Paper _____
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`STEADYMED LTD.
`
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`
`Patent Owner
`
`
`
`U.S. Patent No. 8,497,393
`Issue Date: Jul. 30, 2013
`Title: PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE
`INGREDIENT IN REMODULIN®
`_______________
`
`Case IPR2016-00006
`_______________
`
`JOINT 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
`
`
`
`
`
`
`
`4822‐9938‐5644.2
`
`WEST\269177402.1
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`STEADYMED LTD.
`
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`
`Patent Owner
`
`
`
`U.S. Patent No. 8,497,393
`Issue Date: Jul. 30, 2013
`Title: PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE
`INGREDIENT IN REMODULIN®
`_______________
`
`Case IPR2016-00006
`_______________
`
`JOINT 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
`
`
`
`
`
`
`
`4822‐9938‐5644.2
`
`WEST\269177402.1
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`
`
`Pursuant to the Board’s Order in Paper No. 14, United Therapeutics
`
`Corporation (“Patent Owner”) and SteadyMed Ltd. (“Petitioner”) hereby
`
`submit this Joint Motion to Seal, accompanied by a Joint Written Statement and a
`
`redacted copy of the Decision to Institute, identifying the specific parts of the
`
`Decision to Institute that should remain under seal as follows (the exact words
`
`being redacted are shown in the attached redacted version of the Decision to
`
`Institute):
`
`On page 17, lines 21-23;
`
`On page 18, line 24;
`
`On page 19, lines 1-4, 16-18, and 20-22;
`
`On page 20, lines 1-17 and footnote 7; and
`
`On page 21, lines 1-3 and 6-9.
`
`As directed by the Board’s Order (Paper No. 14), Patent Owner has
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`discussed the proposed redactions with Petitioner, who has indicated that it has no
`
`objection. Pursuant to 37 C.F.R. § 42.12, Patent Owner seeks to seal these limited
`
`portions of the Decision to Institute because they discuss information that is
`
`confidential for the same reasons stated in Patent Owner’s prior outstanding
`
`Motion to Seal (Paper No. 7), which relates to sealing portions of Patent Owner’s
`
`Preliminary Response and also Exhibits 2003-2006 in their entireties. The
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`WEST\269177402.1
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`2
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`proposed portions of the Decision to Institute to be placed under seal are limited
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`strictly to those which discuss the same information requested to be placed under
`
`seal in the Patent Owner’s prior outstanding Motion to Seal (Paper No. 7).
`
`I. Good Cause Exists for Sealing Certain Confidential Information
`The Office Patent Trial Practice Guide provides that “the rules aim to strike
`
`a balance between
`
`the public’s
`
`interest
`
`in maintaining a complete and
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`understandable file history and the parties’ interest in protecting truly sensitive
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`information.” 77 Fed. Reg. 48756, 48760 (Aug. 14, 2012). These rules
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`“identify confidential information in a manner consistent with Federal Rule of
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`Civil Procedure 26(c)(1)(G), which provides for protective orders for trade secret
`
`or other confidential research, development, or commercial information.” Id.
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`(citing 37 C.F.R. § 42.54).
`
`On page 17, lines 21-23, the Decision to Institute discusses proprietary purity
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`information from Exhibit 2006 submitted to and held in confidence by the FDA (the
`
`reasons why this information should be sealed are presented below).
`
`On page 18, line 24, the Decision to Institute discusses proprietary purity
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`information from multiple sources, including Exhibits 2003-2006 submitted to and
`
`held in confidence by the FDA, and its relationship to the Walsh Declaration (the
`
`reasons why this information should be sealed are presented below).
`
`On page 19, lines 1-4, 16-18, and 20-22, the Decision to Institute discusses
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`3
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`IPR2016-00006
`Patent 8,497,393
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`proprietary purity information from multiple sources, including Exhibits 2003-2006
`
`submitted to and held in confidence by the FDA (the reasons why this information
`
`should be sealed are presented below).
`
`On page 20, lines 1-17 and footnote 7, the Decision to Institute discusses
`
`specific data from Exhibits 2003-2006 submitted to and held in confidence by the
`
`FDA (the reasons why this information should be sealed are presented below).
