UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`ALLERGAN, INC.
`Patent Owner
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`Case IPR2016-011281
`Patent 8,629,111
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`PATENT OWNER’S REPLY TO PETITIONER’S OPPOSITION TO
`MOTION TO EXCLUDE EVIDENCE
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`1 Cases IPR2017-00578 and IPR2017-00596 have been joined with this
`proceeding.
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
`Petitioner
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`v.
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`ALLERGAN, INC.
`Patent Owner
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`Case IPR2016-011281
`Patent 8,629,111
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`PATENT OWNER’S REPLY TO PETITIONER’S OPPOSITION TO
`MOTION TO EXCLUDE EVIDENCE
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`1 Cases IPR2017-00578 and IPR2017-00596 have been joined with this
`proceeding.
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`I. Allergan’s Motion Satisfies the Board’s Rules
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`Mylan criticizes Allergan’s motion because Allergan failed to identify
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`specific paragraphs in Mylan’s three new expert declarations that Allergan seeks to
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`exclude. Allergan seeks to exclude each declaration in its entirety. Allergan’s
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`motion, therefore, is compliant.
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`II. Mylan’s Reply Is Really a New Petition
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`Mylan changed its theory of unpatentability between its petition and its
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`reply. In its petition, Mylan and its sole declarant, Dr. Amiji, argued that Sall
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`demonstrated the superiority of the 0.05% CsA emulsion. Petition, pp. 8, 50; EX.
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`1002, ¶¶ 107-108. Mylan had to make these arguments in order to support its
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`theory of obviousness based on Ding ’979 and Sall—specifically, that a POSA
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`would have selected a 0.05% CsA emulsion based upon Sall.
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`In its owner’s response, Allergan agreed that Sall demonstrated the
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`superiority of the 0.05% CsA emulsion particularly with respect to tear production,
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`as measured by the Schirmer Tear Test (“STT”) with anesthesia. As Allergan
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`noted, the real issue was how much castor oil a POSA would have combined with
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`the 0.05% CsA, since Sall is silent as to the amount of castor oil used with the
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`0.05% CsA. Allergan proved that based upon thermodynamic principles, and
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`confirmed by bioavailability studies, a POSA would not have selected 1.25%
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`castor oil but, in fact, would have chosen far less. Patent Owner Response, pp. 24-
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`28. Allergan established that a POSA would have expected that increasing the
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`amount of castor oil would have caused less CsA to reach the lacrimal glands
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`relative to an emulsion containing 0.1% CsA and 1.25% castor oil. Id. In this
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`context, the fact that an emulsion having 0.05% CsA/1.25% castor oil was better at
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`increasing tear production than an emulsion having 0.1% CsA/1.25% castor oil
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`was surprising and unexpected. As to Mylan’s argument that increasing castor oil
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`had beneficial effects, Allergan proved, with the aid of the STT with anesthesia
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`data shown in Sall Fig. 2, that the castor oil vehicle alone decreased tear
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`production and was worse than either CsA-containing emulsion. Id. at 30. Thus,
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`selecting 1.25% castor oil was not a matter of optimizing castor oil concentration,
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`as the Board suggested in its Institution Decision. Institution Decision, p. 21.
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`Rather, Sall shows that the 0.05% CsA/1.25% castor oil emulsion is critical to
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`increasing tear production and works differently than the 0.1% CsA/1.25% castor
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`oil emulsion (the closest prior art).
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`With the aid of three new declarants, Mylan now turns its back on Sall and
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`tries to argue that Sall shows no real difference between the 0.05% and 0.1% CsA
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`emulsions. Notably absent is any new testimony from Dr. Amiji. Mylan tries to
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`argue that it criticized Sall’s data all along. Opposition, pp. 2-4. However,
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`Mylan’s citations to “data” in its Opposition reveal that it criticized the data in Dr.
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`Schiffman’s declaration, and used Sall as a reliable, robust source of data to
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`support its criticism. Mylan did not criticize Sall’s data.
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`Allergan’s Response did not rely on Dr. Schiffman’s data—it relied on Sall.
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`Having seen the Response, Mylan is simply trying to re-write its original petition.
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`III. Drs. Bloch and Calman’s Methodology Is Scientifically Unsound and
`Unreliable
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`To perform his “statistical” analysis, Dr. Bloch relied on numbers that he
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`“gleaned” from Sall Fig. 2 using a ruler and magnifying glass. EX. 1040 at ¶¶ 26,
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`44; EX. 2083 at 40:4-41:4. Dr. Calman attempted to “infer” raw Schirmer scores
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`from the categorized Schirmer scores disclosed in Sall. EX. 1039 at ¶ 68. Neither
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`is scientifically sound, as Dr. Calman admitted. EX. 2082 at 106:23-107:21.
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`Mylan attempts to justify their unscientific methods by complaining that
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`Allergan withheld the underlying data. But Mylan never requested raw data for the
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`purpose of attacking the Phase 3 clinical data reported in Sall—a peer-reviewed
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`paper that included error bars and p-values. Mylan never established any reason to
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`doubt the data presented in Sall, especially since Mylan’s petition and its original
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`expert, Dr. Amiji, relied upon Sall. Mylan sought the raw data for the purpose of
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`challenging the data Dr. Schiffman presented to the Patent Office. See Paper No.
