Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 1 of 62 PageID #: 9344
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 14-113-RGA-MPT
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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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`PRETRIAL ORDER EXHIBIT 2:
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`SANOFI’S STATEMENT OF FACTS
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 2 of 62 PageID #: 9345
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`Page
`I. DISPUTED FACTS CONCERNING THE ASSERTED DEVICE PATENTS ...................... 1
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`TABLE OF CONTENTS
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`A. The Device Patents-In-Suit ................................................................................................. 1
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`a. The ’044 and ’069 Patents .............................................................................................1
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`b. The ’864 Patent ..............................................................................................................2
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`c. Development of the Asserted Device Patents ................................................................3
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`B. New Drug Applications (“NDAS”) .................................................................................... 4
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`a. Sanofi’s NDA.................................................................................................................4
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`b. Lilly’s NDA and BIV 60 KwikPen ................................................................................4
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`C. Sanofi’s SoloSTAR® Device Practice All Elements of the Asserted Claims ..................... 6
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`D. Infringement of the Asserted Device Patents (’044, ’069, and ’864 Patents) ..................... 7
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` Meets the Disputed Claim Limitations of the ’044 Patent .........7
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` Meets the Disputed Claim Limitations of the ’069 Patent .......20
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` Meets the Disputed Claim Limitations of the ’864 Patent .......20
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`E. Validity of the Asserted Device Patents (’044, ’069, and ’864 Patents) .......................... 26
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`a. Obviousness .................................................................................................................27
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`F. Prosecution of the Device Patents ..................................................................................... 35
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`a. ’225 Application Family ..............................................................................................36
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`b. ‘866 Application Family ..............................................................................................36
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`c. Prioritized Examination ...............................................................................................37
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`II. DISPUTED FACTS CONCERNING THE ASSERTED FORMULATION PATENTS ...... 37
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`A. The Formulation Patents-In-Suit....................................................................................... 37
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`a. The Asserted Formulation Patents (ʼ652 and ʼ930 Patents) ........................................38
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`B. New Drug Applications (“NDAS”) .................................................................................. 38
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`a. Sanofi’s NDA...............................................................................................................38
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`b. Lilly’s NDA .................................................................................................................40
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 3 of 62 PageID #: 9346
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`C. Sanofi’s Reformulated Lantus® Product Practices All Elements of the Asserted Claims 43
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`D. Infringement of the Asserted Formulation Patents (’652 and ’930 Patents) .................... 43
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`a. We believe Lilly will concede that Lilly’s Proposed Insulin Glargine Product
`Meets Certain Claim Limitations of the ’652 and ’930 Patents ...................................43
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`E. Validity of the Asserted Formulation Patents (’652 and ’930 Patents) ............................ 57
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`a. Written Description ......................................................................................................57
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 4 of 62 PageID #: 9347
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`Pursuant to Local Rule 16.3(c)(4), Plaintiffs Sanofi-Aventis U.S. LLC (“Sanofi U.S.”)
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`and Sanofi-Aventis Deutschland GmbH (“Sanofi GmbH”) (collectively, “Plaintiffs” or
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`“Sanofi”)1 submit the following issues of fact that remain to be litigated. Sanofi’s identification
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`of the issues of fact that remain to be litigated is based upon its current understanding of the
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`arguments Defendant Eli Lilly and Company (“Eli Lilly”) is likely to make, based on the
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`pleadings, discovery, and expert reports in the action to date. To the extent that Lilly introduces
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`different or additional facts or alleged facts to meet its burden of proof, Sanofi reserves its right
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`to contest such facts or alleged facts, and to present any and all rebuttal evidence in response.
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`I.
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`DISPUTED FACTS CONCERNING THE ASSERTED DEVICE PATENTS
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`A.
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`1.
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`The Device Patents-In-Suit
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`U.S. Patent No.8,603,044 (“the ’044 Patent”), U.S. Patent No. 8,679,069
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`(“the ’069 Patent”), and U.S. Patent No. 8,556,864 (“the’864 Patent”) are referred to herein as
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`the “Asserted Device Patents.” By assignment, Sanofi GmbH owns all right, title, and interest to
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`each of the Asserted Device Patents-in-Suit.
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`2.
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`Sanofi U.S. is the exclusive licensee of the Asserted Device Patents-in-Suit with
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`exclusive rights, including the rights to sell and offer to sell in the United States the technologies,
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`products, or services claimed by the Patents-in-Suit, further including the right to sue and recover
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`for the infringement of the Patents-in-Suit.
