Paper No. __
`Filed: July 18, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`__________________
`
`Case IPR2015-01097 (Patent 8,754,131 B2) 1
`Case IPR2015-01100 (Patent 8,927,606 B1) 2
` Case IPR2015-01105 (Patent 8,871,813 B2) 3, 4
`__________________
`
`SECOND MOTION FOR ENTRY OF STIPULATED
`PROTECTIVE ORDER
`
`
`1 Case IPR2016-00089 has been joined with this proceeding.
`
`2 Case IPR2016-00091 has been joined with this proceeding.
`
`3 Case IPR2016-00090 has been joined with this proceeding.
`
`4 A word-for-word identical paper has been filed in each proceeding identified in
`
`the heading.
`
`
`
`1
`
`
`Filed: July 18, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`__________________
`
`Case IPR2015-01097 (Patent 8,754,131 B2) 1
`Case IPR2015-01100 (Patent 8,927,606 B1) 2
` Case IPR2015-01105 (Patent 8,871,813 B2) 3, 4
`__________________
`
`SECOND MOTION FOR ENTRY OF STIPULATED
`PROTECTIVE ORDER
`
`
`1 Case IPR2016-00089 has been joined with this proceeding.
`
`2 Case IPR2016-00091 has been joined with this proceeding.
`
`3 Case IPR2016-00090 has been joined with this proceeding.
`
`4 A word-for-word identical paper has been filed in each proceeding identified in
`
`the heading.
`
`
`
`1
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`Pursuant to the Final Rules of Practice for Trials Before the Patent Trial and
`
`
`
`
`
`Appeal Board and Judicial Review of Patent Trial and Appeal Board Decisions (77
`
`Fed. Reg. 157, Aug. 14, 2012), 35 U.S.C. § 316, and 37 C.F.R. § 42.54, Petitioners
`
`Lupin and Innopharma and Patent Owner Senju jointly move for entry of a
`
`Stipulated Protective Order attached hereto as Appendix A.
`
`
`
`Following the Board’s Decision Denying Patent Owner’s Motion to Seal and
`
`Denying Entry of the Amended Proposed Stipulated Protective Order of June 21,
`
`2016 (“Decision”) (Paper 58), the Parties met and conferred regarding revisions to
`
`the Stipulated Protective Order.
`
`
`
`The revised Stipulated Protective Order is based on the Default Protective
`
`Order provided in Appendix B of the Trial Practice Guide, with modifications
`
`agreed upon by the Parties. A document comparing the Parties’ Stipulated
`
`Protective Order with the Default Protective order is attached as Exhibit B. The
`
`Parties modified the previously Stipulated Protective Order to be in line with the
`
`Board’s Decision, and provisions of the Default Protective Order by, for example:
`
`(1) removing the use of the term “party” with apparently different meanings
`
`(Decision at 3) in favor of the narrowly defined term “Non-Joinder Party”;
`
`(2) removing the category of confidential information that may be marked as
`
`“PROTECTIVE ORDER MATERIAL-FED R. EVID 615” (Decision at 4)
`
`
`
`2
`
`
`
`
`
`
`because this category is no longer necessary now that discovery has been
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`completed; and (3) removing the discussion of the Stipulated Discovery
`
`Confidentiality Order filed in the parallel district court litigation (Decision at 5).
`
`
`
`The revised Stipulated Protective Order now contains only one level of
`
`additional confidentiality, “PROTECTIVE ORDER MATERIAL - BOARD’S
`
`EYES ONLY.” This additional level of confidentiality is necessary in order to
`
`ensure the preservation of confidentiality of Petitioner Lupin’s Abbreviated New
`
`Drug Application (“ANDA”) (Ex. 2109) and portions of the confidential versions
`
`of Patent Owner’s pleadings and expert declarations citing to the confidential
`
`information contained in Ex. 2109. In the Decision Denying Petitioner Lupin’s
`
`and Patent Owner’s Joint Motion to Seal Exhibits 2082, 2109, and Patent Owner’s
`
`Response of June 21, 2016 (Paper 60 at 3-4), the Board found that the parties had
`
`“established that [Exhibit 2109, among others] represent or contain confidential
`
`information[,]” but declined to seal the documents because an adequate protective
`
`order had not been entered.
`
`
`
`For the above reasons, the Parties respectfully request the Board enter the
`
`Stipulated Protective Order attached hereto as Appendix A.
