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 MOTION TO FILE UNDER SEAL
`37 C.F.R. § 42.14
`
`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
`
`
`
`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 MOTION TO FILE UNDER SEAL
`37 C.F.R. § 42.14
`
`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
`
`
`
`Pursuant to 37 C.F.R. § 42.12, United Therapeutics Corporation (“Patent
`
`Owner”) hereby submits this Motion 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) filed concurrently herewith.
`
`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
`
`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 four documents (i.e., Exhibits 2003-2006) be
`
`placed under seal in their entireties.
`
`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
`2
`
`
`4822-9938-5644.2
`
`
`
`
`
`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 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 thoroughly interspersed with confidential details about the
`
`manufacturing process.
`
`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.
`
`3
`4822-9938-5644.2
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`
`
`IPR2016-00006
`Patent 8,497,393
`
`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 ( i n w h i c h o n l y l i m i t e d p o r t i o n s o f
`
`s e c t i o n I X a r e r e d a c t e d ) has been publicly filed. To preserve
`
`confidentiality of this information, Patent Owner moves to maintain the entireties
`
`of Exhibits 2003-2006 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 sealed by this Motion to 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.
`
`III. Certification of Conference with Opposing Party Pursuant to 37
`C.F.R. § 42.54
`
`
`
`Patent Owner has conferred with Petitioner about both this motion to seal
`
`and the acceptance of the appended default protective order, and Petitioner has
`
`consented to the default protective order attached as Appendix A.
`
`
`4822-9938-5644.2
`
`4
`
`
`
`
`
`
`
`IV. Proposed Protective Order
`Patent Owner submits a copy of the stipulated protective order attached as
`
`Appendix A, to which both parties have agreed. It is the Default Protective
`
`Order in the Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48771
`
`(Aug. 14, 2012).
`
`V. Conclusion
`For the reasons stated above, Patent Owner respectfully requests that
`
`Exhibits 2003-2006, as well as the non-redacted version of Patent Owner’s
`
`Preliminary Response, remain under seal.
`
`Date: January 14, 2016
`
`Respectfully submitted,
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`Reg. No. 35,264
`Counsel for Patent Owner
`
`
`4822-9938-5644.2
`
`5
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s
`
`Motion to Seal, including the Proposed Protective Order, was served on counsel of
`
`record for Petitioner on January 14, 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: Jan. 14, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`signature: /Stephen B. Maebius/
`
`
`Stephen B. Maebius
`
`
`4822-9938-5644.2
`
`6
`
`
`
`
`
`
`
`
`
`4822-9938-5644.24822-9938-5644.2
`4822-9938-5644.2
`
`7
`
`
`
`APPENDIX A
`
`IPR2016-00006
`Patent 8,497,393
`
`
`
`
`
`4822-9938-5644.2
`
`8
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`STEADYMED LTD.
`
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`
`Patent Owner
`_______________
`
`Case IPR2016-00006
`_______________
`
`PROPOSED PROTECTIVE ORDER
`
`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
`
`9
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`
`
`
`This standing protective order governs the treatment and filing of confidential
`
`information, including documents and testimony.
`
`1. Confidential information shall be clearly marked “PROTECTIVE ORDER
`
`MATERIAL.”
`
`2. Access to confidential information is limited to the following individuals
`
`who have executed the acknowledgement appended to this order:
`
` (A) Parties. Persons who are owners of a patent involved in the proceeding
`
`and other persons who are named parties to the proceeding.
`
` (B) Party Representatives. Representatives of record for a party in the
`
`proceeding.
`
` (C) Experts. Retained experts of a party in the proceeding who further
`
`certify in the Acknowledgement that they are not a competitor to any party, or a
`
`consultant for, or employed by, such a competitor with respect to the subject matter
`
`of the proceeding.
`
` (D) In-house counsel. In-house counsel of a party.
`
` (E) Other Employees of a Party. Employees, consultants or other persons
`
`performing work for a party, other than in-house counsel and in-house counsel’s
`
`support staff, who sign the Acknowledgement shall be extended access to
`
`confidential information only upon agreement of the parties or by order of the Board
`
`
`4822-9938-5644.2
`
`10
`
`
`
`
`
`upon a motion brought by the party seeking to disclose confidential information to
`
`that person. The party opposing disclosure to that person shall have the burden of
`
`proving that such person shall be restricted from access to confidential information.