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`a.
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`The ’044 and ’069 Patents
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`United States Patent 8,679,069 (“the ’069 Patent”) is titled “Pen-Type Injector.”
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`United States Patent No. 8,603,044 (“the ’044 Patent”) is titled “Pen-Type
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`3.
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`4.
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`Injector.”
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` 1 Plaintiffs refer to Sanofi throughout to refer to the current corporate entities Sanofi-Aventis U.S. LLC and
`Sanofi-Aventis Deutschland GmbH, as well as their predecessors-in-interest.
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 5 of 62 PageID #: 9348
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`5.
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`The ’069 Patent received a Patent Term Adjustment of 406 days under 35 U.S.C.
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`§ 154(b).
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`6.
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`On June 4, 2013, U.S Patent Application No. 13/909,649 (which issued as
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`the ’044 Patent) was filed as a continuation of U.S. Patent Application No. 12/944,544 (which
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`issued as the ’069 Patent).
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`7.
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`On November 11, 2010, U.S. Application No. 12/944,544 (which issued as
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`the ’069 Patent) was filed as a continuation of U.S. Patent Application No. 11/483,546, filed July
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`11, 2006. U.S. Patent Application No. 11/483,546 issued as U.S. Patent No. 7,918,833 on April
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`5, 2011.
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`8.
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`On July 11, 2006, U.S. Patent Application No. 11/483,546 was filed as a
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`continuation of U.S. Patent Application No. 10/790,225.
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`9.
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`On March 2, 2004 U.S. Patent Application No. 10/790,225 was filed and claimed
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`priority to Great Britain Patent Application No. 0304822.0.
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`10.
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`On March 3, 2003, GB Patent Application No. 0304822.0 was filed.
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`b.
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`The ’864 Patent
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`11.
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`U.S. Patent No. 8,556,864 (“the ’864 Patent”) is titled “Drive Mechanisms
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`Suitable for Use in Drug Delivery Devices.”
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`12.
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`The ’864 Patent received a Patent Term Adjustment of 301 days under 35 U.S.C.
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`§ 154(b).
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`13.
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`On March 30, 2011, U.S. Patent Application No. 13/075,212 (which issued as the
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`’864 Patent) was filed as a continuation of U.S. Patent Application No. 11/520,598.
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`14.
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`On September 14, 2009, U.S. Patent Application No. 11/520,598 was filed as a
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`continuation of U.S. Patent Application No. 10/790,866.
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 6 of 62 PageID #: 9349
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`15.
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`On March 3, 2004, U.S. Patent Application No. 10/790,866 was filed, claiming
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`priority to GB 0304822.0.
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`16.
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`On March 3, 2003, Great Britain Patent Application No. 0304822.0 was filed.
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`c.
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`Development of the Asserted Device Patents
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`17.
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`The inventions described and claimed in the Asserted Device Patents were
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`developed at DCA Design International, Ltd. (“DCA”), in Warwick, England.
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`18.
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`In 2001,
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`19.
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`20.
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`Between late 2001 and December 2002,
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 7 of 62 PageID #: 9350
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`22.
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`23.
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`24.
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`On March 3, 2003, DCA filed Great Britain Patent Application No. 0304822.0,
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`which is the priority application for the Asserted Device Patents.
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`B.
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`New Drug Applications (“NDAS”)
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`a.
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`Sanofi’s NDA
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`25.
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`At various times, Sanofi U.S. listed the ’864, ’044, and ’069 Patents in the FDA’s
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`Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”) as
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`covering its Lantus® SoloSTAR® products.
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`b.
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`Lilly’s NDA
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`26.
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`On or around December 18, 2013, Lilly submitted NDA No. 205-692 to the FDA
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`under 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 FDA’s approval to manufacture commercially and sell its proposed
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`product—an insulin glargine [rDNA origin] for injection, 100 units/mL (“Lilly’s Proposed
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`Insulin Glargine Product”), in a prefilled insulin delivery device
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` prefilled insulin delivery device that contains Lilly’s Proposed Insulin Glargine
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`Product. Lilly’s Proposed Insulin Glargine Product and
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` collectively
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`referred to as the “Proposed Product.”
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`27.
