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 IPR2018-01675
`U.S. Patent No. 8,603,044
`
`
`
`
`PATENT OWNER’S OBJECTIONS TO DOCUMENTS SERVED WITH
`THE PETITION
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`
`v.
`
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`Case IPR2018-01675
`U.S. Patent No. 8,603,044
`
`
`
`
`PATENT OWNER’S OBJECTIONS TO DOCUMENTS SERVED WITH
`THE PETITION
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b), Patent Owner Sanofi-Aventis Deutschland
`
`GmbH hereby makes the following objections to the admissibility of documents
`
`submitted with the Petition.
`
`Evidence
`
`Petitioner’s
`Description
`Ex. 1001 U.S. Patent
`8,679,069, Pen-Type
`Injector (issued Mar.
`25, 2014)
`Ex. 1003 U.S. Patent
`8,992,486, Pen-Type
`Injector (issued Mar.
`31, 2015)
`Ex. 1004 U.S. Patent
`9,526,844, Pen-Type
`Injector (issued Dec.
`27, 2016)
`Ex. 1005 U.S. Patent
`9,604,008, Drive
`Mechanisms Suitable
`for Use in Drug
`Delivery Devices
`(issued Mar. 28,
`2017)
`Ex. 1006 File History for U.S.
`Patent 8,679,069
`
`Ex. 1008 File History for U.S.
`Patent 8,992,486
`
`Objections
`
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`confusing the issues and wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`
`
`2
`
`
`
`Evidence
`
`Petitioner’s
`Description
`
`Ex. 1009 File History for U.S.
`Patent 9,526,844
`
`Ex. 1010 File History for U.S.
`Patent. 9,604,008
`
`Ex. 1011 Expert Declaration of
`Karl Leinsing
`MSME, PE in
`Support of Petition
`for Inter Partes
`Review of U.S. Patent
`Nos. 8,679,069;
`8,603,044; 8,992,486;
`9,526,844 and
`9,604,008
`
`Ex. 1014 U.S. Patent 6,235,004
`– S. Steenfeldt-Jensen
`
`Objections
`
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`confusing the issues and wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`confusing the issues and wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`confusing the issues and wasting resources.
`FRE 701/702/703: Patent Owner objects to
`Ex. 1011 as being improper expert testimony
`because paragraphs 113-124, 126, 128-129,
`131, 133-135, 137, 139-140, 142-144, 146-
`147, 150, 152-855 comprise testimony not
`based on sufficient facts or data, that is
`irrelevant, that is not based on a reliable
`foundation, and that constitutes conclusory
`opinions without sufficient support. It
`includes opinions that are not admissible
`under FRE 701, 702, or 703 or Daubert v.
`Merrell Dow Pharms., Inc., 509 U.S. 579
`(1993).
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition.
`
`
`
`3
`
`
`
`Evidence
`
`Petitioner’s
`Description
`& S. Hansen,
`“Injection Syringe”
`(issued May 22,
`2001)
`
`Ex. 1015 U.S. Patent
`Application US
`2002/0053578 A1 –
`C.S. Møller,
`“Injection Device”
`(pub’d May 2, 2002)
`
`Ex. 1016 U.S. Patent 6,932,794
`B2 – L. Giambattista
`& A. Bendek,
`“Medication Delivery
`Pen” (issued Aug. 23,
`2005)
`
`Ex. 1017 U.S. Patent 6,582,404
`B1 – P.C. Klitgaard et
`al., “Dose Setting
`Limiter” (issued June
`24, 2003)
`
`Ex. 1018 File History for U.S.
`Patent 6,582,404
`
`Objections
`
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`
`
`4
`
`
`
`Evidence
`
`Petitioner’s
`Description
`
`Ex. 1019 Plaintiffs’
`Preliminary Claim
`Constructions and
`Preliminary
`Identification of
`Supporting Intrinsic
`and Extrinsic
`Evidence, Sanofi-
`Aventis U.S. LLC v.
`Mylan GmbH, No.
`2:17-cv-09105
`(D.N.J.)
`Ex. 1020 U.S. Patent 4,865,591
`– B. Sams,
`“Measured Dose
`Dispensing Device”
`(issued Sep. 12, 1989)
`
`Ex. 1021 U.S. Patent 6,248,095
`B1 – L. Giambattista
`et al., “Low-cost
`Medication Delivery
`Pen” (issued June 19,
`2001)
`
`Ex. 1022 U.S. Patent 6,921,995
`B1 – A.A. Bendek et
`
`Objections
`
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`
`
`
`5
`
`
`
`Evidence
`
`Petitioner’s
`Description
`al., “Medication
`Delivery Pen Having
`An Improved Clutch
`Assembly” (issued
`July 13, 1999)
`
`Ex. 1023 U.S. Patent 5,226,895
`– D.C. Harris,
`“Multiple Dose
`Injection Pen” (issued
`July 13, 1993)
`
`Ex. 1024 U.S. Patent 5,851,079
`– R.L. Horstman et
`al., “Simplified
`Unidirectional Twist-
`Up Dispensing
`Device With
`Incremental Dosing”
`(issued Dec. 22,
`1998)
`
`Ex. 1025 Application as filed:
`U.S. Patent App.
