`
`Paper No. ___
`Filed: May18, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC. and AKORN INC.,1
`Petitioners,
`
`v.
`
`ALLERGAN, INC.
`Patent Owner.
`
`_____________________________
`
`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)
`_____________________________
`
`PETITIONER’S MOTION FOR
`DISCOVERY FROM PATENT OWNER
`
`
`
`
`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).
`
`
`
`
`
`
`
`
`
`I.
`
`RELIEF REQUESTED
`
`As authorized in Paper 22, Petitioner requests an order requiring Allergan to
`
`produce (i) the phase 2 clinical trial (192371-001) data, (ii) the phase 3 clinical trial
`
`data (192371-002 and -003), and (iii) the pharmacokinetic (“PK”) data underlying
`
`Schiffman Exhibits B-F, Attar Exhibits B-D, and Sall Figures 1-4. Allergan relies
`
`upon these figures and the Schiffman and Attar declarations to allege criticality of,
`
`and unexpected results from, combining 0.05% cyclosporin A (“CsA”) with 1.25%
`
`castor oil. The underlying data is necessary to evaluate how it was purportedly
`
`used to arrive at the values Allergan depicted in these figures and whether the data
`
`support the allegations of Allergan and its witnesses. 37 C.F.R. §§ 42.65(b). Thus,
`
`an order requiring production of the underlying data is in the interests of justice
`
`and is necessary to afford Petitioner a fair cross-examination of Allergan’s
`
`witnesses. 37 C.F.R. §§ 42.51(b)(2)(i)-(ii).
`
`Allergan has provided extremely limited deposition availability for each
`
`witness (Dr. Schiffman is said to be available only on June 1, 2017, and Dr.
`
`Sheppard is said to be available only on one day, beginning only at 5:00pm), and
`
`has insisted that it will not provide additional availability. Thus, Petitioner
`
`requests that the discovery be produced by May 25, 2017, or, as suggested by the
`
`Board during the call, that Allergan be required to make its witnesses available for
`
`depositions again at a later date if necessary.
`
`
`-1-
`
`
`
`
`
`II.
`
`FACTUAL BACKGROUND
`
`Allergan relied upon the declarations of Drs. Schiffman and Attar (e.g.,
`
`IPR2016-01127, EX1004, 0190-0242) during prosecution to support the alleged
`
`criticality of, and unexpected results from, the claimed percentages of cyclosporin
`
`A and castor oil. Dr. Schiffman asserted (¶¶1, 6, 8, 13-19) that his Exhibits B and
`
`D respectively depicted the results of Allergan’s phase 2 and phase 3 studies for
`
`Restasis® and that his Exhibits E-F compared the results of these trials.
`
`Dr. Attar (¶¶9-13) adopted Schiffman Figures E-F as Attar Exhibits C-D.
`
`She also discusses (¶¶6-8) at least two “Pharmacokinetic studies [that] were
`
`performed in animal eyes” that she summarized in Exhibit B. One study evaluated
`
`cyclosporin tissue penetration when “the amount of oil present in the formulation
`
`was decreased and the “weight percentage of cyclosporin stayed the same” (0.05%
`
`CsA in 0.625% or 1.25% castor oil). Another study evaluated tissue penetration
`
`using a formulation having 0.10% CsA and 1.25% castor oil. Dr. Schiffman (¶¶9-
`
`12) adopted Attar’s Figure B as Schiffman Exhibit C. The patents issued based on
`
`these figures. See, e.g., IPR2016-01127, EX1004, 0273-0278.
`
`The Petitions showed that these figures “failed to demonstrate unexpected
`
`results because they failed to provide parameters necessary for scientific
`
`interpretations, including raw data values and error rates.” See, e.g., IPR2016-
`
`01127 Petition at 47-57. The Board agreed, but stated that it was “appropriate to
`
`-2-
`
`
`
`
`
`allow further evidence to be developed during trial regarding any such alleged
`
`criticality.” See, e.g., IPR2016-01127, Paper 8 at 18 & n.4. That evidence includes
`
`not only the cross-examinations of Drs. Schiffman and Attar, but also the data
`
`underlying the study results upon which they rely. Id. at 22.
