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`Paper No. ___
`Filed: May18, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________________
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`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC. and AKORN INC.,1
`Petitioners,
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`v.
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`ALLERGAN, INC.
`Patent Owner.
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`_____________________________
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`Case IPR2016-01127 (US 8,685,930 B2)
`Case IPR2016-01128 (US 8,629,111 B2)
`Case IPR2016-01129 (US 8,624,556 B2)
`Case IPR2016-01130 (US 8,633,162 B2)
`Case IPR2016-01131 (US 8,648,048 B2)
`Case IPR2016-01132 (US 9,248,191 B2)
`_____________________________
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`PETITIONER’S MOTION FOR
`DISCOVERY FROM PATENT OWNER
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`1 Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017 -
`00596, IPR2017 -00579 and IPR2017-00598, IPR2017 -00583 and IPR2017-
`00599, IPR2017-00585 and IPR2017-00600, and IPR2017 -00586 and IPR2017-
`00601, have respectively been joined with the captioned proceedings. The word-
`for-word identical paper is filed in each proceeding identified in the caption
`pursuant to the Board’s Scheduling Order (Paper 10).
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`I.
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`RELIEF REQUESTED
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`As authorized in Paper 22, Petitioner requests an order requiring Allergan to
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`produce (i) the phase 2 clinical trial (192371-001) data, (ii) the phase 3 clinical trial
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`data (192371-002 and -003), and (iii) the pharmacokinetic (“PK”) data underlying
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`Schiffman Exhibits B-F, Attar Exhibits B-D, and Sall Figures 1-4. Allergan relies
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`upon these figures and the Schiffman and Attar declarations to allege criticality of,
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`and unexpected results from, combining 0.05% cyclosporin A (“CsA”) with 1.25%
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`castor oil. The underlying data is necessary to evaluate how it was purportedly
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`used to arrive at the values Allergan depicted in these figures and whether the data
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`support the allegations of Allergan and its witnesses. 37 C.F.R. §§ 42.65(b). Thus,
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`an order requiring production of the underlying data is in the interests of justice
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`and is necessary to afford Petitioner a fair cross-examination of Allergan’s
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`witnesses. 37 C.F.R. §§ 42.51(b)(2)(i)-(ii).
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`Allergan has provided extremely limited deposition availability for each
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`witness (Dr. Schiffman is said to be available only on June 1, 2017, and Dr.
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`Sheppard is said to be available only on one day, beginning only at 5:00pm), and
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`has insisted that it will not provide additional availability. Thus, Petitioner
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`requests that the discovery be produced by May 25, 2017, or, as suggested by the
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`Board during the call, that Allergan be required to make its witnesses available for
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`depositions again at a later date if necessary.
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`-1-
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`II.
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`FACTUAL BACKGROUND
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`Allergan relied upon the declarations of Drs. Schiffman and Attar (e.g.,
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`IPR2016-01127, EX1004, 0190-0242) during prosecution to support the alleged
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`criticality of, and unexpected results from, the claimed percentages of cyclosporin
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`A and castor oil. Dr. Schiffman asserted (¶¶1, 6, 8, 13-19) that his Exhibits B and
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`D respectively depicted the results of Allergan’s phase 2 and phase 3 studies for
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`Restasis® and that his Exhibits E-F compared the results of these trials.
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`Dr. Attar (¶¶9-13) adopted Schiffman Figures E-F as Attar Exhibits C-D.
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`She also discusses (¶¶6-8) at least two “Pharmacokinetic studies [that] were
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`performed in animal eyes” that she summarized in Exhibit B. One study evaluated
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`cyclosporin tissue penetration when “the amount of oil present in the formulation
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`was decreased and the “weight percentage of cyclosporin stayed the same” (0.05%
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`CsA in 0.625% or 1.25% castor oil). Another study evaluated tissue penetration
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`using a formulation having 0.10% CsA and 1.25% castor oil. Dr. Schiffman (¶¶9-
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`12) adopted Attar’s Figure B as Schiffman Exhibit C. The patents issued based on
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`these figures. See, e.g., IPR2016-01127, EX1004, 0273-0278.
