Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 1 of 14 PageID #:3205
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF
`ILLINOIS EASTERN DIVISION
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`C.A. No. 1:16-cv-00651
`C.A. No. 1:17-cv-07903
`(Consolidated)
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`Hon. Rebecca R. Pallmeyer
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`PUBLIC VERSION—REDACTED
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`Plaintiff,
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`Defendants.
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`v.
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`FRESENIUS KABI USA, LLC,
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`HOSPIRA, INC.
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`LOCAL RULE 56.1 STATEMENT IN SUPPORT OF FRESENIUS KABI’S MOTION
`FOR PARTIAL SUMMARY JUDGMENT ON PRIOR SALE
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF
`ILLINOIS EASTERN DIVISION
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`
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`
`
`C.A. No. 1:16-cv-00651
`C.A. No. 1:17-cv-07903
`(Consolidated)
`
`Hon. Rebecca R. Pallmeyer
`
`PUBLIC VERSION—REDACTED
`
`Plaintiff,
`
`Defendants.
`
`v.
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`FRESENIUS KABI USA, LLC,
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`HOSPIRA, INC.
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`LOCAL RULE 56.1 STATEMENT IN SUPPORT OF FRESENIUS KABI’S MOTION
`FOR PARTIAL SUMMARY JUDGMENT ON PRIOR SALE
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`Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 2 of 14 PageID #:3206
` HIGHLY CONFIDENTIAL – SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
`
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`Parties and Jurisdiction
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`The parties are Hospira, Inc. (“Hospira”) and Fresenius Kabi USA, LLC (“Fresenius
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`I.
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`1.
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`Kabi”), both with operations in this District. Complaint, Hospira, Inc. v. Fresenius Kabi USA,
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`LLC, No. 1:16-cv-00651 (N.D. Ill. Jan. 15, 2016), D.I. 1, No. 1:17-cv-07903 (N.D. Ill. Nov. 1,
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`2017), D.I. 1.
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`2.
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`Subject matter jurisdiction arises under the patent laws of the United States. Id. The
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`parties have consented to subject matter jurisdiction, personal jurisdiction, and venue in this case.
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`Id.; Answer, Hospira, Inc. v. Fresenius Kabi USA, LLC, No. 1:16-cv-00651 (N.D. Ill. Jan. 19,
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`2016), D.I. 10, No. 1:17-cv-07903 (N.D. Ill. Dec. 1, 2017), D.I. 18.
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`II.
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`3.
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`Background
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`An investigational new drug application (“IND”) is a submission to the United States
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`Food and Drug Administration (“FDA”) that explains all of the details about a drug product, so
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`that clinical studies can be done, which then is used to submit a New Drug Application (“NDA”).
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`21 C.F.R. §§ 312.1(a), 312.20.
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`III. The Dexmedetomidine Agreements
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`4.
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`)1, and obtained U.S. Patent No. 4,910,214 claiming dexmedetomidine in
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`March 1990. See Hospira, Inc. v. Sandoz Inc., No. 09–4591, 2012 WL 1587688, *1 (D.N.J. May
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`4, 2012).
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`1 Citations to Ex. __ refer to the exhibits to the Declaration of Tara L. Kurtis in Support of
`Fresenius Kabi’s Motion for Partial Summary Judgment On Prior Sale, filed contemporaneously
`herewith.
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`2
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`Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 3 of 14 PageID #:3207
` HIGHLY CONFIDENTIAL – SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
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`A.
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`Orion License and Supply Agreement with Abbott
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`5.
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` The public was aware of the successful
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`completion of these negotiations and the fact that Abbott had obtained the right to bring a
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`dexmedetomidine drug product to market in the United States. (See, e.g., Ex. E, FK-
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`DEXMED0196073.)
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`3
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`Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 4 of 14 PageID #:3208
` HIGHLY CONFIDENTIAL – SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
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`1.
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`Sale of the Dexmedetomidine IND
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`14.
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`Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 5 of 14 PageID #:3209
` HIGHLY CONFIDENTIAL – SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
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`15.
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`Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 6 of 14 PageID #:3210
` HIGHLY CONFIDENTIAL – SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
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`2.
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`Offer For Sale of Dexmedetomidine Product Ampoules
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`21.
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`Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 7 of 14 PageID #:3211
` HIGHLY CONFIDENTIAL – SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
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`30.