`
`3
`
`
`
`Respectfully,
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`Fax: 919-862-2260
`
`Lance Soderstrom
`Reg. No. 65405
`ALSTON & BIRD LLP
`90 Park Avenue
`15th Floor
`New York, New York 10016-1387
`Telephone: 212.210.9400
`Fax: 212.210.9444
`
`Hidetada James Abe
`Reg. No. 61,182
`Alston & Bird LLP
`333 South Hope Street, 16th Floor
`Los Angeles, California 90071
`Telephone: (213) 576-1000
`
`Counsel for Petitioner InnoPharma
`
` /Joshua L. Goldberg/
`By:
`Bryan C. Diner, Lead Counsel
`Reg. No. 32,409
`Justin J. Hasford, Back-up Counsel
`Reg. No. 62,180
`Joshua L. Goldberg, Back-up Counsel
`Reg. No. 59,369
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`Telephone: (202) 408-4000
`
`Counsel for Patent Owner
`
`
`
`
`
`
`
` 4
`
`
`
`
`
`
`
`
`
`By: /Deborah Yellin/
`
`
`
`
`
`Deborah Yellin, Lead Counsel
`Reg. No. 45,904
`Jonathan Lindsay, Back-up Counsel
`Reg. No. 45,810
`Teresa Stanek Rea, Back-up Counsel
`Reg. No. 30,427
`CROWELL & MORING LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2595
`Telephone: (202) 624-2947
`Fax: (202) 628-8844
`
`Chiemi Suzuki
`CROWELL & MORING LLP
`Intellectual Property Group
`590 Madison Avenue, 20th Floor
`New York, NY 10022-2524
`Telephone: (212) 803-4050
`Fax: (212) 223-4134
`
`Counsel for Petitioners
`
`
`By: /Jitendra Malik/
`Jitendra Malik, Lead Counsel
`Reg. No. 55823
`Bryan L. Skelton, Ph.D.
`Reg. No. 50893
`ALSTON & BIRD LLP
`4721 Emperor Boulevard, Suite 400
`Durham, North Carolina 27703
`Telephone: 919-862-2200
`
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`
`APPENDIX A
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Paper No. __
`Filed: July 18, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`__________________
`
`Case IPR2015-01097 (Patent 8,754,131 B2) 1
`Case IPR2015-01100 (Patent 8,927,606 B1) 2
` Case IPR2015-01105 (Patent 8,871,813 B2) 3, 4
`__________________
`
`AMENDED PROPOSED STIPULATED PROTECTIVE ORDER
`
`
`1 Case IPR2016-00089 has been joined with this proceeding.
`
`2 Case IPR2016-00091 has been joined with this proceeding.
`
`3 Case IPR2016-00090 has been joined with this proceeding.
`
`4 A word-for-word identical paper has been filed in each proceeding identified in
`
`the heading.
`
`
`
`1
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`This standing protective order governs the treatment and filing of
`
`
`
`
`
`confidential information, including documents and testimony.
`
`1.
`
`Confidential information shall be clearly marked as “PROTECTIVE
`
`ORDER MATERIAL” or as “PROTECTIVE ORDER MATERIAL - BOARD’S
`
`EYES ONLY”.
`
`2.
`
`For the confidential information marked, “PROTECTIVE ORDER
`
`MATERIAL”, access 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) Party Representatives. Representatives of record for a party in the
`
`proceeding.
`
`(C) Experts. Retained experts of a party who further certify in the
`
`Acknowledgement that they are not 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
`
`
`
`2
`
`
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`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.
`
`(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
`
`
`
`
`
`
`3.
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`For the confidential information marked, “PROTECTIVE ORDER
`
`MATERIAL – BOARD’S EYES ONLY”, access is limited to the following
`
`individuals who have executed the Acknowledgment appended to this order:
`
`(A) Non-Joinder Parties. Lupin Petitioners and Patent Owner.
`
`(B) Non-Joinder Party Representatives. Representatives of record for a
`
`Non-Joinder Party in the proceeding.
`
`(C) Experts. Retained experts of a Non-Joinder Party who further certify
`
`in the Acknowledgement that they are not 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 Non-Joinder Party.
`
`(E) 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.
`
`(F) Support Personnel. Administrative assistants, clerical staff, court
`
`reporters and other support personnel of the foregoing persons who are
`
`
`
`4
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`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.
`
`
`
`
`
`
`
`4.
