Case 1:14-cv-00113-RGA-MPT Document 278 Filed 09/25/15 Page 1 of 22 PageID #: 9314
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`SANOFI-AVENTIS U.S. LLC, SANOFI-
`AVENTIS DEUTSCHLAND GMBH,
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`Plaintiffs,
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`v.
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`ELI LILLY AND COMPANY,
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`Defendant.
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`)
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`C.A. No. 14-113-RGA-MPT
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`PRE-TRIAL ORDER PURSUANT TO L.R. 16.3(D)(1)
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`
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`FARNAN LLP
`Brian E. Farnan (#4089)
`Michael J. Farnan (#5165)
`919 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 777-0300
`bfarnan@farnanlaw.com
`mfarnan@farnanlaw.com
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`Attorneys for Defendant
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`ASHBY & GEDDES
`Steven J. Balick (#2114)
`Tiffany Geyer Lydon (#3950)
`Andrew C. Mayo (#5207)
`500 Delaware Avenue, 8th Floor
`P.O. Box 1150
`Wilmington, DE 19899
`(302) 654-188
`sbalick@ashby-geddes.com
`tlydon@ashby-geddes.com
`amayo@ashby-geddes.com
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`Attorneys for Plaintiffs
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`Dated: September 15, 2015
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`Case 1:14-cv-00113-RGA-MPT Document 278 Filed 09/25/15 Page 2 of 22 PageID #: 9315
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`TABLE OF CONTENTS
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`Page
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`I.
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`A.
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`B.
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`C.
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`II.
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`III.
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`IV.
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`V.
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`VI.
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`A.
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`B.
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`Nature Of the Action [L.R. 16.3(c)(1)] ........................................................................... 1
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`Parties and Patents .......................................................................................................... 1
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`Commencement of Civil Action No. 1:14-cv-00113-RGA-MPT ................................... 2
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`Amended Complaint and Subsequent Proceedings ........................................................ 4
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`Jurisdiction [L.R. 16.3(c)(2)] .......................................................................................... 5
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`Admitted Facts [L.R. 16.3(c)(3)] .................................................................................... 5
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`Disputed Facts [L.R. 16.3(c)(4)] ..................................................................................... 5
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`Issues of Law [L.R. 16.3(c)(5)] ....................................................................................... 5
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`Exhibits [L.R. 16.3(c)(6)] ............................................................................................... 6
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`Trial Exhibits ................................................................................................................... 6
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`Demonstrative Exhibits ................................................................................................... 8
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`VII.
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`Witnesses [L.R. 16.3(c)(7)] ........................................................................................... 10
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`A.
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`Deposition Designations ............................................................................................... 11
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`VIII.
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`Brief Statement of Intended Proofs [L.R. 16.3(c)(8)–(10)] ........................................... 12
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`IX.
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`X.
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`XI.
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`A.
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`B.
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`C.
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`D.
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`E.
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`F.
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`G.
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`Proposed Amendments to the Pleadings [L.R. 16.3(c)(11)] ......................................... 13
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`Certification of Settlement Discussions [L.R. 16.3(c)(12)] ........................................... 13
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`Miscellaneous Issues ..................................................................................................... 13
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`Stipulations .................................................................................................................... 13
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`In Limine Requests ........................................................................................................ 14
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`Damages and Other Remedies [L.R. 16.3(c)(8)–(10)] .................................................. 15
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`Expected Duration and Scope of Trial ........................................................................... 17
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`Type of Trial .................................................................................................................. 17
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`Order of Proof ................................................................................................................ 17
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`Late-Disclosure of Sanofi’s Pre-Trial Order Documents ............................................. 19
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`XII.
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`Order To Control Course Of Action [L.R. 16.3(d)(4)] .................................................. 20
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`Case 1:14-cv-00113-RGA-MPT Document 278 Filed 09/25/15 Page 3 of 22 PageID #: 9316
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`NATURE OF THE ACTION [L.R. 16.3(C)(1)]
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`Parties and Patents
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`This is an action alleging patent infringement arising under the patent laws of the United
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`States, Title 35, United States Code based on Defendant’s filing of a New Drug Application
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`(“NDA”) with the Food and Drug Administration (“FDA”).