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 8 of 62 PageID #: 9351
`Case l:14—cv—OO113—RGA—MPT Document 278-2 Filed 09/25/15 Page 8 of 62 Page|D #: 9351
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`28.
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`7.
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 9 of 62 PageID #: 9352
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`C.
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`Sanofi’s SoloSTAR® Device Practice All Elements of the Asserted Claims
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`32.
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`The dosing mechanisms of Sanofi’s Lantus® SoloSTAR® and Sanofi’s Apidra®
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`SoloSTAR® (collectively “SoloSTAR®”) are identical.
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`33.
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`Sanofi currently markets and sells SoloSTAR® devices in the United States.
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`34. We believe that Lilly will concede that the SoloSTAR® practices claim 2 of
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`the ’864 Patent.
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`35.
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`SoloSTAR® practices claims 1, 5, 7, and 10 of the ’044 Patent.
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`36.
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`SoloSTAR® practices claim 1 of the ’069 Patent.
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`37.
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`Lantus® SoloSTAR® has been a commercially successful product.
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`38.
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`The Lantus® SoloSTAR® that Sanofi launched in the United States is depicted
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`below:
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 10 of 62 PageID #:
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`D.
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`Infringement of the Asserted Device Patents (’044, ’069, and ’864 Patents)
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`a.
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`The
`the ’044 Patent
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` Meets the Disputed Claim Limitations of
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`39.
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`The prefilled insulin device containing Lilly’s Proposed Insulin Glargine Product
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` infringes claims 1, 5, 7, and 10 of U.S. Patent No. 8,603,044 (“the ’044
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`Patent”). Claim 5 depends from claim 4, which depends from claim 1. Claims 7 and 10 also
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`depend from claim 1.
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`i.
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` has a “main housing” that “extend[s]
`from a distal end to a proximal end.”
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`40.
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`Claim 1 of the ’044 Patent requires “a main housing, said main housing extending
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`from a distal end to a proximal end.”
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`41. We believe Lilly will concede that the
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` housing extends from a
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`distal end (the needle end of the device according to this patent) to a proximal end (the non-
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`needle end of the device).
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`ii.
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` has a “dose dial sleeve positioned within
`The
`said housing, said dose dial sleeve comprising a helical groove
`configured to engage a threading provided by said main
`housing, said helical groove provided along an outer surface of
`said dose dial sleeve.”
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`42.
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`Claim 1 of the ’044 Patent further requires “a dose dial sleeve positioned within
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`said housing, said dose dial sleeve comprising a helical groove configured to engage a threading
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`provided by said main housing, said helical groove provided along an outer surface of said dose
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`dial sleeve.”
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`43.
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 12 of 62 PageID #:
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`44.
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 13 of 62 PageID #:
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`iii.
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` has a “a dose dial grip disposed near a
`proximal end of said dose dial sleeve.”
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`46.
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`Claim 1 of the ’044 Patent requires “a dose dial grip disposed near a proximal end
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`of said dose dial sleeve.”
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`47.
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`The Court construed “dose dial grip” as “[a] component that a user rotates to dial
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`a dose.” Markman Order (D.E. 192) at 15. We believe Lilly will concede
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` is a component that a user rotates to dial a dose, and that the button is disposed
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`near a proximal end of the dose dial sleeve.
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`iv.
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` has “a piston rod provided within said
`housing, said piston rod is non-rotatable during a dose setting
`step relative to said main housing.”
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`48.
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`Claim 1 of the ’044 Patent requires “a piston rod provided within said housing,
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`said piston rod is non-rotatable during a dose setting step relative to said main housing.” We
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`believe Lilly will concede
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 14 of 62 PageID #:
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`49.
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`The Court construed the phrase “said piston rod is non-rotatable during a dose
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`setting step relative to said main housing” to mean “[a] piston rod that is prevented from rotating
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`at the time when the dose is being set.” Markman Order (D.E. 192) at 16. We believe Lilly will
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`concede that
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`v.
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` has “a drive sleeve extending along a
`portion of said piston rod, said drive sleeve comprising an
`internal threading near a distal portion of said drive sleeve,
`said internal threading adapted to engage an external thread of
`said piston rod.”
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`50.
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`Claim 1 of the ’044 Patent requires “a drive sleeve extending along a portion of
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`said piston rod, said drive sleeve comprising an internal threading near a distal portion of said
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`drive sleeve, said internal threading adapted to engage an external thread of said piston rod.” We
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 15 of 62 PageID #:
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`believe Lilly will concede that
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`51.