`
`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
`
`
`
`5
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`(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.
`
`5.
`
`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 nonconfidential 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
`
`
`
`6
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`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(s) 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” or “PROTECTIVE
`
`ORDER MATERIAL - BOARD’S EYES ONLY” and shall be produced in
`
`a manner that maintains its confidentiality.
`
`
`
`
`
`
`
`6. 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:
`
`
`
`
`
`
`
`7
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`__________________
`
`Case IPR2015-01097 (Patent 8,754,131 B2) 5
`Case IPR2015-01100 (Patent 8,927,606 B1) 6 Case IPR2015-01105 (Patent
`8,871,813 B2) 7, 8
`__________________
`
`ACKNOWLEDGMENT FOR ACCESS TO
`PROTECTIVE ORDER MATERIAL
`
`
`
`5 Case IPR2016-00089 has been joined with this proceeding.
`
`6 Case IPR2016-00091 has been joined with this proceeding.
`
`7 Case IPR2016-00090 has been joined with this proceeding.
`
`8 A word-for-word identical paper has been filed in each proceeding identified in
`
`the heading.
`
`
`
`8
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`I __________________________________________, affirm that I have
`
`
`
`
`
`read the Stipulated 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 block]
`
`
`
`
`
`
`
`
`
`
`Dated:
`
`
`
`
`
`9
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`Respectfully submitted,
`
`
`
`By: /Deborah Yellin/
`
`Deborah Yellin, Lead Counsel
`Reg. No. 45,904
`Jonathan Lindsay, Back-up Counsel
`Reg. No. 45,810
`Teresa Stanek Rea, Back-up Counsel
`Reg. No. 30,427
`CROWELL & MORING LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2595
`Telephone: (202) 624-2947
`Fax: (202) 628-8844
`
`Chiemi Suzuki
`CROWELL & MORING LLP
`Intellectual Property Group
`590 Madison Avenue, 20th Floor
`New York, NY 10022-2524
`Telephone: (212) 803-4050
`Fax: (212) 223-4134
`
`
`
`Counsel for Petitioners
`
`
`
`
`
`
`By: / Jitendra Malik/
`Jitendra Malik, Lead Counsel
`Reg. No. 55823
`Bryan L. Skelton, Ph.D.
`Reg. No. 50893
`ALSTON & BIRD LLP
`4721 Emperor Boulevard, Suite 400
`Durham, North Carolina 27703
`
`
`
`
`
`Date: July 18, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`10
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`Telephone: 919-862-2200
`Fax: 919-862-2260
`
`Lance Soderstrom
`Reg. No. 65405
`ALSTON & BIRD LLP
`90 Park Avenue
`15th Floor
`New York, New York 10016-1387
`Telephone: 212.210.9400
`Fax: 212.210.9444
`
`Hidetada James Abe
`Reg. No. 61,182
`Alston & Bird LLP
`333 South Hope Street, 16th Floor
`Los Angeles, California 90071
`Telephone: (213) 576-1000
`
`Counsel for Petitioner InnoPharma
`
`
`
`
`By: /Joshua L. Goldberg/
`Bryan C. Diner, Lead Counsel
`Reg. No. 32,409
`Justin J. Hasford, Back-up Counsel
`Reg. No. 62,180
`Joshua L. Goldberg, Back-up Counsel
`Reg. No. 59,369
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`Telephone: (202) 408-4000
`
`Counsel for Patent Owner
`
`11
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`
`
`APPENDIX B
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Paper No. __
`Filed: July 18, 2016
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`__________________
`
`Case IPR2015-01097 (Patent 8,754,131 B2) 1
`Case IPR2015-01100 (Patent 8,927,606 B1) 2
` Case IPR2015-01105 (Patent 8,871,813 B2) 3, 4
`__________________
`
`AMENDED PROPOSED STIPULATED PROTECTIVE ORDER
`
`
`1 Case IPR2016-00089 has been joined with this proceeding.
`
`2 Case IPR2016-00091 has been joined with this proceeding.
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`3 Case IPR2016-00090 has been joined with this proceeding.
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`4 A word-for-word identical paper has been filed in each proceeding identified in
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`the heading.
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`1
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
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`This standing protective order governs the treatment and filing of
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`confidential information, including documents and testimony.
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`1.
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`Confidential information shall be clearly marked as “PROTECTIVE
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`ORDER MATERIAL” or as “PROTECTIVE ORDER MATERIAL - BOARD’S
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`EYES ONLY”.
