Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 1 of 14 PageID #:2483
`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 1 of 14 PageID #:2483
`
`EXHIBIT 5
`
`EXHIBIT 5
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`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 1 of 14 PageID #:2483
`
`EXHIBIT 5
`
`EXHIBIT 5
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`
`
`
`
`HOSPIRA, INC.,
`
`
`Plaintiff,
`
`
`
`
`
`
`
`
`C.A. No. 1:16-cv-00651
`
`CONTAINS INFORMATION
`DESIGNATED CONFIDENTIAL BY
`PLAINTIFFS
`
`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 2 of 14 PageID #:2484
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
`
`v.
`
`FRESENIUS KABI USA, LLC
`
`
`Defendants.
`
`
`
`
`FRESENIUS KABI’S THIRD SET OF INTERROGATORIES
`TO PLAINTIFF (NOS. 14-16)
`
`Pursuant to Federal Rule of Civil Procedure 33 and the applicable Local Rules of the
`
`United States District Court of the Northern District of Illinois, Defendant Fresenius Kabi USA,
`
`LLC (“Fresenius Kabi”) submits to Plaintiff Hospira, Inc. (“Plaintiff”) the following
`
`interrogatories. Plaintiff is required to answer each interrogatory separately and fully in writing,
`
`under oath, and to serve a copy of its answers within thirty (30) days from service hereof. The
`
`interrogatories shall be read and interpreted in accordance with the definitions and instructions
`
`set forth below.
`
`DEFINITIONS & INSTRUCTIONS
`
`The definitions set forth in Fresenius Kabi’s First Set of Requests for Production of
`
`Documents and Things to Plaintiff (Nos. 1-54) and Fresenius Kabi’s First Set of Interrogatories
`
`(Nos. 1–9) are incorporated herein by reference.
`
`“1994 License and Supply Agreement” means the September 9, 1994 License and Supply
`
`agreement between Abbott Laboratories and Orion Corporation, which Abbott assigned to
`
`
`
`
`
`
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`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 3 of 14 PageID #:2485
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`Hospira on May 1, 2004, including all supplements, riders, related agreements, and other
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`documents incorporated by reference.
`
`“Abbott” means Abbott Laboratories, an Illinois corporation having its principal place of
`
`business in Abbott Park, Illinois.
`
`“DDI Presentation” means the “Precedex®Pre-mix Research presented to Hospira, Inc. in
`
`July 2009 by Decision Development, Inc.” at HOSPIRA_00507545, which summarized research
`
`Decision Development, Inc. conducted on behalf of Hospira.
`
`“Dexmedetomidine IND” means the Investigational New Drug Application No. 32,934
`
`for dexmedetomidine hydrochloride submitted on March 17, 1989 by Farmos Group Ltd.
`
`“Orion” means Orion Corporation, a corporation organized under the laws of Finland and
`
`having its principal place of business in Espoo, Finland, including Farmos Group Ltd., a former
`
`subsidiary of Orion, which merged with Orion in 1990.
`
`
`
`Interrogatory No. 14
`
`INTERROGATORIES
`
`Describe Hospira’s acquisition of the dexmedetomidine product from Abbott as identified
`
`in e.g., HOSPIRA_00356713–21, including, but not limited to:
`
`• any cash, shares, or dividends paid to Abbott or its investors as a result of the
`
`Hospira spin-off;
`
`• contractual rights and obligations transferred from Abbott to Hospira;
`
`•
`
`•
`
`regulatory rights and obligations transferred from Abbott to Hospira, including the
`
`Dexmedetomidine IND, any NDAs, or other regulatory files;
`
`rights to intellectual property transferred from Abbott to Hospira;
`
`2
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`
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`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 4 of 14 PageID #:2486
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`• physical property transferred from Abbott to Hospira, including physical files
`
`related to the dexmedetomidine product, inventory of dexmedetomidine products,
`
`product ampoules manufactured by Orion, pharmaceutical ingredients, or
`
`manufacturing equipment; and
`
`• documents identifying the payment of royalty, milestone, and other payments to
`
`Orion as a result of the 1994 License and Supply Agreement.
