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`Paper _____
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`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. 38)
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`4835-2070-3549.1
`
`
`
`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 July 13, 2016 (Paper
`
`No. 38) Patent Owner had moved to seal certain portions of Patent Owner’s Response, Ex. 2020,
`
`Ex. 2022, 2037, and Ex. 2051 and to seal Exhibits 2052-2054 in their entireties. In the present
`
`amended motion, Patent Owner moves to retain the sealed status of Ex. 2037, 2052-2054 as
`
`specified in the prior motion, and to unseal certain portions of Patent Owner’s Response, Ex.
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`2020, 2022 and 2051 that were previously held confidential.
`
`Accordingly, new redacted versions of Patent Owner’s Response, Ex. 2020, 2022 and 2051
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`are submitted herewith, identifying the specific parts of these documents that should remain under
`
`seal:
`
`(1) Patent Owner’s Response: p. 3;
`
`(2) Williams Declaration (Ex. 2020): Appendix B;
`
`(3) Ruffolo Declaration (Ex. 2022): at paragraphs 66, 68, and 73;
`
`(4) Ex. 2051: at p. 77 .
`
`Pursuant to 37 C.F.R. § 42.14, Patent Owner seeks to seal these limited portions of Patent
`
`Owner’s Response, Ex. 2020, Ex. 2022, Ex. 2037, and Ex. 2051, as well as the entireties of Ex.
`
`2052-2054, because they discuss information that the Board has already ruled upon and
`
`determined to be confidential: “we agree with the parties that the disclosed numerical amounts
`
`
`4835-2070-3549.1
`
`2
`
`
`
`
`
`and ranges, identity of the impurities detected, and particulars of the FDA treprostinil purity
`
`standard is confidential information concerning the manufacturing process for Remodulin®,
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`submitted and held in confidence to the FDA, and susceptible to misuse by competitors seeking
`
`commercial advantage” (Paper No. 27 at p. 5). With respect to Exhibits 2052-2054, the
`
`references to confidential material are so extensive that Patent Owner requests sealing them in
`
`their entireties, as was requested for Exhibits 2003-2006 in the earlier Motion to Seal (Paper No.
`
`7).
`
`I. Good Cause Exists for Sealing Certain Confidential Information
`
`Each of the proposed redactions and proposed exhibits to be sealed in their entireties
`
`contain information that the Board has already ruled upon and determined to be confidential in
`
`Paper No. 27, so good cause has already been found by the Board for sealing this information.
`
`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 Motion to Seal has not been published or
`
`otherwise made public.
`
`III. Conclusion
`
`For the reasons stated above, Patent Owner respectfully requests that the portions
`
`indicated herein of the Patent Owner’s Response, Ex. 2020, Ex. 2022, Ex. 2037, and Ex. 2051,
`
`along with the entireties of Exhibits 2052-2054, remain under seal and only the accompanying
`
`
`
`
`
`
`4835-2070-3549.1
`
`3
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`redacted versions of the Patent Owner’s Response, Ex. 2020, Ex. 2022, and Ex. 2051 be made
`
`available to the public.
`
`Date: Nov. 23, 2016
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`Reg. No. 35,264
`Counsel for Patent Owner
`
`
`
`4835-2070-3549.1
`
`4
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Motion to Seal and
`
`accompanying documents and exhibits were 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
`
`
`
`
`
`
`
`
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`
`
`
`
`
`
`
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`
`
`signature: /Stephen B. Maebius/
`
`Stephen B. Maebius
`
`
`
`
`4835-2070-3549.1
`
`5
`
`
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