UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.
`and PFIZER, INC.,
`Petitioners,
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`v.
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`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
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`Case IPR2018-01676
`Patent No. 8,603,044
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`PETITIONERS’ REPLY IN SUPPORT OF
`PETITIONERS’ MOTION TO EXCLUDE
`37 CFR §42.64(c)
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.
`and PFIZER, INC.,
`Petitioners,
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`v.
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`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
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`Case IPR2018-01676
`Patent No. 8,603,044
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`PETITIONERS’ REPLY IN SUPPORT OF
`PETITIONERS’ MOTION TO EXCLUDE
`37 CFR §42.64(c)
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`Case IPR2018-01676
`Patent No. 8,603,044
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`The petitioners (Mylan) seeks exclusion of patent owner (Sanofi) exhibits
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`2001-2014, 2017-2026, 2100-2102, 2104-2107, 2111-2153, 2158-2201, 2203-
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`2212, 2214-2218, and 2225, and of the redirect testimony in Mylan exhibit 1054.
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`Page number references are to Sanofi’s opposition unless otherwise indicated.
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`I.
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`ARGUMENT
`A. EX2001-EX2011, EX2019-EX2026
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`At 1, Sanofi states these exhibits “are not cited in connection with any
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`disputed issues raised in the post-institution briefing[ so] the Board will have no
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`further reason to refer to them.” Sanofi thus concedes the papers have no relevance
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`to any issue at trial. The institution issues to which Sanofi says the exhibits relate
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`are not appealable so the exhibits are no longer relevant for any legitimate purpose.
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`35 U.S.C. 314(d). The papers should be excluded under FRE402-403 as irrelevant
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`and likely to cause confusion. If not, their admissibility should be limited to the
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`purpose for which they were submitted. FRE105.
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`B.
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`EX2012, EX2017, EX2018, EX2117, EX2147-EX2152,
`EX2162, EX2167, EX2168, EX2206, EX2207, EX2211,
`EX2215-EX2218 – animations
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`At 2, 3-4, and 12-13, Sanofi does not contest that these exhibits are hearsay,
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`but says that its expert relied on the exhibits. While an expert may rely on hearsay
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`in forming an opinion (FRE703), that fact does not make the evidence admissible
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`Case IPR2018-01676
`Patent No. 8,603,044
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`in trial. In any case, if these exhibits are not excluded they should be limited to the
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`purpose for which they were submitted (showing basis for expert testimony) and
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`should not be used for any other purpose. FRE105.
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`C. EX1054 (redirect), EX2107 – Slocum testimony
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`At 4 and 6-13, Sanofi contends that Dr. Slocum’s lack of experience and
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`flawed methodology are inconsequential. Sanofi misstates Mylan’s challenge and
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`fails to rebut the key problems with the testimony. Mylan’s Daubert challenge
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`does not pose the subjective question of whether Dr. Slocum could be an expert on
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`the involved technology; 1 instead, Mylan shows that Dr. Slocum objectively failed
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`to act as an expert in this case regardless of whatever potential he might possess.
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`Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 597 (1993) (requiring “that
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`an expert's testimony both rests on a reliable foundation and is relevant to the task
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`at hand”).
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`Sanofi also tries to turn its opposition into an unauthorized briefing
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`opportunity to attack Mylan’s expert, Karl Leinsing, an undisputed expert with
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`1 Hence, whether another tribunal found Dr. Slocum qualified is irrelevant
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`without showing that Dr. Slocum gave the same testimony with the same bases.
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`-2-
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`Patent No. 8,603,044
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`personal experience in the field at all relevant times. This improper briefing
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`violates the rules requiring objections and motions to exclude, prejudices Mylan by
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`impinging on Mylan’s limited reply briefing opportunity, and is simply wrong.
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`Sanofi’s improper attacks on Mr. Leinsing should be disregarded entirely.
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`Sanofi argues (at 6-7) argues that Dr. Slocum need not have been an expert
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`in the involved technology at the relevant time. Sanofi misses the point. Absence
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`of relevant experience should be considered in weighing credibility.2 FRE702
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`(listing experience as a relevant consideration). A purported expert who lacks such
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`experience (or knowledge, skill, training, or education directly related to the
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`involved technology) must demonstrate that “the testimony is based on sufficient
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`facts or data; ... is the product of reliable principles and methods; and [has been]
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`reliably applied the principles and methods to the facts of the case.” Id.
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`Sanofi says Dr. Slocum considered the prior art, other literature on design
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`considerations, and discussions with Dr. Goland (an endocrinologist) and Mr.
