UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner
`
`Case No. IPR2018-01675
`U.S. Patent No. 8,603,044
`
`
`
`
`
`AMENDED PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sanofi Exhibit 2025.001
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`I. 
`
`II. 
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION .......................................................................................... 1 
`
`THE BOARD SHOULD EXERCISE ITS DISCRETION TO DENY
`INSTITUTION PURSUANT TO §§ 314(A) AND 324(A) ............................ 4 
`
`A. 
`
`B. 
`
`C. 
`
`Procedural Background ......................................................................... 6 
`
`The Board Has Discretion to Deny Institution Under 35 U.S.C.
`§§ 314(a) and 324(a) ............................................................................. 8 
`
`NHK Spring Co. v. Intri-Plex Technologies, Inc., IPR2018-
`00752 ..................................................................................................... 9 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`The parties are engaged in District Court litigation on the
`same patent ................................................................................ 10 
`
`The Petitioner relies on the same prior art in the Petition
`as in the District Court case ...................................................... 11 
`
`The District Court trial will conclude before the IPR ............... 12 
`
`Instituting the IPR permits the Petitioner a tactical
`advantage .................................................................................. 12 
`
`D.  General Plastic Industrial Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357 ................................................................................... 14 
`
`1. 
`
`General Plastics Factors 1, 2, 4, and 5: whether the same
`petitioner previously filed a petition directed to the same
`claims of the same patent; whether at the time of filing of
`the first petition the petitioner knew of the prior art
`asserted in the second petition or should have known of it;
`the length of time that elapsed between the time the
`petitioner learned of the prior art asserted in the second
`petition and the filing of the second petition; whether the
`petitioner provides adequate explanation for the time
`elapsed between the filings of multiple petitions directed
`to the same claims of the same patent ....................................... 15 
`i
`
`Sanofi Exhibit 2025.002
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`2. 
`
`3. 
`
`General Plastics Factor 3: whether at the time of filing of
`the second petition the petitioner already received the
`patent owner’s preliminary response to the first petition or
`received the Board’s decision on whether to institute
`review in the first petition ......................................................... 17 
`
`General Plastics Factors 6 and 7: the finite resources of
`the Board; and the requirement under 35 U.S.C. §
`316(a)(11) to issue a final determination not later than 1
`year after the date on which the Director notices institution
`of review ................................................................................... 17 
`
`III.  THE 044 PATENT ........................................................................................ 19 
`
`IV.  CLAIM CONSTRUCTION .......................................................................... 24 
`
`A. 
`
`B. 
`
`“helical groove” (claim 11) ................................................................. 24 
`
`“tubular clutch” (claim 11) and “clicker” (claim 14) .......................... 28 
`
`V. 
`
`THE PRIOR ART .......................................................................................... 29 
`
`A. 
`
`Burroughs ............................................................................................ 29 
`
`VI.  REASONS WHY THE PETITION SHOULD BE DENIED ....................... 36 
`
`A.  Ground 1 Should Be Denied Because Burroughs Does Not
`Disclose Or Render Obvious A Helical Groove Provided Along
`An Outer Surface Of Said Dose Dial Sleeve ...................................... 36 
`
`1. 
`
`2. 
`
`3. 
`
`Burroughs Does Not Disclose A Helical Groove Provided
`Along An Outer Surface Of Said Dose Dial Sleeve ................. 36 
`
`Burroughs In View Of The Knowledge Of A POSA Does
`Not Render Obvious A Helical Groove Provided Along
`An Outer Surface Of Said Dose Dial Sleeve ............................ 36 
`
`Petitioner Does Not Establish A Motivation To Modify
`Burroughs’ Threads To Include A Groove ........................... 4139 
`
`ii
`
`Sanofi Exhibit 2025.003
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`B. 
`
`Ground 1 Should Be Denied Because Burroughs Does Not
`Disclose Or Render Obvious That The Helical Groove Of The
`Dose Dial Sleeve Has A Different Lead Than The Internal
`Threading Of The Drive Sleeve ...................................................... 4341 
`
`1. 
`
`2. 
`
`3. 
