`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`KASHIV PHARMA, LLC,
`Petitioner,
`
`v.
`
`PURDUE PHARMA L.P.,
`THE P.F. LABORATORIES, INC., and
`PURDUE PHARMACEUTICALS L.P.,
`
`Patent Owners.
`____________________
`
`Case IPR2018-00625
`Case IPR2018-00717
`U.S. Patent No. 9,492,392
`U.S. Patent No. 9,492,393
`_____________________
`
`JOINT MOTION FOR ENTRY OF STIPULATED PROTECTIVE ORDER
`
`
`
`
`
`
`
`
`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, Petitioner
`
`Kashiv Pharma, LLC and Patent Owners Purdue Pharma L.P., The P.F.
`
`Laboratories, Inc., and Purdue Pharmaceuticals L.P. jointly move for entry of a
`
`Stipulated Protective Order attached hereto as Exhibit A. This 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.
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`
`
`/Tedd W. Van Buskirk/
`Tedd W. Van Buskirk (Reg. No.
`46,282)
`Michael H. Teschner (Reg. No. 32,862)
`Nichole M. Valeyko (Reg. No. 55,832)
`tvanbuskirk@lernerdavid.com
`mteschner.ipr@ldlkm.com
`nvaleyko@lernerdavid.com
`LERNER DAVID LITTENBERG
`KRUMHOLZ & MENTLIK, LLP
`600 South Avenue West
`Westfield, NJ 07090
`Telephone: 908.654.5000
`Fax: 908.654.7866
`
`Attorneys for Petitioner Kashiv Pharma,
`LLC
`
`
`
`
`
`
`
`/Gasper J. LaRosa/
`Gasper J. LaRosa (Reg. No. 62,477)
`Pablo Hendler (Reg. No. 40,015)
`Kelsey I. Nix (Reg. No. 33,119)
`Kenneth S. Canfield (Reg. No. 58,442)
`Sarah A. Geers (Reg. No. 69,123)
`gjlarosa@jonesday.com
`phendler@jonesday.com
`knix@jonesday.com
`kcanfield@jonesday.com
`sgeers@jonesday.com
`JONES DAY
`250 Vesey Street
`New York, NY 10281
`Telephone: 212-326-3939
`Fax: 212-755-7306
`
`Attorneys for Patent Owners Purdue
`Pharma L.P., The P.F. Laboratories,
`Inc., and Purdue Pharmaceuticals L.P.
`
`- 2 -
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned Attorney certifies that on the date set forth below, a true
`
`and correct copy of the preceding document has been caused to be served via
`
`electronic mail upon all counsel of record for Kashiv Pharma, LLC.
`
`Dated: June 8, 2018
`
`Respectfully submitted,
`/Kenneth S. Canfield/
`Kenneth S. Canfield (Reg. No. 58,442)
`JONES DAY
`250 Vesey Street
`New York, NY 10281
`(212) 326-3939
`
`
`
`EXHIBIT A
`
`EXHIBIT A
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`KASHIV PHARMA, LLC,
`Petitioner,
`
`v.
`
`PURDUE PHARMA L.P.,
`THE P.F. LABORATORIES, INC., and
`PURDUE PHARMACEUTICALS L.P.,
`
`Patent Owners.
`____________________
`
`Case IPR2018-00625
`Case IPR2018-00717
`U.S. Patent No. 9,492,392
`U.S. Patent No. 9,492,393
`_____________________
`
`STIPULATED PROTECTIVE ORDER
`
`
`
`
`
`
`
`
`
`
`
`
`It is stipulated and agreed by and between Petitioner Kashiv Pharma, LLC
`
`and Patent Owners Purdue Pharma L.P., The P.F. Laboratories, Inc., and Purdue
`
`Pharmaceuticals L.P. (collectively, “Parties,” and individually, a “Party”), and
`
`subject to the approval of the Patent Trial and Appeal Board (the “Board”), that the
`
`following provisions shall control the disclosure, dissemination, and use of
`
`confidential information in the above-captioned proceedings (collectively,
`
`“Proceedings,” and, individually, a “Proceeding”):
`
`1.
`
`This Protective Order governs the treatment and filing of confidential
`
`information in the Proceedings, including documents and testimony, 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.
`
`2.
`
`Confidential information shall be clearly marked “PROTECTIVE
`
`ORDER MATERIAL,” “CONFIDENTIAL,” or “HIGHLY CONFIDENTIAL”
`
`and is referred to herein as “Protective Order Material.”
