`
`Filed: September 25, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN INSTITUTIONAL LLC,
`Petitioner
`v.
`NOVO NORDISK A/S,
`Patent Owner
`
`
`Case No. IPR2020-00324
`U.S. Patent No. 8,114,833
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EXHIBITS
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Mylan Institutional LLC
`
`(“Petitioner”) objects to the admissibility of the following exhibits filed by Patent
`
`Owner Novo Nordisk A/S (“Patent Owner”) with the Patent Owner Preliminary
`
`Response in the above-captioned inter partes review.
`
`Petitioner’s objections are timely under 37 C.F.R. § 42.64(b)(1) because
`
`they are being filed and served within five (5) business days of the Patent Owner
`
`Response filed by Patent Owner on September 18, 2020, Paper Nos. 20
`
`(Confidential) and 22 (Redacted). Petitioner’s objections provide notice to Patent
`
`Owner that Petitioner may move to exclude these exhibits under 37 C.F.R. §
`
`42.64(c).
`
`In this paper, a reference to “FRE” means the Federal Rules of Evidence, a
`
`reference to “CFR” means the Code of Federal Regulations, and “’833 patent”
`
`means U.S. Patent No. 8,114,833. All objections under FRE 801-803 (hearsay)
`
`apply to the extent that Patent Owner relies on the exhibit identified in connection
`
`with that objection for the truth of the matter asserted therein.
`
`Exhibit descriptions provided in this table are from Patent Owner’s exhibit
`
`list and are used for identification purposes only. The use of an exhibit description
`
`does not indicate that Petitioner agrees with that description or characterization of
`
`the document.
`
`Petitioner objects to paragraphs in the Patent Owner Preliminary Response that
`
`2
`
`
`
`rely on exhibits objected to in this Petitioner’s Objection to Evidence.
`
`Exhibit
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`Patent Owner’s Description
`Declaration of Peter M. Tessier, Ph.D. dated
`September 18, 2020 (Confidential – Protective
`Order Material)
`Declaration of Dorthe Kot Engelund dated
`September 16, 2020 (Confidential – Protective
`Order Material)
`Declaration of Tina Bjeldskov Pedersen, Ph.D.
`dated September 17, 2020
`
`Declaration of David Nolan dated September 17,
`2020
`
`Curriculum Vitae of Peter M. Tessier (dated
`09/2020)
`Berge, S. M., et al. Pharmaceutical salts. 66
`JOURNAL OF PHARMACEUTICAL SCIENCES, 1-19
`(1977) (“Berge”)
`Bourne, E. J. The polyhydric alcohols. Acyclic
`polyhydric alcohols. 6 SPRINGER-VERLAG, 345-
`362 (1958)
`Chang, X., et al. NMR studies of the aggregation
`of glucagon-like peptide-1: formation of a
`symmetric helical dimer. 515 FEBS LETTERS,
`165-170 (2002)
`Cornford, E. M. Correlation between lipid
`partition coefficients and surface permeation in
`Schistosoma japonicum. 64 THE JOURNAL OF
`MEMBRANE BIOLOGY, 217-224 (1982)
`Danielli, J. F. Chapter VIII: Permeability to Non-
`Electrolytes. CAMBRIDGE: UNIVERSITY PRESS,
`80-104 (1952)
`
`Objection
`A, D, F, K, L,
`O, P, T
`
`A, D, F, K, L,
`Q, R, S, W, X
`
`A, D, F, K, L,
`Q, R, S, W, X
`A, D, F, K, L,
`Q, R, S, U, W,
`X
`
`A, B, G, K, L
`
`A, B, D, F, J,
`K, L, R
`
`A, B, C, D, E,
`F, G, I, K, L, R
`
`D, F, J, R
`
`A, B, D, F, J,
`K, L, R
`
`A, B, D, E, F,
`G, I, J, K, L, R
`
`3
`
`
`
`Exhibit
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`Patent Owner’s Description
`Fort, F. L., et al. Hemolysis study of aqueous
`polyethylene glycol 400, propylene glycol and
`ethanol combinations in vivo and in vitro. 38
`PDA JOURNAL OF PHARMACEUTICAL SCIENCE
`AND TECHNOLOGY, 82-87 (1984) (“Fort”)
`Hammarlund, E. R., & Pedersen‐Bjergaard, K.