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`Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 8 of 14 PageID #:3212
` HIGHLY CONFIDENTIAL – SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
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`31.
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`B.
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`Abbott Separation and Distribution Agreement with Hospira
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`34.
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`It was publicly known in the pharmaceutical and investor communities that Abbott
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`intended to spin off its hospital products business because it was Abbott’s “least profitable,
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`slowest growing division,” and because Abbott was trying to move its under-performing assets
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`outside the company. (See, e.g., Ex. O, FK-DEXMED0196871.)
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`35.
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`Nearly one year prior to the effective date of the Separation and Distribution Agreement,
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`it had already been determined that the then president of Abbott’s hospital product division and a
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`8
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`Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 9 of 14 PageID #:3213
` HIGHLY CONFIDENTIAL – SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
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`retired Abbott board member would be CEO and chairman of the board, respectively, of the new
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`company. (See Ex. P, FK-DEXMED0196688.)
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`36.
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`37.
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`for example, a manufacturing and supply agreement under which Hospira would continue to sell
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` These agreements included,
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`certain products to Abbott. (
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`DEXMED0196425.)
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`; Ex. S, FK-
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`38.
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`39.
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`Portions of this agreement were disclosed publicly through submission to SEC. (See Ex.
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`U, FK-DEXMED0196497–526.)
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`40.
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`9
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`Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 10 of 14 PageID #:3214
` HIGHLY CONFIDENTIAL – SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
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`41.
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`10
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`Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 11 of 14 PageID #:3215
` HIGHLY CONFIDENTIAL – SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
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`45.
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`51.
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`After consummating the Separation and Distribution Agreement on April 30, 2004,
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`Abbott retained no control or ownership over Hospira. (Ex. Z, FK-DEXMED0197108; Ex. S,
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`FK-DEXMED0196394
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`.)
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`11
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`Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 12 of 14 PageID #:3216
` HIGHLY CONFIDENTIAL – SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
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`A publicly available draft of Hospira’s Information Sheet to its new shareholders dated
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`52.
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`March 31, 2004, expressly stated that “after the separation and distribution, Abbott and Hospira
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`will operate as separate, independent companies and Abbott will not own any shares of Hospira
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`common stock.” (Ex. Z, FK-DEXMED0197105.)
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` The Information
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`Sheet further noted that although Hospira would contract with Abbott to help with the transition
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`in foreign markets, this would not occur in the United States. (Ex. Z, FK-DEXMED0197120.)
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`53.
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`Further, in its SEC filings, Hospira characterized itself as operating as an independent
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`company beginning on April 30, 2004, when the transfer of assets in exchange for Hospira
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`common stock was consummated. (Ex. S, FK-DEXMED0196394.)
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`Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 13 of 14 PageID #:3217
` HIGHLY CONFIDENTIAL – SUBJECT TO STIPULATION REGARDING
`CONFIDENTIALITY AND PROTECTIVE ORDER
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`Dated: May 8, 2018
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`Respectfully submitted,
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`
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`/s/ Imron Aly
`Imron T. Aly
`Kevin M. Nelson
`Joel M. Wallace
`Emily M. Peña
`Tara L. Kurtis
`233 South Wacker Drive, Suite 7100
`Chicago, Illinois 60606
`(312) 258-5500
`ialy@schiffhardin.com
`knelson@schiffhardin.com
`jwallace@schiffhardin.com
`epena@schiffhardin.com
`tkurtis@schiffhardin.com
`
`Ahmed M.T. Riaz (pro hac vice)
`666 Fifth Avenue, 17th Floor
`New York, NY 10103
`(212) 753-5000
`ariaz@schiffhardin.com
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`Attorneys for Defendant Fresenius Kabi USA,
`LLC
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`13
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`Case: 1:16-cv-00651 Document #: 106 Filed: 05/08/18 Page 14 of 14 PageID #:3218
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`CERTIFICATE OF SERVICE
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`I, Tara Kurtis, an attorney at the law firm of Schiff Hardin LLP, hereby certify that on
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`May 8, 2018, I caused a true and correct copy of the foregoing LOCAL RULE 56.1
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`STATEMENT IN SUPPORT OF FRESENIUS KABI’S MOTION FOR PARTIAL SUMMARY
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`JUDGMENT ON PRIOR SALE to be electronically served on counsel of record via the Court’s
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`CM/ECF system.
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`/s/ Tara Kurtis
`Tara Kurtis
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