`
`3.
`
`Any Party producing Protective Order Material pursuant to the
`
`provisions of this Protective Order may designate such information (according to
`
`Paragraph 1) if such Party in good faith believes it to be so competitively sensitive
`
`that it is entitled to extraordinary protections. Any summary, compilation, notes,
`
`memoranda, analysis, or copy containing Protective Order Material and any
`
`
`
`electronic image or database containing Protective Order Material shall be
`
`considered Protective Order Material to the same extent as the material or
`
`information from which such summary, compilation, notes, copy, memoranda,
`
`analysis, electronic image, or database is derived. Examples of the types of
`
`information that may be requested in discovery and designated as “Protective
`
`Order Material” if produced include, but are not limited to:
`
`(i)
`
`The names, or other information tending to reveal the identities,
`
`of a Party’s suppliers, present or prospective customers, or distributors or the
`
`personal information of a Party’s employees;
`
`(ii)
`
`Information relating to pending patent applications;
`
`(iii) Financial information of a Party, including, but not limited to,
`
`identifying the number of products sold, total dollar value of products sold,
`
`and profit margins for products, both forecasted and actual;
`
`(iv)
`
`Information constituting product specifications, formulations,
`
`and/or regarding the manufacture of the Party’s products;
`
`(v) Technical notebooks and technical reports of a Party, including
`
`product and manufacturing specifications, schematic diagrams, technical
`
`reference manuals, operations manuals, or other similar information;
`
`(vi) Confidential marketing plans, market research, and business
`
`strategy, including research regarding competitors;
`
`
`
`
`2
`
`
`
`(vii) Information the Producing Party believes is a proprietary trade
`
`secret;
`
`(viii) Personal information and/or identities of physicians and
`
`patients;
`
`(ix) All information relating to a Party’s research and development
`
`efforts leading to the creation of its products; and
`
`(x) Abbreviated New Drug Applications (including any
`
`supplements or amendments), confidential portions of New Drug
`
`Applications, or Drug Master Files.
`
`4.
`
`Access to confidential information is limited to the following
`
`individuals:
`
`(i)
`
`Author/Party: The author of the confidential information or
`
`Party who produced the confidential information.
`
`(ii) Party Representatives. Outside counsel for a Party in the
`
`Proceedings or in Civil Action No. 15-1152 (RGA) (SRF) (consolidated)
`
`pending in the United States District Court for the District of Delaware.
`
`(iii) Experts. The following applies for each independent expert and
`
`consultant to whom Protective Order Material is to be given, shown,
`
`disclosed, made available, or communicated in any way:
`
`(a)
`
`Such expert or consultant shall first read this Protective
`
`
`
`
`3
`
`
`
`Order and sign the Acknowledgement of Protective Order of
`
`Paragraph 12 below (“Acknowledgement”).
`
`(b) At least five (5) business days prior to the receiving Party
`
`giving, showing, disclosing, making available, or communicating
`
`Protective Order Material to any expert or consultant, the receiving
`
`Party shall deliver (by electronic mail) to the producing Party a copy
`
`of the signed Acknowledgement and a resume, curriculum vitae, or
`
`description setting forth the person’s (1) name, (2) residence and
`
`office addresses, (3) present employer, job title and job description,
`
`(4) any consulting activities within the last five years relating to the
`
`pharmaceutical industry, (5) any relationship to the Parties in this
`
`action, and (6) a brief job history for the past five years.
`
`(c)
`
`If a Party has a good faith basis for believing it would be
`
`harmed by any proposed disclosure of Protective Order Material, the
`
`Party shall be entitled to object to such disclosure within five (5)
`
`business days after service of the information called for in the
`
`preceding sentence. Objections must be in writing and state with
`
`particularity the basis for the objection.
`
`(d)
`
`In the event of such an objection to disclosure of
`
`Protective Order Material, the Parties shall meet and confer within
`
`
`
`
`4
`
`
`
`three (3) business days to attempt to resolve the concerns giving rise
`
`to the objection. If the Parties are unable to reach an agreement
`
`regarding such disclosure, the Party objecting to disclosure may,
`
`within five (5) business days of the meet and confer, request that the
`
`Board issue an order barring such disclosure. The objecting Party
`
`shall have the burden of showing why that person should not have
`
`access to Protective Order Material. Pending resolution of any such
`
`motion or application, no disclosure of Protective Order Material shall
`
`be made to that person.