`
`Allergan and its experts continue to rely on the Schiffman and Attar
`
`declarations and their summaries of the results of the phase 2, phase 3, and PK
`
`studies. POR at 21 n.5; EX2024, 48, 50. They also rely on the results of the phase
`
`3 trials reported in Sall and on Allergan’s pharmacokinetic studies. See, e.g., POR
`
`at 2, 9; EX2024, ¶¶35-48; EX2025, ¶¶29-47. Notably, however, Allergan
`
`selectively produced only a single volume of its NDA (EX2001), and did not
`
`produce the remaining volumes of the NDA containing the data underlying the
`
`phase 2 and 3 studies and PK studies despite Petitioner’s request for these
`
`documents. EX2001 at 217 (identifying “Study Report References” for 192371-
`
`001, -002, -003, and PK studies in Volumes 27, 40, 60, and 19 of the NDA,
`
`respectively); 60-109 (identifying additional PK studies and data in Volumes 19
`
`and 23, and “Clinical Data” and “Statistical Appendices” for 192374-001, -002, -
`
`003 in Volumes 25-29, 40-46, 60-66, 90-91, 96, 102, and 106).
`
`Further, Allergan produced only one PK study report summarizing the
`
`underlying data of the PK study that compared different doses of CsA at constant
`
`castor oil percentages (1.25%). Allergan did not produce any report summarizing
`
`-3-
`
`
`
`
`
`the data for the PK study referred to by Dr. Attar in which the same doses of CsA
`
`at different castor oil percentage (0.05% CsA in 0.625% and 1.25% castor oil)
`
`were compared, and did not produce the underlying data for either PK study.
`
`EX2026 at 9 & n.4, 10 (identifying the phase 2 trial as 192371-001 and the phase 3
`
`trials as 192371-002, -003 and specifying use of constant castor oil concentration
`
`of 1.25% in PK-98-074 ); id. at 6, 13 (identifying lab notebooks L-1998-5707 and -
`
`5709 and explaining that “All data were compiled into Allergan laboratory
`
`logbooks…stored in Allergan’s R&D Records Management”). Petitioner requested
`
`the data for each of the studies. Allergan refused.
`
`III. ARGUMENT
`
`The phase 2, phase 3, and PK study data relied upon by Allergan and its
`
`witnesses in Schiffman Exhibits B-F, Attar Exhibits B-D, and Sall should be
`
`produced pursuant to 37 C.F.R. §§ 42.51(b)(2)(i)-(ii), 42.65. In evaluating
`
`additional discovery, the Board considers whether: (1) it is “beyond speculation”
`
`that something useful regarding a contention of the party will be uncovered; (2) the
`
`request does not seek litigation positions; (3) equivalent information is not easily
`
`obtainable by other means; (4) instructions are easy to understand; and (5) requests
`
`are not overly burdensome. Garmin Int’l Inc. et. al. v. Cuozzo Speed Techs. LLC,
`
`IPR2012-00001, Paper 26, 6-16 (precedential). Additional discovery is
`
`appropriate here, where evidence on an issue raised by Allergan (criticality and
`
`-4-
`
`
`
`
`
`unexpected results) is “uniquely in the possession of the party that raised it.” 77
`
`Fed. Reg. 48756, 48761 (Aug. 14, 2012).
`
`The Board has previously explained that it is in the interests of justice to
`
`order the production of underlying data from studies relied upon by a party to
`
`permit the countering party to evaluate its deficiencies. In Corning Inc. v. DSM IP
`
`Assets B.V., the Board ordered the production of “Laboratory notebooks and other
`
`documents containing the protocols followed in creating and testing the
`
`compositions and the underlying data for the test results.” IPR2013-0043, Paper
`
`27, 2-4. The Board required production because the petitioner’s expert had relied
`
`on the studies and the patent owner contended that the declarations “are missing
`
`critical information” required to evaluate the expert’s conclusions. Because the
`
`request pertained to data underlying test results petitioner relied upon, it was clear
`
`that “the information DSM seeks exists,” that the notebooks were “per se useful,”
`
`and that each of the remaining Garmin factors favored production. Id. Here, the
`
`interests of justice similarly favor production of the underlying data.