`
`Burroughs Does Not Disclose Or Render Obvious A
`Helical Groove Of The Dose Dial Sleeve ............................. 4341 
`
`Burroughs Does Not Disclose That The First Lead And
`Second Lead Are Different ................................................... 4442 
`
`Burroughs Does Not Render Obvious That The First Lead
`And Second Lead Are Different ........................................... 4442 
`
`C. 
`
`The Petition Fails To Put Patent Owner On Notice Of How The
`Claims Are To Be Construed In The Grounds As Required By
`37 C.F.R. § 42.104(b) ...................................................................... 4745 
`
`VII.  CONCLUSION .......................................................................................... 5048 
`
`
`
`
`
`iii
`
`Sanofi Exhibit 2025.004
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases 
`Compass Bank, Commerce Bankshares, Inc. v. Intellectual Ventures II, LLC,
`IPR2014-00786, Paper 46 (P.T.A.B. Sept. 23, 2015) .......................................... 38
`Corning Inc. v. DSM IP Assets,
`IPR2013-00050, Paper 77 (P.T.A.B. May 1, 2014) ............................................. 38
`Cutsforth, Inc. v. MotivePower, Inc.,
`636 F. App’x 575 (Fed. Cir. 2016) ................................................................. 4042
`Gen. Electric Co. v. Vestas Wind Systems A/S,
`IPR2018-00928, Paper 9 (P.T.A.B. Nov. 5, 2018) ......................................... 4647
`Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper 19 (P.T.A.B. Sept. 6, 2017) ................................. 5, 14, 16
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) ....................................................................... 4042
`Microsoft Corp. v. Koninklijke Philips N.V.,
`IPR2018-00277, Paper 10 (P.T.A.B. June 8, 2018) ............................................... 5
`NetApp, Inc. v. Realtime Data LLC,
`PR2017-01195, Paper 9 (P.T.A.B. Oct. 12, 2017) ....................................... 14, 17
`NHK Spring Co. v. Intri-Plex Techs., Inc.,
`IPR2018-00752, Paper 8 (P.T.A.B. Sept. 12, 2018) .................................... passim
`Polaris Indus., Inc. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018) ............................................................. 4042, 4446
`Williamson v. Citrix Online, LLC,
`792 F.3d 1339 (Fed. Cir. 2015) ............................................................................ 29
`Statutes and Rules 
`21 C.F.R. § 314.50, et seq. .....................................................................................6, 7
`21 C.F.R. § 314.52 ..................................................................................................... 6
`
`iv
`
`Sanofi Exhibit 2025.005
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`21 U.S.C. § 355(b)(2) and (3) .................................................................................... 6
`21 U.S.C. § 355(b)(3)(b)(ii) ....................................................................................... 7
`21 U.S.C. § 355(c)(3)(C) ........................................................................................... 8
`35 U.S.C. § 314(a) ........................................................................................... passim
`35 U.S.C. § 315(b) .............................................................................................. 7, 16
`35 U.S.C. § 316(a)(11) ............................................................................................. 17
`35 U.S.C. §§ 314(a) and 324(a) ....................................................................... passim
`35 U.S.C. §§ 316(b) and 326(b) ................................................................................. 9
`37 C.F.R. § 42.104, et seq. ............................................................................... passim
`37 C.F.R. § 42.65(a) ................................................................................................. 38
`
`v
`
`Sanofi Exhibit 2025.006
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`Exhibit #
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`EXHIBIT LIST
`
`Description
`Press Release, “Mylan Enhances Partnership with Biocon through
`Strategic Collaboration for Insulin Products”, Feb. 13, 2013 (PR
`Newswire), available at http://newsroom.mylan.com/press-
`releases?item=122834
`Press Release, “Mylan Commences Phase III Clinical Trials for its
`Generic Version of Advair Diskus® and Insulin Analog to Lantus®”,
`Sept. 16, 2014 (PR Newswire), available at
`http://newsroom.mylan.com/press-releases?item=123251
`Press Release, “Mylan and Biocon Present Clinical Data on Insulin
`Glargine at the American Diabetes Association’s 77th Scientific
`Sessions”, June 10, 2017 (PR Newswire), available at
`http://newsroom.mylan.com/2017-06-10-Mylan-and-Biocon-
`Present-Clinical-Data-on-Insulin-Glargine-at-the-American-
`Diabetes-Associations-77th-Scientific-Sessions
`Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC,
`Sanofi-Aventis Deutschland GmbH v. Eli Lilly and Company, C.A.
