Paper No. _
`Date Filed: December 23, 2016
`
`Filed on behalf of: Aventis Pharma S.A.
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`PATENT OWNER’S MOTION TO SEAL AND MOTION TO ENTER
`STIPULATED PROTECTIVE ORDER
`
`
`Date Filed: December 23, 2016
`
`Filed on behalf of: Aventis Pharma S.A.
`
`By:
`
`Dominick A. Conde
`dconde@fchs.com
`(212) 218-2100
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`PATENT OWNER’S MOTION TO SEAL AND MOTION TO ENTER
`STIPULATED PROTECTIVE ORDER
`
`
`
`I.
`
`RELIEF REQUESTED
`
`Pursuant to 37 C.F.R. §§ 42.14 and 42.54, and for the reasons set forth
`
`below, Patent Owner Aventis Pharma S.A. (“Aventis”) respectfully requests that
`
`the Board seal Patent Owner’s Exhibits 2170, 2171, 2179, 2182, 2211 and portions
`
`of Exhibit 2149 (December 23, 2016 Expert Declaration of Michael E. Tate (“Tate
`
`Declaration”)) and Exhibit 2176 (December 23, 2016 Expert Declaration of Alton
`
`Oliver Sartor (“Sartor Declaration”)). Aventis further requests entry of the
`
`proposed Stipulated Protective Order (Appendix A, attached below).
`
`Aventis submits concurrently with this motion to seal the following:
`
`(i)
`
`(ii)
`
`Confidential Exhibit 2170;
`
`Confidential Exhibit 2171;
`
`(iii) Confidential Exhibit 2179;
`
`(iv) Redacted version of Exhibit 2149 (Tate Declaration);
`
`(v)
`
`Confidential version of Exhibit 2149 (Tate Declaration);
`
`(vi) Confidential Exhibit 2182;
`
`(vii) Confidential Exhibit 2211;
`
`(viii) Redacted version of Exhibit 2176 (Sartor Declaration);
`
`(ix) Confidential version of Exhibit 2176 (Sartor Declaration);
`
`(x)
`
`Stipulated Protective Order (Appendix A, attached below); and
`
`(xi) Redlined Default Protective Order (Appendix B, attached below).
`
`1
`
`
`
`II. GOOD CAUSE EXISTS FOR SEALING THE REQUESTED
`INFORMATION
`
`Documents filed in an IPR are generally available to the public. 37 C.F.R.
`
`§ 42.14. However, the Board may, for good cause, protect confidential
`
`information from public disclosure. 37 C.F.R. § 42.14; see also Garmin Int’l v.
`
`Cuozzo Speed Tech., LLC, IPR2012-00001, Paper 36 at 3-4 (PTAB Apr. 5, 2013).
`
`Where possible, parties should redact sensitive information from their filings,
`
`rather than seek to seal entire documents. Office Trial Practice Guide, 77 Fed.
`
`Reg. 48756, 48761 (2012).
`
`When determining good cause, the Board must balance the public’s interest
`
`in a complete and understandable file history with the party’s interest in protecting
`
`sensitive information. See Garmin, IPR2012-00001, Paper 36, 3-4 (citing Office
`
`Trial Practice Guide, 77 Fed. Reg. at 48760). However, the public’s interest in
`
`having access to a party’s confidential business or clinical research information
`
`that is only indirectly related to patent validity is “minimal.” Id. at 8-9 (granting
`
`the patent owner’s motion to seal an agreement relating to the
`
`“commercializ[ation]” of the patent-at- issue). Here, the Patent Owner’s interests
`
`in protecting its confidential business and clinical research information outweighs
`
`the public’s interest in viewing that information.
`
`2
`
`
`
`a. Background
`
`Aventis and Petitioner Mylan Laboratories Limited (“Mylan”) are also
`
`currently litigating the patent-at-issue in this IPR before the United States District
`
`Court for the District of New Jersey in Sanofi-Aventis U.S. LLC v. Mylan
`
`Laboratories Limited, Civil Action No. 3-15-cv-03392-MAS-LHG (“the
`
`Litigation”). The Court has entered a protective order in the Litigation.
