UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`and PFIZER INC.,
`Petitioners,
`
`
`v.
`
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2018-01676
`U.S. Patent No. 8,603,044
`
`
`
`
`PATENT OWNER’S OBJECTIONS TO DOCUMENTS SERVED BY
`PETITIONER
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`and PFIZER INC.,
`Petitioners,
`
`
`v.
`
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`
`
`Case IPR2018-01676
`U.S. Patent No. 8,603,044
`
`
`
`
`PATENT OWNER’S OBJECTIONS TO DOCUMENTS SERVED BY
`PETITIONER
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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 Petitioner Mylan Pharmaceuticals Inc.’s Reply.
`
`Evidence
`
`1044
`
`Petitioner’s
`Description
`Nat’l. Diabetes
`Statistic Report 2017,
`“Estimates of
`Diabetes and Its
`Burden in the United
`States, CDC, p.1-20
`
`1045
`
`Teresa L. Pearson,
`“Practical Aspects of
`Insulin Pen Devices”,
`Journal of Diabetes
`Science and
`Technology, Vol. 4,
`Issue 3, May 2010,
`p.522-531
`
`Objections
`
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition.
`
`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
`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.
`
`
`
`
`
`1
`
`
`
`Evidence
`
`1046
`
`Petitioner’s
`Description
`Nancy J.V.
`Bohannon, “Insulin
`Delivery Using Pen
`Devices”,
`Postgraduate
`Medicine, Vol. 106,
`No.5, Oct. 15, 1999,
`p. 57-68, ISSN: 0032-
`5481 (Print) 1941-
`9260 – (Online)
`Journal homepage:
`https://www.tandfonli
`ne.com/loi/ipgm20
`
`1047
`
`Marilyn R. Graff,
`RN, CDE et al.,
`“Assessment by
`Patients with
`Diabetes Mellitus of
`Two Insulin Pen
`Delivery Systems
`Versus a Vial and
`Syringe”, Clinical
`Therapeutics, Vol.
`20, No. 3, 1998,
`p.486-196
`
`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 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.
`
`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.
`
`
`
`
`
`2
`
`
`
`Evidence
`
`1048
`
`Petitioner’s
`Description
`Expert Declaration of
`William Curtis Biggs,
`M.D., FACE, ECNU
`in Support of Mylan-
`Pfizer Reply
`
`1057
`
`1058
`
`Benita Lee, MPH,
`“How Much Does
`Insulin Cost? Here’s
`How 23 Brands
`Compare”, Good RX,
`Aug. 23, 2019, pp. 1-
`11,
`https:www.goodrx.co
`m/glo/how-much-
`does-insuling-
`cost,compare-brands/
`Certified English
`Translation of DE
`Patent 102 37 258A1,
`Dr. Roney Graf
`(Issued Mar. 182004)
`
`Objections
`
`FRE 701/702/703: Patent Owner objects to
`Ex. 1048 as being improper expert testimony
`because paragraphs 25-58 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.
`
`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.
`
`37 C.F.R. § 42.63(b): This exhibit does not
`contain an adequate attestation to the
`“accuracy” of the translation.
`
`
`FRE 801, 802: This exhibit lacks an original
`copy of the allegedly translated document.
`The certification statement contained in the
`exhibit is thus 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.
`
`
`
`
`
`3
`
`
`
`Evidence
`
`1059
`
`1060
`
`Petitioner’s
`Description
`M. Eledrisi, et al.,
`“Twice-Daily Insulin
`Glargine for Patients
`with Uncontrolled
`Type 2 Diabetes
`Mellitus, Journal of
`Clinical &
`Translational
`Endocrinology 15
`(2019), p. 35-36
`
`Declaration and c.v.
`of DeForrest McDuff,
`Ph.D.
`
`1061
`
`1062
`
`2011 Orange Book
`(Excerpts)
`
`2019 Orange Book
`(Excerpt – ADA 132
`of 263)
`
`Objections
`
`FRE 401/402: This evidence is not relevant
`as it is not cited in the Petition.
`
`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 701/702/703: Patent Owner objects to
`Ex. 1060 as being improper expert testimony
`because paragraphs 16-71 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 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.