`No. 1-14-cv-00113-RGA (D. Del), Dkt. No. 1
`Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC,
`Sanofi-Aventis Deutschland GmbH, and Sanofi Winthrop Industrie
`v. Merck Sharp & Dohme Corp., C.A. No. 1-16-cv-00812-RGA (D.
`Del), Dkt. No. 1
`Stipulation and Proposed Order, Sanofi-Aventis U.S. LLC v. Mylan,
`N.V., Civil Action No. 17-9105-SRC-SLW (D.N.J. Feb 5, 2018),
`Dkt. No. 45
`Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC et al.
`v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.
`Oct. 24, 2017), Dkt. No. 1
`Excerpts from Defendants’ Invalidity Contentions, dated Jan. 25,
`2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No.
`2:17-cv-09105-SRC-CLW (D.N.J.)
`Excerpts from Mylan GMBH’s Amended Invalidity Contentions,
`dated April 25, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V.
`et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`Excerpts from Mylan GMBH’s Exhibit C to Amended Invalidity
`Contentions, dated April 25, 2018, Sanofi-Aventis U.S. LLC et al. v.
`Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`vi
`
`Sanofi Exhibit 2025.007
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`2011
`
`2012
`2013
`
`2014
`
`2015
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`Aug. 13, 2018 Service of Sanofi’s Responses to Mylan’s Amended
`Contentions, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al.,
`Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`MP4 file of Sanofi’s Patented Pen animation
`Excerpts from McGraw Hill Dictionary of Scientific and Technical
`Terms (Sixth edition, McGraw-Hill 2003), p. 972 and 1873
`Excerpts from Merriam-Webster’s Collegiate Dictionary (10th
`edition, Merriam-Webster, Inc. 2001), p. 538
`The New Oxford American Dictionary (Oxford University Press
`2001), p. 789-90
`Defendants’ Opposition to Plaintiffs’ Motion to Stay dated Nov.
`22, 2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case
`No. 1:17-cv-00181-IMK (N.D. Va.), Dkt. No. 44
`Joint Proposed Discovery Plan dated Dec. 14, 2017, Sanofi-Aventis
`U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-
`CLW (D.N.J.)
`Letter from A. Calmann to Judge Waldor dated Apr. 24, 2018,
`Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-
`cv-09105-SRC-CLW (D.N.J.), Dkt. No. 90
`Motion to Expedite Defendants’ Motion Requesting an Expedited
`Scheduling Conference dated Nov. 22, 2017 , Sanofi-Aventis U.S.
`LLC et al. v. Mylan N.V. et al., Case No. 1:17-cv-00181-IMK (N.D.
`Va.), Dkt. No. 46
`Initial Planning Meeting Report and Discovery Proposals dated
`Dec. 22, 2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al.,
`Case No. 1:17-cv-00181-IMK (N.D. Va.), Dkt. No. 61
`Transcript of Motion / Scheduling Conference dated Jan. 3, 2018,
`Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 1:17-
`cv-00181-IMK (N.D. Va.), Dkt. No. 64
`Excerpts from Transcript, Conference Call dated Aug. 2, 2018,
`Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-
`cv-09105-SRC-CLW (D.N.J.) (confidentiality designation
`removed)
`Report of the Local Patent Rules Committee, Explanatory Notes for
`2016 Amendments
`Transcript, Conference Call for Case IPR2018-01675, -01676, -
`01678, -01680 (P.T.A.B. Feb. 5, 2019)
`Redline of Amended Patent Owner Preliminary Response (filed
`February 20, 2019)
`
`vii
`
`Sanofi Exhibit 2025.008
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`surface of the dose dial sleeve. Although Petitioner contends that it would have been
`
`obvious to provide a “helical groove, formed by protruding, grooved threads 110,
`
`112 on the outer surface of Burroughs’ dial mechanism 34,” Petition at 42, this
`
`contention fails to carry Petitioner’s burden because the proposed modification does
`
`not result in a “helical groove” as properly construed.
