UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`COALITION FOR AFFORDABLE DRUGS VII LLC
`Petitioner
`
`v.
`
`POZEN INC.
`Patent Owner
`______________
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`______________
`
`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
`
`
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`COALITION FOR AFFORDABLE DRUGS VII LLC
`Petitioner
`
`v.
`
`POZEN INC.
`Patent Owner
`______________
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`______________
`
`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
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`Pursuant to 37 C.F.R. § 42.12, Horizon Pharmaceuticals, Inc. and Pozen Inc.
`
`(hereinafter, “Patent Owner”) hereby submits this Motion to Seal Exhibit 2011 to
`
`Patent Owner’s Preliminary Response 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 to file two documents under seal. Exhibit 2011 is a
`
`confidential communication from the FDA to Patent Owner regarding the
`
`development of Patent Owner’s proprietary Vimovo product. Exhibit 2011 is cited
`
`in Patent Owner’s Preliminary Response. 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 has been publicly filed. To preserve its
`
`confidentiality, Patent Owner moves to maintain Exhibit 2011 and the non-
`
`redacted version of Patent Owner’s Preliminary Response as filed under seal.
`
`2
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`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 a related district court
`
`proceeding. Exhibit 2011 has been produced in co-pending patent infringement
`
`litigation in the United States District Court for the District of New Jersey1 directed
`
`to, inter alia, U.S. Patent No. 6,926,907 (“the ’907 patent”) under the parties’
`
`agreed upon protective order, and designated confidential in those cases.
`
`III. Certification of Conference with Opposing Party Pursuant to 37
`C.F.R. § 42.54
`
`
`1 Horizon Pharma, Inc. and Pozen Inc. v. Dr. Reddy’s Laboratories, Inc. & Dr.
`
`Reddy’s Laboratories, Ltd., 3:11-cv-02317-MLC-DEA (D.N.J.); Horizon Pharma,
`
`Inc. and Pozen Inc. v. Dr. Reddy’s Laboratories, Inc. & Dr. Reddy’s Laboratories,
`
`Ltd., 3:13-cv-00091-MLC-DEA (D.N.J.); Horizon Pharma, Inc. and Pozen Inc. v.
`
`Lupin Ltd. & Lupin Pharmaceuticals, Inc., 3:11-cv-04275-MLC-DEA (D.N.J);
`
`Horizon Pharma, Inc. and Pozen Inc. v. Mylan Pharmaceuticals, Inc., 3:13-cv-
`
`04022 (D.N.J.); and Horizon Pharma, Inc., AstraZeneca AB, AstraZeneca LP and
`
`Pozen Inc. v. Actavis Labs., FL, et. al., 3:13-cv-03038-MLC-DEA (D.N.J.)
`
`(collectively, “the ’907 litigation”).
`
`3
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`Patent Owner has conferred with Petitioner and both parties consent to the
`
`proposed protective order filed attached as Appendix A.
`
`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 a revised version of the
`
`Default Protective Order in the Office Patent Trial Practice Guide, 77 FED. REG.
`
`48756, 48771 (Aug. 14, 2012), and a red-line reflecting the revisions is also
`
`attached as Appendix B. Almost all of the provisions remain unchanged (including
`
`access by the PTO staff). The single revision made to Paragraph 2(A) allows both
`
`parties and real parties-in-interest to access confidential information.
`
`V. Conclusion
`
`For the reasons stated above, Patent Owner respectfully requests that Exhibit
`
`2011, as well as the non-redacted version of Patent Owner’s Preliminary Response,
`
`remain under seal.
`
`Date: September 18, 2015
`
`Respectfully submitted,
`
`/s/ Ricardo Rodriguez
`Ricardo Rodriguez
`Reg. No. 40,789
`Counsel for Patent Owner
`
`4
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`CERTIFICATION OF SERVICE UNDER 37 C.F.R. §§ 42.6(e)
`
`I, Ricardo Rodriguez, hereby certify that on this 18th day of
`
`September 2015, the foregoing Patent Owner’s Motion to File Under Seal Under
`
`37 C.F.R. § 42.14 was served electronically via email on the following:
`
`Amy E. LaValle
`amy.lavalle@wickphillips.com
`
`Jerry C. Harris, Jr.
`jerry.harris@wickphillips.com
`
`CFAD.IPRs@wickphillips.com
`
`Wick Phillips Gould & Martin, LLP
`3131 McKinney Avenue, Suite 100
`Dallas, TX 75204
`
`Date: September 18, 2015
`
`BY:
`
`/s/ Ricardo Rodriguez
`Ricardo Rodriguez
`Reg. No. 40,789
`Counsel for Patent Owner
`
`5
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`EXHIBIT A
`
`6
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`COALITION FOR AFFORDABLE DRUGS VII LLC
`Petitioner
`
`v.
`
`POZEN INC.
`Patent Owner
`______________
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`______________
`
`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
`
`7
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`PROTECTIVE ORDER
`
`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 acknowledgment appended to this order:
`
`(A)
`
`Parties and Real Parties-in-Interest. Persons who are owners of a
`
`patent involved in the proceeding and other persons who are named parties and real
`
`parties-in-interest 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
`
`8
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`Board 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 should 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;
`
`9
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`(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;
`
`(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.
`
`10
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`(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 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.
`
`11
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`ACKNOWLEDGEMENT 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 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.
`
`_______________________________________
`
`Signature
`
`_______________________________________
`
`Date
`
`12
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`EXHIBIT B
`
`13
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`REDLINED PROTECTIVE ORDER
`
`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 acknowledgment appended to this order:
`
`(A)
`
`Parties and Real Parties-in-Interest. Persons who are owners of a
`
`patent involved in the proceeding and other persons who are named parties and real
`
`parties-in-interest 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 upon a motion brought by the party seeking to disclose confidential
`
`14
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`information to that person. The party opposing disclosure to that person shall have
`
`the burden of proving that such person should 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
`15
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`uses to maintain the confidentiality of information not received from the disclosing
`
`party;
`
`(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
`
`16
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`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 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.
`
`17
`
`
`
`Case No. IPR2015-01241
`Patent No. 6,926,907
`
`ACKNOWLEDGEMENT 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 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.
`
`_______________________________________
`
`Signature
`
`_______________________________________
`
`Date
`
`18
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