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`52.
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`The Court construed “drive sleeve” to mean “[a]n essentially tubular component
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`of essentially circular cross-section which is further releasably connected to the dose dial
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`sleeve.” Markman Order (D.E. 192) at 10. The Court also construed the phrase “a drive sleeve
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`releasably connected to the dose dial sleeve” in the context of U.S. Patent No. 8,556,864 (“’864
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`Patent”) (one of the other asserted device patents) to mean “[a] drive sleeve that is reversibly
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`joined to the dose dial sleeve, which allows coupling and decoupling.” Markman Order (D.E.
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`192) at 11. We believe Lilly will concede
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`53.
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`The only requirement Lilly disputes is
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 16 of 62 PageID #:
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`54.
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 17 of 62 PageID #:
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`56.
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`vi.
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` has “a tubular clutch located adjacent a
`distal end of said dose dial grip, said tubular clutch operatively
`coupled to said dose dial grip, wherein said dose dial sleeve
`extends circumferentially around at least a portion of said
`tubular clutch.”
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`57.
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`Claim 1 of the ’044 Patent requires “a tubular clutch located adjacent a distal end
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`of said dose dial grip, said tubular clutch operatively coupled to said dose dial grip, wherein said
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`dose dial sleeve extends circumferentially around at least a portion of said tubular clutch.”
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 18 of 62 PageID #:
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`58.
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`The Court construed the term “tubular clutch” to mean “[a] clutch having the
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`shape of a hollow cylindrical structure.” Markman Order (D.E. 192) at 13. The Court also
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`construed the term “tubular clutch” as “[a] structure that couples and decouples a moveable
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`component from another component.” Markman Order (D.E. 192) at 12. We believe Lilly will
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`concede that (1) the clutch is located adjacent a distal end of the dose dial grip; (2) the clutch is
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`operatively coupled to the dose dial grip; (3) the dose dial sleeve extends circumferentially
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`around a portion of the clutch; and (4) the clutch couples and decouples a moveable component
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`from another component.
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`59.
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`The only requirement Lilly disputes is whether the clutch is tubular. During oral
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`argument regarding claim construction, the parties “agreed that a ‘tubular clutch’ does not need
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`to be ‘continuous’ or have ‘circumferential ends.’” Markman Order (D.E. 192) at 13.
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` is in the shape of a hollow cylindrical structure.
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`60.
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`This is confirmed by U.S. Patent No. 7,291,132 (“’132 Patent”), which Lilly’s
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`witnesses confirmed describe
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` The ’132 Patent states: “Nut 364 is made
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`from injection molded plastic and includes a cylindrical, tube-shaped body 392, plunging rib 394
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`and a pair of torque fingers 396.” ’132 Patent at 16:48-50.
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 19 of 62 PageID #:
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`Nut 364 from ’132 Patent
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`61.
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`Like the nut of the ’132 Patent,
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`vii.
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` has “a cartridge retaining part
`operatively coupled to said main housing, said cartridge
`retaining part comprising a fluid container.”
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`62.
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`Claim 1 of the ’044 Patent requires “a cartridge retaining part operatively coupled
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`to said main housing, said cartridge retaining part comprising a fluid container.” We believe
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`Lilly will concede that the
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`viii. The fluid container of the
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`medicament filled reservoir with a movable cartridge piston at
`a proximal end and an outlet at a distal end.”
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`63.
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`Claim 1 of the ’044 Patent requires that the fluid container “define[] a
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`medicament filled reservoir with a movable cartridge piston at a proximal end and an outlet at a
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`distal end.” We believe Lilly will concede that this limitation is met by the
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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 20 of 62 PageID #:
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`ix.
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` is “movable by
`The cartridge piston of the
`said piston rod to be advanced toward an outlet of said fluid
`container when said piston rod is moved distally.”
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`64.
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`Claim 1 of the ’044 Patent requires that the cartridge piston of th
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` be “movable by said piston rod to be advanced toward an outlet of said fluid container
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`when said piston rod is moved distally.” We believe Lilly will concede that during injection, the
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`plunger (the cartridge piston) is advanced toward an outlet of cartridge as the piston rod
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`advances toward the same direction.
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`65.