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`Plaintiffs are Sanofi-Aventis U.S. LLC (“Sanofi U.S.”) and Sanofi-Aventis Deutschland
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`GmbH (“Sanofi GmbH”) (collectively “Sanofi” or “Plaintiffs”). Sanofi is represented by Steven
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`J. Balick, Andrew Mayo, and Tiffany Geyer Lydon of Ashby & Geddes. Sanofi is also
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`represented by Mark A. Perry, Frederick Brown, Tracey Davies, Joseph Evall, Ernest Hsin, and
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`R. Scott Roe of Gibson, Dunn & Crutcher LLP.
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`Sanofi U.S. is the holder of approved NDA No. 21-081 for insulin glargine [rDNA
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`origin] for injection to treat diabetes, which is prescribed and sold in the United States under the
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`trademarks Lantus® and Lantus® SoloSTAR®.
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`Sanofi asserts five patents asserted in this litigation (collectively, “Patents-in-Suit”).
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`United States Patents Nos. 8,556,864 (“the ’864 Patent”), 8,603,044 (“the ’044 Patent”), and
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`8,679,069 (“the ’069 Patent”) are referred to herein by Sanofi as the “Asserted Device Patents.”
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`U.S. Patent Nos. 7,476,652 (“the ’652 Patent”) and 7,713,930 (“the ’930 Patent”) are referred to
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`herein by Sanofi as the “Asserted Formulation Patents.” Sanofi U.S. has listed the Patents-in-
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`Suit in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange
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`Book”).
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`On or about February 10, 2009, Sanofi submitted the ’652 patent for listing in the Orange
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`Book. On or about May 13, 2010, Sanofi submitted the ’930 patent for listing in the Orange
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`Book. On or about October 25, 2013, Sanofi submitted the ’864 patent for listing in the Orange
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`Book. On or about January 6, 2014, Sanofi submitted the ’044 patent for listing in the Orange
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`Case 1:14-cv-00113-RGA-MPT Document 278 Filed 09/25/15 Page 4 of 22 PageID #: 9317
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`Book. On or about March 25, 2014, Sanofi submitted the ’069 patent for listing in the Orange
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`Book. The Orange Book provides the following expiration dates for the Patents-in-Suit:
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`a) ’864 Patent: March 3, 2024
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`b) ’044 Patent: March 2, 2024
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`c) ’069 Patent: April 12, 2025
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`d) ’652 Patent: July 23, 2023
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`e) ’930 Patent: June 13, 20231
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`By assignment, Sanofi GmbH owns all right, title, and interest in and to the Patents-in-
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`Suit. Sanofi U.S. is an exclusive licensee of the Patents-in-Suit with exclusive rights, including
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`the rights to sell and offer to sell in the United States the technologies, products, or services
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`claimed by the Patents-in-Suit, further including the right to sue and recover for the infringement
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`of the Patents-in-Suit.
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`Defendant is Eli Lilly and Company (“Eli Lilly” or “Defendant”). Eli Lilly is represented
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`by Joseph J. Farnan, Jr., Brian E. Farnan and Michael J. Farnan of Farnan LLP. Eli Lilly is also
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`represented by Bruce M. Wexler, Gerald J. Flattmann, David M. Conca, Steven L. Park, and
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`Nicholas A. Tymoczko of Paul Hastings LLP.
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`Commencement of Civil Action No. 1:14-cv-00113-RGA-MPT
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`On or about
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`, Eli Lilly submitted NDA No. 205-692 to the FDA under
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`Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (“FFDCA”), 21 U.S.C.
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`§ 355(b)(2), seeking the approval to manufacture commercially and sell its proposed product—
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` 1 The ’652 and ’930 Patents are subject to an additional six months of pediatric exclusivity.
