`
`Filed: July 7, 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 ten (10) business days of the Institution
`
`Decision issued by the Board on June 23, 2020, Paper No. 12. 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
`
`rely on exhibits objected to in this Petitioner’s Objection to Evidence.
`
`2
`
`
`
`Exhibit
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`Patent Owner’s Description
`Chien-Hua Niu, FDA Perspective on Peptide
`Formulation and Stability Issues, 87 J. PHARM.
`SCIENCES 1331 (1998)
`C. Goolcharran, et al., Chemical Pathways of
`Peptide and Protein Degradation, in
`PHARMACEUTICAL FORMULATION DEVELOPMENT
`OF PEPTIDES AND PROTEINS 70 (Sven Frokjaer &
`Lars Hovgaard eds., 2000)
`Mark C. Manning et al., Stability of Protein
`Pharmaceuticals, 6 PHARM. RESEARCH 903
`(1989)
`R.W. Payne, et al., Peptide Formulation:
`Challenges and Strategies, INNOVATIONS PHARM.
`TECH. 64 (2009)
`E.T. Kaiser et al., Secondary structures of
`proteins and peptides in amphiphilic
`environments (A Review), 80 PROC. NATL. ACAD.
`SCI. 1137 (1983)
`Dean K. Clodfelter et al., Effects of Non-
`Covalent Self-Association on the Subcutaneous
`Absorption of a Therapeutic Peptide, 15
`PHARM. RES. 254 (1998)
`Eva Y. Chi et al., Physical Stability of Proteins in
`Aqueous Solution: Mechanism and Driving
`Forces in Nonnative Protein Aggregation, 20
`PHARM. RESEARCH 1325 (2003)
`U.S. Patent No. 5,932,547
`Lotte Knudsen, et al., Potent Derivatives of
`Glucagon-like Peptide-1 with Pharmacokinetic
`Properties Suitable for Once Daily
`Administration, 43 J. MED. CHEM. 1664 (2000)
`U.S. Patent Application Publication No.
`2002/0061838
`
`Objection
`
`A, B, D, F, J,
`K, L
`
`A, B, D, F, G,
`J, K, L
`
`A, B, D, F, J,
`K, L
`
`A, B, C, D, E,
`F, J, K, L
`
`A, B, D, F, J,
`K, L
`
`A, B, D, F, J,
`K, L
`
`A, B, D, F, J,
`K, L
`
`A, B, D, F, J,
`K, L
`
`A, B, D, F, J,
`K, L
`
`A, B, D, F, J,
`K, L
`
`3
`
`
`
`Exhibit
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`Patent Owner’s Description
`Humira® Package Insert (revised 01/2003)
`Norditropin® Approved Labeling (revised
`05/2000)
`United States Pharmacopeia and National
`Formulary (USP 26-NF 21) 2003
`Alfred Doenicke, et al., Osmolalities of
`Propylene Glycol Containing Drug Formulations
`for Parenteral Use. Should Propylene Glycol Be
`Used as a Solvent?, 75 ANESTH. ANALG. 431
`(1992)
`Joseph M. Catanzaro et al., Propylene glycol
`dermatitis, 24 J. AM. ACAD. DERMATOLOGY 90
`(1991)
`Bahar Vardar et al., Incidence of lipohypertrophy
`in diabetic patients and a study of influencing
`factors, 77 DIABETES RESEARCH & CLINICAL
`PRAC. 231 (2007)
`Kenneth Strauss et al., A pan‐European
`epidemiologic study of insulin injection
`technique in patients with diabetes, 19
`PRACTICAL DIABETES INT’L 71 (2002)
`Omnitrope® Highlights of Prescribing
`Information (dated 06/2009)
`U.S. Food & Drug Admin., New and Revised
`Draft Q&As on Biosimilar Development and the
`BPCI Act (Revision 2), Guidance for Industry
`(Dec. 2018)
`
`Objection
`A, B, C, D, F,
`J, K, L, M, N
`A, B, C, D, F,
`J, K, L, M, N
`A, B, D, F, G,
`I, J, N
`
`A, B, D, F, J,
`K, L
`
`A, B, D, F, J,
`K, L
`
`A, B, C, D, E,
`F, J, K, L
`
`A, B, D, F, J,
`K, L
`
`A, B, C, D, E,
`F, J, K, L, N
`
`A, B, C, D, E,
`F, G, J, K, L,
`M
`
`4
`
`
`
`Objection Key:
`
`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)
`37 C.F.R. § 42.65 (fails to provide underlying facts or data on which opinion
`is based)
`
`
`
`5
`
`A:
`B:
`C:
`
`D:
`
`E:
`
`F:
`
`G:
`
`H:
`I:
`J:
`K:
`
`L:
`
`M:
`
`N:
`O:
`
`
`
`
`
`
`
`Dated: July 7, 2020
`
`
`/s/ Brandon M. White
`Brandon M. White, Esq.
`Reg. No. 52,354
`Perkins Coie LLP
`700 Thirteenth Street, N.W. Suite 800
`Washington, DC 20005-3960
`bmwhite@perkinscoie.com
`Tel: 202-654-6206
`Fax: 202-654-9681
`
`Counsel for Petitioner
`
`6
`
`
`
`
`
`
`
`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: July 7, 2020
`
`
`
`
`/s/ Brandon M. White
`Brandon M. White
`Reg. No. 52,354
`
`Counsel for Petitioner
`
`
`
`7
`
`
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