`
`(iv) Other Employees of a Party. Employees, consultants, or other
`
`persons performing work for a Party who sign the Acknowledgement shall
`
`be extended access to confidential information of the opposing Party 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 seeking disclosure to that person shall have the burden of
`
`proving that such disclosure is necessary.
`
`(v)
`
`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
`
`
`
`
`5
`
`
`
`clerical staff, other support personnel, court reporters, and other persons
`
`acting on behalf of the Office.
`
`(vi) No more than three (3) designated in-house counsel for the
`
`Petitioner and no more than three (3) designated in-house counsel
`
`(collectively) for the Patent Owners, who have signed the
`
`Acknowledgement, and who, for the duration of three years after the
`
`conclusion of any Proceeding in connection with which such counsel
`
`received Protective Order Information, including appeals, will not engage
`
`directly in the drafting, crafting, or amending of patent claims before the
`
`United States Patent and Trademark Office involving oxycodone.
`
`Notwithstanding the foregoing, nothing herein shall preclude designated in-
`
`house counsel from being involved in post-grant proceedings before the
`
`Board under 35 U.S.C. § 311 et seq. or 35 U.S.C. § 321 et seq. with respect
`
`to the patents involving oxycodone. Said in-house counsel identified below:
`
`In-House Counsel for Petitioner: Joseph P. Pieroni.
`
`In-House Counsel for Patent Owner: Bruce J. Koch.
`
`(vii) 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
`
`
`
`
`6
`
`
`
`and requirements of the Protective Order by the person they are supporting
`
`who receives confidential information.
`
`5.
`
`Persons receiving Protective Order Material shall use reasonable
`
`efforts to maintain the confidentiality of such Protective Order Material, including:
`
`(i) Maintaining such information in a secure location to which
`
`persons not authorized to receive the information shall not have access;
`
`(ii) 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;
`
`(iii) 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
`
`(iv) 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.
`
`Persons receiving Protective Order Material shall use the following
`
`procedures to maintain the confidentiality of the information:
`
`(i) Documents and information filed with the Board.
`
`
`
`
`7
`
`
`
`(a) A Party shall file Protective Order Material with the
`
`Board under seal, with availability limited to the Board and the
`
`Parties, together with a Motion to Seal (attaching this Protective
`
`Order) setting forth the reasons why the information contained therein
`
`is confidential and should not be made available to the public. The
`
`submission of Protective Order Material 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.
`
`(b) 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 (attaching this
`
`Protective Order) 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 non-confidential 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, with availability limited to the Board and the Parties.
`
`
`
`
`8
`
`
`
`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.
`
`(ii) Documents and information exchanged among the parties:
`
`Information designated as Protective Order Material by a Party that is
`
`disclosed to another Party during discovery or otherwise shall be clearly
`
`marked according to Paragraph 1 and shall be produced in a manner that
`
`maintains its confidentiality.
`
`7.
`
`No limitations on Party’s use of its own information: Except as
`
`specifically noted herein, this Protective Order shall not limit a producing Party’s
`
`use of its own Protective Order Material.
`
`8. Within 90 days after the final conclusion of a Proceeding, including
`
`all appeals, all Protective Order Material received in the context of that Proceeding
`
`(and no other ongoing Proceedings), and all copies of the same, shall be destroyed.
`
`This includes all notes, memoranda or other documents that summarize, discuss or
`
`quote materials produced and designated as Protective Order Material, except that,
`
`with respect to word processing and database tapes and disks, the receiving Party
`
`shall not be required to destroy or erase such tapes or disks unless otherwise
`
`practicable and not unduly burdensome. Outside counsel of record in the
`
`
`
`
`9
`
`
`
`Proceeding for each Party may retain (even if such documents or things contain
`
`Protective Order Material), all correspondence; papers filed with the Board in the
`
`Proceeding; deposition, hearing, and trial transcripts; and attorney work product
`
`provided that all such documents shall remain subject to this Protective Order. In
`
`particular, such counsel, and employees of such counsel, shall not disclose any
`
`Protective Order Material contained in such correspondence, papers, transcripts, or
`
`attorney work product to any person or entity except pursuant to a written
`
`agreement with the producing Party or by order of the Board. Outside counsel of
`
`record shall make certification of compliance herewith and shall deliver the same
`
`to outside counsel of record for the producing Party not more than 120 days after
`
`conclusion of the Proceeding, including all appeals.