`
`
`
`Interrogatory No. 15
`
`
`
`Describe Hospira’s knowledge of use by anyone of any ready to use dexmedetomidine
`
`formulations, including, but not limited to, dexmedetomidine formulations containing a
`
`concentration of dexmedetomidine of 5, 10, 20, 100 or 200 mcg/ml dexmedetomidine
`
`hydrochloride (e.g., knowledge of the dexmedetomidine formulations used for Study No. F-DEX-
`
`CL-0690-USA
`
`identified
`
`in
`
`the Dexmedetomidine
`
`IND
`
`(HOSPIRA_00312435;
`
`HOSPIRA_00132584; HOSPIRA_00312442; HOSPIRA_00312443)), and identify whether
`
`Hospira used any ready to use dexmedetomidine formulations prior to 2012, including use in
`
`clinical trials.
`
`
`
`Interrogatory No. 16
`
`
`
`Identify whether the contents of the DDI Presentation were subject to any confidentiality
`
`or non-disclosure provisions, including whether Hospira contends that the physicians and hospital
`
`pharmacists interviewed for the DDI Presentation were bound by non-disclosure and/or
`
`confidentiality agreements. If so, please describe the non-disclosure or confidentiality obligations
`
`and provisions, and provide or identify all evidence that substantiates Hospira’s contentions.
`
`
`
`3
`
`
`
`
`
`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 5 of 14 PageID #:2487
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`Dated: January 2, 2018
`
`SCHIFF HARDIN LLP
`
`
`
`
`/s/_Joel M. Wallace
`Imron T. Aly
`Joel M. Wallace
`Tara Kurtis
`Emily M. Peña
`233 South Wacker Drive, Suite 6600
`Chicago, Illinois 60606
`(312) 258-5500
`ialy@schiffhardin.com
`jwallace@schiffhardin.com
`tkurtis@schiffhardin.com
`epena@schiffhardin.com
`
`Ahmed M.T. Riaz (pro hac vice)
`666 Fifth Avenue, 17th Floor
`New York, NY 10103
`(212) 753-5000
`ariaz@schiffhardin.com
`
`
`Attorneys for Defendant/Counterclaimant Fresenius Kabi
`USA, LLC
`
`
`4
`
`
`
`
`
`
`
`
`
`
`
`
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`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 6 of 14 PageID #:2488
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`CERTIFICATE OF SERVICE
`
`I hereby certify pursuant to Fed. R. Civ. P. 5 and LR 5.5 that on January 2, 2018, I caused
`
`a copy of the foregoing FRESENIUS KABI’S THIRD SET OF INTERROGATORIES TO
`
`PLAINTIFF (NOS. 14-16) to be transmitted via electronic mail to the following counsel of
`
`record:
`
`
`
`
`
`
`
`
`
`Bradford P. Lyerla
`Sara T. Horton
`Yusuf Esat
`Chad Ray
`JENNER & BLOCK LLP
`353 N. Clark Street
`Chicago, IL 60654-3456
`Tel.: (312) 222-9350
`Fax: (312) 527-0484
`blyerla@jenner.com
`shorton@jenner.com
`yesat@jenner.com
`cray@jenner.com
`
`Attorneys for Plaintiff Hospira, Inc.
`
` /s/__Joel M. Wallace
`Joel M. Wallace
`
`
`
`
`
`5
`
`
`
`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 7 of 14 PageID #:2489
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
`
`HOSPIRA, INC.,
`
`Plaintiff,
`
`C.A. No. 1:16-cv-00651
`
`v.
`
`FRESENIUS KABI USA, LLC
`
`Defendants.
