UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`NOVO NORDISK A/S,
`
`Patent Owner.
`
`_________________________
`
`IPR2023-00724
`Patent 10,335,462 B2
`_________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EXHIBITS
`
`
`
`
`
`
`_________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`NOVO NORDISK A/S,
`
`Patent Owner.
`
`_________________________
`
`IPR2023-00724
`Patent 10,335,462 B2
`_________________________
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EXHIBITS
`
`
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner Mylan Pharmaceuticals Inc.
`
`(“Petitioner”) objects to the admissibility of the following exhibits filed by Patent
`
`Owner Novo Nordisk A/S (“Novo” or “Patent Owner”) in 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 October 4, 2023, Paper No. 10. Petitioner’s objections
`
`provide notice to Novo 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 “’462 patent”
`
`means U.S. Patent No. 10,335,462. All objections under FRE 801-803 (hearsay)
`
`apply to the extent Patent Owner relies on the exhibits 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 the description does not
`
`indicate that Petitioner agrees with the descriptions or characterizations of the
`
`documents.
`
`Exhibit
`
`Patent Owner’s Description
`
`EX2001 U.S. Patent No. 9,764,003 File History
`
`Objection
`A, B, C, D, E, F, I, K, L,
`M, N, O
`
`
`
`
`
`
`
`
`
`Exhibit
`
`Patent Owner’s Description
`
`EX2002 U.S. Patent No. 9,764,003
`
`Excerpt of Amended Joint Claim
`Construction Chart, In re: Ozempic
`(Semaglutide) Patent Litigation, No.
`1:22-cv-01040-CFC, Dkt. 101 (D. Del.
`May 23, 2023)
`Miller, M., et al., “Low Viscosity
`Highly Concentrated Injectable
`Nonaqueous Suspensions of Lysozyme
`Microparticles,” Langmuir, Author
`Manuscript (2011), PMC 2011 (Feb
`17)
`Knight, A., “Systematic Reviews of
`Animal Experiments Demonstrate Poor
`Contributions Toward Human
`Healthcare,” Reviews on Recent
`Clinical Trials, Vol.3, Issue 2, 89-96
`(2008)
`Arrowsmith, J., “Phase II failures:
`2008–2010,” Nature Reviews, Drug
`Discovery, Vol. 10 (May 2011)
`Excerpt of Novo Nordisk’s Initial
`Responses to Defendants’ Initial
`Invalidity Contentions Regarding U.S.
`Patent Nos. 8,129,343; 8,536,122;
`8,114,833; 8,920,383; 9,775,953;
`9,457,154; and 10,335,462, In re:
`Ozempic (Semaglutide) Patent
`Litigation, No. 1:22-cv-01040-CFC,
`(D. Del. Dec. 21, 2022)
`Ozempic®, Prescribing Information
`(October 2022)
`
`EX2003
`
`EX2004
`
`EX2005
`
`EX2006
`
`EX2007
`
`EX2008
`
`EX2009 Declaration of Sayem Osman
`
`Objection
`A, B, C, D, E, F, I, K, L,
`M, N, O
`
`A, B, C, D, E, F, I, K, L,
`M, N, O, V
`
`A, B, C, D, E, F, I, J, K,
`L, M, N, O, R, T, U
`
`A, B, C, D, E, F, I, J, K,
`L, M, N, O, R, T, U
`
`A, B, C, D, E, F, I, J, K,
`L, M, N, O, R, T, U
`
`A, B, C, D, E, F, I, J, K,
`L, M, N, O, U, V, W
`
`A, B, C, D, E, F, I, J, K,
`L, M, N, O, T, U
`A, D, E, F, J, K, L, M, N,
`O, R
`
`Petitioner objects to paragraphs in the Patent Owner Preliminary Response
`
`
`
`
`
`that rely on exhibits objected to in this Petitioner’s Objection to Evidence.
`
`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 ’462 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 ’462 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 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 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 701, 702 (improper expert testimony) improper expert testimony by a
`lay witness
`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
`
`A:
`B:
`C:
`
`D:
`
`E:
`
`F:
`
`G:
`
`H:
`
`I:
`
`J:
`
`K:
`L:
`M:
`N:
`
`O:
`
`
`
`
`
`
`
`P:
`Q:
`
`R:
`S:
`
`issue in the IPR proceeding
`No exhibit filed.
`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 602 (lack of personal knowledge)
`FRE 702/703 to the extent that the expert declarant relies on an exhibit
`objected to under grounds G and H, 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 1006 (improper summary)
`37 C.F.R. § 42.65 (fails to provide underlying facts or data on which opinion
`is based)
`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 403 (confusing, waste of time, unfair prejudice) the paper, declaration,
`or opinion has been filed in a proceeding to which Petitioner is not a party
`and/or had no opportunity to cross-examine the witness in this proceeding
`and/or assess the basis or correctness of the opinions offered, and/or for
`which the Petitioner does not have access to or is precluded from using
`discovery in such other proceeding
`Petitioner was excluded from participation in proceeding, deposition, or
`cross examination of the declarant or witness.
`
`T:
`U:
`
`V:
`
`X:
`
`
`Dated: October 19, 2023
`
`
`PERKINS COIE LLP
`700 Thirteenth Street, N.W., Suite 800
`Washington, D.C. 20005-3960
`202.654.6200 (phone)
`202.654.6211 (fax)
`
`
`Respectfully submitted,
`
`/Brandon M. White/
`Lead Counsel
`Brandon M. White, Reg No. 52,354
`
`
`Attorneys for Petitioner
`
`
`
`
`
`
`
`
`
`
`
`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:
`
`
`
`J. Steven Baughman
`Megan Raymond
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`steve.baughman@groombridgewu.com
`megan.raymond@groombridgewu.com
`Novo-Semaglutide-IPR@groombridgewu.com
`
`
`Dated: October 19, 2023
`
`
`PERKINS COIE LLP
`700 Thirteenth Street, N.W., Suite 800
`Washington, D.C. 20005-3960
`202.654.6200 (phone)
`202.654.6211 (fax)
`
`
`/Brandon M. White/
`Lead Counsel
`Brandon M. White, Reg No. 52,354
`
`
`Attorneys for Petitioner
`
`
`
`
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