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`The Petitions showed that these figures “failed to demonstrate unexpected
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`results because they failed to provide parameters necessary for scientific
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`interpretations, including raw data values and error rates.” See, e.g., IPR2016-
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`01127 Petition at 47-57. The Board agreed, but stated that it was “appropriate to
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`allow further evidence to be developed during trial regarding any such alleged
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`criticality.” See, e.g., IPR2016-01127, Paper 8 at 18 & n.4. That evidence includes
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`not only the cross-examinations of Drs. Schiffman and Attar, but also the data
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`underlying the study results upon which they rely. Id. at 22.
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`Allergan and its experts continue to rely on the Schiffman and Attar
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`declarations and their summaries of the results of the phase 2, phase 3, and PK
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`studies. POR at 21 n.5; EX2024, 48, 50. They also rely on the results of the phase
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`3 trials reported in Sall and on Allergan’s pharmacokinetic studies. See, e.g., POR
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`at 2, 9; EX2024, ¶¶35-48; EX2025, ¶¶29-47. Notably, however, Allergan
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`selectively produced only a single volume of its NDA (EX2001), and did not
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`produce the remaining volumes of the NDA containing the data underlying the
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`phase 2 and 3 studies and PK studies despite Petitioner’s request for these
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`documents. EX2001 at 217 (identifying “Study Report References” for 192371-
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`001, -002, -003, and PK studies in Volumes 27, 40, 60, and 19 of the NDA,
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`respectively); 60-109 (identifying additional PK studies and data in Volumes 19
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`and 23, and “Clinical Data” and “Statistical Appendices” for 192374-001, -002, -
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`003 in Volumes 25-29, 40-46, 60-66, 90-91, 96, 102, and 106).
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`Further, Allergan produced only one PK study report summarizing the
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`underlying data of the PK study that compared different doses of CsA at constant
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`castor oil percentages (1.25%). Allergan did not produce any report summarizing
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`the data for the PK study referred to by Dr. Attar in which the same doses of CsA
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`at different castor oil percentage (0.05% CsA in 0.625% and 1.25% castor oil)
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`were compared, and did not produce the underlying data for either PK study.
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`EX2026 at 9 & n.4, 10 (identifying the phase 2 trial as 192371-001 and the phase 3
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`trials as 192371-002, -003 and specifying use of constant castor oil concentration
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`of 1.25% in PK-98-074 ); id. at 6, 13 (identifying lab notebooks L-1998-5707 and -
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`5709 and explaining that “All data were compiled into Allergan laboratory
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`logbooks…stored in Allergan’s R&D Records Management”). Petitioner requested
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`the data for each of the studies. Allergan refused.
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`III. ARGUMENT
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`The phase 2, phase 3, and PK study data relied upon by Allergan and its
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`witnesses in Schiffman Exhibits B-F, Attar Exhibits B-D, and Sall should be
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`produced pursuant to 37 C.F.R. §§ 42.51(b)(2)(i)-(ii), 42.65. In evaluating
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`additional discovery, the Board considers whether: (1) it is “beyond speculation”
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`that something useful regarding a contention of the party will be uncovered; (2) the
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`request does not seek litigation positions; (3) equivalent information is not easily
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`obtainable by other means; (4) instructions are easy to understand; and (5) requests
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`are not overly burdensome. Garmin Int’l Inc. et. al. v. Cuozzo Speed Techs. LLC,
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`IPR2012-00001, Paper 26, 6-16 (precedential). Additional discovery is
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`appropriate here, where evidence on an issue raised by Allergan (criticality and
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`unexpected results) is “uniquely in the possession of the party that raised it.” 77
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`Fed. Reg. 48756, 48761 (Aug. 14, 2012).
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`The Board has previously explained that it is in the interests of justice to
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`order the production of underlying data from studies relied upon by a party to
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`permit the countering party to evaluate its deficiencies. In Corning Inc. v. DSM IP
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`Assets B.V., the Board ordered the production of “Laboratory notebooks and other
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`documents containing the protocols followed in creating and testing the
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`compositions and the underlying data for the test results.” IPR2013-0043, Paper
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`27, 2-4. The Board required production because the petitioner’s expert had relied
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`on the studies and the patent owner contended that the declarations “are missing
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`critical information” required to evaluate the expert’s conclusions. Because the
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`request pertained to data underlying test results petitioner relied upon, it was clear
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`that “the information DSM seeks exists,” that the notebooks were “per se useful,”
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`and that each of the remaining Garmin factors favored production. Id. Here, the
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`interests of justice similarly favor production of the underlying data.
