`
`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
`_______________
`
`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
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`
`
`United Therapeutics Corporation (“Patent Owner”) hereby submits this
`
`Motion 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. The exact
`
`words and numbers being redacted are shown in the attached, redacted versions of:
`
`(1) Patent Owner’s Response: pp. 3, 4, 9-11, 21, 25, 27, 28, 30, 34, 45, 48,
`
`and 49;
`
`(2) Williams Declaration (Ex. 2020): at footnote 1, paragraphs 91, 94-98,
`
`102, and 103, and Appendix B;
`
`(3) Ruffolo Declaration (Ex. 2022): at paragraphs 66-73;
`
`(4) Ex. 2037: everything except certain data at pp. 44 and 195; and
`
`(5) Ex. 2051: at pp. 77, 78, 81, 82, 84, 86-88, 128, 129, 130, 131-133, and
`
`135.
`
`For Exhibits 2052-2054, Patent Owner requests that they be sealed in their entireties
`
`for the reasons discussed below.
`
`Patent Owner has discussed the proposed redactions with Petitioner, who has
`
`indicated that it has no objection if the sealed information follows the Board’s
`
`earlier ruling in Paper No. 27. Pursuant to 37 C.F.R. § 42.12, 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
`
`
`
`
`
`2
`
`
`
`
`
`information that the Board has already ruled upon and determined to be
`
`confidential: “we agree with the parties that the disclosed numerical amounts and
`
`ranges, identity of the impurities detected, and particulars of the FDA treprostinil
`
`purity standard is confidential information concerning the manufacturing process
`
`for Remodulin®, 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. Certification of Conference with Opposing Party Pursuant to 37
`C.F.R. § 42.54
`
`
`
`
`4822-9938-5644.2
`
`Patent Owner and Petitioner have conferred about this Motion to Seal and
`3
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`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 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 redacted versions of the Patent Owner’s Response,
`
`Ex. 2020, Ex. 2022, Ex. 2037, and Ex. 2051 be made available to the public.
`
`Date: July 13, 2016
`
`Respectfully submitted,
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`Reg. No. 35,264
`Counsel for Patent Owner
`
`
`
`
`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 July 13, 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: July 13, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`signature: /Stephen B. Maebius/
`
`
`Stephen B. Maebius
`
`
`
`
`4822-9938-5644.2
`
`5