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`2.
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`For the confidential information marked, “PROTECTIVE ORDER
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`MATERIAL”, access is limited to the following individuals who have executed the
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`Acknowledgment appended to this order:
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`(A) Parties. Persons who are owners of a patent involved in the
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`proceeding and other persons who are named parties to the proceeding.
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`(B) Party Representatives. Representatives of record for a party in the
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`proceeding.
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`(C) Experts. Retained experts of a party who further certify in the
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`Acknowledgement that they are not competitor to any party, or a consultant
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`for, or employed by, such a competitor with respect to the subject matter of
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`the proceeding.
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`(D)
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`In-house counsel. In-house counsel of a party.
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`(E) Other Employees of a Party. Employees, consultants or other persons
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`2
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
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`performing work for a party, other than in-house counsel and in-house
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`counsel’s support staff, who sign the Acknowledgement shall be extended
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`access to confidential information only upon agreement of the parties or by
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`order of the Board upon a motion brought by the party seeking to disclose
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`confidential information to that person. The party opposing disclosure to that
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`person shall have the burden of proving that such person should be restricted
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`from access to confidential information.
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`(F) The Office. Employees and representatives of the Office who have a
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`need for access to the confidential information shall have such access
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`without the requirement to sign an Acknowledgement. Such employees and
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`representatives shall include the Director, members of the Board and their
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`clerical staff, other support personnel, court reporters, and other persons
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`acting on behalf of the Office.
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`(G) Support Personnel. Administrative assistants, clerical staff, court
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`reporters and other support personnel of the foregoing persons who are
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`reasonably necessary to assist those persons in the proceeding shall not be
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`required to sign an Acknowledgement, but shall be informed of the terms
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`and requirements of the Protective Order by the person they are supporting
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`who receives confidential information.
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`3
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`3.
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
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`For the confidential information marked, “PROTECTIVE ORDER
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`MATERIAL – BOARD’S EYES ONLY”, access is limited to the following
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`individuals who have executed the Acknowledgment appended to this order:
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`(A) Non-Joinder Parties. Lupin Petitioners and Patent Owner.
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`(B) Non-Joinder Party Representatives. Representatives of record for a
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`Non-Joinder Party in the proceeding.
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`(C) Experts. Retained experts of a Non-Joinder Party who further certify
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`in the Acknowledgement that they are not competitor to any party, or a
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`consultant for, or employed by, such a competitor with respect to the subject
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`matter of the proceeding.
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`(D)
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`In-house counsel. In-house counsel of a Non-Joinder Party.
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`(E) The Office. Employees and representatives of the Office who have a
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`need for access to the confidential information shall have such access
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`without the requirement to sign an Acknowledgement. Such employees and
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`representatives shall include the Director, members of the Board and their
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`clerical staff, other support personnel, court reporters, and other persons
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`acting on behalf of the Office.
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`(F) Support Personnel. Administrative assistants, clerical staff, court
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`reporters and other support personnel of the foregoing persons who are
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`4
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
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`reasonably necessary to assist those persons in the proceeding shall not be
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`required to sign an Acknowledgement, but shall be informed of the terms
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`and requirements of the Protective Order by the person they are supporting
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`who receives confidential information.
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`3. 4. Persons receiving confidential information shall use reasonable efforts to
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`maintain the confidentiality of the information, including:
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`(A) Maintaining such information in a secure location to which persons
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`not authorized to receive the information shall not have access;
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`(B) Otherwise using reasonable efforts to maintain the confidentiality of
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`the information, which efforts shall be no less rigorous than those the
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`recipient uses to maintain the confidentiality of information not received
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`from the disclosing party;
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`(C) Ensuring that support personnel of the recipient who have access to
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`the confidential information understand and abide by the obligation to
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`maintain the confidentiality of information received that is designated as
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`confidential; and
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`5
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
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`(D) Limiting the copying of confidential information to a reasonable
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`number of copies needed for conduct of the proceeding and maintaining a
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`record of the locations of such copies.
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`4. 5. Persons receiving confidential information shall use the following
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`procedures to maintain the confidentiality of the information:
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`(A) Documents and Information Filed With the Board.
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`(i) A party may file documents or information with the Board under
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`seal, together with a non-confidential description of the nature of the
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`confidential information that is under seal and the reasons why the
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`information is confidential and should not be made available to the
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`public. The submission shall be treated as confidential and remain
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`under seal, unless, upon motion of a party and after a hearing on the
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`issue, or sua sponte, the Board determines that the documents or
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`information do not to qualify for confidential treatment.