`
`CONTAINS INFORMATION
`DESIGNATED CONFIDENTIAL BY
`PLAINTIFF
`
`FRESENIUS KABI’S SECOND SET OF REQUESTS FOR ADMISSION
`TO PLAINTIFF (NOS. 121– 135)
`
`Pursuant to Federal Rule of Civil Procedure 34 and the applicable Local Rules of the
`
`United States District Court of the Northern District of Illinois, Defendant Fresenius Kabi USA,
`
`LLC (“Fresenius Kabi”) submits to Plaintiff Hospira, Inc. (“Plaintiff”) the following requests for
`
`admission. Plaintiff is required to answer each request for admission separately and fully in
`
`writing, under oath, and to serve a copy of its answers within thirty (30) days from service
`
`hereof. The requests for admission shall be read and interpreted in accordance with the
`
`definitions and instructions set forth below.
`
`DEFINITIONS & INSTRUCTIONS
`
`The definitions set forth in Fresenius Kabi’s First Set of Requests for Production of
`
`Documents and Things to Plaintiff (Nos. 1-54) and First Set of Interrogatories (Nos. 1–9) are
`
`incorporated herein by reference.
`
`1.
`
`Any term not yet defined should be read consistent with the ordinary usage of the
`
`term in the art.
`
`
`
`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 8 of 14 PageID #:2490
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`2.
`
`“Asserted Claims” means the claims of the patents-in-suit asserted by Hospira
`
`against Fresenius Kabi in this action, as set forth in Hospira’s Final Infringement Contentions.
`
`3.
`
` “1994 License and Supply Agreement” means the September 9, 1994 License
`
`and Supply agreement, originallybetween Abbott Laboratories and Orion Corporation, and later
`
`assigned by Abbott to Hospira on May 1, 2004. The assignment to Hospira included all
`
`supplements, riders, related agreements, and other documents incorporated by reference into the
`
`1994 License and Supply Agreement.
`
`4.
`
`“Abbott” means Abbott Laboratories, an Illinois corporation having its principal
`
`place of business in Abbott Park, Illinois.
`
`5.
`
`“Dexmedetomidine IND” means Investigational New Drug Application No.
`
`32,934 for dexmedetomidine hydrochloride submitted on March 17, 1989 by Farmos Group Ltd.
`
`6.
`
`“Orion” means Orion Corporation, a corporation organized under the laws of
`
`Finland and having its principal place of business in Espoo, Finland.
`
`7.
`
`“Farmos” means Farmos Group Ltd., a corporation that was organized under the
`
`laws of Finland and had its principal place of business in Turku, Finland, prior to becoming a
`
`subsidiary of Orion Corporation in 1989 and merging with Orion in 1990.
`
`8.
`
`“Dexmedetomidine Know-How” is defined in the 1994 License and Supply
`
`Agreement at HOSPIRA_02013606 as Orion Know-How. The definition includes all non-
`
`patented and unpublished non-clinical, pre-clinical and clinical documentation, information, and
`
`data relating to dexmedetomidine hydrochloride.
`
`9.
`
`“The December 18, 1989 Study” means the clinical trial identified at
`
`HOSPIRA_00312454 titled “The pharmacokinetics and pharmacodynamics of dexmedetomidine
`
`hydrochloride in adult volunteers” and dated December 18, 1989.
`
`2
`
`
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`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 9 of 14 PageID #:2491
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`10.
`
`Respond to each request separately in a written response containing one or more
`
`of the following: an admission, a denial, an objection.
`
`11.
`
`12.
`
`If a portion of a request is true, admit that portion of the request in your response.
`
`If a portion of your response to a request is subject to attorney-client privilege or
`
`the work-product doctrine: (i) specify the subject matter for which you claim protection (ii) state
`
`the type of protection claimed – attorney-client privilege and/or work-product doctrine (iii) state
`
`the factual grounds on which your claim rests.
`
`13.
`
`Respond to this set of requests as of the date of service. If additional information
`
`becomes available and your response to one or more of these requests changes, pursuant to
`
`Federal Rule of Civil Procedure 26(e) there is a continuing obligation on your part to supplement
`
`your initial responses.