`14/946,203 – R.F.
`Veasey, “Relating to
`a Pen-Type Injector”
`(filed Nov. 19, 2015)
`
`Objections
`
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`
`
`
`6
`
`
`
`Evidence
`
`Petitioner’s
`Description
`Ex. 1026 GB 0304822.0 –
`“Improvements in and
`relating to a pen-type
`injector” (filed Mar.
`3, 2003) (‘844
`Priority Doc.)
`
`Ex. 1027 WO 99/38554 –
`S.Steenfeldt-Jensen &
`S.Hansen, “An
`Injection Syringe”
`(pub’d Aug. 5, 1999)
`(Steenfeldt-Jensen
`PCT)
`
`Ex. 1031 N. Sclater & N.P.
`Chironis,
`Mechanisms &
`Mechanical Devices
`Sourcebook 191-95,
`“Twenty Screw
`Devices” (3d ed., July
`2, 2001)
`
`Objections
`
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`
`FRE 801, 802: This exhibit is an out of court
`statement offered for its truth, and because it
`does not fall within any exception to the rule
`against hearsay, it is inadmissible hearsay.
`
`
`
`
`7
`
`
`
`Evidence
`
`Petitioner’s
`Description
`
`Ex. 1032 EP 0 608 343 B1 – L.
`Petersen & N.-A.
`Hansen, “Large Dose
`Pen” (pub’d Oct. 18,
`1991)
`
`Ex. 1033 A.G. Erdman & G.N.
`Sandor, “Mechanical
`Advantage”, §3.7 in
`1 Mechanism Design:
`Analysis and
`Synthesis (1984)
`
`Ex. 1034 WO 01/83008 – S.
`Hansen & T.D.
`Miller., “An Injection
`Device, A
`Preassembled Dose
`Setting And Injection
`Mechanism For An
`
`Objections
`
`FRE 901: This exhibit is an unauthenticated
`document and is not self-authenticating
`under FRE 902.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`
`FRE 801, 802: This exhibit is an out of court
`statement offered for its truth, and because it
`does not fall within any exception to the rule
`against hearsay, it is inadmissible hearsay.
`
`FRE 901: This exhibit is an unauthenticated
`document and is not self-authenticating
`under FRE 902.
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition or in the
`portions of the expert declaration relied upon
`by the Petition.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`
`
`
`8
`
`
`
`Evidence
`
`Petitioner’s
`Description
`Injection Device, And
`A Method Of
`Assembling An
`Injection Device”
`(pub’d Nov. 8, 2001)
`Ex. 1035 K.J. Lipska et al.,
`Association of
`Initiation of Basal
`Insulin Analogs
`vs Neutral Protamine
`Hagedorn Insulin
`With Hypoglycemia-
`Related Emergency
`Department Visits or
`Hospital Admissions
`and With Glycemic
`Control in Patients
`With Type 2 Diabetes,
`320 J. Am. Med.
`Ass’n 53-62 (2018).
`
`Objections
`
`unfair prejudice, confusing the issues and
`wasting resources.
`
`FRE 403: The exhibit’s probative value to
`any ground upon which trial was instituted is
`substantially outweighed by the danger of
`unfair prejudice, confusing the issues and
`wasting resources.
`
`FRE 801, 802: This exhibit is an out of court
`statement offered for its truth, and because it
`does not fall within any exception to the rule
`against hearsay, it is inadmissible hearsay.
`
`FRE 901: This exhibit is an unauthenticated
`document and is not self-authenticating
`under FRE 902.
`
`9
`
`
`
`
`
`
`
`Dated: April 16, 2019
`
`Respectfully submitted,
`/Elizabeth Stotland Weiswasser/
`Elizabeth Stotland Weiswasser
`(Reg. No. 55,721)
`Anish R. Desai (Reg. No. 73,760)
`Sudip K. Kundu (Reg. No. 74,193)
`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
`sudip.kundu@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
`Redwood Shores, CA 94065
`Phone: 650-802-300
`adrian.percer@weil.com
`brian.chang@weil.com
`
`Sanofi.IPR.Service@weil.com
`
`
`
`
`
`
`
`
`10
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`The undersigned hereby certifies that on April 16, 2019 the foregoing
`
`PATENT OWNER’S OBJECTIONS TO DOCUMENTS SERVED WITH THE
`
`PETITION was 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
`Elham F. Steiner
`Wilson Sonsini Goodrich & Rosati
`12235 El Camino Real
`San Diego, CA 92130
`dcarsten@wsgr.com
`jguise@wsgr.com
`adykhuis@wsgr.com
`esteiner@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
`
`
`
`11
`
`
`
`650 Page Mill Road
`Palo Alto, CA 94304
`lwestin@wsgr.com
`
`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/ a
`Timothy J. Andersen
`Case Manager
`Weil, Gotshal & Manges LLP
`2001 M Street, NW, Suite 600
`Washington, DC 20036
`timothy.andersen@weil.com
`
`
`12
`
`
`
`
`
`
`
`
`
`
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