`
`b. Exhibits 2170 and 2179
`
`Aventis seeks to seal Exhibit 2170, which is a document that includes
`
`confidential business data that compares the market share of treatments for prostate
`
`cancer post-docetaxel, including Jevtana®. Aventis also seeks to seal Exhibit
`
`2179, which is the underlying business data that is used to generate the charts in
`
`Exhibit 2170. The information was privately commissioned from the data analysis
`
`company AlphaImpact Rx under their BrandImpact product line, and is relied on
`
`for business and marketing strategy. See Exh. 2231 at ¶¶ 2-3.
`
`Aventis seeks to maintain the confidentiality of Exhibits 2170 and 2179
`
`because they contain highly sensitive business information. If this information is
`
`made public, it could cause competitive harm to Aventis by giving direct
`
`competitors knowledge of Aventis’s business and marketing operations.
`
`In addition, the public version of Exhibit 2149 (Tate Declaration), which
`
`relies in part on Exhibits 2170 and 2179, has been written so that the thrust of the
`
`3
`
`
`
`underlying argument can still be reasonably discerned. Greene’s Energy Grp.,
`
`LLC, Inc. v. Oil States Energy Svcs., LLC, IPR 2014-00216, Paper 27 at 5 (PTAB
`
`Sept. 23, 2014). Accordingly, the public’s interest in knowing Aventis’s business
`
`information is relatively low, and is outweighed by Aventis’s interest in keeping it
`
`confidential.
`
`c. Exhibit 2171
`
`Aventis seeks to seal Exhibit 2171, which is a document that includes
`
`confidential business data that compares the market share of treatments for prostate
`
`cancer post-docetaxel, including Jevtana®. The information was privately
`
`commissioned from the data analysis company AlphaImpact Rx (a subsidiary of
`
`Symphony Health Solutions) under their BrandImpact product line, and is relied on
`
`for business and marketing strategy. See Exh. 2231 at ¶¶ 2-3.
`
`Aventis seeks to maintain the confidentiality of Exhibit 2171 because it
`
`contains highly sensitive business information. If this information is made public,
`
`it could cause competitive harm to Aventis by giving direct competitors knowledge
`
`of Aventis’s business and marketing operations.
`
`In addition, the public version of Exhibit 2149 (Tate Declaration), which
`
`relies in part on Exhibit 2171, has been written so that the thrust of the underlying
`
`argument can still be reasonably discerned. Greene’s Energy Grp., LLC, Inc., IPR
`
`2014-00216, Paper 27 at 5. Accordingly, the public’s interest in knowing Aventis’s
`
`4
`
`
`
`financial information is relatively low, and is outweighed by Aventis’s interest in
`
`keeping it confidential.
`
`d. Exhibit 2149 – Tate Declaration
`
`Aventis seeks to seal portions of Exhibit 2149, the December 23, 2016
`
`Expert Declaration of Michael E. Tate, which discusses the commercial success of
`
`Jevtana®. Aventis seeks to maintain the confidentiality of select portions Exhibit
`
`2149 that rely on the above mentioned Exhibits 2170, 2171, and 2179 for their
`
`highly sensitive business information. The portions Aventis seeks to seal have been
`
`redacted from the publicly-filed version of Exhibit 2149.
`
`For the reasons set forth here and above, see supra Part II.b-c., Aventis
`
`respectfully requests that the Board seal portions of Exhibit 2149 (Tate
`
`Declaration).
`
`e. Exhibit 2182
`
`Aventis seeks to seal Exhibit 2182, which is the informed consent form
`
`provided by Sanofi to the investigators of the TROPIC study that includes
`
`confidential research information involving the clinical trial of Jevtana®. Exhibit
`
`2182 was intended to be a confidential document and is labeled “Property of the
`
`sanofi-aventis group - strictly confidential” on every page.
`
`Aventis seeks to maintain the confidentiality of Exhibit 2182 because it
`
`contains highly sensitive clinical research information. If this information is made
`
`5
`
`
`
`public, it could cause competitive harm to Aventis by giving direct competitors
`
`knowledge of Aventis’s clinical research operations.