`Hemolysis of erythrocytes in various iso‐osmotic
`solutions. 50 JOURNAL OF PHARMACEUTICAL
`SCIENCES, 24-30 (1961)
`Hutak, C. M., et al. The use of cell lysis as an
`index of ocular irritation potential. 5 JOURNAL
`OF TOXICOLOGY: CUTANEOUS AND OCULAR
`TOXICOLOGY, 143-161 (1986)
`Kim, Y., et al. FT‐IR and near‐infared
`FT‐Raman studies of the secondary structure of
`insulinotropin in the solid state: α‐helix to
`β‐sheet conversion induced by phenol and/or by
`high shear force. 83 JOURNAL OF
`PHARMACEUTICAL SCIENCES, 1175-1180 (1994)
`(“Kim”)
`Fu, R. C. C., et al. The biocompatibility of
`parenteral vehicles—in vitro/in vivo screening
`comparison and the effect of excipients on
`hemolysis. 41 PDA JOURNAL OF
`PHARMACEUTICAL SCIENCE AND TECHNOLOGY,
`164-168 (1987) (“Fu”)
`Naccache, P., & Sha'afi, R. I. Patterns of
`nonelectrolyte permeability in human red blood
`cell membrane. 62 THE JOURNAL OF GENERAL
`PHYSIOLOGY, 714-736 (1973) (“Naccache”)
`Padrick, S. B., & Miranker, A. D. Islet amyloid
`polypeptide: identification of long-range contacts
`and local order on the fibrillogenesis pathway.
`308 JOURNAL OF MOLECULAR BIOLOGY, 783-794
`(2001)
`
`Objection
`
`A, B, D, F, J,
`K, L, R
`
`A, B, D, F, J,
`K, L, R
`
`A, B, C, D, E,
`F, J, K, L, R
`
`A, B, D, F, J,
`K, L, R
`
`A, B, D, F, J,
`K, L, R
`
`A, B, D, F, J,
`K, L, R
`
`A, B, D, F, J,
`K, L, R
`
`4
`
`
`
`Exhibit
`
`2039
`
`2040
`
`2041
`
`2042
`
`2043
`
`2044
`
`2045
`
`2046
`
`Patent Owner’s Description
`Patel, N., & Newsham, L. G., Experiments in
`Physical Pharmacy. VI. Factors Influencing
`Erythrocyte Fragility and Isotonicity
`Determination. 35 AMERICAN JOURNAL OF
`PHARMACEUTICAL EDUCATION, 1-7 (1971)
`(“Patel & Newsham”)
`Rowley, S. D. Hematopoietic stem cell
`cryopreservation: a review of current techniques.
`1 JOURNAL OF HEMATOTHERAPY, 233-250 (1992)
`Schellekens, H. Bioequivalence and the
`immunogenicity of biopharmaceuticals. 1
`NATURE REVIEWS DRUG DISCOVERY, 457-462
`(2002) (“Schellekens”)
`Senderoff, R. I., et al. Consideration of
`conformational transitions and racemization
`during process development of recombinant
`glucagon-like peptide-1. 87 JOURNAL OF
`PHARMACEUTICAL SCIENCES, 183-189 (1998)
`Setnikar, I., & Temelcou, O. Osmotic
`concentration and osmotic pressure in injectable
`solutions. 48 JOURNAL OF THE AMERICAN
`PHARMACEUTICAL ASSOCIATION (SCIENTIFIC
`ED.), 628-630 (1959) (“Setnikar & Temelcou”)
`Stratton, L. P., et al. Controlling deamidation
`rates in a model peptide: Effects of temperature,
`peptide concentration, and additives. 90
`JOURNAL OF PHARMACEUTICAL SCIENCES, 2141-
`2148 (2001)
`Sztein, J. M., et al. Comparison of permeating
`and nonpermeating cryoprotectants for mouse
`sperm cryopreservation. 42 CRYOBIOLOGY, 28-
`39 (2001) (“Sztein”)
`Thorens, B., & Waeber, G. Glucagon-like
`peptide-I and the control of insulin secretion in
`the normal state and in NIDDM. 42 DIABETES,
`1219-1225 (1993)
`
`Objection
`
`A, B, C, D, E,
`F, J, K, L, R
`
`A, B, D, F, J,
`K, L, R
`
`A, B, D, F, J,