`
`Petitioner contends that the threads 110 and 112 on Burroughs’ dial
`
`mechanism form a “helical rib,” such that if a groove is added to each thread 110
`
`and 112, the result would be a “helical groove.” Petition at 40-42. As discussed in
`
`Section III, however, the term “helical” refers to a structure that is formed in the
`
`shape of a spiral. As shown below in Figures 7 and 9 of Burroughs, the threads 110
`
`and 112 are discrete, tooth-like protrusions on the surface of dial mechanism 34, not
`
`a spiral-shaped rib or thread. Petitioner’s assertions are both unsupported and
`
`unreliable.
`
`
`
`Ex. 1013, Figs. 7 and 9.
`
`
`
`The only evidence Petitioner cites paragraph 165 of its expert’s declaration in
`
`support of its flawed contention that the threads 110 and 112 form a “helical” rib is
`
`37
`
`Sanofi Exhibit 2025.009
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`paragraph 165 of its expert’s declaration.9 Petition at 25. Dr. Leinsing, however,
`
`offers nothing but his own conclusory opinion that these threads constitute a
`
`“discontinuous ‘helical rib.’” Ex. 1011, ¶ 165. This unsupported testimony should
`
`be given no weight. 37 C.F.R. § 42.65(a); Compass Bank, Commerce Bankshares,
`
`Inc. v. Intellectual Ventures II, LLC, IPR2014-00786, Paper 46 at 31 (P.T.A.B. Sept.
`
`23, 2015); see also Corning Inc. v. DSM IP Assets, IPR2013-00050, Paper 77 at 22-
`
`23, 25 (P.T.A.B. May 1, 2014).
`
`Petitioner also cites Exhibit 1002 at 3:62-64, but this nonetheless does not
`
`support Petitioner’s position that Burroughs’ threads 110 and 112 are “helical.”
`
`Specifically, Exhibit 1002 at 3:62-64 discusses an embodiment of the 044 Patent’s
`
`injector pen in which helical thread 24 includes discrete interruptions. This is
`
`illustrated in Figures 1 and 2 of the 044 Patent:
`
`
`9 Petitioner also cites Exhibit 1002 at 3:42-44, but this is a portion of the 044 Patent
`
`discussing the replaceable cap of the claimed invention, and includes no discussion
`
`of threads or grooves, helical or otherwise. See Ex. 1002, 3:42-44.
`
`38
`
`Sanofi Exhibit 2025.010
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`Ex. 1002, Figs. 1 and 2 (highlighted).
`
`
`
`As shown in the above figures, there is no question that thread 24 is a thread
`
`formed in the shape of a spiral, even though it may have discontinuities. This,
`
`39
`
`Sanofi Exhibit 2025.011
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`however, does not support Petitioner’s contention that Burroughs’ threads 110 and
`
`112 are a helical rib. As discussed in further detail below, Burroughs’ threads 110
`
`and 112, which are only small, tooth-like structures, are clearly not formed in the
`
`shape of a spiral.
`
`
`
`
`
`Ex. 1013, Figs. 7 and 9 (highlighted).
`
`Additionally, Dr. Leinsing’s testimony is unreliable because it fails to apply
`
`an appropriate construction of “helical,” as set forth in Section III, which requires a
`
`“helical” structure to be a structure formed in the shape of a spiral. Dr. Leinsing
`
`admits that the threads 110 and 112 are formed in the shape of “rib-like protrusions,”
`
`not in the shape of a spiral. Ex. 1011, ¶ 165. And, as noted above, Figures 7 and 9
`
`depict the threads as being discrete, tooth-like structures and not spiral. Rather than
`
`evaluating the shape of the threads 110 and 112 themselves, Dr. Leinsing
`
`erroneously bases his opinion on the alleged relative position between the two
`
`threads. Id. In other words, Dr. Leinsing’s opinion is based on his contention that
`
`one could trace an imaginary, spiral-shaped path between the threads, rather than the
`
`threads themselves being formed in the shape of a spiral. Neither Dr. Leinsing nor
`
`40
`
`Sanofi Exhibit 2025.012
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`
`
`Dated: January 3February 20, 2019
`
`
`
`
`Respectfully submitted,
`
`/Elizabeth Stotland Weiswasser/
`Elizabeth Stotland Weiswasser
`Reg. No. 55,721
`Anish R. Desai
`Reg. No. 73,760
`Kathryn M. Kantha
`Reg. No. 70,371
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`Phone: 212-310-8000
`elizabeth.weiswasser@weil.com
`anish.desai@weil.com
`kathryn.kantha@weil.com
`
`William S. Ansley
`Reg. No. 67,828
`Matthew D. Sieger
`Reg. No. 76,051
`Weil, Gotshal & Manges LLP
`2001 M Street NW, Ste. 600
`Washington, D.C. 20036
`Phone: 202-682-7000
`sutton.ansley@weil.com
`matthew.sieger@weil.com
`
`Adrian C. Percer
`Reg. No. 46,986
`Brian C. Chang
`Reg. No. 74,301
`Weil, Gotshal & Manges LLP
`201 Redwood Shores Parkway
`Phone: 650-802-3000
`adrian.percer@weil.com
`brian.chang@weil.com
`
`Sanofi.IPR.Service@weil.com
`
`51
`
`Sanofi Exhibit 2025.013
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`CERTIFICATE OF COMPLIANCE
`The undersigned certifies that this brief complies with the type volume
`
`1.