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`Case 1:14-cv-00113-RGA-MPT Document 278 Filed 09/25/15 Page 5 of 22 PageID #: 9318
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`On or about December 18, 2013, Eli Lilly sent Sanofi a “Notice of Paragraph IV
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`Certifications” pursuant to § 505(b)(2)(A)(iv) and (b)(3) of the FFDCA, which discloses that its
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`NDA No. 205-692 contained Paragraph IV certifications for the patents listed in the Orange
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`Book as of the time of the Notice, including, inter alia, the ’864, ’652, and ’930 Patents. Sanofi
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`U.S. received Eli Lilly’s Notice of Paragraph IV Certifications on December 19, 2013, and Sanofi
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`GmbH received Eli Lilly’s Notice of Paragraph IV Certifications on December 20, 2013.
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`On or about January 23, 2014, Eli Lilly sent Sanofi an amendment to its “Notice of
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`Paragraph IV Certifications” pursuant to § 505(b)(2)(A)(iv) and (b)(3) of the FFDCA, disclosing
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`that Eli Lilly amended its Paragraph IV certifications contained in NDA No. 205-692 to include
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`the ’044 Patent. Sanofi U.S. received Eli Lilly’s amendment to its Notice of Paragraph IV
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`Certifications on January 24, 2014, and Sanofi GmbH received Eli Lilly’s amendment to its
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`Notice of Paragraph IV Certifications on or about January 27, 2014.
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`Sanofi commenced case number 1:14-cv-00113-RGA-MPT (the “Action”) within 45
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`days after receiving Eli Lilly’s Notice of Paragraph IV Certifications by filing a Complaint on
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`January 30, 2014. Sanofi asserted that Eli Lilly was infringing under 35 U.S.C. § 271(e)(2)(A)
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`by its submission of NDA No. 205-692 prior to the expiration of the ’864, ’044, ’652, and ’930
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`Patents. See No. 14-113-RGA-MPT, D.I. 1. Sanofi also asserted that if Eli Lilly’s NDA No.
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`205-692 were to be approved, then Eli Lilly’s manufacture, use, sale and/or offer to sell in the
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`United States, and/or importation into the United States, of its Proposed Product would infringe
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`the ’864, ’044, ’652, and ’930 Patents under 35 U.S.C. § 271(a), (b), and (c), literally and/or
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`under the Doctrine of Equivalents. Id. On or about February 19, 2014, Lilly filed its Answer
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`Case 1:14-cv-00113-RGA-MPT Document 278 Filed 09/25/15 Page 6 of 22 PageID #: 9319
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`and Counterclaims denying infringement and alleging counterclaims of, inter alia, patent
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`invalidity and unenforceability with respect to the Asserted Patents. See No. 14-113-RGA-MPT,
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`D.I. 8.
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`On or about May 14, 2014, Eli Lilly sent Sanofi a “Notice of Paragraph IV Certification
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`Regarding NDA No. 012081 with Respect to U.S. Patent No. 8,679,069” (the “’069 Patent
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`Notice of Paragraph IV Certification”) pursuant to § 505(b)(2)(A)(iv) and (b)(3) of the FFDCA,
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`disclosing that Eli Lilly amended its Paragraph IV certifications contained in NDA No. 205-692
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`to include the ’069 Patent. Sanofi U.S. received Eli Lilly’s ’069 Patent Notice of Paragraph IV
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`Certification on May 15, 2014, and Sanofi GmbH received Eli Lilly’s Notice of Paragraph IV
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`Certification soon thereafter.