`
`
`
`
`
`4
`
`
`
`Evidence
`
`1063
`
`1064
`
`1065
`
`1066
`
`1067
`
`Petitioner’s
`Description
`2011-02-09 - Sanofi
`SA Earnings
`Conference Call
`
`2012-02-08 – Sanofi
`SA Earnings
`Conference Call
`
`2013-02-26 – Sanofi
`SA at Citi Global
`HealthCare
`Conference
`2014-02-06 – Sanofi
`SA Earnings
`Conference Call
`
`Asamoah et al.,
`“Insulin Pen – The
`“iPod” for Insulin
`Delivery (Why Pen
`Wins Over Syringe)”,
`J. of Diabetes Sci.
`and Technology, Vol.
`2, Issue 2, March
`2008, p.292-296
`
`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
`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.
`
`
`
`
`
`5
`
`
`
`Evidence
`
`1068
`
`Petitioner’s
`Description
`Aventis 2002 20-F
`Form
`
`1069
`
`1070
`
`1071
`
`Aventis 2003 20-F
`Form
`
`Sanofi-Aventis 2006
`20 F Form
`
`Correa, Carlos,
`“Ownership of
`Knowledge – the
`Role of Patents in
`Pharmaceutical
`R&D”, Round Table,
`Bulletin of World
`Health Org., 2004;
`82; p.1-7
`
`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 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.
`
`
`
`
`
`6
`
`
`
`Evidence
`
`1072
`
`Petitioner’s
`Description
`Carter, Alan W.,
`“Analysis of the
`Injection Force of
`Solostar® Compared
`with Other
`Disposable Insulin
`Pen Devices At
`Constant Volume
`Flow Rates”, J. of
`Diabetes Sci. and
`Tech., Vol. 5, Issue 1,
`Jan. 2011, p. 156-157
`
`1073
`
`1074
`
`“About Diabetes”,
`CDC Basics, p.1-2,
`https://www.cdc.gov/
`diabetes/bascis/diabet
`es
`David, J. et al.
`“Commercial
`Success: Economic
`Principles Applied to
`Patent Litigation”,
`NERA Economic
`Consulting
`(copyrighted
`material), p. 159-160
`
`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 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 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 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.
`
`
`
`
`
`7
`
`
`
`Evidence
`
`1075
`
`Petitioner’s
`Description
`“Top Ten Tips on
`Writing Effectiveness
`Case Studies”, By
`Design Business
`Association, May 23,
`2016, p.1-5,
`https://www.dba.org.
`uk/review-top-ten-
`tips-on-writing-
`effectiveness-case-
`studies/
`
`1076
`
`DiMasi, J., et al.
`“Innovation in the
`Pharmaceutical
`Industry: New
`Estimates of R&D
`Costs”, J. of Health
`Economics47 (2016),
`p. 20-33
`
`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 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 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.
`
`
`
`
`
`8
`
`
`
`Evidence
`
`1077
`
`1078
`
`Petitioner’s
`Description
`Grabowski, H., et al.
`“Returns on Research
`and Development for
`1990s New Drug
`Introductions”,
`Pharmacoeconomics
`2002; 20 Suppl. 3: p.
`11-29
`Pietrangelo, Ann
`“Levemir vs. Lantus:
`Similarities and
`Differences”,
`Healthline, Oct. 19,
`2016, p.1-14,
`https://www.healthlin
`e.com/health/deiabete
`s/levemir-lantus
`
`1079
`
`“A21, B30, Modified
`Insulin Derivatives
`having An Altered
`Action Profile”, M.
`Dörschug (issued
`Aug. 12, 1997)
`
`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 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 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
`
`
`
`Evidence
`
`1080
`
`1081
`
`1082
`
`Petitioner’s
`Description
`Lewcock, Anna,
`“Sanofi’s SoloStar
`Hits US Market
`Despite Patent Suit”,
`in-Pharma
`Technologist.com,
`Jul. 20, 2007,
`https://www.in-
`pharmatechnologist.c
`om/Article/2007/07/3
`1/Sanofi-s-SoloStar-
`hits-US-market-
`despite-patent-suit
`Lantus, “Get to Know
`the Lantus®
`SoloStar® Insulin
`Pen, p. 1-7,
`https://www.lantus.co
`m/get-to-know-the-
`lantus-solostar-pen
`Lantus SoloStar
`Brochure: “High
`Blood Sugar, You’re
`Going Down” (2012)
`
`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 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 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 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.