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`The only requirement Lilly disputes is whether the piston rod moves distally. The
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`Court did not construe the claim term a “cartridge piston movable by said piston rod to be
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`advanced toward an outlet of said fluid container when said piston rod is moved distally.”
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`Lilly’s technical expert construes the term to require that the piston rod rotate as it is moved
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`distally. However, the Court stated that “[t]he ’864 specification defines ‘piston rod’ . . . [and
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`the] patentee’s definition does not require the piston rod to be ‘rotatable.’” Markman Order
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`(D.E. 192) at 16. As such, the Court construed the term of claim 1 the ’044 Patent, “said piston
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`rod is non-rotatable during a dose setting step relative to said main housing,” to mean “[a] piston
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`rod that is prevented from rotating at the time when the dose is being set.” Id. The Court
`
`rejected Lilly’s proposed construction for that term of the ’044 Patent that would require “said
`
`piston rod” to be rotatable. Id. Nonetheless, Lilly contends that it does not infringe claim 1 of
`
`the ’044 Patent because the piston rod of
`
`
`
`The claims do not require the piston rod “rotate” as it is “moved distally,”
`
`
`
` the element as required by claim 1 of the ’044 Patent.
`
`{01044150;v1 }
`
`17
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`

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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 21 of 62 PageID #:
` 9364
`
`x.
`
` includes a “clicker” that provides
`The
`“audible feedback to the user” when the “dose dial grip is
`rotated.”
`
`66.
`
`Claim 4 of the ’044 Patent requires that the housing part for the medication
`
`dispensing apparatus include a “clicker, said clicker providing at least an audible feedback to a
`
`user when said dose dial grip is rotated.” Claim 5 requires that the clicker comprise “at least one
`
`flexible arm, said flexible arm comprising at least one tooth member, and at least one spline,
`
`wherein when said dose dial grip is rotated, said at least one flexible arm deforms and drags said
`
`tooth member over said at least one spline so as to provide said audible feedback.”
`
`
`
`
`
`
`
`
`
`67.
`
`
`
`
`
`
`
`
`
`
`
`xi.
`
` includes “a first thread
`The piston rod of the
`and a second thread, wherein at least one of said first or said
`
`{01044150;v1 }
`
`18
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`

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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 22 of 62 PageID #:
` 9365
`
`second thread comprises at least one part threads rather than a
`complete thread.”
`
`68.
`
`Claim 7 of the ’044 Patent requires that the piston rod include “a first thread and a
`
`second thread, wherein at least one of said first or said second thread comprises at least one part
`
`threads rather than a complete thread.”
`
`
`
`
`
`69.
`
`The Court construed the term “thread” and ”threading” to mean “[a] rib or groove
`
`on a first structure that engages a corresponding groove or rib on a second structure.” Markman
`
`Order (D.E. 192) at 9-10. We believe Lilly will concede that the piston rod includes a first
`
`thread, and that the first thread is a part thread rather than a complete thread.
`
`70.
`
`Lilly disputes, however, that the piston rod includes a second thread. The Court
`
`accurately noted that “[t]he only point of dispute between the parties is whether the word
`
`‘helical’ should be included before ‘groove’ in the construction,” and rejected Lilly’s proposed
`
`construction seeking to limit “thread” to a “helical” thread.
`
`
`
`
`
`
`
`
`
`
`
`xii.
`
` includes “a radial
`The dose dial sleeve of the
`stop” at the end of the helical groove on its outer surface,
`which, when the maximum dose is reached, abuts the end of
`the internal thread of the housing to prevent further rotation
`of the dose dial sleeve.
`
`71.
`
`Claim 10 of the ’044 Patent requires that the dose dial sleeve include “at least one
`
`radial stop, said radial stop positioned near an end of said helical groove, wherein when said dose
`
`dial sleeve is rotated to set a maximum dose of said medication dispensing apparatus, said radial
`
`{01044150;v1 }
`
`19
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`

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`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 23 of 62 PageID #:
` 9366
`
`stop near said end of said helical groove abuts an end of said threading provided on said inner
`
`surface of said main housing and thereby prevents rotation of said dose dial sleeve.”
`
`72. We believe Lilly will concede that the dose dial sleeve and housing components
`
`of
`
` meet the requirements of claim 10 of the ’044 Patent. Specifically, we
`
`believe that Lilly will admit that when maximum dose is reached, a radial stop located at the end
`
`of the helical groove on the outer surface of the dose dial sleeve abuts the end of the internal
`
`thread inside the housing, thus preventing further rotation of the dose dial sleeve.
