Filed: February 4, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN INSTITUTIONAL LLC and PFIZER INC.,
`Petitioners
`v.
`NOVO NORDISK A/S,
`Patent Owner
`
`
`Case No. IPR2020-003241
`U.S. Patent No. 8,114,833
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S
`SUR-REPLY EVIDENCE
`
`
`
`
`
`
`1
`IPR2020-01252 has been joined with this proceeding.
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`MYLAN INSTITUTIONAL LLC and PFIZER INC.,
`Petitioners
`v.
`NOVO NORDISK A/S,
`Patent Owner
`
`
`Case No. IPR2020-003241
`U.S. Patent No. 8,114,833
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S
`SUR-REPLY EVIDENCE
`
`
`
`
`
`
`1
`IPR2020-01252 has been joined with this proceeding.
`
`
`
`
`
`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 Sur-Reply 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
`
`Sur-Reply filed by Patent Owner on January 29, 2021, Paper Nos. 44
`
`(Confidential) and 45 (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 Sur-Reply that rely on
`
`2
`
`
`
`exhibits objected to in this Petitioner’s Objections to Sur-Reply Evidence.
`
`Exhibit
`
`2095
`
`2096
`
`2097
`
`Patent Owner’s Description
`Witte, R. & Witte, J. Chapter 11: More about
`Hypothesis Testing. 11 STATISTICS, 195-220
`(2017)
`Deposition Transcript of Laird Forrest, Ph.D.,
`dated January 21, 2021 (Confidential –
`Protective Order Material)
`Redacted Version of Deposition Transcript of
`Laird Forrest, Ph.D., dated January 21, 2021
`
`Objection
`A, B, C, E, G,
`J, K, L
`
`J, Z
`
`J, Z
`
`3
`
`
`
`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)
`
`4
`
`
`
`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
`
`U:
`V:
`
`X:
`
`Y:
`
`Z:
`
`5
`
`
`
`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: February 4, 2021
`
`
`
`
`
`
`/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
`
`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 SUR-REPLY EVIDENCE by email to the electronic service addresses for
`
`Patent Owner: and Petitioner Pfizer Inc.:
`
`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
`
`Counsel for Patent Owner
`
`Jovial Wong
`Charles B. Klein
`Sharon Lin
`WINSTON & STRAWN
`PfizerIPRs@winston.com
`
`Thomas J. Meloro
`Michael W. Johnson
`WILLKIE FARR & GALLAGHER LLP
`tmeloro@willkie.com
`mjohnson1@willkie.com
`
`Counsel for Petitioner Pfizer Inc.
`
`Dated: February 4, 2021
`
`
`
`
`/s/ Lara Dueppen
`Lara Dueppen
`Reg. No. 65,002
`
`Counsel for Petitioner
`
`7
`
`
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