`
`In addition, the public version of Exhibit 2176 (Sartor Declaration), which
`
`relies in part on Exhibit 2182, has been written so that the thrust of the underlying
`
`argument can still be reasonably discerned. Greene’s Energy Grp., LLC, Inc., IPR
`
`2014-00216, Paper 27 at 5. Accordingly, the public’s interest in knowing Aventis’s
`
`clinical research information is relatively low, and is outweighed by Aventis’s
`
`interest in keeping it confidential.
`
`f. Exhibit 2211
`
`Aventis seeks to seal Exhibit 2211, which is an email and its attachment of
`
`meeting minutes that includes confidential research information involving a
`
`clinical trial of Jevtana®. The meeting minutes of Exhibit 2211 detail the
`
`discussion between various members of Sanofi and the FDA regarding the clinical
`
`trial.
`
`Aventis seeks to maintain the confidentiality of Exhibit 2211 because it
`
`contains highly sensitive clinical research information. If this information is made
`
`public, it could cause competitive harm to Aventis by giving direct competitors
`
`knowledge of Aventis’s clinical research operations.
`
`In addition, the public version of Exhibit 2176 (Sartor Declaration), which
`
`relies in part on Exhibit 2211, has been written so that the thrust of the underlying
`
`6
`
`
`
`argument can still be reasonably discerned. Greene’s Energy Grp., LLC, Inc., IPR
`
`2014-00216, Paper 27 at 5. Accordingly, the public’s interest in knowing Aventis’s
`
`clinical research information is relatively low, and is outweighed by Aventis’s
`
`interest in keeping it confidential.
`
`g. Exhibit 2176 – Sartor Declaration
`
`Aventis seeks to seal portions of Exhibit 2176, the December 23, 2016
`
`Expert Declaration of Alton Oliver Sartor, which discusses the validity of U.S.
`
`Patent 8,927,592 and of proposed amended claims. Aventis seeks to maintain the
`
`confidentiality of select portions Exhibit 2176 that rely on the above mentioned
`
`Exhibits 2182 and 2211 for their highly sensitive clinical research information. The
`
`portions Aventis seeks to seal have been redacted from the publicly-filed version
`
`of Exhibit 2176.
`
`For the reasons set forth here and above, see supra Part II.e-f., Aventis
`
`respectfully requests that the Board seal portions of Exhibit 2176 (Sartor
`
`Declaration).
`
`III. CERTIFICATION OF NON-PUBLICATION
`
`On behalf of the Patent Owner, the undersigned counsel certifies that, to the
`
`best of his knowledge, the information sought to be sealed by this Motion has not
`
`been published or otherwise made public.
`
`7
`
`
`
`IV. CERTIFICATION OF CONFERENCE WITH OPPOSING PARTY
`PURSUANT TO 37 C.F.R. § 42.54
`
`On behalf of Aventis, the undersigned has conferred in good faith with
`
`Mylan’s counsel. The parties have agreed to a protective order that, like the default
`
`protective order, allows the parties to file highly confidential information under
`
`seal. Aventis requests entry of the proposed Stipulated Protective Order, which is
`
`attached to this Motion as Appendix A. The Stipulated Protective Order is based
`
`on, and is highly similar to, the default Protective Order. Also attached to this
`
`Motion is a redlined default Protective Order, Appendix B, which indicates the
`
`differences between the Stipulated Protective Order and the Board’s default
`
`Protective Order.
`
`V.
`
`CONCLUSION
`
`For the foregoing reasons, Patent Owner respectfully requests that the Board
`
`grant this Motion to Seal and Motion to Enter Stipulated Protective Order.
`
`December 23, 2016
`
`Respectfully submitted,
`
`/Dominick A. Conde/
`Dominick A. Conde (Reg. No. 33,856)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`Attorney for Patent Owner,
`Aventis Pharma S.A.