`K, L, R
`
`A, B, D, F, J,
`K, L, R
`
`A, B, D, F, J,
`K, L, R
`
`A, B, D, F, J,
`K, L, R
`
`A, B, D, F, J,
`K, L, R
`
`A, B, D, F, J,
`K, L, R
`
`5
`
`
`
`Exhibit
`
`2047
`
`2048
`
`2049
`
`2050
`
`2051
`
`2052
`
`2053
`
`2054
`
`2055
`
`2056
`
`Patent Owner’s Description
`Yang, X., et al. Subzero nonfreezing storage of
`the mammalian cardiac explant: I. Methanol,
`ethanol, ethylene glycol, and propylene glycol as
`colligative cryoprotectants. 30 CRYOBIOLOGY,
`366-375 (1993)
`Wolffenbuttel, B. H., & Graal, M. B. New
`treatments for patients with type 2 diabetes
`mellitus. 72 POSTGRADUATE MEDICAL JOURNAL,
`657-662 (1996)
`Highlights of Prescribing Information, Revised
`08/2020 (“Victoza® Prescribing Information”)
`Internal Novo Nordisk Report, dated December
`3, 2001 (Confidential – Protective Order
`Material)
`Internal Novo Nordisk Email Chain, beginning
`December 19, 2001 and certified translation
`thereof (Confidential – Protective Order
`Material)
`Internal Novo Nordisk Report, dated December
`19, 2001 and certified translation thereof
`(Confidential – Protective Order Material)
`Internal Novo Nordisk Protocol, dated January
`22, 2002 and certified translation thereof
`(Confidential – Protective Order Material)
`De Vos, A. M., et al. Human growth hormone
`and extracellular domain of its receptor: crystal
`structure of the complex. 255 SCIENCE, 306-312
`(1992)
`Internal Novo Nordisk Meeting Minutes, dated
`April 12, 2002 and certified translation thereof
`(Confidential – Protective Order Material)
`Internal Novo Nordisk Protocol, dated April 29,
`2002 (Confidential – Protective Order Material)
`
`Objection
`
`A, B, D, F, J,
`K, L, R
`
`A, B, D, F, J,
`K, L, R
`
`A, B, C, D, E,
`F, J, K, L, R
`
`A, B, D, F, K,
`L, R, S, W, X,
`
`A, B, D, F, K,
`L, R, S, U, W,
`X, Y
`
`A, B, D, F, K,
`L, R, S, W, X,
`Y
`A, B, D, F, K,
`L, R, S, W, X,
`Y
`
`A, B, D, F, J,
`K, L, R
`
`A, B, D, F, K,
`L, R, S, W, X,
`Y
`A, B, D, F, K,
`L, R, S, W, X
`
`6
`
`
`
`Exhibit
`
`2057
`
`2058
`
`2059
`
`2060
`
`2061
`
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`Patent Owner’s Description
`Internal Novo Nordisk Protocol, dated June 3,
`2002 and certified translation thereof
`(Confidential – Protective Order Material)
`Internal Novo Nordisk Study Plan, dated June 5,
`2002 and certified translation thereof
`(Confidential – Protective Order Material)
`Internal Novo Nordisk Memo, dated June 27,
`2002 and certified translation thereof
`(Confidential – Protective Order Material)
`Internal Novo Nordisk Study Plan, dated July 23,
`2002 and certified translation thereof
`(Confidential – Protective Order Material)
`Center for Drug Evaluation and Research “Final
`Printed Labeling – Application Number 21-319:
`FORTEO” (2002)
`Internal Novo Nordisk Lab Notebook (excerpt),
`dated July 24, 2002 and certified translation
`thereof (Confidential – Protective Order
`Material)
`Internal Novo Nordisk Meeting Minutes, dated
`November 14, 2002 and certified translation
`thereof (Confidential – Protective Order
