLP
`901 New York Avenue, NW
`Washington, DC 20001
`
`
`
`8
`
`
`
`Tel: (202) 346-4090
`Email: markdavis@goodwinlaw.com
`Email: pmccarthy@goodwinlaw.com
`
`Scott Bornstein
`Brian J. Prew
`GREENBERG TRAURIG, LLP
`MetLife Building
`200 Park Avenue
`New York, NY 10166
`Tel: (212) 801-9200
`Email: bornsteins@gtlaw.com
`Email: prewb@gtlaw.com
`
`ATTORNEYS FOR COMPLAINANT THE
`BRACCO CORPORATION
`
`
`
`9
`
`
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I, Colleen Sphar, hereby certify that on this 6th day of August, 2018, copies of the
`
`foregoing were served upon the following parties as indicated:
`
`Via Email
`
`Via Email
`
`Brian Koo
`The Office of Unfair Import Investigations
`U.S. International Trade Commission
`500 E Street, S.W., Suite 401
`Washington, DC 20436
`brian.koo@usitc.gov
`
`Counsel for the Office of Unfair Import Investigations
`T. Cy Walker
`Robert L. Hails, Jr.
`Shawnna M. Yashar
`BAKER & HOSTETLER LLP
`1050 Connecticut Ave. NW
`Washington, DC 20036
`Phone: 202-861-1500
`Facsimile: 202-861-1783
`Jubilant-Baker@bakerlaw.com
`
`Jared A. Brandyberry
`BAKER & HOSTETLER LLP
`1801 California Street, Suite 4400
`Denver, CO 80202
`Phone: 303-861-0600
`Facsimile: 303-861-7805
`Jubilant-Baker@bakerlaw.com
`
`Kevin P. Flynn
`BAKER & HOSTETLER LLP
`312 Walnut Street, Suite 3200
`Cincinnati, OH 45202
`Phone: 513-929-3400
`Facsimile: 513-929-0303
`Jubilant-Baker@bakerlaw.com
`
`Theresa Weisenberger
`BAKER & HOSTETLER LLP
`1170 Peachtree Street, NE., Suite 2400
`Atlanta, GA 30309
`Phone: 404-459-0050
`Facsimile: 404-459-5734
`
`10
`
`
`
`Jubilant-Baker@bakerlaw.com
`
`Charlie Lyu
`BAKER & HOSTETLER LLP
`Cira Centre
`2929 Arch Street, 12th Floor
`Philadelphia, PA 19104
`Phone: 215-568-3100
`Facsimile: 215-568-3439
`Jubilant-Baker@bakerlaw.com
`
`John T. Gallagher
`James F. Harrington
`Hoffmann & Baron, LLP
`6900 Jericho Turnpike
`Syosset, New York 11791
`Telephone: (516) 822-3550
`Facsimile: (516) 822-3582
`jgallagher@hbiplaw.com
`jharrington@hbiplaw.com
`
`Counsel for Respondents Jubilant Draximage Inc.,
`Jubilant Pharma Limited, And Jubilant Life Sciences
`
`/s/ Colleen Sphar
`Colleen Sphar
`Paralegal
`
`11
`
`
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