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`2 A ceramics appraiser need not be a Ming Dynasty potter to appraise a Ming
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`vase, but cannot simply uncritically accept the seller’s word on the vase’s value
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`and provenance.
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`-3-
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`Patent No. 8,603,044
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`Veasey (an unproduced inventor). Dr. Slocum himself, however, explained that he
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`lacked any knowledge and so started with Mr. Veasey, whose data he accepted
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`without question because he had no relevant knowledge or experience as recently
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`as three weeks ago (EX1115, 553:20-555:12), yet Sanofi hid Mr. Veasey from
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`cross examination on the basis he provided. Models theoretical or physical that
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`ultimately depend on undisclosed inputs from a self-interested inventor are
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`intrinsically unreliable. Cf. United States v. Esquivel-Rios, 725 F.3d 1231, 1234 &
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`n.1 (10th Cir. 2013) (Gorsuch, J., explaining the limitations of a law-enforcement
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`database) (“Garbage in, garbage out. Everyone knows that much about computers:
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`you give them bad data, they give you bad results.”).
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`Sanofi argues in a footnote that Mylan could have cross examined Mr.
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`Veasey on an irrelevant authentication declaration or sought additional discovery
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`(a transparent burden shift), but fails to explain why it should be absolved of its
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`obligation to show the bases of its expert’s testimony. Cross examining the expert
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`is not sufficient if the expert does not know and can only revert to an absent
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`inventor.
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`Dr. Slocum also relied on post-critical date publications regarding the
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`importance of injection force, and on an off-record discussion with Dr. Goland
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`-4-
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`about her dubious opinion that injection force is paramount with patients, a
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`position she could not support even with her own patient experience.
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`D. EX2136, EX2137, EX2175 –injection force
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`At 14, Sanofi argues that these exhibits should be retained despite not
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`relating to any claimed feature because they are relevant to motivation. Yet
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`motivation is determined at the time of filing. All three of these exhibits post-date
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`Sanofi’s claimed priority date. Hence, unless Sanofi concedes that it is not entitled
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`to its benefit and priority dates, these exhibits remain irrelevant to any pending
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`issue. Sanofi’s effort to use these exhibits for an issue to which they are not
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`pertinent underscores the potential for misuse and prejudice to Mylan. These
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`exhibits should be excluded as irrelevant, misleading, and prejudicial. FRE402-
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`403. If not, the exhibits should be limited to the purpose for which they were
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`submitted (showing the benefits of unclaimed features). FRE105.
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`II. CONCLUSION
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`Sanofi exhibits 2001-2014, 2017-2026, 2100-2102, 2104-2107, 2111-2153,
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`2158-2201, 2203- 2212, 2214-2218, and 2225, and the redirect testimony in Mylan
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`exhibit 1054 should be excluded.
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`Case IPR2018-01676
`Patent No. 8,603,044
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`Respectfully submitted,
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`Dated: 23 December 2019
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`/Richard Torczon/
`Richard Torczon, Reg. No. 34,448
`Counsel for Mylan
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`Case IPR2018-01676
`Patent No. 8,603,044
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`CERTIFICATE OF SERVICE
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`I certify that this paper was served today on the electronic service addresses
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`of Sanofi 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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`Sundip K. Kundu
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`anish.desai@weil.com
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`sundip.kundu@weil.com
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`Kathryn M. Kantha
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`kathryn.kantha@weil.com
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`William S. Ansley
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`Matthew D. Sieger
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`Adrian C. Percer
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`Brian C. Chang
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`Robert T. Vlasis
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`sutton.ansley@weil.com
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`matthew.sieger@weil.com
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`adrian.percer@weil.com
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`brian.chang@weil.com
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`robert.vlasis@weil.com
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`WEIL, GOTSHAL & MANGES LLP
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`Sanofi.IPR.Service@weil.com
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`John S. Goetz, Joshua A. Griswold,
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`PTABInbound@fr.com
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`Matthew S. Colvin, Kenneth W. Darby
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`and W. Karl Renner
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`and on joinder counsel as follows:
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`-7-
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`Case IPR2018-01676
`Patent No. 8,603,044
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`Jovial Wong
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`Charles B. Klein
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`Dan H. Hoang
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`jwong@winston.com
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`cklein@winston.com
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`dhoang@winston.com
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`WINSTON & STRAWN LLP
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`PfizerIPRs@winston.com
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`Dated: 23 December 2019
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`Respectfully submitted,
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`/Richard Torczon/
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`-8-
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