`Material)
`Internal Novo Nordisk Design Review
`Presentation, dated November 29, 2002
`(Confidential – Protective Order Material)
`Internal Novo Nordisk Meeting Minutes, dated
`February 3, 2003 and certified translation thereof
`(Confidential – Protective Order Material)
`Internal Novo Nordisk Statement, dated April 9,
`2003 (Confidential – Protective Order Material)
`
`Objection
`A, B, D, F, K,
`L, R, S, W, X,
`Y
`A, B, D, F, K,
`L, R, S, W, X,
`Y
`A, B, D, F, K,
`L, R, S, W, X,
`Y
`A, B, D, F, K,
`L, R, S, W, X,
`Y
`
`A, B, C, D, E,
`F, K, L, R, S
`
`A, B, D, F, K,
`L, R, S, W, X,
`Y
`
`A, B, D, F, K,
`L, R, S, W, X,
`Y
`
`A, B, D, F, K,
`L, R, S, W, X
`
`A, B, D, F, K,
`L, R, S, W, X,
`Y
`A, B, D, F, K,
`L, R, S, W, X
`
`Internal Novo Nordisk Report, dated April 10,
`2003 (Confidential – Protective Order Material)
`
`A, B, D, F, K,
`L, R, S, W, X
`
`7
`
`
`
`Exhibit
`
`2068
`
`2069
`
`2070
`
`2071
`
`2072
`
`2073
`
`2074
`
`2075
`
`2076
`
`2077
`
`2078
`
`2079
`
`Patent Owner’s Description
`Internal Novo Nordisk Report, dated April 22,
`2003 (Confidential – Protective Order Material)
`(“April 22, 2003 Report”)
`Internal Novo Nordisk Report, dated June 10,
`2003 and certified translation thereof
`(Confidential – Protective Order Material)
`Internal Novo Nordisk Trial Protocol, dated June
`11, 2003 (Confidential – Protective Order
`Material)
`Internal Novo Nordisk Report, dated June 18,
`2003 (Confidential – Protective Order Material)
`
`Internal Novo Nordisk Report, dated June 27,
`2003 (Confidential – Protective Order Material)
`Internal Novo Nordisk Protocol, dated January
`30, 2018 (Confidential – Protective Order
`Material)
`Internal Novo Nordisk Report, dated May 17,
`2018 (Confidential – Protective Order Material)
`
`Internal Novo Nordisk Report, dated May 17,
`2018 (Confidential – Protective Order Material)
`Berg, J. M. et al. Biochemistry: Chapter 3:
`Protein Structure and Function, 5 W.H.
`FREEMAN AND COMPANY, 41-76 (2002) (“Berg”)
`Physician’s Desk Reference, 54th ed.,
`“Norditropin” pp. 2061-2062 (2000)
`
`Physician’s Desk Reference, Supplement A,
`“Humira” pp. A5-A6 (2003)
`
`Objection
`A, B, D, F, K,
`L, R, S, W, X
`
`A, B, D, F, K,
`L, R, S, W, X,
`Y
`
`A, B, D, F, K,
`L, R, S, W, X
`
`A, B, D, F, K,
`L, R, S, W, X
`
`A, B, D, F, K,
`L, R, S, W, X
`A, B, C, D, E,
`F, K, L, R, S,
`W, X
`A, B, C, D, E,
`F, K, L, R, S,
`W, X
`A, B, C, D, E,
`F, K, L, R, S,
`W, X
`A, B, D, F, G,
`I, K, L, R
`
`A, B, C, D, E,
`F, G, I, K, L, R
`
`A, B, C, D, E,
`F, G, I, K, L, R
`
`Deposition Transcript of Laird Forrest, Ph.D.,
`dated September 3, 2020
`
`Z
`
`8
`
`
`
`Exhibit
`
`2080
`
`2081
`
`2082
`
`Patent Owner’s Description
`Redacted Version of Declaration of Peter
`Tessier, Ph.D. dated September 18, 2020
`
`Remington’s Pharmaceutical Science, Vol. I,
`19th ed., Chapter 36 (1995) (“Remington 1995”)
`Claim Construction Order in Novo Nordisk Inc.
`et al. v. Mylan Institutional LLC, C.A. No. 19-
`1551 (CFC) (SRF), D.I. 106 (D. Del. Sept. 17,
`2020).