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`Amended Complaint and Subsequent Proceedings
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`On May 29, 2014, Sanofi filed an Amended Complaint to add the ’069 Patent. Sanofi
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`asserts in the Amended Complaint that Eli Lilly is infringing each of the Patents-in-Suit under 35
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`U.S.C. § 271(e)(2)(A) by its submission of NDA No. 205-692 prior to the expiration of the ’864,
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`’044, ’652, ’930, and ’069 Patents. See No. 14-113-RGA-MPT, D.I. 53. Sanofi also asserted
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`that if Eli Lilly’s NDA No. 205-692 were to be approved, then Eli Lilly’s manufacture, use, sale
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`and/or offer to sell in the United States, and/or importation into the United States, of its Proposed
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`Product would infringe the ’864, ’044, ’652, ’930, and ’069 Patents under 35 U.S.C. § 271(a),
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`(b), and (c), literally and/or under the Doctrine of Equivalents. See id.
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`On June 16, 2014, Eli Lilly filed its Answer, denying infringement of the Patents-in-Suit
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`and alleging that the claims of the Patents-in-Suit are invalid. Eli Lilly also filed counterclaims
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`consisting of seven counts, including, inter alia, a declaration of non-infringement with respect
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`to the Patents-in-Suit, a declaration of invalidity with respect to the Patents-in-Suit, and a
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`Case 1:14-cv-00113-RGA-MPT Document 278 Filed 09/25/15 Page 7 of 22 PageID #: 9320
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`declaration that certain Patents-in-Suit are unenforceable due to prosecution laches. See D.I. 65.
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`On July 10, 2014, Sanofi filed its Answer and affirmative defenses, denying each of Eli Lilly’s
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`counterclaims. See D.I. 77.
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`JURISDICTION [L.R. 16.3(C)(2)]
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`This action arises under the patent laws of the United States. This Court has federal
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`subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1338(a), 2201 and 2202. Subject
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`matter jurisdiction and personal jurisdiction are not disputed for purposes of this action.
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`ADMITTED FACTS [L.R. 16.3(C)(3)]
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`The parties stipulate to the facts listed in Exhibit 1 hereto. These stipulated facts require
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`no proof at trial and will become part of the evidentiary record in this case.
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`DISPUTED FACTS [L.R. 16.3(C)(4)]
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`Sanofi’s statement of issues of fact that are not stipulated for purposes of this pre-trial
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`order is attached hereto as Exhibit 2.
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`Eli Lilly’s statement of issues of fact are not stipulated for purposes of this pre-trial order
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`is attached hereto as Exhibit 3.
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`ISSUES OF LAW [L.R. 16.3(C)(5)]
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`Sanofi’s statement of issues of law that provide a legal framework for issues remaining to
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`be litigated is attached hereto as Exhibit 4.
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`Eli Lilly’s statement of issues of law that provide a legal framework for issues remaining
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`to be litigated is attached hereto as Exhibit 5.
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`Case 1:14-cv-00113-RGA-MPT Document 278 Filed 09/25/15 Page 8 of 22 PageID #: 9321
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`EXHIBITS [L.R. 16.3(C)(6)]
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`A. Trial Exhibits
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`The list of exhibits which, subject to continued meeting and conferring in advance of and
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`during trial, may ultimately be offered jointly by Sanofi and Eli Lilly, is attached hereto as
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`Exhibit 6.
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`The list of exhibits which may be offered by Sanofi, including Eli Lilly’s objections
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`thereto, is attached hereto as Exhibit 7.
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`The list of exhibits which may be offered by Eli Lilly, including Sanofi’s objections
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`thereto, is attached hereto as Exhibit 8.
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`The parties agree to make physical exhibits, if any, reasonably available for inspection by
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`September 21, 2015. For the avoidance of doubt, this does not include demonstrative exhibits,
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`described below.
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`The parties agree that non-English documents included on a party’s exhibit list must be
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`accompanied by a certified English translation. Once the pre-trial order is filed with the Court,
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`modification of trial exhibits will be permitted until 6:00 p.m. ET on September 20, 2015, to the
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`extent necessary to comply with any rulings made by the Court at the pre-trial conference. After
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`that time, modification of trial exhibit lists will not be permitted except upon order of the Court
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`for good cause shown, or upon agreement of the Parties.