`
`Finally, on page 21, lines 1-3 and 6-9, the Decision to Institute discusses
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`specific data from Exhibit 2006 submitted to and held in confidence by the FDA
`
`(the reasons why this information should be sealed are presented below) and
`
`compares it to certain data in Exhibit 1002.
`
`Exhibit 2003 is a confidential communication from the FDA to Patent Owner
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`approving a process change in the manufacture of Patent Owner’s proprietary
`
`Remodulin® product. Exhibit 2004 is a process validation report (Protocol No.
`
`“VAL-00131”) that provides confidential information about the manufacture of
`
`Remodulin®. Exhibit 2005 is a Process Optimization Report that provides
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`confidential information about the manufacture of Remodulin®. Exhibit 2006 is a
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`confidential communication from the Patent Owner t o t h e F D A regarding
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`the manufacturing of Remodulin®.
`
`
`
`Exhibits 2003-2006 contain information about the manufacturing process for
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`Remodulin®. Such information could be improperly used by competitors to gain
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`4
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`unfair business and competitive advantage with customers in the marketplace,
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`including using details of Patent Owner’s process for competitive commercial
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`products. The entireties of Exhibits 2003-2006 relate to highly confidential
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`manufacturing process details for Remodulin®, as discussed with FDA and
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`presently held in confidence by the FDA.
`
`Exhibits 2003-2006 were produced in a litigation (United Therapeutics
`
`Corp. v. Sandoz, Inc., Civ. No. 14-cv-05499) as confidential documents and
`
`remain under seal in the litigation. The information contained in Exhibits
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`2003-2006 is also held in confidence by the FDA.
`
`The Board has granted a Motion to Seal certain exhibits in their entireties for
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`similar reasons in Purdue Pharma L.P. v. Depomed, Inc., IPR2014-00377, Paper
`
`No. 62 at 4-6, (PTAB March 17, 2015), where “Patent Owner avers that the ‘highly
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`confidential nature of’ the information contained in those documents makes it
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`‘impossible to reasonably redact [them] for public disclosure.’” Id. at 4.
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`II. Certification of Non-Publication
`
`On behalf of Patent Owner, undersigned counsel certifies that, to the best of
`
`their knowledge, the information sought to be sealed by this Joint Motion to Seal
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`has not been published or otherwise made public. Efforts to maintain the
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`confidentiality of this information have also been undertaken by Patent Owner in
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`the related district court proceeding and with the FDA, and such information
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`5
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`IPR2016-00006
`Patent 8,497,393
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`currently is under seal in that litigation and at the FDA.
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`III. Certification of Conference with Opposing Party Pursuant to 37
`C.F.R. § 42.54
`
`Patent Owner and Petitioner have conferred about this Joint Motion to Seal
`
`and Petitioner has no objection.
`
`IV. Protective Order
`The Board has entered a protective order in Paper No. 16, which the parties
`
`have agreed will govern handling of information designated confidential in this
`
`proceeding.
`
`V. Conclusion
`For the reasons stated above, Patent Owner respectfully requests that the
`
`portions indicated herein of the Decision to Institute remain under seal and only the
`
`accompanying redacted version of the Decision to Institute be made available to
`
`the public, and Petitioner does not object.
`
`
`
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`WEST\269177402.1
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`6
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`Date: April 21, 2016
`
`Respectfully submitted,
`
`/s/ Stuart E. Pollack /
`Stuart E. Pollack
`Reg. No. 43,862
`Lisa A. Haile
`Reg. No. 38,347
`Counsel for Petitioner
`
`/s/ Stephen B. Maebius
`Stephen B. Maebius
`Reg. No. 35,264
`Counsel for Patent Owner
`
`
`
`
`7
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`IPR2016-00006
`Patent 8,497,393
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the attached Joint Motion to Seal was
`
`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
`
`
`
`Respectfully submitted,
`
`
`/s Lisa A. Haile /
`Lisa A. Haile, J.D., Ph.D.
`Reg. No. 38,347
`DLA Piper LLP (US)
`
`
`
`Date: April 21, 2016
`
`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D., Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
`
`
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`WEST\269177402.1
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