`
`Objection
`See objections
`to Ex. 2022
`
`A, B, D, F, G,
`I, K, L, R
`
`A, K, L, R, S,
`V
`
`9
`
`
`
`Objection Key:
`
`A:
`B:
`C:
`
`D:
`
`E:
`
`F:
`
`G:
`
`H:
`I:
`J:
`K:
`
`L:
`
`M:
`
`N:
`
`FRE 801/802/803 (hearsay)
`FRE 901/902 (lacking authentication)
`FRE 402 (relevance) the document is not relevant to any issue in this IPR
`proceeding because the purported date of the document is after the filing
`date of the ’833 patent or the prior art status is not clear
`FRE 402 (relevance) to the extent the document is relied upon for secondary
`considerations of nonobviousness, there is no nexus to the claimed
`compositions and methods
`FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in this IPR proceeding because the purported date of the document is
`after the filing date of the ’833 patent or the prior art status is not clear
`FRE 403 (confusing, waste of time) to the extent the document is relied
`upon for secondary considerations of nonobviousness, there is no nexus to
`the claimed compositions and methods
`FRE 106 (completeness) the document is incomplete and includes only a
`select portion of a larger document that in fairness should be considered
`along with this document
`FRE 1001-1003 (best evidence)
`FRE 403, 901 (improper compilation)
`FRE 403 (cumulative)
`FRE 402 (relevance) the document is not relevant to any issue in the IPR
`proceeding
`FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in the IPR proceeding
`FRE 702/703 to the extent that Patent Owner submits an Expert Declaration
`that improperly or unreasonably relies on the exhibit
`FRE 1006 (improper summary)
`
`10
`
`
`
`O:
`
`P:
`
`Q:
`
`R:
`
`S:
`
`T:
`
`37 C.F.R. § 42.65 (fails to provide underlying facts or data on which opinion
`is based)
`Expert testimony fails to identify with particularity the underlying facts or
`data on which the opinion is based, violating 37 C.F.R. § 42.65(a)
`FRE 701, 702 (improper expert testimony) improper expert testimony by a
`lay witness
`FRE 702 (improper expert testimony) expert testimony that relies on the
`document is not based on sufficient facts or data and/or is not the product of
`reliable principles and methods
`FRE 703 (bases of expert opinion) expert testimony that relies on the
`document is unreliable because the document is not of a type reasonably
`relied upon by experts in the field
`FRE 702/703 to the extent that the expert declarant relies on an exhibit
`objected to under grounds R and S, the testimony is (i) not based on
`sufficient facts or data and/or is not the product of reliable principles and
`methods and/or is (ii) is unreliable because the exhibit is not of a type
`reasonably relied upon by experts in the field
`FRE 602 (lack of personal knowledge)
`FRE 403 (confusing, waste of time, unfair prejudice) the document is in a
`different forum and its use would unfairly prejudice Petitioner, waste time
`and confuse the issues
`W: FRE 402 (relevance) the document is not relevant to any issue in this IPR
`proceeding because the disclosure and/or purported date of the document is
`not sufficient to antedate Exhibit 1005 as a prior art reference.
`FRE 403 (confusing, waste of time) the document is not relevant to any
`issue in this IPR proceeding because the disclosure and/or purported date of
`the document is not sufficient to antedate Exhibit 1005 as a prior art
`reference.
`37 C.F.R. § 42.63(b) (failing to file an affidavit) the translation filed with the
`underlying document is not filed with an affidavit in accordance with 37
`C.F.R. § 42.63(b)
`37 C.F.R. § 42.53(f)(5) as the deposition transcript is unsigned and (i) the
`11
`
`U:
`V:
`
`X:
`
`Y:
`
`Z:
`
`
`
`parties have not agreed in writing to waive reading and signature by the
`witness, (ii) the parties have not waived reading and signature by the witness
`on the record at the deposition, nor (iii) has any indication been provided
`that the witness refused to read or sign the deposition transcript
`
`Dated: September 25, 2020
`
`/s/ Lara Dueppen
`Lara Dueppen
`Reg. No. 65,002
`Perkins Coie LLP
`1888 Century Park East Suite 1700
`Los Angeles, CA 90067
`ldueppen@perkinscoie.com
`Tel: 310-788-3349
`Fax: 310-843-1266
`
`Counsel for Petitioner
`
`12
`
`
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
`
`correct copy of the foregoing: PETITIONER’S OBJECTIONS TO PATENT
`
`OWNER’S EXHIBITS by email to the electronic service addresses for Patent Owner:
`
`Jeffrey Oelke
`Laura T. Moran
`Ryan P. Johnson
`FENWICK & WEST LLP
`joelke@fenwick.com
`laura.moran@fenwick.com
`ryan.johnson@fenwick.com
`Novo833IPR@fenwick.com
`
`Dated: September 25, 2020
`
`/s/ Lara Dueppen
`Lara Dueppen
`Reg. No. 65,002
`
`Counsel for Petitioner
`
`13
`
`
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