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`Except as otherwise set forth herein (including but not limited to paragraph 0 regarding
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`impeachment), any document not listed in Exhibits 6–8 above, as supplemented per paragraph 0
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`if applicable, will not be admitted into evidence, unless the parties agree otherwise or absent
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`good cause shown.
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`Case 1:14-cv-00113-RGA-MPT Document 278 Filed 09/25/15 Page 9 of 22 PageID #: 9322
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`Each party reserves the right to offer exhibits set forth on the other party’s exhibit list,
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`even if not set forth on its own exhibit list. Any trial exhibit, once admitted, may be used equally
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`by either party subject to any limitations as to its admission into evidence.
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`The parties reserve their rights to raise all objections to exhibits as set forth on the trial
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`exhibit lists. The listing of a trial exhibit does not constitute an admission as to the admissibility
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`of the trial exhibit (i.e., a waiver of any applicable objection). Each party reserves the right to
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`object to the relevance or admissibility of any evidence offered by the other party (or jointly), at
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`the time such evidence is offered, in view of the specific context in which such evidence is
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`offered, or for any other reason as set forth in the Federal Rules of Evidence or other applicable
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`principles of law.
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`Each party shall serve on opposing counsel by electronic mail a written list by exhibit
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`number of the trial exhibits (i.e., the subset of trial exhibits already disclosed on Exhibits 6–8
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`and any timely supplements thereto) that each party intends to use during direct examination of a
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`witness, by 7:00 p.m. ET on the calendar day before such direct examination is expected to take
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`place. The party receiving the identification of exhibits intended for use during direct
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`examination of a witness will inform the party identifying the exhibits of any objections by 9:30
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`p.m. that same day, and the parties shall meet and confer by 10:00 p.m. ET that evening in a
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`good-faith effort to discuss and resolve any objections to the trial exhibits. The advance
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`notification provision for exhibits does not apply to exhibits to be used during cross-examination.
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`Other than trial exhibits jointly designated by the parties in Exhibit 6 and any
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`supplements thereto, or as otherwise agreed by the parties, no exhibit shall be admitted unless
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`offered into evidence through a witness, who must at least be shown the exhibit. At some point
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`before the completion of the parties’ case in chief, any party that has used an exhibit with a
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`witness and wishes for that exhibit to be admitted into evidence must formally move the exhibit
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`into evidence, by exhibit number.
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`The parties agree that exhibits to be used solely for impeachment need not be included on
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`the lists of trial exhibits or disclosed in advance of being used or offered at trial. Certified
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`translations of non-English documents intended to be used for impeachment must be affixed to
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`the non-English document and for any non-English document, the translation and non-English
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`document must be served by 7:00 pm ET one calendar day prior to its use in Court. The party
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`receiving the translations will inform the party providing the translations of any objections to the
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`translations by 9:30 p.m. that same day, unless for good cause shown more time is required (e.g.,
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`due to the volume of translated documents). The parties shall meet and confer by 10:00 p.m. ET
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`that evening in a good-faith effort to discuss and resolve any objections to the translations.
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`Demonstrative Exhibits
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`Exhibits that the parties intend to use at trial solely for demonstrative purposes without
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`admitting into evidence (“demonstrative exhibits”) do not need to be described on their
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`respective lists of trial exhibits.
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`Each demonstrative exhibit shall clearly indicate on the face of the demonstrative exhibit,
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`if practicable, all information sources (including, if available, trial exhibit numbers) that form the
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`basis for the demonstrative exhibit. If not practicable to indicate the sources on the face of the
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`demonstrative exhibit itself, an identification of the sources shall accompany the demonstrative
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`exhibit.
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`Each party shall serve on opposing counsel by electronic mail and/or electronic media
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`full color copies (or videos, for the case of animations) of any demonstrative exhibits that each
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`party intends to use at trial during opening statements or during direct examination of a witness
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`according to the schedule below. For irregularly sized physical demonstrative exhibits, the party
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`seeking to use the demonstrative exhibit will provide a color representation as a PDF of 8.5 x 11
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`inch copies of the demonstrative exhibit and make the original available for inspection by the
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`opposing party.