`
`14.
`
`The terms “describe” or “description,” when used with respect to any act, action,
`
`accounting, activity, audit, practice, process, occurrence, occasion, course of conduct, happening,
`
`negotiation, relationship, scheme, communication, conference, discussion, development, service,
`
`transaction, instance, incident or event, means provide the following information: its general
`
`nature; the time and place thereof; a chronological account setting forth each element thereof,
`
`what such element consisted of and what transpired as a part thereof; the identity of each person
`
`who performed any function or had any role in connection therewith (e.g., speaker, participant,
`
`contributor of information, witness) or who has any knowledge thereof together with a
`
`description of each such person’s function, role, or knowledge; the identity of each document
`
`that refers thereto, or that was used, referred to, or prepared in the course or as a result thereof;
`
`and the identity of each communication that was a part thereof or referred thereto.
`
`
`
`3
`
`
`
`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 10 of 14 PageID #:2492
`
`
`
`Request No. 121.
`
`
`
`REQUESTS FOR ADMISSION
`
`Admit that claim 1 of the ’106 patent does not state whether the claim limitation
`
`“wherein the liquid pharmaceutical composition when stored in the glass container for at least
`
`five months for at least five months exhibits no more than about 2% decrease in the
`
`concentration of dexmedetomidine” is tested at room temperature or accelerated testing
`
`conditions.
`
`Request No. 122.
`
`
`
`Admit that a glass ampoule is a sealed glass container.
`
`Request No. 123.
`
`
`
`Admit that the Dexmedetomidine IND discloses a dexmedetomidine hydrochloride
`
`20 mcg/ml injection test solution that is sealed in glass ampoules at the Farmos facility following
`
`manufacture. HOSPIRA_00308724; HOSPIRA_00308752.
`
`Request No. 124.
`
`
`
`Admit that the Dexmedetomidine IND discloses that glass ampoules containing
`
`dexmedetomidine hydrochloride 20 mcg/ml injection test solution are terminally sterilized in an
`
`autoclave. HOSPIRA_00308724.
`
`Request No. 125.
`
`
`
`Admit that the FDA requires that all parenteral products be sterilized to be suitable for
`
`administration to a human subject.
`
`Request No. 126.
`
`
`
`Admit that the Dexmedetomidine IND discloses the process for manufacturing a liquid
`
`pharmaceutical composition that is suitable for parenteral administration to a patient of
`
`4
`
`
`
`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 11 of 14 PageID #:2493
`
`dexmedetomidine for parenteral administration containing dexmedetomidine at a concentration
`
`of about 20 mcg/mL and sodium chloride at a concentration of about 0.9% disposed within a
`
`glass ampoule. HOSPIRA_00308723.
`
`Request No. 127.
`
`
`
`Admit that the liquid pharmaceutical composition of dexmedetomidine disclosed as batch
`
`NI 027 L1 in the Dexmedetomidine IND contains dexmedetomidine at a concentration of about
`
`20 mcg/mL and sodium chloride at a concentration of about 0.9% disposed within a glass
`
`ampoule. E.g., HOSPIRA_00308723; HOSPIRA_00308752.
`
`Request No. 128.
`
`
`
`Admit that the Dexmedetomidine IND reports stability data for dexmedetomidine batch
`
`NI 027 L1 exhibiting no more than about 2% decrease in the concentration of dexmedetomidine
`
`after 6 months of storage in a glass ampoule at 25 o C. HOSPIRA_00308756.
`
`Request No. 129.
`
`
`
`Admit that the inventors of the patents-in-suit did not conduct the December 18, 1989
`
`Study.
`
`Request No. 130.
`
`
`
`Admit that the intravenous doses of dexmedetomidine hydrochloride used in the clinical
`
`protocol dated December 18, 1989 were not diluted to another concentration of
`
`dexmedetomidine prior to administration to a subject. HOSPIRA_00312442.