`
`A. Garmin Factor One Strongly Favors Production
`
`As explained in Section II above, Allergan and its witnesses relied upon the
`
`results of these studies to support the alleged criticality of, and unexpected results
`
`from, the specific combination of 0.05% CsA with 1.25% castor oil. However, the
`
`absence of actual data values and error bars renders the Schiffman and Attar
`
`-5-
`
`
`
`
`
`Exhibits meaningless. See Section II supra. Similarly, the absence of the
`
`underlying data for the Sall figures and PK studies precludes a complete evaluation
`
`of whether the data support Allergan’s contentions. 37 C.F.R. §42.65.
`
`Allergan has produced a study report that summarizes the results of only one
`
`of two PK studies relied upon by Dr. Attar. PK-98-074 compares CsA tissue
`
`concentrations for the formulations in which the castor oil concentration was held
`
`constant at 1.25% and the CsA concentration was either at 0.05% or 0.10%.
`
`EX2026 at 9 & n.4, 10. But Dr. Attar relied upon at least one other PK study for
`
`her Exhibit B that evaluated CsA tissue concentration of the 0.05% CsA / 0.625%
`
`emulsion. See Section II above (Attar declaration ¶¶6-8). Moreover, the sample
`
`sizes in PK-98-074 were very small (N=4), and the error bars were large in
`
`comparison to the reported mean value and repeatedly overlap between the
`
`formulations. EX2026 at 22, 28 (Fig. 1). Petitioner and the Board need the second
`
`PK study report and the lab notebooks underlying both studies (EX2026 at 6, 13)
`
`to evaluate the data and Allergan’s contentions based thereon.
`
`For each of the reasons discussed above, it is “beyond speculation” that the
`
`underlying data and the additional PK study report will provide useful information.
`
`The first Garmin factor thus heavily favors production of the requested documents.
`
`B.
`
`The Remaining Garmin Factors Favor Production
`
`Each of Garmin factors 2-5 also support Petitioner’s request. Petitioner is
`
`-6-
`
`
`
`
`
`not seeking litigation positions, the requested information is held confidentially by
`
`Allergan such that Petitioner cannot obtain it by other means, and the request is
`
`easily understandable because it is directed to data underlying specific studies and
`
`figures prepared by Allergan and relied upon by its witnesses. Moreover, Petitioner
`
`has identified specific sections of Allergan’s NDA (e.g., Volumes 19, 23, 25-29,
`
`40-46, 60-66, 90-91, 96, 102, and 106) that provide Allergan’s clinical trial results.
`
`Finally, Petitioner’s request is not overly burdensome. Allegan is best
`
`positioned to identify the data that underlies its own witnesses’ figures, and
`
`Petitioner has identified specific documents containing that data. Further,
`
`Allergan’s counsel admitted to the Board that the very underlying data that is the
`
`subject of this motion has already been produced in Allergan’s district court
`
`litigation with Petitioner. The material is thus ready for production without
`
`additional effort or expense. Allergan can easily identify the relevant documents to
`
`Petitioner from its district court production, and the parties can agree to deem those
`
`same documents produced in these proceedings. Petitioner offered to meet and
`
`confer with Allergan to identify documents for such a production, but Allergan has
`
`not agreed. Thus, any production burden is solely of Allergan’s own making.
`
`IV. CONCLUSION
`
`Petitioner requests the relief detailed above.
`
`
`
`-7-
`
`
`
`
`
`Dated: May 18, 2017
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
`
`
`
`
`-8-
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`This is to certify that I caused to be served a true and correct copy of the
`
`foregoing Petitioner’s Motion for Discovery from Patent Owner, on this 18th day
`
`of May, 2017, on the Patent Owner at the correspondence address of the Patent
`
`Owner as follows:
`
`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
`
`
`
`Dated: May 18, 2017
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
`
`
`
`
`
`-9-
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