`
`limitations of 37 CFR § 42.24(a)(1)(i). This brief contains 9,15810,836 words
`
`(excluding the table of contents, the table of authorities, mandatory notices under
`
`37 CFR § 42.8, the certificate of service, certificate of compliance, and appendix of
`
`exhibits), as calculated by the “Word Count” feature of Microsoft Word 2016, the
`
`word processing program used to create it.
`
`2.
`
`The undersigned further certifies that this brief complies with the
`
`typeface requirements of 37 CFR § 42.6(a)(2)(ii) and typestyle requirements of
`
`37 CFR § 42.6(a)(2)(iii). This brief has been prepared in a proportionally spaced
`
`typeface using Microsoft Word 2016 in Times New Roman 14 point font.
`
`
`
`Dated: January 3February 20, 2019
`
`
`
`
`
`
`Respectfully submitted,
`
`/Elizabeth Stotland Weiswasser/
`Elizabeth Stotland Weiswasser
`Reg. No. 55,721
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`Phone: 212-310-8000
`elizabeth.weiswasser@weil.com
`
`
`
`52
`
`Sanofi Exhibit 2025.014
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`
`
`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that on January 3February 20, 2019, the
`
`foregoing Amended Patent Owner’s Preliminary Response and accompanying
`
`exhibits were served via electronic mail upon the following:
`
`Richard Torczon
`Wesley Derryberry
`Tasha Thomas
`Wilson Sonsini Goodrich & Rosati
`1700 K Street NW, 5th Floor
`Washington, D.C. 20006-3817
`rtorczon@wsgr.com
`wderryberry@wsgr.com
`tthomas@wsgr.com
`
`Douglas Carsten
`Jeffrey W. Guise
`Arthur Dykhuis
`Wilson Sonsini Goodrich & Rosati
`12235 El Camino Real
`San Diego, CA 92130
`dcarsten@wsgr.com
`jguise@wsgr.com
`adykhuis@wsgr.com
`
`Franklin Chu
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Ste. 5100
`Seattle, WA 98104
`ychu@wsgr.com
`
`Lorelei Westin
`Wilson Sonsini Goodrich & Rosati
`650 Page Mill Road
`Palo Alto, CA 94304
`lwestin@wsgr.com
`
`53
`
`Sanofi Exhibit 2025.015
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`
`
`
`
`
`
`
`
`
`
`Nicole W. Stafford
`Wilson Sonsini Goodrich & Rosati
`900 South Capital of Texas Highway
`Las Cimas, IV Fifth Floor
`Austin, TX 78746-5546
`nstafford@wsgr.com
`
`
`
`Timothy J. Andersen
`Timothy J. Andersen
`Case Manager
`Weil, Gotshal & Manges LLP
`2001 M Street NW, Ste. 600
`Washington, D.C. 20036
`Phone: 202-682-7000
`timothy.andersen@weil.com
`
`
`
`
`
`
`54
`
`Sanofi Exhibit 2025.016
`Mylan v. Sanofi
`IPR2018-01675
`
`