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`A. Garmin Factor One Strongly Favors Production
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`As explained in Section II above, Allergan and its witnesses relied upon the
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`results of these studies to support the alleged criticality of, and unexpected results
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`from, the specific combination of 0.05% CsA with 1.25% castor oil. However, the
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`absence of actual data values and error bars renders the Schiffman and Attar
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`Exhibits meaningless. See Section II supra. Similarly, the absence of the
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`underlying data for the Sall figures and PK studies precludes a complete evaluation
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`of whether the data support Allergan’s contentions. 37 C.F.R. §42.65.
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`Allergan has produced a study report that summarizes the results of only one
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`of two PK studies relied upon by Dr. Attar. PK-98-074 compares CsA tissue
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`concentrations for the formulations in which the castor oil concentration was held
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`constant at 1.25% and the CsA concentration was either at 0.05% or 0.10%.
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`EX2026 at 9 & n.4, 10. But Dr. Attar relied upon at least one other PK study for
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`her Exhibit B that evaluated CsA tissue concentration of the 0.05% CsA / 0.625%
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`emulsion. See Section II above (Attar declaration ¶¶6-8). Moreover, the sample
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`sizes in PK-98-074 were very small (N=4), and the error bars were large in
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`comparison to the reported mean value and repeatedly overlap between the
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`formulations. EX2026 at 22, 28 (Fig. 1). Petitioner and the Board need the second
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`PK study report and the lab notebooks underlying both studies (EX2026 at 6, 13)
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`to evaluate the data and Allergan’s contentions based thereon.
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`For each of the reasons discussed above, it is “beyond speculation” that the
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`underlying data and the additional PK study report will provide useful information.
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`The first Garmin factor thus heavily favors production of the requested documents.
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`B.
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`The Remaining Garmin Factors Favor Production
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`Each of Garmin factors 2-5 also support Petitioner’s request. Petitioner is
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`not seeking litigation positions, the requested information is held confidentially by
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`Allergan such that Petitioner cannot obtain it by other means, and the request is
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`easily understandable because it is directed to data underlying specific studies and
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`figures prepared by Allergan and relied upon by its witnesses. Moreover, Petitioner
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`has identified specific sections of Allergan’s NDA (e.g., Volumes 19, 23, 25-29,
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`40-46, 60-66, 90-91, 96, 102, and 106) that provide Allergan’s clinical trial results.
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`Finally, Petitioner’s request is not overly burdensome. Allegan is best
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`positioned to identify the data that underlies its own witnesses’ figures, and
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`Petitioner has identified specific documents containing that data. Further,
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`Allergan’s counsel admitted to the Board that the very underlying data that is the
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`subject of this motion has already been produced in Allergan’s district court
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`litigation with Petitioner. The material is thus ready for production without
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`additional effort or expense. Allergan can easily identify the relevant documents to
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`Petitioner from its district court production, and the parties can agree to deem those
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`same documents produced in these proceedings. Petitioner offered to meet and
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`confer with Allergan to identify documents for such a production, but Allergan has
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`not agreed. Thus, any production burden is solely of Allergan’s own making.
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`IV. CONCLUSION
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`Petitioner requests the relief detailed above.
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`Dated: May 18, 2017
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`Respectfully submitted,
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`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
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`CERTIFICATE OF SERVICE
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`This is to certify that I caused to be served a true and correct copy of the
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`foregoing Petitioner’s Motion for Discovery from Patent Owner, on this 18th day
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`of May, 2017, on the Patent Owner at the correspondence address of the Patent
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`Owner as follows:
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`Dorothy P. Whelan
`Michael Kane
`Susan Morrison Colletti
`Robert M. Oakes
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Email: IPR13351-0008IP1@fr.com
`Email: IPR13351-0008IP2@fr.com
`Email: IPR13351-0008IP3@fr.com
`Email: IPR13351-0008IP4@fr.com
`Email: IPR13351-0008IP5@fr.com
`Email: IPR13351-0008IP6@fr.com
`Email: PTABInbound@fr.com
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`Dated: May 18, 2017
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`Respectfully submitted,
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`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
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