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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
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`Petitioner,
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`V.
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`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
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`Case IPR2018-01676
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`Patent No. 8,603,044
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`MYLAN PHARMACEUTICALS INC.
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`OBJECTIONS T0 EVIDENCE SUBMITTED WITH
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`PATENT OWNER RESPONSE
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`37 CFR §42.64(b)(1)
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`
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`Case IPR2018-01676
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`Patent No. 8,603,044
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`I.
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`OBJECTIONS
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`Petitioner (“Mylan”) submits the following objections:
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`1.
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`Declarations of Dr. Alexander Slocum, Dr. Robin S. Goland
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`(Exhibits 2107, 2108, 2111, 2112)
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`Grounds for objection: FRE 801-804.
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`To the extent that the declarants have not yet been made available for
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`deposition, the declarations constitute hearsay.
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`Grounds for objection: FRE 702, 703, 705.
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`The declarations of Dr. Slocum and Dr. Goland do not provide sufficient
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`facts or data, are not the product of reliable principles and methods, and have not
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`applied the proper principles to the facts of this proceeding. In addition, the
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`declarations do not disclose the underlying facts and data, and do not set forth the
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`bases of their opinions.
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`For example, Appendices A through F of Dr. Slocum’s Declaration
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`(EX2107) do not set forth the principles used nor do they demonstrate the
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`calculations used in generating the spreadsheets.
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`Grounds for objection: FRE 402-403.
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`The declarations of Dr. Slocum and Dr. Goland do not apply a proper
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`obviousness standard, and are thus irrelevant to the grounds of challenge. In
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`addition, to the extent the declarants are alleging secondary considerations, they do
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`Case IPR2018-01676
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`Patent No. 8,603,044
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`not establish a nexus between those considerations and the claims, and are again
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`irrelevant. The declarations are also prejudicial and confuse the issues as a result.
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`To the extent the exhibits are admitted, their scope should be restricted to the
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`purpose for which it was originally submitted. FRE 105.
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`2.
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`Animations (Exhibits 2117, 2147-2152, 2162, 2167, 2168,
`2206, 2207, 2211, 2215-2218)
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`Grounds for objection: FRE 801-804, 901.
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`The animations are offered, without sufficient foundation, purportedly to
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`show animated operations of prior art and non-prior art injection pens. The
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`animations are hearsay because they are offered for the truth of its content without
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`satisfying any of the hearsay exceptions. In addition, the animations lack sufficient
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`support to show that it is what Sanofi purports it to be.
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`Grounds for Objection: 401-402.
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`The animations are irrelevant to the extent they rely on an improper standard
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`of obViousness.
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`To the extent the exhibits are admitted, their scope should be restricted to the
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`purpose for which they were originally submitted. FRE 105.
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`3.
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`Exhibits not discussed in Patent Owner Response (Exhibits
`2100-2106, 2111-2116, 2118-2135, 2138-2146, 2151, 2158-
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`2161, 2166-2174, 2176-2201, 2203—2205, 2208-2210, 2212,
`2214)
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`Grounds for objection: FRE 402-403.
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`-2-
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`Case IPR2018-01676
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`Patent No. 8,603,044
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`The exhibits are irrelevant as they are not discussed in the Patent Owner
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`Response. These exhibits are also prejudicial and confuse the issues as a result.
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`To the extent the exhibits are admitted, their scope should be restricted to the
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`purpose for which they were originally submitted. FRE 105.
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`4.
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`Exhibits related to commercial pens (Exhibits 2136, 2137,
`2175)
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`Grounds for objection: FRE 402-403.
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`The exhibits, which relate to commercial pens and their properties, such as
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`injection force, are irrelevant to the extent they rely on an improper standard of
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`obViousness. These exhibits are also prejudicial and confuse the issues as a result.
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`To the extent the exhibits are admitted, their scope should be restricted to the
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`purpose for which they were originally submitted. FRE 105.
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`Dated: 2 July 2019
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`Respectfully submitted,
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`/ Richard Torczon/
`Richard Torczon, Reg. No. 34,448
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`
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`Case IPR2018-01676
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`Patent No. 8,603,044
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`CERTIFICATE OF SERVICE
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`I certify that today I caused a true and correct copy of Mylan
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`Pharmaceuticals Inc. Objections to Evidence Submitted with Patent Owner
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`Response, on the Patent Owner at the email correspondence addresses of the
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`Patent Owner as follows:
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`Elizabeth Stotland Weiswasser
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`elizabeth.weiswasser@weil.com
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`Anish R. Desai
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`anish.desai@weil.com
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`Sundip K. Kundu
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`sundip.kundu@weil.com
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`Kathryn M. Kantha
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`kat
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`n.kantha weil.com
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`William S. Ansley
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`sutton.ansley@weil.com
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`Matthew D. Sieger
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`matthew.sieger@weil.com
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`Adrian C. Percer
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`adrian.p_ercer@weil.com
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`Brian C. Chang
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`brian.chan weil.com
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`WEIL, GOTSHAL & MANGES LLP Sanof1.IPR.Service@weil.com
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`FISH & RICHARDSON
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`PTABInbound@fr.com
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`Dated: 2 July 2019
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`Respectfully submitted,
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`/ Richard Torczon/
`Richard Torczon, Reg. No. 34,448
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`