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`23. When Allergan confirmed that its Response did not rely on Dr. Schiffman’s
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`figures but instead relied solely on the data and analysis presented in Sall, the
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`Board denied Mylan’s request for the raw data. See Paper No. 28.
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`Based upon the reasons Mylan presented in its motion for additional
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`discovery, Mylan was never entitled to the raw STT data underlying Sall Fig. 2.
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`Moreover, Mylan’s real, albeit unstated, objective in seeking the raw data to
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`challenge Sall Fig. 2 underscores that Mylan’s statistical challenge is an entirely
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`new argument supported by new evidence presented for the first time in its reply.
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`IV. Allergan Is Unable to Offer Its Own Rebuttal Declarations
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`The Board authorized Allergan to file a surreply. It did not authorize
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`Allergan to file supporting declarations. Nevertheless, the positions Mylan
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`continues to advance make clear that without the ability to offer declarations from
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`its own biostatistician and clinician, Allergan lacks a meaningful opportunity to
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`respond to Mylan’s new arguments and evidence. Contrary to Mylan’s arguments
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`in its Opposition, Allergan’s witnesses (Drs. Sheppard and Loftsson) never
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`confirmed Dr. Bloch and Dr. Calman’s analyses. How could they have confirmed
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`analyses that Mylan did not present until after Drs. Sheppard and Loftsson had
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`submitted their declarations? As to Mylan’s argument that neither of Allergan’s
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`witnesses performed a statistical analysis, this is true—because neither Dr.
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`Sheppard nor Dr. Loftsson is a biostatistician and Mylan’s Petition embraced,
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`rather than attacked, Sall’s data and statistical analysis.
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`Allergan now specifically requests leave to file declarations from its own
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`biostatistician and clinician in support of its surreply. The biostatistician would
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`testify inter alia that based upon Sall and FDA’s Medical Review, the 0.05%
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`CsA/1.25% castor oil formulation was statistically significantly better than both the
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`0.1% CsA/1.25% castor oil formulation and vehicle in increasing tear production
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`in clinically relevant patient populations, and that Allergan’s PK studies show a
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`statistically significant difference in bioavailability between the two formulations.
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`The clinician would testify inter alia that the Phase 3 results were clinically
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`significant for increasing tear production in the treatment of dry eye patients, and
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`the Kaswan and Oellerich references do not teach the level of CsA in the ocular
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`tissues necessary to cause a clinically significant increase in tear production.
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`In seeking leave, Allergan recognizes that Mylan may wish to depose each
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`of Allergan’s rebuttal declarants and that the depositions may require adjusting the
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`current scheduling order. Given the importance of ensuring that both parties have
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`a full and fair opportunity to present their respective arguments, Allergan does not
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`object to adjusting the schedule, including extending Due Date 7 and the final
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`written decision deadline. With respect to the latter, Allergan notes that because
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`the current proceeding is a joined proceeding, the Board has the option of
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`extending the final written decision deadline. See 35 U.S.C. 316(a)(11).
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
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`Respectfully submitted,
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`/Dorothy P. Whelan/
`Dorothy P. Whelan, Reg. No. 33,814
`Michael J. Kane, Reg. No. 39,722
`Attorneys for Allergan, Inc.
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`Date:/August 3, 2017/
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`Customer Number 26191
`Fish & Richardson P.C.
`Telephone: (612) 337-2509
`Facsimile: (612) 288-9696
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`6
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
`CERTIFICATE OF SERVICE
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`Pursuant to 37 CFR §§ 42.6(e)(4) and 42.205(b), the undersigned certifies
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`that on August 3, 2017, a complete and entire copy of this Patent Owner Allergan,
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`Inc.’s Reply to Opposition to Motion to Exclude Evidence was provided via
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`electronic service, to the Petitioner by serving the correspondence address of
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`record as follows:
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`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`Wendy L. Devine
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`wdevine@wsgr.com
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`Michael R. Dzwonczyk
`Azy S. Kokabi
`Travis B. Ribar
`Sughrue Mion, PLLC
`2100 Pennsylvania Ave., NW, Suite 800
`Washington, DC 20037
`mdzwonczyk@sughrue.com
`akokabi@sughrue.com
`tribar@sughrue.com
`sblackston@sughrue.com
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`Case IPR2016-01128
`Attorney Docket No: 13351-0008IP2
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`Gary J. Speier
`Mark D. Schuman
`Carlson, Caspers, Vandenburgh, Lindquist & Schuman, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, Minnesota 55402
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`gspeier@carlsoncaspers.com
`mschuman@carlsoncaspers.com
`IPRCyclosporine@carlsoncaspers.com
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` /Jessica K. Detko/
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`Jessica K. Detko
`Fish & Richardson P.C.
`60 South Sixth Street, Suite 3200
`Minneapolis, MN 55402
`(612) 337-2516
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