`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`STEADYMED LTD.,
`
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`
`Patent Owner.
`
`
`
`Case IPR2016-00006
`
`Patent No. 8,497,393
`
`____________
`
`PETITIONER’S MOTION TO SEAL
`
`
`
`
`
`
`
`
`Mail Stop "Patent Board"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`
`
`
`
`
`
`SteadyMed Ltd. (“Petitioner”) hereby submits this Motion to Seal certain
`
`portions of its Reply to Patent Owner’s Response to Petition (“Reply”) and Exhibit
`
`1021 in its entirety filed in support of its Reply.
`
`The exact words and numbers being redacted are shown in the redacted
`
`version of the Reply filed concurrently herewith: pp. (i); 2-6; 8-13; 16-17; and 24.
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`For Exhibit 1021, Petitioner requests that it be sealed in its entirety for the reasons
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`discussed below.
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`Petitioner has discussed the proposed redactions with Patent Owner, who has
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`indicated that it has no objection. Pursuant to 37 C.F.R. § 42.12, Petitioner seeks
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`to seal these limited portions of the Reply and the entirety of Ex. 1021 because
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`they discuss information that the Board has already ruled upon and determined to
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`be confidential: “we agree with the parties that the disclosed numerical amounts
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`and ranges, identity of the impurities detected, and particulars of the FDA
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`treprostinil purity standard is confidential information concerning the
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`manufacturing process for Remodulin®, submitted and held in confidence to the
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`FDA, and susceptible to misuse by competitors seeking commercial advantage”
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`(Paper No. 27, at p. 5). Exhibit 1021 is a spreadsheet listing proprietary purity
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`information of Patent Owner from sealed Exhibits 2036, 2052, and 2053. The
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`proposed redactions in the Reply cite to the same proprietary purity information,
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`
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`2
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`
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`the identity of impurities, confidential manufacturing information, and information
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`from sealed Exhibit 2006.
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`I.
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`Good Cause Exists for Sealing Certain Confidential Information
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`Each of the proposed redactions and Exhibit 1021 contain information that
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`the Board has already ruled upon and determined to be confidential in Paper No.
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`27, so good cause has already been found by the Board for sealing this
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`information.
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`II. Certification of Non-Publication
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`On behalf of Petitioner, the undersigned counsel certifies that, to the best of
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`their knowledge the information sought to be sealed by this Motion to Seal has not
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`been published or otherwise made public.
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`III. Certification of Conference with Opposing Party Pursuant to 37
`C.F.R. § 42.54
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`Petitioner and Patent Owner have conferred about this Motion to Seal and
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`Patent Owner has no objection.
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`IV. Protective Order
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`The Board has entered a protective order in Paper No. 16, which the parties
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`have agreed will govern handling of information designated confidential in this
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`proceeding.
`
`
`
`
`
`
`
`3
`
`
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`V. Conclusion
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`For the reasons stated above, Petitioner respectfully requests that the
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`portions indicated herein of its Reply and the entirety of Exhibit 1021 remain under
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`seal and only the redacted versions of its Reply be made available to the public.
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`
`
`Date: September 27, 2016
`
`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D. Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
`
`
`
`Respectfully submitted,
`
`
`/s Lisa A. Haile /
`Lisa A. Haile, J.D., Ph.D.
` Reg. No. 38,347
`DLA Piper LLP (US)
`
`
`
`4
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the attached Motion to Seal was
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`served via electronic mail to the following:
`
`Stephen B. Maebius
`George Quillin
`FOLEY & LARDNER LLP
`UT393-IPR@foley.com
`
`Shaun R. Snader
`UNITED THERAPEUTICS CORP.
`ssnader@unither.com
`
`Douglas Carsten
`Richard Torczon
`Robert Delafield
`WILSON, SONSINI, GOODRICH & ROSATI
`dcarsten@wsgr.com
`rtorczon@wsgr.com
`bdelafield@wsgr.com
`
`
`Date: September 27, 2016
`
`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D., Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
`
`WEST\271972275.1
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`Respectfully submitted,
`
`
`
`
`/s Lisa A. Haile /
`Lisa A. Haile, J.D., Ph.D.
` Reg. No. 38,347
`DLA Piper LLP (US)
`
`
`
`
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