`
` (F) The Office. Employees and representatives of the Office who have a
`
`need for access to the confidential information shall have such access without the
`
`requirement to sign an Acknowledgement. Such employees and representatives shall
`
`include the Director, members of the Board and their clerical staff, other support
`
`personnel, court reporters, and other persons acting on behalf of the Office.
`
` (G) Support Personnel. Administrative assistants, clerical staff, court
`
`reporters and other support personnel of the foregoing persons who are reasonably
`
`necessary to assist those persons in the proceeding shall not be required to sign an
`
`Acknowledgement, but shall be informed of the terms and requirements of the
`
`Protective Order by the person they are supporting who receives confidential
`
`information.
`
`3. Persons receiving confidential information shall use reasonable efforts to
`
`maintain the confidentiality of the information, including:
`
` (A) Maintaining such information in a secure location to which persons not
`
`authorized to receive the information shall not have access;
`
` (B) Otherwise using reasonable efforts to maintain the confidentiality of
`
`the information, which efforts shall be no less rigorous than those the recipient uses
`
`to maintain the confidentiality of information not received from the disclosing party;
`
`11
`4822-9938-5644.2
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`
`
`IPR2016-00006
`Patent 8,497,393
`
` (C) Ensuring that support personnel of the recipient who have access to the
`
`confidential information understand and abide by the obligation to maintain the
`
`confidentiality of information received that is designated as confidential; and
`
` (D) Limiting the copying of confidential information to a reasonable
`
`number of copies needed for conduct of the proceeding and maintaining a record of
`
`the locations of such copies.
`
`4. Persons receiving confidential information shall use the following
`
`procedures to maintain the confidentiality of the information:
`
` (A) Documents and Information Filed With the Board
`
` (i) A party may file documents or information with the Board
`
`under seal, together with a non-confidential description of the nature of the
`
`confidential information that is under seal and the reasons why the information is
`
`confidential and should not be made available to the public. The submission shall be
`
`treated as confidential and remain under seal, unless, upon motion of a party and
`
`after a hearing on the issue, or sua sponte, the Board determines that the documents
`
`or information do not to qualify for confidential treatment.
`
` (ii) Where confidentiality is alleged as to some but not all of the
`
`information submitted to the Board, the submitting party shall file confidential and
`
`non-confidential versions of its submission, together with a Motion to Seal the
`
`confidential version setting forth the reasons why the information redacted from the
`
`
`4822-9938-5644.2
`
`12
`
`
`
`
`
`non-confidential version is confidential and should not be made available to the
`
`public. The nonconfidential version of the submission shall clearly indicate the
`
`locations of information that has been redacted. The confidential version of the
`
`submission shall be filed under seal. The redacted information shall remain under
`
`seal unless, upon motion of a party and after a hearing on the issue, or sua sponte, the
`
`Board determines that some or all of the redacted information does not qualify for
`
`confidential treatment.
`
` (B) Documents and Information Exchanged Among the Parties.
`
`Information designated as confidential that is disclosed to another party during
`
`discovery or other proceedings before the Board shall be clearly marked as
`
`“PROTECTIVE ORDER MATERIAL” and shall be produced in a manner that
`
`maintains its confidentiality.
`
`(i) Standard Acknowledgement of Protective Order. The following form may be used
`
`to acknowledge a protective order and gain access to information covered by the
`
`protective order:
`
`**************************
`
`STANDARD ACKNOWLEDGMENT FOR
`
`ACCESS TO PROTECTIVE ORDER MATERIAL
`
`I, _________________________, affirm that I have read the Protective Order;
`
`that I will abide by its terms; that I will use the confidential information only in
`
`connection with this proceeding and for no other purpose; that I will only allow
`
`13
`4822-9938-5644.2
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`access to support staff who are reasonably necessary to assist me in this proceeding;
`
`that prior to any disclosure to such support staff I informed or will inform them of
`
`the requirements of the Protective Order; that I am personally responsible for the
`
`requirements of the terms of the Protective Order and I agree to submit to the
`
`jurisdiction of the Office and the United States District Court for the Eastern District
`
`of Virginia for purposes of enforcing the terms of the Protective Order and providing
`
`remedies for its breach.
`
`
`
`
`
`Signed by: _______________________________
`
`Title: ___________________________________
`
`Company: _______________________________
`
`
`
`
`4822-9938-5644.2
`
`14
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