`
`9.
`
`Nothing herein shall restrict any counsel from advising his or her
`
`client with respect to these Proceedings, or from relying in a general way upon an
`
`examination of material designated pursuant to this Protective Order in giving such
`
`advice; provided, however, that in giving such advice and communicating with the
`
`client, counsel shall not disclose the contents of any confidential information
`
`designated according to Paragraph 1, except as permitted under the provisions of
`
`this Protective Order, any order of the Board, or any Court order.
`
`10.
`
`Survival. This Protective Order shall survive and remain in full force
`
`and effect after termination of these Proceedings. Neither the termination of these
`
`
`
`
`10
`
`
`
`Proceedings nor the termination of employment of any person with access to any
`
`Protective Order Material shall relieve such person from the obligation of
`
`maintaining the confidentiality of such information.
`
`11. Pending Entry by the Board. Until such time as this Protective Order
`
`has been entered by the Board, the Parties agree that upon execution by the Parties,
`
`it will be treated as though it had been entered. To the extent the Parties have
`
`agreed on the terms of this Stipulated Protective Order, such stipulation is for the
`
`Board’s consideration and approval as a Stipulated Protective Order.
`
`12. Acknowledgement of Protective Order. The following form may be
`
`used to acknowledge the Protective Order and gain access to information covered
`
`by this Protective Order:
`
`
`
`
`
`
`
`
`11
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`KASHIV PHARMA, LLC,
`Petitioner,
`
`v.
`
`PURDUE PHARMA L.P.,
`THE P.F. LABORATORIES, INC., and
`PURDUE PHARMACEUTICALS L.P.,
`
`Patent Owners.
`____________________
`
`Case IPR2018-00625
`Case IPR2018-00717
`U.S. Patent No. 9,492,392
`U.S. Patent No. 9,492,393
`_____________________
`Acknowledgment for Access to Protective Order Material
`
`
`
`12
`
`
`
`
`
`
`
`
`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.
`
`Signed ______________________________
`
`
`
`
`
`
`
`13
`
`
`
`
`
`
`
`EXHIBIT B
`
`EXHIBIT B
`
`
`
`Standing Protective Order
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________
`KASHIV PHARMA, LLC,
`Petitioner,
`
`v.
`
`PURDUE PHARMA L.P.,
`THE P.F. LABORATORIES, INC., and
`PURDUE PHARMACEUTICALS L.P.,
`
`Patent Owners.
`____________________
`
`Case IPR2018-00625
`Case IPR2018-00717
`U.S. Patent No. 9,492,392
`U.S. Patent No. 9,492,393
`_____________________
`
`This standingSTIPULATED PROTECTIVE ORDER
`
`
`
`It is stipulated and agreed by and between Petitioner Kashiv Pharma, LLC
`
`and Patent Owners Purdue Pharma L.P., The P.F. Laboratories, Inc., and Purdue
`
`Pharmaceuticals L.P. (collectively, “Parties,” and individually, a “Party”), and
`
`subject to the approval of the Patent Trial and Appeal Board (the “Board”), that the
`
`following provisions shall control the disclosure, dissemination, and use of
`
`confidential information in the above-captioned proceedings (collectively,
`
`“Proceedings,” and, individually, a “Proceeding”):
`
`1.
`
`This Protective Order governs the treatment and filing of confidential
`
`information in the Proceedings, including documents and testimony, 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.
`
`12. Confidential information shall be clearly marked ‘‘“PROTECTIVE
`
`ORDER MATERIAL.’’,” “CONFIDENTIAL,” or “HIGHLY CONFIDENTIAL”
`
`and is referred to herein as “Protective Order Material.”
`
`3.