`
`b.
`
` Meets the Disputed Claim Limitations of
`
`the ’069 Patent
`
`73.
`
` infringes claim 1 of U.S. Patent No. 8,679,069 (“the ’069
`
`Patent”). Claim 1 of the ’069 Patent is a subset of the elements of claim 1 of the ’044 Patent.
`
`Thus,
`
` infringes claim 1 of the ’069 Patent for the same reasons it satisfies
`
`claim 1 of the ’044 Patent, as explained above.
`
`74.
`
`
`
`
`
`
`
`
`
`
`
`c.
`
`the ’864 Patent
`
` Meets the Disputed Claim Limitations of
`
`75.
`
` infringes claim 2 of U.S. Patent No. 8,556,864.
`
`i.
`
` has a “main housing” that “extend[s]
`from a distal end to a proximal end.”
`
`76.
`
`Claim 2 of the ’864 Patent requires “a housing having a helical thread along an
`
`inner surface.” We believe Lilly will concede that the
`
`{01044150;v1 }
`
`20
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`
`
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 24 of 62 PageID #:
` 9367
`
`
`
`
`
`ii.
`
` has a “dose dial sleeve having a helical
`thread on an outer surface engaged with the helical thread of
`the housing.”
`
`77.
`
`Claim 2 of the ’864 Patent requires “dose dial sleeve having a helical thread on an
`
`outer surface engaged with the helical thread of the housing.”
`
`
`
`
`
`
`
`
`
`
`
`iii.
`
` has a “drive sleeve releasably connected
`to the dose dial sleeve.”
`
`78.
`
`Claim 2 of the ’864 Patent requires “a drive sleeve releasably connected to the
`
`dose dial sleeve.” For the same reasons discussed above in relation to the ’044 Patent,
`
`
`
`
`
`iv.
`
` has “a clutch mechanism located
`between the dose dial sleeve and the drive sleeve.”
`
`79.
`
`Claim 2 of the ’864 Patent requires “a clutch mechanism located between the dose
`
`dial sleeve and the drive sleeve.” The Court construed the term “clutch mechanism” as “[a]
`
`structure that couples and decouples a moveable component from another component.”
`
`Markman Order (D.E. 192) at 12. We believe Lilly will concede that the
`
`{01044150;v1 }
`
`
`
`21
`
`
`
`
`
`
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 25 of 62 PageID #:
` 9368
`
`80.
`
` Lilly only disputes that its clutch mechanism is “located between” the dose dial
`
`sleeve and the drive sleeve. The Court did not construe the term “located between,” but instead
`
`adopted the term’s plain and ordinary meaning. Markman Order (D.E. 192) at 13–14.
`
`81.
`
`
`
`
`
`
`
`
`
`
`
`82.
`
`According to Lilly, the clutch is not “located between” the drive sleeve and the
`
`dose dial sleeve in the above arrangement because the clutch is not located in the cylindrical
`
`space between the drive sleeve and the dose dial sleeve. However, in its claim construction
`
`order, the Court explicitly stated that it “agree[d] with Sanofi that Lilly’s ‘in the cylindrical
`
`space’ limitation is not supported by the intrinsic record. . . .” Markman Order at 14. Lilly’s
`
`position is contrary to the Court’s claim construction order. In addition, Lilly’s position is
`
`contrary to the plain and ordinary meaning of the phrase “located between” and is also contrary
`
`to the specifications of the asserted patents
`
`v.
`
` clutch mechanism is configured such
`The
`that “when the dose dial sleeve and the drive sleeve are
`
`{01044150;v1 }
`
`22
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`
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 26 of 62 PageID #:
` 9369
`
`coupled, both are allowed to rotate with respect to the
`housing.”
`
`83.
`
`Claim 2 of the ’864 Patent requires that the “clutch mechanism” be “configured
`
`such that” “when the dose dial sleeve and drive sleeve are coupled, both are allowed to rotate
`
`with respect to the housing.”
`
`
`
`
`
`
`
`
`
`vi.
`
` clutch mechanism is configured such
`that “when the dose dial sleeve and the drive sleeve are de-
`coupled, rotation of the dose dial sleeve with respect to the
`housing is allowed, while rotation of the drive sleeve with
`respect to the housing is prevented, whereby axial movement of
`the drive sleeve is allowed so that a force is transferred in a
`longitudinal direction to a proximal end of the drug delivery
`device.”