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`For demonstrative exhibits to be used in connection with opening statements, each party
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`shall exchange such demonstrative exhibits by 4:00 pm ET the day before opening statements.
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`The party receiving identification of demonstrative exhibits for opening statements will inform
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`the party identifying the demonstrative exhibits of any objections by 9:30 pm ET on the day
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`before opening statements, and the parties will meet and confer as soon as possible thereafter to
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`resolve such objections, but in any event by 10:00 pm ET that same day.
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`For demonstrative exhibits to be used in connection with direct examination of a witness,
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`each party shall exchange such demonstrative exhibits by 7:00 pm ET on the calendar day before
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`such direct examination is expected to take place. The party receiving identification of
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`demonstrative exhibits for direct examination will inform the party identifying the demonstrative
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`exhibits of any objections by 9:30 pm ET on the day of receipt, and the parties will meet and
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`confer as soon as possible thereafter to resolve such objections, but in any event by 10:00 pm ET
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`that same day.
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`For the avoidance of doubt, a demonstrative exhibit that falls into one (and only one) of
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`the following categories is not required to be provided to the other side in advance of its use: (a)
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`a copy of a single trial exhibit or part of a single trial exhibit, or a blow-up or highlighting of a
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`single trial exhibit or part of a single trial exhibit, or (b) a blow-up or highlighting of a single
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`deposition or trial transcript or part of a single deposition or trial transcript.
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`Case 1:14-cv-00113-RGA-MPT Document 278 Filed 09/25/15 Page 12 of 22 PageID #: 9325
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`The advance notification provisions for demonstrative exhibits do not apply to
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`demonstrative exhibits used in closing statements (to the extent closing statements are required
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`by the Court), or to demonstratives used for cross-examination, which do not need to be provided
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`to the other side in advance of their use.
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`WITNESSES [L.R. 16.3(C)(7)]
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`Sanofi’s list of fact and expert witnesses they may call at trial, either live or by
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`deposition, is attached hereto as Exhibit 9.
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`Eli Lilly’s list of fact and expert witnesses they may call at trial, either live or by
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`deposition, is attached hereto as Exhibit 10.
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`Any witness not listed in Exhibits 9 or 10 above will be precluded from trial absent good
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`cause shown.
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`The curricula vitae of live witnesses a party intends to call at trial may be submitted at
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`the time of the pre-trial conference.
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`The listing of a witness on a party’s witness list does not require that party to call that
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`witness to testify, either in person or by deposition, nor shall it constitute an admission as to the
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`availability or unavailability of that witness to appear live at trial.
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`[Sanofi’s proposal: Dr. Norbert Lill will testify primarily in English, but may need the
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`occasional assistance of a German translator.] [Lilly’s proposal: No party expects that its
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`witnesses will testify live at trial in a foreign language.]
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`Each party shall serve on opposing counsel by electronic mail a list of all witnesses
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`(whether live or via deposition testimony) that the party intends to call at trial by 6:00 p.m. ET
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`on the calendar day before such testimony is expected to take place. The party receiving
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`identification of the witnesses will inform the party identifying the witnesses of any objections
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`Case 1:14-cv-00113-RGA-MPT Document 278 Filed 09/25/15 Page 13 of 22 PageID #: 9326
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`by 8:00 pm ET on the day of receipt, and the parties will meet and confer as soon as possible
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`thereafter to resolve such objections, but in any event by 9:00 pm ET that same day.
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`A. Deposition Designations
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`Deposition testimony that Sanofi may offer into evidence, together with Eli Lilly’s
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`counter-designations and the parties’ respective objections, is identified in Exhibit 11 hereto.