`
`Request No. 131.
`
`
`
`Admit that the December 18, 1989 Study discloses a method of providing sedation to a
`
`patient comprising parenteral administration of a liquid pharmaceutical composition of
`
`dexmedetomidine at a concentration of about 20 mcg/mL and sodium chloride at a concentration
`
`5
`
`
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`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 12 of 14 PageID #:2494
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`of about 0.9% that is disposed within a sealed glass container. E.g., HOSPIRA_00308704;
`
`HOSPIRA_00308724; HOSPIRA_00308499; HOSPIRA_00312442.
`
`Request No. 132.
`
`
`
`Admit that Abbott received consideration from Hospira when Abbott spun-off its hospital
`
`products business, including the transfer of dexmedetomidine products, to Hospira. E.g., Hospira
`
`Form 10-Q (filed May 27, 2004), available at
`
`https://www.sec.gov/Archives/edgar/data/1274057/000110465904015693/a04-6330_110q.htm.
`
`Request No. 133.
`
`
`
`Admit that Abbott assigned all of its rights and responsibilities under the 1994 License
`
`and Supply Agreement to Hospira in 2004. HOSPIRA_01768594.
`
`Request No. 134.
`
`
`
`Admit that Abbott publicly transferred the Dexmedetomidine IND, NDA, and Know-
`
`How to Hospira as part of Abbott’s spin-off of its hospital products business to Hospira.
`
`HOSPIRA_01768591-600; HOSPIRA_01751658;
`
`https://www.sec.gov/Archives/edgar/data/1274057/000110465904015693/a04-6330_110q.htm.
`
`Request No. 135.
`
`
`
`Admit that the clinical protocol for the December 18, 1989 Study does not include or
`
`reference any confidentiality agreements preventing individuals, including but not limited to
`
`clinical investigators and clinical trial subjects, from disclosing information about the study.”
`
`
`
`6
`
`
`
`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 13 of 14 PageID #:2495
`
`/
`
`Dated: January 2, 2018
`
`SCHIFF HARDIN LLP
`
`
`
`
`/s/Joel M. Wallace
`Imron T. Aly
`Joel M. Wallace
`Tara Kurtis
`Emily M. Peña
`233 South Wacker Drive, Suite 6600
`Chicago, Illinois 60606
`(312) 258-5500
`ialy@schiffhardin.com
`jwallace@schiffhardin.com
`tkurtis@schiffhardin.com
`epena@schiffhardin.com
`
`Ahmed M.T. Riaz (pro hac vice)
`666 Fifth Avenue, 17th Floor
`New York, NY 10103
`(212) 753-5000
`ariaz@schiffhardin.com
`
`
`Attorneys for Defendant/Counterclaimant Fresenius Kabi
`USA, LLC
`
`
`7
`
`
`
`
`
`
`
`Case: 1:16-cv-00651 Document #: 81-5 Filed: 01/16/18 Page 14 of 14 PageID #:2496
`
`CERTIFICATE OF SERVICE
`
`I hereby certify pursuant to Fed. R. Civ. P. 5 and LR 5.5 that on January 2, 2018, I caused
`
`a copy of the foregoing FRESENIUS KABI’S SECOND SET OF REQUEST FOR ADMISSION
`
`TO PLAINTIFF (NOS. 121–135) to be transmitted via electronic mail to the following counsel
`
`of record:
`
`Bradford P. Lyerla
`Sara T. Horton
`Yusuf Esat
`Chad Ray
`JENNER & BLOCK LLP
`353 N. Clark Street
`Chicago, IL 60654-3456
`Tel.: (312) 222-9350
`Fax: (312) 527-0484
`blyerla@jenner.com
`shorton@jenner.com
`yesat@jenner.com
`cray@jenner.com
`Attorneys for Plaintiff Hospira, Inc.
`
` /s/ Joel M. Wallace
`Joel M. Wallace
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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