`
`8
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e)(4), I certify that a copy of the foregoing
`
`PATENT OWNER’S MOTION TO SEAL AND MOTION TO ENTER
`
`STIPULATED PROTECTIVE ORDER was served on December 23, 2016 by
`
`causing it to be sent by email to counsel for Petitioner at the following email
`
`addresses:
`
`sparmelee@wsgr.com
`
`mrosato@wsgr.com
`
`jmills@wsgr.com
`
`December 23, 2016
`
`Respectfully submitted,
`
`/Dominick A. Conde/
`Dominick A. Conde (Reg. No. 33,856)
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`Tel: (212) 218-2100
`
`9
`
`
`
`APPENDIX A
`
`APPENDIX A
`
`PROPOSED STIPULATED PROTECTIVE ORDER
`
`PROPOSED STIPULATED PROTECTIVE ORDER
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`STIPULATED PROTECTIVE ORDER
`
`
`
`This stipulated 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 acknowledgment appended to this order:
`
`(A) Party Representatives. Representatives of record for a party in
`
`the proceeding.
`
`(B)
`
`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.
`
`(C)
`
`In-house counsel. Charlotte L. Barney as in-house counsel for
`
`Patent Owner, and Thomas Jenkins and Vinny Lee as in-house
`
`counsel for Petitioner, provided that Ms. Barney, Mr. Jenkins, and Ms.
`
`Lee do not have and will not assume responsibility for the prosecution
`
`of patent applications claiming cabazitaxel, compositions or devices
`
`containing cabazitaxel, methods of making cabazitaxel or cabazitaxel-
`
`containing products, or methods of using cabazitaxel. Ms. Barney,
`
`Mr. Jenkins, and Ms. Lee may receive “PROTECTIVE ORDER
`
`1
`
`
`
`MATERIAL” of the opposing party only if such material is contained
`
`in or attached to documents filed or to be filed with the Board or if
`
`such documents are marked at a deposition taken in connection with
`
`this proceeding.
`
`(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 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.
`
`2
`
`
`
`(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;
`
`(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
`
`3
`
`
`
`(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
`
`4
`
`
`
`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.
`
`5
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`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 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
`
`1
`
`
`
`APPENDIX B
`
`APPENDIX B
`
`REDLINED DEFAULT PROTECTIVE ORDER
`
`REDLINED DEFAULT PROTECTIVE ORDER
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`DEFAULT STIPULATED PROTECTIVE ORDER
`
`
`
`This standing stipulated protective order governs the treatment and filing of
`
`confidential information, including documents and testimony.
`
`5.
`
`Confidential information shall be clearly marked
`
`“PROTECTIVE ORDER MATERIAL.”
`
`6.
`
`Access to confidential information is limited to the following
`
`individuals who have executed the acknowledgment 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)(A)
`
`Party Representatives. Representatives of record for a
`
`party in the proceeding.
`
`(C)(B)
`
`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)(C)
`
`In-house counsel. In-house counsel of a party Charlotte
`
`L. Barney as in-house counsel for Patent Owner, and Thomas Jenkins
`
`and Vinny Lee as in-house counsel for Petitioner, provided that Ms.
`
`Barney, Mr. Jenkins, and Ms. Lee do not have and will not assume
`
`responsibility for the prosecution of patent applications claiming
`
`1
`
`
`
`cabazitaxel, compositions or devices containing cabazitaxel, methods
`
`of making cabazitaxel or cabazitaxel-containing products, or methods
`
`of using cabazitaxel. Ms. Barney, Mr. Jenkins, and Ms. Lee may
`
`receive “PROTECTIVE ORDER MATERIAL” of the opposing party
`
`only if such material is contained in or attached to documents filed or
`
`to be filed with the Board or if such documents are marked at a
`
`deposition taken in connection with this proceeding.
`
`(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 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
`
`2
`
`
`
`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.
`
`7.
`
`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;
`
`(C)
`
`Ensuring that support personnel of the recipient who have
`
`access to the confidential information understand and abide by the
`
`3
`
`
`
`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.
`
`8.
`
`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
`
`4
`
`
`
`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
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`clearly marked as “PROTECTIVE ORDER MATERIAL” and shall
`
`be produced in a manner that maintains its confidentiality.
`
`5
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`MYLAN LABORATORIES LIMITED
`Petitioner,
`v.
`AVENTIS PHARMA S.A.
`Patent Owner.
`________________
`
`Case IPR2016-00712
`U.S. Patent No. 8,927,592
`________________
`
`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 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
`
`1
`
`
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