`
`Any Party producing Protective Order Material pursuant to the
`
`provisions of this Protective Order may designate such information (according to
`
`Paragraph 1) if such Party in good faith believes it to be so competitively sensitive
`
`that it is entitled to extraordinary protections. Any summary, compilation, notes,
`
`memoranda, analysis, or copy containing Protective Order Material and any
`
`
`
`electronic image or database containing Protective Order Material shall be
`
`considered Protective Order Material to the same extent as the material or
`
`information from which such summary, compilation, notes, copy, memoranda,
`
`analysis, electronic image, or database is derived. Examples of the types of
`
`information that may be requested in discovery and designated as “Protective
`
`Order Material” if produced include, but are not limited to:
`
`(i)
`
`The names, or other information tending to reveal the identities,
`
`of a Party’s suppliers, present or prospective customers, or distributors or the
`
`personal information of a Party’s employees;
`
`(ii)
`
`Information relating to pending patent applications;
`
`(iii) Financial information of a Party, including, but not limited to,
`
`identifying the number of products sold, total dollar value of products sold,
`
`and profit margins for products, both forecasted and actual;
`
`(iv)
`
`Information constituting product specifications, formulations,
`
`and/or regarding the manufacture of the Party’s products;
`
`(v)
`
`Technical notebooks and technical reports of a Party, including
`
`product and manufacturing specifications, schematic diagrams, technical
`
`reference manuals, operations manuals, or other similar information;
`
`(vi) Confidential marketing plans, market research, and business
`
`strategy, including research regarding competitors;
`
`2
`
`
`
`(vii)
`
`Information the Producing Party believes is a proprietary trade
`
`secret;
`
`(viii) Personal information and/or identities of physicians and
`
`patients;
`
`(ix) All information relating to a Party’s research and development
`
`efforts leading to the creation of its products; and
`
`(x) Abbreviated New Drug Applications (including any
`
`supplements or amendments), confidential portions of New Drug
`
`Applications, or Drug Master Files.
`
`24. 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) 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.
`
`(i)
`
`Author/Party: The author of the confidential information or
`
`Party who produced the confidential information.
`
`(ii)
`
`Party Representatives. Outside counsel for a Party in the
`
`3
`
`
`
`Proceedings or in Civil Action No. 15-1152 (RGA) (SRF) (consolidated)
`
`pending in the United States District Court for the District of Delaware.
`
`(iii) Experts. The following applies for each independent expert and
`
`consultant to whom Protective Order Material is to be given, shown,
`
`disclosed, made available, or communicated in any way:
`
`(a)
`
`Such expert or consultant shall first read this Protective
`
`Order and sign the Acknowledgement of Protective Order of
`
`Paragraph 12 below (“Acknowledgement”).
`
`(b) At least five (5) business days prior to the receiving Party
`
`giving, showing, disclosing, making available, or communicating
`
`Protective Order Material to any expert or consultant, the receiving
`
`Party shall deliver (by electronic mail) to the producing Party a copy
`
`of the signed Acknowledgement and a resume, curriculum vitae, or
`
`description setting forth the person’s (1) name, (2) residence and
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`office addresses, (3) present employer, job title and job description,
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`(4) any consulting activities within the last five years relating to the
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`pharmaceutical industry, (5) any relationship to the Parties in this
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`action, and (6) a brief job history for the past five years.
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`(c)
`
`If a Party has a good faith basis for believing it would be
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`harmed by any proposed disclosure of Protective Order Material, the
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`4
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`
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`Party shall be entitled to object to such disclosure within five (5)
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`business days after service of the information called for in the
`
`preceding sentence. Objections must be in writing and state with
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`particularity the basis for the objection.
`
`(d)
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`In the event of such an objection to disclosure of
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`Protective Order Material, the Parties shall meet and confer within
`
`three (3) business days to attempt to resolve the concerns giving rise
`
`to the objection. If the Parties are unable to reach an agreement
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`regarding such disclosure, the Party objecting to disclosure may,
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`within five (5) business days of the meet and confer, request that the
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`Board issue an order barring such disclosure. The objecting Party
`
`shall have the burden of showing why that person should not have
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`access to Protective Order Material. Pending resolution of any such
`
`motion or application, no disclosure of Protective Order Material shall
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`be made to that person.
`
`(E)iv) 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,Party who sign the Acknowledgement shall be extended
`
`access to confidential information of the opposing Party only upon
`
`agreement of the partiesParties or by order of the Board upon a motion
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`5
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`
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`brought by the partyParty seeking to disclose confidential information to that
`
`person. The party opposingParty seeking disclosure to that person shall have
`
`the burden of proving that such person should be restricted from access to
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`confidential informationdisclosure is necessary.
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`(F)v) 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
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`representatives shall include the Director, members of the Board and their
`
`clerical staff, other support personnel, court reporters, and other persons
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`acting on behalf of the Office.
