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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. 50)
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`4852-8237-6765.1
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`
`
`IPR2016-00006
`Patent 8,497,393
`
`
`
`Pursuant to 37 C.F.R. § 42.14 and the E-mail communication of the Patent Trial and
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`Appeal Board (“Board”) dated November 23, 2016, United Therapeutics Corporation (“Patent
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`Owner”) hereby submits this Amended Motion to File Under Seal in order to exclude certain
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`materials that Patent Owner intends to include in its demonstratives for the Final Hearing
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`scheduled to be held on November 29, 2016.
`
`In Patent Owner’s Motion to File Under Seal previously filed on September 22, 2016
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`(Paper No. 50), Patent Owner had moved to seal certain portions of the deposition transcripts of
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`Dr. Ruffolo (Ex. 2058) and Dr. Williams (Ex. 2059). In the present amended motion, Patent
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`Owner moves to make public certain portions of Ex. 2058 and 2059 that were previously held
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`confidential.
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`(1) Accordingly, new redacted versions of Ex. 2058 and 2059 are submitted herewith,
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`identifying the specific parts of these documents that should remain under seal: Dr.
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`Ruffolo’s deposition transcript (Ex. 2058): pp. 76-81, 139-140, 142, 160-161, 182-
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`184, 186, 194-196, 214, 216-218, 230, 265, 269-270, 274-277, 279-281, 308, 317-318,
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`320, 323, 330-333, 335-337, 339-343, 345-348, 350-351, and 353-358; and
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`(2) Dr. Williams’ deposition transcript (Ex. 2059): pp. 46, 48, 50, 60, 62, 64-67, 78, 86,
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`91-96, 98, 100-102, 105-107, 113, 115-116, 119, 121-125, 127, 194, 196, 203, 217-
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`219, 251, 281-284, 286, 304, and 308-309 .
`
`Pursuant to 37 C.F.R. § 42.14, Patent Owner seeks to seal these limited portions of Ex.
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`2058 and Ex. 2059 because they discuss information that the Board has already ruled upon and
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`determined to 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 treprostinil purity
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`standard is confidential information concerning the manufacturing process for Remodulin®,
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`2
`4852-8237-6765.1
`
`
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`
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`submitted and held in confidence to the FDA, and susceptible to misuse by competitors seeking
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`commercial advantage” (Paper No. 27 at p. 5).
`
`I. Good Cause Exists for Sealing Certain Confidential Information
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`Each of the proposed redactions contains information that the Board has already ruled
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`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
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`On behalf of Patent Owner, undersigned counsel certifies that, to the best of their
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`knowledge, the information sought to be sealed by this Motion to Seal has not been published or
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`otherwise made public.
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`III. Conclusion
`
`For the reasons stated above, Patent Owner respectfully requests that the portions
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`indicated herein of Ex. 2058 and Ex. 2059 remain under seal and only the accompanying redacted
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`versions of Ex. 2058 and Ex. 2059 be made available to the public.
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`Date: Nov. 23, 2016
`
`
`
`
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`
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`Respectfully submitted,
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`Reg. No. 35,264
`Counsel for Patent Owner
`
`
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`4852-8237-6765.1
`
`3
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`
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`IPR2016-00006
`Patent 8,497,393
`
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Motion to Seal and
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`accompanying documents and exhibits were served on counsel of record for Petitioner on Nov. 23,
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`2016 by delivering a copy via email to Stuart Pollack and Lisa Haile (the counsel of record for the
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`Petitioner) at the following address:
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`Steadymed-IPR@dlapiper.com
`
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`Date: Nov. 23, 2016
`
`
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`signature: /Stephen B. Maebius/
`
`Stephen B. Maebius
`
`
`
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`4852-8237-6765.1
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`4
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`
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