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`Deposition testimony that Eli Lilly may offer into evidence, together with Sanofi’s counter-
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`designations and the parties’ respective objections, is identified in Exhibit 12 hereto. Deposition
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`testimony to be used solely for cross-examination but not admitted into evidence need not be
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`identified to the other side in advance of its use.
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`Each party shall serve on opposing counsel by electronic mail a written list of the final
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`remaining lines and pages of each deposition transcript (i.e., the subset of deposition
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`designations already disclosed in Exhibits 11 and 12 and any timely supplements thereto), prior
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`to reading or playing a video of the deposition at trial (other than for impeachment of a witness
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`or cross-examination) that a party intends to use at trial by 7:00 p.m. ET on the calendar day
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`before such deposition designation is expected to be used. The party receiving the identification
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`of deposition designations will inform the party identifying the deposition designations of any
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`objections and counter-designations by 9:30 p.m. that same day, and the parties shall meet and
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`confer by 10:00 p.m. ET that evening in a good-faith effort to discuss and resolve any objections
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`to the deposition designations.
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`To the extent that deposition designations or counter-designations are admitted into
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`evidence, they must either be played by video or read in open court. The parties will request that
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`the court reporter transcribe any deposition video testimony that is played in open Court. If a
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`party opts to introduce deposition testimony, any counter-designation of that same witnesses’
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`{01044340;v1 }
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`testimony must be submitted in the same medium, and the testimony designated by both parties
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`will be played or read consecutively in the sequence in which the testimony was originally given
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`at deposition. To the extent deposition designations are read or played in open court, each party
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`will be charged the time taken to read or play its designations. For convenience, if both parties’
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`designations are played together, the time charged to each party will be measured by the
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`proportion of the number of lines of testimony for each party’s designations as compared to the
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`total number of lines of testimony read or played. Prior to the introduction of deposition
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`designations or counter-designations, counsel for the introducing party may provide a short
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`introduction to the Court about the identity of the witness and subject matter of deposition
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`testimony, which introduction the parties agree is not evidence and the time for which will be
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`charged against that party.
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`All irrelevant and redundant colloquy between counsel and objections will be eliminated
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`when the deposition transcript is presented at trial. However, any objections that the parties
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`intend to seek a ruling on from the Court will be made at trial.
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`Sanofi and Eli Lilly each reserve the right to read or play as counter-designations any of
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`the other party’s affirmative deposition designations that are not read or played at trial, subject to
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`the limitations set forth in Fed. R. Civ. P. 32(a)(6), Fed. R. Evid. 106, and any other applicable
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`Federal or Local Rule.
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`The listing of a deposition designation does not constitute an admission as to the
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`admissibility of the testimony nor is it a waiver of any applicable objection.
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`BRIEF STATEMENT OF INTENDED PROOFS [L.R. 16.3(C)(8)–(10)]
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`In support of their claims and in addition to the facts not in dispute, Sanofi expects to
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`offer the proofs set forth in Exhibit 13.
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`{01044340;v1 }
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`In support of its claims and in addition to the facts not in dispute, Eli Lilly expects to
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`offer the proofs set forth in Exhibit 14.
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`PROPOSED AMENDMENTS TO THE PLEADINGS [L.R. 16.3(C)(11)]
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`Neither party seeks to amend the pleadings at this time.
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`CERTIFICATION OF SETTLEMENT DISCUSSIONS [L.R. 16.3(C)(12)]
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`The parties certify that they have engaged in a good faith effort to explore the resolution
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`of the controversy by settlement. A settlement has not yet been reached.
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`MISCELLANEOUS ISSUES
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`A. Stipulations
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`The parties’ agreed stipulations for the case are set forth below.