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`(ii) Where confidentiality is alleged as to some but not all of the
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`information submitted to the Board, the submitting party shall file
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`confidential and nonconfidential versions of its submission, together
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`with a Motion to Seal the confidential version setting forth the reasons
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`why the information redacted from the non-confidential version is
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`6
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
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`confidential and should not be made available to the public. The
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`nonconfidential version of the submission shall clearly indicate the
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`locations of information that has been redacted. The confidential
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`version(s) of the submission shall be filed under seal. The redacted
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`information shall remain under seal unless, upon motion of a party
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`and after a hearing on the issue, or sua sponte, the Board determines
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`that some or all of the redacted information does not qualify for
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`confidential treatment.
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`(B) Documents and Information Exchanged Among the Parties.
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`Information designated as confidential that is disclosed to another party
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`during discovery or other proceedings before the Board shall be clearly
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`marked as “PROTECTIVE ORDER MATERIAL” or “PROTECTIVE
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`ORDER MATERIAL - BOARD’S EYES ONLY” and shall be produced in
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`a manner that maintains its confidentiality.
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`6. Standard Acknowledgement of Protective Order. The following form may be
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`used to acknowledge a protective order and gain access to information covered by
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`the protective order:
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`7
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC., INNOPHARMA
`LICENSING, INC., INNOPHARMA LICENSING LLC, INNOPHARMA
`INC., INNOPHARMA LLC, MYLAN PHARMACEUTICALS INC., and
`MYLAN INC.
`Petitioner
`v.
`
` SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner
`__________________
`
`Case IPR2015-01097 (Patent 8,754,131 B2) 5
`Case IPR2015-01100 (Patent 8,927,606 B1) 6 Case IPR2015-01105 (Patent
`8,871,813 B2) 7, 8
`__________________
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`STANDARD ACKNOWLEDGMENT FOR ACCESS TO
`PROTECTIVE ORDER MATERIAL
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`
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`5 Case IPR2016-00089 has been joined with this proceeding.
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`6 Case IPR2016-00091 has been joined with this proceeding.
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`7 Case IPR2016-00090 has been joined with this proceeding.
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`8 A word-for-word identical paper has been filed in each proceeding identified in
`
`the heading.
`
`
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`8
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`
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
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`I __________________________________________, affirm that I have
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`read the Stipulated Protective Order; that I will abide by its terms; that I will use
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`the confidential information only in connection with this proceeding and for no
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`other purpose; that I will only allow access to support staff who are reasonably
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`necessary to assist me in this proceeding; that prior to any disclosure to such
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`support staff I informed or will inform them of the requirements of the Protective
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`Order; that I am personally responsible for the requirements of the terms of the
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`Protective Order and I agree to submit to the jurisdiction of the Office and the
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`United States District Court for the Eastern District of Virginia for purposes of
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`enforcing the terms of the Protective Order and providing remedies for its breach.
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`[Signature block]
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`Dated:
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`9
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
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`Respectfully submitted,
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`
`
`By: /Deborah Yellin/
`
`Deborah Yellin, Lead Counsel
`Reg. No. 45,904
`Jonathan Lindsay, Back-up Counsel
`Reg. No. 45,810
`Teresa Stanek Rea, Back-up Counsel
`Reg. No. 30,427
`CROWELL & MORING LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2595
`Telephone: (202) 624-2947
`Fax: (202) 628-8844
`
`Chiemi Suzuki
`CROWELL & MORING LLP
`Intellectual Property Group
`590 Madison Avenue, 20th Floor
`New York, NY 10022-2524
`Telephone: (212) 803-4050
`Fax: (212) 223-4134
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`
`
`Counsel for Petitioners
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`By: / Jitendra Malik/
`Jitendra Malik, Lead Counsel
`Reg. No. 55823
`Bryan L. Skelton, Ph.D.
`Reg. No. 50893
`ALSTON & BIRD LLP
`4721 Emperor Boulevard, Suite 400
`Durham, North Carolina 27703
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`Date: July 18, 2016
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`10
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`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
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`Telephone: 919-862-2200
`Fax: 919-862-2260
`
`Lance Soderstrom
`Reg. No. 65405
`ALSTON & BIRD LLP
`90 Park Avenue
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