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`(vi) No more than three (3) designated in-house counsel for the
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`Petitioner and no more than three (3) designated in-house counsel
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`(collectively) for the Patent Owners, who have signed the
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`Acknowledgement, and who, for the duration of three years after the
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`conclusion of any Proceeding in connection with which such counsel
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`received Protective Order Information, including appeals, will not engage
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`directly in the drafting, crafting, or amending of patent claims before the
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`United States Patent and Trademark Office involving oxycodone.
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`Notwithstanding the foregoing, nothing herein shall preclude designated in-
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`house counsel from being involved in post-grant proceedings before the
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`6
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`
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`Board under 35 U.S.C. § 311 et seq. or 35 U.S.C. § 321 et seq. with respect
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`to the patents involving oxycodone. Said in-house counsel identified below:
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`In-House Counsel for Petitioner: Joseph P. Pieroni.
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`In-House Counsel for Patent Owner: Bruce J. Koch.
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`(G)vii)
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`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
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`not be required to sign an Acknowledgement, but shall be informed of the
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`terms and requirements of the Protective Order by the person they are
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`supporting who receives confidential information.
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`35.
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`Persons receiving confidential informationProtective Order Material shall
`
`use reasonable efforts to maintain the confidentiality of the informationsuch
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`Protective Order Material, including:
`
`(A)i) Maintaining such information in a secure location to which
`
`persons not authorized to receive the information shall not have access;
`
`(B)ii) Otherwise using reasonable efforts to maintain the
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`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 partyParty;
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`(C)iii) Ensuring that support personnel of the recipient who have
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`7
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`
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`access to the confidential information understand and abide by the obligation
`
`to maintain the confidentiality of information received that is designated as
`
`confidential; and
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`(D)iv) Limiting the copying of confidential information to a
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`reasonable number of copies needed for conduct of the proceeding and
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`maintaining a record of the locations of such copies.
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`46.
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`Persons receiving confidential informationProtective Order Material shall
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`use the following procedures to maintain the confidentiality of the information:
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`(A)i) Documents and Information Filed Withinformation filed with the
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`Board.
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`(ia) A party may file documents or informationParty shall file
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`Protective Order Material with the Board under seal, together with a non-
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`confidential description of the nature of the confidential information that is under
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`seal andwith availability limited to the Board and the Parties, together
`
`with a Motion to Seal (attaching this Protective Order) setting forth
`
`the reasons why the information contained therein is confidential and
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`should not be made available to the public. The
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`submissionshallsubmission of Protective Order Material shall be treated
`
`as confidential and remain under seal, unless, upon motion of a
`
`partyParty and after a hearing on the issue, or sua sponte, the Board
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`8
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`
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`determines that the documents or information do not to qualify for
`
`confidential treatment.
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`(ii) Where confidentiality is alleged as to
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`(b) Where confidentiality is alleged as to some but not all of
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`the information submitted to the Board, the submitting partyParty shall
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`file confidential and non-confidential versions of its submission,
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`together with a Motion to Seal the confidential version (attaching this
`
`Protective Order) setting forth the reasons why the information
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`redacted from the non-confidential version is confidential and should
`
`not be made available to the public. The nonconfidentialnon-confidential
`
`version of the submission shall clearly indicate the locations of
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`information that has been redacted. The confidential version of the
`
`submission shall be filed under seal, with availability limited to the
`
`Board and the Parties. The redacted information shall remain under
`
`seal unless, upon motion of a partyParty 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.
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`(B)ii) Documents and Information Exchanged Among the Parties.information exchanged
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`among the parties: Information designated as confidentialProtective Order Material
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`9
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`
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`by a Party that is disclosed to another partyParty during discovery or other
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`proceedings before the Boardotherwise shall be clearly marked as
`
`according to Paragraph 1 ‘‘PROTECTIVE ORDER MATERIAL’’ and shall
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`be produced in a manner that maintains its confidentiality.
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`7.
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`No limitations on Party’s use of its own information: Except as
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`specifically noted herein, this Protective Order shall not limit a producing Party’s
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`use of its own Protective Order Material.
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`8. Within 90 days after the final conclusion of a Proceeding, including
`
`all appeals, all Protective Order Material received in the context of that Proceeding
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`(and no other ongoing Proceedings), and all copies of the same, shall be destroyed.
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`This includes all notes, memoranda or other documents that summarize, discuss or
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`quote materials produced and designated as Protective Order Material, except that,
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`with respect to wor
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