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`The parties agree that neither side shall require the other side to lay a business record
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`foundation for the introduction of a document as an exhibit, and that the document shall qualify as
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`a business record under Fed. R. Evid. 803(6), unless the document meets one or more of the
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`following conditions: (i) the document was disclosed after the close of discovery, and the
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`disclosing party seeks to introduce the document into evidence; (ii) the document was not
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`identified on the introducing party’s “list of pre-marked exhibits” [i.e., Exhibits 6–8] pursuant to
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`Local Rule 16.3(c)(6) and 16.3(d) prior to the deadline for supplementation of trial exhibits (see
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`¶ 0); or (iii) the opposing party has made a specific written objection prior to September 24 (see
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`¶ 0) that specifically explains the basis for why the document in question was not created and
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`maintained in the ordinary course of business.
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`The parties agree that neither side shall require the other side to lay an authenticity
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`foundation for the introduction of a document or thing, including a sample, as an exhibit, and that
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`such document or thing shall be deemed authentic under Fed. R. Evid. 901, unless the document
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`meets one or more of the following conditions: (i) the document was disclosed after the close of
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`{01044340;v1 }
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`Case 1:14-cv-00113-RGA-MPT Document 278 Filed 09/25/15 Page 16 of 22 PageID #: 9329
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`discovery, and the disclosing party seeks to introduce the document into evidence; (ii) the
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`document was not identified on the introducing party’s “list of pre-marked exhibits” [i.e.,
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`Exhibits 6–8] pursuant to Local Rule 16.3(c)(6) and 16.3(d) prior to the deadline for
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`supplementation of trial exhibits (see ¶ 0); or (iii) the opposing party has made a specific written
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`objection prior to September 24 (see ¶ 0) that specifically explains the basis for why the document
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`in question is not authentic.
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`Each party agrees that complete legible copies of documents may be offered and received
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`into evidence to the same extent as an original unless a genuine question is raised as to the
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`authenticity of the original, or if in the circumstances it would be unfair to admit the copy in lieu
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`of the original. Complete legible copies of United States and foreign patents and/or applications,
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`and the contents of associated file histories, may be offered and received into evidence in lieu of
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`certified copies thereof, subject to all other objections which might be made to the admissibility
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`of certified copies.
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`In Limine Requests
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`Pursuant to paragraph 13 of the Scheduling Order (D.I. 29), Sanofi’s in limine requests,
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`along with Eli Lilly’s oppositions thereto and Sanofi’s replies, are set forth as follows:
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`a) Exhibit 15 contains Sanofi’s In Limine Request Concerning Dr. Ochoa’s
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`Opinions Contradicting the Court’s Claim Construction. Exhibit 15.1
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`contains Sanofi’s opening brief and attachments thereto; Exhibit 15.2
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`contains Eli Lilly’s opposition brief and attachments thereto; and Exhibit
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`15.3 contains Sanofi’s reply and attachments thereto.
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`b) Exhibit 16 contains Sanofi’s In Limine Request Concerning Lilly’s
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`Failure to Disclose Facts and Data Considered by Dr. White in Forming
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`{01044340;v1 }
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`Case 1:14-cv-00113-RGA-MPT Document 278 Filed 09/25/15 Page 17 of 22 PageID #: 9330
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`His Opinions. Exhibit 16.1 contains Sanofi’s opening brief and
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`attachments thereto; Exhibit 16.2 contains Eli Lilly’s opposition brief and
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`attachments thereto; and Exhibit 16.3 contains Sanofi’s reply and
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`attachments thereto.
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`Pursuant to paragraph 13 of the Scheduling Order (D.I. 29), Eli Lilly’s in limine requests,
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`along with Sanofi’s oppositions thereto and Eli Lilly’s replies, are set forth as follows:
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`a) Exhibit 17 withdrawn]
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`b) Exhibit 18 contains Eli Lilly’s Motion in Limine to Preclude Sanofi from
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`Contending that Lilly’s NDA Product Infringes the ’930 Patent on the
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`Basis of “POE Sorbitan.” Exhibit 18.1 contains Eli Lilly’s opening brief
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`and attachments thereto; Exhibit 18.2 contains Sanofi’s opposition brief
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`and attachments thereto; and Exhibit 18.3 contain