`
`84.
`
`Claim 2 of the ’864 Patent requires that the “clutch mechanism” be “configured
`
`such that” “when the dose dial sleeve and the drive sleeve are de-coupled, rotation of the dose
`
`dial sleeve with respect to the housing is allowed, while rotation of the drive sleeve with respect
`
`to the housing is prevented.” We believe Lilly will
`
`
`
`
`
`
`
` We also believe that Lilly will concede that when the dose dial sleeve
`
`and drive sleeve are de-coupled, axial movement of the drive sleeve is allowed so that a force is
`
`transferred in a longitudinal direction to a proximal end (as used in the ’864 Patent, refers to the
`
`needle end) of the drug delivery device.
`
`{01044150;v1 }
`
`23
`
`
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 27 of 62 PageID #:
` 9370
`
`85.
`
`
`
` The Court did not construe the term “the
`
`clutch mechanism is configured such that . . . when the dose dial sleeve and the drive sleeve are
`
`de-coupled . . . rotation of the drive sleeve with respect to the housing is prevented” but instead
`
`adopted the term’s plain and ordinary meaning. Markman Order (D.E. 192) at 14-15.
`
`
`
`86.
`
`
`
`87.
`
`88.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`{01044150;v1 }
`
`24
`
`
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 28 of 62 PageID #:
` 9371
`
`89.
`
`
`
`
`
`
`
`
`
`
`
`{01044150;v1 }
`
`25
`
`
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 29 of 62 PageID #:
` 9372
`
`Validity of the Asserted Device Patents (’044, ’069, and ’864 Patents)
`
`
`
`
`
`90.
`
`E.
`
`91.
`
`
`
`92.
`
`A person of ordinary skill in the art for the Asserted Device Patents would be one
`
`who understands the structure of various drug injection delivery devices and understands the
`
`basics of device design and manufacturing. That person would have a bachelor’s degree in
`
`mechanical engineering or equivalent degree.
`
`{01044150;v1 }
`
`26
`
`
`
`
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 30 of 62 PageID #:
` 9373
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 31 of 62 PageID #:
` 9374
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 32 of 62 PageID #:
` 9375
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 33 of 62 PageID #:
` 9376
`
`

`
`Case 1:14-cv-00113-RGA-MPT Document 278-2 Filed 09/25/15 Page 34 of 62 PageID #:
` 9377
`
`would not have been motivated to combine the teachings of Steenfeldt-Jensen with those of
`
`Møller, because they address different types of injection pens and teach away from one another.
`
`107. Steenfeldt-Jensen and Møller are fundamentally different mechanisms.
`
`Steenfeldt-Jensen describes a simple mechanism (having only 7 parts) that creates a mechanical
`
`advantage using helical threads, whereas Møller describes a relatively complicated device (more
`
`suitable for a reusable application) that creates a mechanical advantage through a gearbox.
`
`108. Steenfeldt-Jensen teaches away from the type of complex dosing mechanism used
`
`in Møller, explaining that “the number of parts from which the syringe is constructed and the
`
`number of different kinds of materials used in the syringe should be kept at a minimum.”
`
`Steenfeldt-Jensen ’297 Patent at 1:23-26. Steenfeldt-Jensen specifically criticizes the use of
`
`metal parts, which are used in Møller. See id. at 2:28-36.
`
`109. Møller specifically references and then criticizes Steenfeldt-Jensen (WO
`
`99/38554) as causing excessive friction during injection due to its use of helical threads and lack
`
`of a gearbox. See Møller at 2:1-8. Møller teaches that “a traditional gearing using mutual
`
`engaging gear wheels and racks is preferred,” unlike the type of gearing in Steenfeldt-Jensen.
`
`See id. at 2:7-8. Møller also teaches away from mechanisms that transform linear movement to
`
`rotational movement, as is done in Steenfeldt-Jensen. Id. at 2:43-49.
`
`110.
`
`In his Reply Expert Report, Lilly’s expert, Dr. Jorge Ochoa, prepared an
`
`illustration (Figure 9, below) of an alleged combination of Steenfeldt-Jensen and Møller, which
`
`he characterized as “Steenfeldt-Jensen with a Møller Clutch.” Lilly’s other technical expert, Mr.
`
`Claus Møller, testified tha