Paper No. __
`Filed: March 17, 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
`__________________
`
`SUBMISSION OF REDLINE 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
`
`
`Filed: March 17, 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
`__________________
`
`SUBMISSION OF REDLINE 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)
`
`In accordance with the Board’s email of March 14, 2016, the attached
`
`Appendix B contains a red-lined version of the Amended Proposed Stipulated
`
`Protective Order, filed jointly by the parties on March 8, 2016, relative to the
`
`Board’s default protective order.
`
`Dated: March 17, 2016
`
`
`
`
`
`
`
`By: /Bryan C. Diner/
`
`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
`
`
`
`2
`
`
`
`
`APPENDIX B
`
`APPENDIX B
`
`
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`
`
`
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`
`
`Paper No. __
`Filed: February 25, 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 joint protective order governs the treatment and filing of
`
`confidential information, including documents and testimony.5
`
`1. Marking of Confidential Information. Confidential information shall be
`
`clearly marked as either “PROTECTIVE ORDER MATERIAL - BOARD’S EYES
`
`ONLY” or “PROTECTIVE ORDER MATERIAL - FED R. EVID 615” or
`
`“PROTECTIVE ORDER MATERIAL”.
`
`2.
`
`Persons Having Access to Confidential Information Marked
`
`“PROTECTIVE ORDER MATERIAL - BOARD’S EYES ONLY”. For the
`
`confidential information marked “PROTECTIVE ORDER MATERIAL -
`
`BOARD’S EYES ONLY”, access to confidential information is limited to the
`
`Employees and representatives of the Office who have a need for access to the
`
`confidential information. Such employees and representatives 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.
`
`
`5 Nothing in this Order prevents any Party from challenging a confidentiality
`
`designation to any Exhibit by raising the matter with the Board.
`
`
`
`2
`
`
`
`
`
`
`3.
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`Persons Having Access to Confidential Information Marked
`
`“PROTECTIVE ORDER MATERIAL - FED R. EVID 615”. For the
`
`confidential information marked, “PROTECTIVE ORDER MATERIAL - FED R.
`
`EVID 615”, access to confidential information about one expert’s deposition
`
`testimony is limited to the following individuals who have executed the
`
`Acknowledgment appended to this order and shall not be disclosed to any other
`
`expert in any Related Proceeding6 (unless the information is already known to that
`
`expert) until after such time as the Board has lifted the Rule on Witnesses under
`
`Fed. R. Evid. 615, and then only upon the formal request of any Party to the Board,
`
`
`6 Related Proceeding is defined as “any other IPR proceeding or district court
`
`proceeding involving the patent at issue, the patent owners, and any one of
`
`Petitioners InnoPharma Licensing, Inc., InnoPharma Licensing LLC, InnoPharma
`
`Inc., InnoPharma LLC, Mylan Pharmaceuticals Inc., Mylan Inc., Lupin, Ltd., or
`
`Lupin Pharmaceuticals, Inc.”).
`
`
`
`3
`
`
`
`
`
`
`or upon a joint request by the Parties to the Board’s administrative staff to do so
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`without raising the matter with the Board:7
`
`(A) Parties. Persons who are owners of a patent involved in the
`
`proceeding and other persons who are identified as a real party-in-interest in
`
`any Related Proceeding.
`
`(B) Outside Counsel. Outside counsel of record for a party in any Related
`
`Proceeding.
`
`(C)
`
`In-house counsel. In-house counsel of a party or in-house counsel of a
`
`real party-in-interest.
`
`(D) Other Employees of a Party. Employees, 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
`
`
`7 Upon termination of the “PROTECTIVE ORDER MATERIAL - FED R. EVID
`
`615” designation, any party may, in good faith, request that the Information be re-
`
`designated to “PROTECTIVE ORDER MATERIAL.”
`
`
`
`4
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`disclosure to that person shall have the burden of proving that such person
`
`should be restricted from access to confidential information.
`
`(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
`
`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.
`
`4.2. Persons Having Access to Confidential Information Marked
`
`“PROTECTIVE ORDER MATERIAL”. For the confidential information
`
`marked, “PROTECTIVE ORDER MATERIAL”, access to confidential
`
`information is limited to the following individuals who have executed the
`
`Acknowledgment appended to this order:
`
`
`
`5
`
`
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`(A) Parties. Persons who are owners of a patent involved in the
`
`proceeding and other persons who are named parties to the proceeding who
`
`are identified as a real party-in-interest in any Related Proceeding.
`
`(B) Outside Counsel. Outside counsel of record for a party in any Related
`
`Proceeding. Party Representatives. Representatives of record for a party in
`
`the proceeding.