`
`
`
`
`
`10
`
`
`
`Evidence
`
`1083
`
`Petitioner’s
`Description
`Lantus SoloStar
`Brochure: “Your
`Guide to the Lantus
`SoloStar Insulin Pen”
`(2010)
`
`1084
`
`McDuff, et al.,
`“Thinking
`Economically About
`Commercial
`Success”, Landslide,
`March/April 2017, p.
`37-40
`
`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 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 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.
`
`
`
`
`
`11
`
`
`
`Evidence
`
`1085
`
`Petitioner’s
`Description
`Nonaka, H., “FTO
`(Freedom to Operate)
`in the Pharmaceutical
`Industry”, JSTOR,
`Pub. by Nomos
`Verlagsgesellschaft
`mbH (2018), p. 9-59
`
`1086
`
`1087
`
`Senate Comm. On
`Finance Questions for
`the Record, “Drug
`Pricing in America”:
`A Prescription for
`Change Part II,
`Questions for Olivier
`Brandicourt, CEO
`Sanofi, Feb. 26, 2019,
`p. 1-460
`S.G. Cowen,
`“Perspectives”,
`Pharmaceutical
`Therapeutic
`Categories Outlook,
`Oct. 2001, p.134-148
`
`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 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 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 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.
`
`
`
`
`
`12
`
`
`
`Evidence
`
`1088
`
`Petitioner’s
`Description
`Cowen and Co.,
`“Diabetes: Many
`New Drugs, But
`Insulin Still
`Dominant”,
`Therapeutic
`Categories Outlook,
`Feb. 2015, p.477-491
`
`1089
`
`UBS Large Cap
`Pharmaceuticals
`Handbook, “U.S.
`Pharmaceuticals”,
`Apr. 6, 2018, p.45-53
`
`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 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 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.
`
`
`
`
`
`13
`
`
`
`Evidence
`
`1090
`
`Petitioner’s
`Description
`Campbell, K.,
`“Insulin Costs Are
`Skyrocketing. This is
`Why”, U.S. New and
`World Report, Jun.
`29, 2018, p.1-7
`
`1091
`
`1092
`
`1093
`
`U.S. Patent
`5,656,722, “A21,
`B30, Modified
`Insulin Derivatives
`having An Altered
`Action Profile”, M.
`Dörschug (issued
`Aug. 12, 1997)
`U.S. Patent
`7,476,652, “Acidic
`Insulin Preparations
`Having Improved
`Stability”, Brunner-
`Schwarz (issued Jan.
`13, 2009)
`U.S. Patent
`7,713,930, “Acidic
`Insulin Preparations
`Having Improved
`Stability”, Brunner-
`Schwarz (issued May
`11, 2010)
`
`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 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 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.
`
`
`
`
`
`14
`
`
`
`Evidence
`
`1094
`
`1095
`
`Petitioner’s
`Description
`WebMD, “Types of
`Insulin for Diabetes
`Treatment”, p.1-7
`https://www.webmd.c
`om/diabetes/diabetes-
`types-insulin#1
`Reply Declaration of
`Karl Leinsing
`
`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 701/702/703: Patent Owner objects to
`Ex. 1095 as being improper expert testimony
`because paragraphs 7-15, 17-36, 38-77, 79-
`81, 83-122, and 124-156 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).
`
`37 C.F.R. § 42.23(b): Patent Owner objects
`to Ex. 1095 as constituting improper expert
`testimony because paragraphs 42-43, 77, 133
`contain new unpatentability theories that are
`inappropriate for a reply.
`
`15
`
`
`
`
`
`
`
`
`
`
`
`Dated: September 25, 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
`
`
`
`16
`
`
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`The undersigned hereby certifies that on September 25, 2019, the foregoing
`
`PATENT OWNER’S OBJECTIONS TO DOCUMENTS SERVED BY THE
`
`PETITIONER 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
`Jad Mills
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Ste. 5100
`Seattle, WA 98104
`ychu@wsgr.com
`jmills@wsgr.com
`
`
`
`
`
`
`
`17
`
`
`
`Lorelei Westin
`Wilson Sonsini Goodrich & Rosati
`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
`
`Wendy L. Devine
`Wilson Sonsini Goodrich & Rosati
`One Market Plaza
`Spear Street Tower, Suite 3300
`San Francisco, CA 94105
`wdevine@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
`
`
`18
`
`
`
`
`
`
`
`
`
`
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