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`Paper _____
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORP.
`Patent Owner
`
`
`
`Patent No. 9,339,507
`Issue Date: May 17, 2016
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`_______________
`
`Inter Partes Review No. 2017-01622
`____________________________________________________________
`
`PATENT OWNER’S MOTION TO FILE UNDER SEAL
`37 C.F.R. § 42.54
`
`
`
`
`
`
`
`
`
`
`
`
`4833-2830-3203.1
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`
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`
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`Pursuant to 37 C.F.R. § 42.54, United Therapeutics Corporation (“Patent
`
`Owner”) hereby submits this Motion to Seal Exhibits 2049-2051, 2055,
`
`2058, 2065-2068, 2071, 2074, 2075, 2083, 2088, 2089 and certain
`
`portions of Exhibit 2053.
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`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
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`the parties’
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`interest
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`in protecting
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`truly
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`sensitive information.” 77 Fed. Reg. 48756, 48760 (Aug. 14, 2012). These
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`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
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`information.” Id. (citing 37 C.F.R. § 42.54).
`
`Good cause exists to support the sealing of the Exhibits 2049-2051, 2055,
`
`2058, 2065-2068, 2071, 2074, 2075, 2083, 2088, 2089 and the requested portions
`
`of Exhibit 2053. The requested portions of Ex. 2053 to be sealed are narrowly
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`limited to certain information at pp. 26, 32, and 62. These portions contain
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`confidential material describing details about the development and sales of
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`Patent Owner’s commercial product, Tyvaso®, and proprietary information
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`submitted and held in confidence by the FDA.
`
`4833-2830-3203.1
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`
`
`
`
`
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`Paper _____
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`Exhibits 2049-2051, 2055, 2058, 2065-2068, 2071, 2074, 2075, 2083,
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`2088, 2089 were produced in a litigation (United Therapeutics Corp. v. Sandoz,
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`Inc., Civ. No. 14-cv-05499) as confidential documents and remain under seal in
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`the litigation. Exhibits 2055, 2058, 2065-2068, 2071, 2074, 2075, 2088, 2089
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`report marketing, sales, and pricing information for Tyvaso® and other United
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`Therapeutic products. Exhibits 2049-2051 and 2083 describe information on
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`protocols, procedures, and data submitted to and held in confidence by the FDA
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`in relation to the approval of Tyvaso®. Such information could be improperly
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`used by competitors to gain unfair business and competitive advantage with
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`customers in the marketplace, including using details of Patent Owner’s process
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`for competitive commercial products.
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`The Board has granted a Motion to Seal certain exhibits in their entireties
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`for similar reasons in Purdue Pharma L.P. v. Depomed, Inc., IPR2014-00377,
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`paper no. 62 at 4-6, (PTAB March 17, 2015), where “Patent Owner avers that the
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`‘highly confidential nature of’ the information contained in those documents
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`makes it ‘impossible to reasonably redact [them] for public disclosure.’” Id. at 4.
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`The requested portions of Exhibit 2053 report information from one or
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`more of Exhibits 2055, 2058, 2065-2068, 2071, 2074, 2075, 2088, and 2089.
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`The proposed scope of confidential information in Exhibit 2053 is, thus,
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`narrowly limited in this motion to the details taken from the exhibits produced
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`4833-2830-3203.1
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`
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`
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`
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`and under seal in the litigation.
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`The confidential information designated by this motion could be
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`improperly used by competitors to gain unfair business and competitive
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`advantage with customers in the marketplace, including using details of Patent
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`Owner’s development process for competitive commercial products.
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`II. Certification of Non-Publication
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`On behalf of Patent Owner, undersigned counsel certifies that, to the best
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`of their knowledge, the information sought to be sealed by this 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 been undertaken by Patent Owner in
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`the related district court proceeding noted above, and such information currently
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`is under seal in that litigation.
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`III. Certification of Conference with Opposing Party Pursuant to
`37 C.F.R. § 42.54
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`Patent Owner has conferred with Petitioner about both this motion to seal,
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`and Petitioner has consented to the motion.
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`IV. Protective Order
`The confidential information will be subject to the protective order entered
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`by the Board’s Order dated April 27, 2018 (Paper 36).
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`4833-2830-3203.1
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`
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`
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`Paper _____
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`V. Conclusion
`For the reasons stated above, Patent Owner respectfully requests that
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`Exhibits 2049-2051, 2055, 2058, 2065-2068, 2071, 2074, 2075, 2083, 2088,
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`2089 and the requested portions of Exhibit 2053 remain under seal.
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`Date: April 27, 2018
`
`
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`Respectfully submitted,
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`
`George E. Quillin
`Registration No. 32,792
`
`Foley & Lardner LLP
`3000 K Street, N.W., Suite 600
`Washington, D.C. 20007
`
`Shaun R. Snader
`Registration No. 59,987
`United Therapeutics Corporation
`1735 Connecticut Avenue, N.W.
`Second Floor
`Washington, DC 20009
`
`Counsel for Patent Owner
`
`4833-2830-3203.1
`
`
`
`IPR2017-01621
`Patent 9,358,240
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing MOTION TO
`SEAL, is being served on April 27, 2018, by filing this document through the PTAB
`E2E System as well as delivering copies via email to the following counsel for the
`Petitioner:
`Michael K. Nutter (Reg. No. 44,979)
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: mnutter@winston.com
`
`Andrew R. Sommer (Reg. No. 53,932)
`WINSTON & STRAWN LLP
`1700 K Street, N.W.
`Washington, DC 20006-3817
`Email: asommer@winston.com
`
`Kurt A. Mathas
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: kmathas@winston.com
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`George E. Quillin
`Registration No. 32,792
`Shaun R. Snader
`Registration No. 59,987
` Counsel for Patent Owner
`
`
`
`
`4833-2830-3203.1
`
`6
`
`
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