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
`_______________
`
`PATENT OWNER’S AMENDED MOTION TO FILE UNDER SEAL
`(AMENDMENT TO PAPER NO. 7)
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`4825-1223-4813.1
`
`
`
`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
`_______________
`
`PATENT OWNER’S AMENDED MOTION TO FILE UNDER SEAL
`(AMENDMENT TO PAPER NO. 7)
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`4825-1223-4813.1
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`
`
`Pursuant to 37 C.F.R. § 42.14 and the E-mail communication of the Patent Trial and
`
`Appeal Board (“Board”) dated November 23, 2016, United Therapeutics Corporation (“Patent
`
`Owner”) hereby submits this Amended Motion to File Under Seal in order to exclude certain
`
`materials that Patent Owner intends to include in its demonstratives for the Final Hearing
`
`scheduled to be held on November 29, 2016.
`
`In Patent Owner’s Motion to File Under Seal previously filed on January 14, 2016 (Paper
`
`No. 7), Patent Owner had moved to seal Exhibits 2003-2006 in their entireties and a portion
`
`of Patent Owner’s Preliminary Response (limited to section IX where it discusses Exhibits 2003-
`
`2006). In the present amended motion, Patent Owner moves to retain sealed status of all
`
`information in the prior motion except for the following three portions of Exhibit 2006, which
`
`were previously held confidential:
`
`(a) “The chemical manufacturing steps have not changed during the transfer to [supplier A] and
`
`[supplier B] from the process used by UT in Chicago to prepare benzindene triol.”
`
`(b) “There is a release specification for benzindene triol that must be achieved for each lot of
`
`benzindene triol before it is released for use by UT to prepare treprostinil. This is the same
`
`specification that was used by United Therapeutics in our Chicago facility.”
`
`(c) “In all lots [of benzindene triol from suppliers A, B, C, and D], the total unidentified impurity
`
`level (%AUC) decreased from triol [step (a)] to UT-15C intermediate [step (c)].”
`
`Accordingly, a redacted version of Ex. 2006 is submitted herewith in which all but the above 3
`
`statements are redacted.
`
`I. Good Cause Exists for Sealing Certain Confidential Information
`The Office Patent Trial Practice Guide provides that “the rules aim to strike a balance
`
`
`4825-1223-4813.1
`
`2
`
`
`
`
`
`between the public’s interest in maintaining a complete and understandable file history and
`
`the parties’ interest in protecting truly sensitive information.” 77 Fed. Reg. 48756, 48760
`
`(Aug. 14, 2012). These rules “identify confidential information in a manner consistent with
`
`Federal Rule of Civil Procedure 26(c)(1)(G), which provides for protective orders for trade
`
`secret or other confidential research, development, or commercial information.” Id. (citing 37
`
`C.F.R. § 42.54).
`
`Patent Owner requests that three documents (i.e., Exhibits 2003-2005) be placed under
`
`seal in their entireties, and Exhibit 2006 be placed under seal for all except the above-reproduced
`
`contents.
`
`Exhibit 2003 is a confidential communication from the FDA to Patent Owner 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 confidential information about the manufacture of Remodulin®. Exhibit
`
`2006 is a confidential communication from the Patent Owner t o t h e F D A regarding the
`
`manufacturing of Remodulin®.
`
`Exhibits 2003-2006 contain information about the manufacturing process for Remodulin®.
`
`Such information could be improperly used by competitors to gain unfair business and
`
`competitive advantage with customers in the marketplace, including using details of Patent
`
`Owner’s process for competitive commercial products. The entireties of Exhibits 2003-2006,
`
`except for the unredacted text of Ex. 2006 noted above, relate to highly confidential
`
`manufacturing process details for Remodulin®, as discussed with FDA, and it would not be
`
`reasonably possible to separate non-confidential information because the documents are
`
`
`4825-1223-4813.1
`
`thoroughly interspersed with confidential details about the manufacturing process.
`3
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`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 2003-2006 is also held in confidence by
`
`the FDA.
`
`The Board has granted a Motion to Seal certain exhibits in their entireties for 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 confidential nature of’ the
`
`information contained in those documents makes it ‘impossible to reasonably redact [them] for
`
`public disclosure.’” Id. at 4.
`
`Exhibits 2003-2006 are cited and discussed in Patent Owner’s Preliminary Response at
`
`section IX. A non-redacted version of Patent Owner’s Preliminary Response has been filed
`
`under seal and a redacted version of Patent Owner’s Preliminary Response (in which only
`
`limited portions of section IX are redacted) has been publicly
`
`filed. To preserve
`
`confidentiality of this information, Patent Owner moves to maintain the entireties of Exhibits
`
`2003-2005, all except the above reproduced content of Exhibit 2006, and the non-redacted
`
`version of Patent Owner’s Preliminary Response under seal.
`
`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 maintained under seal by this Amended Motion to File
`
`Under Seal has not been published or otherwise made public. Efforts to maintain the
`
`confidentiality of this information have been undertaken by Patent Owner in the related district
`
`court proceeding and with the FDA, and such information currently is under seal in that litigation
`
`and at the FDA.
`
`
`4825-1223-4813.1
`
`4
`
`
`
`
`
`
`
`III. Conclusion
`For the reasons stated above, Patent Owner respectfully requests that Exhibits 2003-2006
`
`(except for the 3 portions of Ex. 2006 noted above), as well as the non-redacted version of Patent
`
`Owner’s Preliminary Response, remain under seal.
`
`
`
`Date: Nov. 23, 2016
`
`Respectfully submitted,
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`Reg. No. 35,264
`Counsel for Patent Owner
`
`
`4825-1223-4813.1
`
`5
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s Amended
`
`Motion to Seal and accompanying exhibit, was served on counsel of record for Petitioner on Nov.
`
`23, 2016 by delivering a copy via email to Stuart Pollack and Lisa Haile (the counsel of record for
`
`the Petitioner) at the following address:
`
`Steadymed-IPR@dlapiper.com
`
`
`Date: Nov. 23, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`signature: /Stephen B. Maebius/
`
`Stephen B. Maebius
`
`
`
`4825-1223-4813.1
`
`6
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