`
`(C) Experts. Retained experts of a party in any Related Proceeding in the
`
`proceeding who sign the Acknowledgement. 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 of a party or in-house counsel of a real party-in-
`
`interest.
`
`(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
`
`6
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`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.
`
`5.3. Maintaining Confidentiality. Persons receiving confidential information
`
`shall use reasonable efforts to maintain the confidentiality of the information,
`
`including:
`
`
`
`7
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`(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
`
`(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.
`
`6.4. Filing and Exchange of Confidential Materials. 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
`
`
`
`8
`
`
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`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
`
`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.
`
`9
`
`
`
`
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`(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” or “PROTECTIVE
`
`ORDER MATERIAL - FED R. EVID 615” and shall be produced in a
`
`manner that maintains its confidentiality.
`
`7. Acknowledgement of Protective Order. The attached form shall be used to
`
`acknowledge a protective order and gain access to information covered by the
`
`protective order, if appropriate. Acknowledgment forms signed in connection with
`
`the Proposed Stipulated Protective Order in the IPR2015-01097, IPR2015-01100,
`
`or IPR2015-01105 prior to the Board’s Order on Joinder (Paper 22) shall remain
`
`effective under this Amended Proposed Stipulated Protective Order.
`
`8.
`
`Nothing herein shall amend or alter the Stipulated Discovery Confidentiality
`
`Order, filed by Petitioners Lupin Ltd. and Lupin Pharmaceuticals, Inc. and Patent
`
`Owner Senju in Senju Pharmaceutical Co., Ltd., Bausch & Lomb, Inc., and Bausch
`
`& Lomb Pharma Holdings Corp. v. Lupin, Ltd. and Lupin Pharmaceuticals, Inc.,
`
`C.A. No. 1:14-cv-00667-JBS-KMV (D.N.J. June 25, 2014) (Dkt. No. 34) and
`
`adopted by InnoPharma in Senju Pharmaceutical Co., Ltd., Bausch & Lomb, Inc.,
`
`
`
`10
`
`
`
`
`
`
`and Bausch & Lomb Pharma Holdings Corp. v. InnoPharma Licensing, Inc.,
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`InnoPharma Licensing, LLC, InnoPharma, Inc., and InnoPharma, LLC, C.A. No.
`
`1:14-cv-06893-JBS-KMW (D.N.J.).
`
`
`
`
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`
`
`
`
`11
`
`
`
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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)
`
`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) 8
`Case IPR2015-01100 (Patent 8,927,606 B1) 9 Case IPR2015-01105 (Patent
`8,871,813 B2) 10, 11
`__________________
`
`STANDARD ACKNOWLEDGMENT FOR ACCESS TO
`PROTECTIVE ORDER MATERIAL
`
`
`
`8 Case IPR2016-00089 has been joined with this proceeding.
`
`9 Case IPR2016-00091 has been joined with this proceeding.
`
`10 Case IPR2016-00090 has been joined with this proceeding.
`
`11 A word-for-word identical paper has been filed in each proceeding identified in
`
`the heading.
`
`
`
`12
`
`
`
`
`
`
`
`
`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:
`
`
`
`
`
`13
`
`
`
`IPR2015-01097 (Patent 8,754,131 B2)
`IPR2015-01100 (Patent 8,927,606 B1)
`IPR2015-01105 (Patent 8,871,813 B2)
`
`Respectfully submitted,
`
`
`
`By: /s/ 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: /s/ 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: February 8, 2016
`
`
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`
`14
`
`
`
`
`
`
`
`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: /Bryan C. Diner/
`
`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
`
`15
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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)
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing
`
`SUBMISSION OF REDLINE AMENDED PROPOSED STIPULATED
`
`PROTECTIVE ORDER was served on March 17, 2016, via email directed to
`
`counsel of record for the Petitioner at the following:
`
`
`
`Deborah Yellin
`DYellin@crowell.com
`
`Jonathan Lindsay
`JLindsay@crowell.com
`
`Teresa Stanek Rea
`TRea@crowell.com
`
`Chiemi Suzuki
`CSuzuki@crowell.com
`
`Jitendra Malik
`jitty.malik@alston.com
`
`Lance Soderstrom
`lance.soderstrom@alston.com
`
`Hidetada James Abe
`james.abe@alston.com
`
`
`Date: March 17, 2016
`
`
`
`
`
`/Bradley J. Moore/
`
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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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`Bradley J. Moore
`Litigation Legal Assistant
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, LLP
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`17
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