`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC., SUN
`PHARMACEUTICAL INDUSTRIES, LTD., SUN PHARMACEUTICAL
`INDUSTRIES, INC., AND SUN PHARMA GLOBAL FZE,
`
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`
`Patent Owner.
`______________________
`Case IPR2017-008541
`U.S. Patent No. 9,187,405
`______________________
`STIPULATED PROTECTIVE ORDER
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been joined
`with this proceeding.
`
`1
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`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2075
`
`
`
`The following Protective OrderThis standing protective order governs the
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`treatment and filing of confidential information, including documents and testimony
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`in the instituted Inter Partes Review captioned above.
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`1. 1. Confidential information shall be clearly marked “PROTECTIVE
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`ORDER MATERIAL.”,” or “OUTSIDE ATTORNEYS’ EYES ONLY –
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`PROTECTIVE ORDER MATERIAL.” Unless otherwise agreed by the Parties,
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`“PROTECTIVE ORDER MATERIAL” and “OUTSIDE ATTORNEYS’ EYES
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`ONLY – PROTECTIVE ORDER MATERIAL” shall be used by a receiving party
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`solely for this proceeding, and shall not be used for any other purpose whatsoever.
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`2. “PROTECTIVE ORDER MATERIAL” designates material that reflects or
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`contains (i) confidential, proprietary, or commercially sensitive information; or (ii)
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`confidential information of a non-party that the producing party is bound to maintain
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`in confidence pursuant to a separate confidentiality agreement or court order and
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`that the producing party is permitted to produce in this proceeding.
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`3. “OUTSIDE ATTORNEYS’ EYES ONLY – PROTECTIVE ORDER
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`MATERIAL” designates material that reflects or contains any of the following
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`categories of information: (i) highly sensitive business planning, trading, marketing,
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`financial, pricing, or sales information; (ii) any confidential, proprietary, or
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`commercially sensitive information that the producing party believes in good faith
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`2
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`will result in significant risk of competitive disadvantage or harm if disclosed to
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`another party without restriction upon use or further disclosure, or that affords the
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`producing party an actual or potential economic advantage over others; or (iii) third
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`party settlement agreements and communications, including discussions or
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`negotiations regarding potential settlements.
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`2. 4. Access to confidential information marked “PROTECTIVE ORDER
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`MATERIAL” is limited to the following individuals who have executed the
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`acknowledgment appended to this order:
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`(A) (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) (B) Party Representatives. Representatives of record for a party in the
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`proceeding.
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`(C) (C) Experts. Retained experts of a party in the proceeding who further
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`certify insign the Acknowledgement that they are not a competitor to any party, or a
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`consultant for, or employed by, such a competitor with respect to the subject matter of the
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`proceeding(attached).
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`(D) (D) In-house counsel. In-house counsel of a party.
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`(E) (E) Other Employees of a Party. Employees, consultants or other
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`3
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`persons performing work for a party, other than in-house counsel and
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`in-house counsel’s support staff, who sign the Acknowledgement shall be
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`extended access to confidential information only upon agreement of the
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`parties or by order of the Board upon a motion brought by the party
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`seeking to disclose confidential information to that person. The party
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`opposing disclosure to that person shall have the burden of proving that
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`such person should be restricted from access to confidential information.
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`(F)
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`(F) The Office. Employees and representatives of the Office who have a need
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`for access to the confidential information shall have such access without the
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`requirement to sign an Acknowledgement. Such employees and representatives
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`shall include the Director, members of the Board and their clerical staff, other
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`support personnel, court reporters, and other persons acting on behalf of the Office.
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`(G)
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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 reasonably
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`necessary to assist those persons in the proceeding shall not be required to sign an
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`Acknowledgement, but shall be informed of the terms and requirements of the
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`Protective Order by the person they are supporting who receives confidential
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`information.
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`4
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`5. Access to Confidential information marked “OUTSIDE ATTORNEYS’
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`EYES ONLY – PROTECTIVE ORDER MATERIAL” is limited to the following
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`individuals:
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`(A) Party Representatives. Representatives of record for a party in the
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`proceeding.
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`(B) Experts. Retained experts of a party in the proceeding who sign the
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`Acknowledgement (attached).
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`(C) In-house counsel. One in-house counsel of a party.
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`(D) The Office. Employees and representatives of the Office who have a need
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`for access to the confidential information shall have such access without the
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`requirement to sign an Acknowledgement. Such employees and representatives
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`shall include the Director, members of the Board and their clerical staff, other
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`support personnel, court reporters, and other persons acting on behalf of the Office.
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`(E) 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
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`Acknowledgement, but shall be informed of the terms and requirements of the
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`5
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`Protective Order by the person they are supporting who receives confidential
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`information.
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`3. 6. 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) (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) (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 recipient uses
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`to maintain the confidentiality of information not received from the disclosing party;
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`(C) (C) Ensuring that support personnel of the recipient who have access to the
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`confidential information understand and abide by the obligation to maintain the
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`confidentiality of information received that is designated as confidential; and
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`(D) (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 record of
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`the locations of such copies.
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`4. 7. Persons receiving confidential information shall use the following
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`procedures to maintain the confidentiality of the information:
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`6
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`
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`(A) (A) Documents and Information Filed With the Board.
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`(i) (i) A party may file documents or information with the Board under seal,
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`together with a non-confidential description of the nature of the confidential
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`information that is under seal and the reasons why the information is confidential
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`and should not be made available to the public. The submission shall be treated as
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`confidential and remain under seal, unless, upon motion of a party and after a
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`hearing on the 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) (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 confidential and
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`non- confidential versions of its submission, together with a Motion to Seal the
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`confidential version setting forth the reasons why the information redacted from the
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`non-confidential version is confidential and should not be made available to the
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`public. The nonconfidential version of the submission shall clearly indicate the
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`locations of information that has been redacted. The confidential version of the
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`submission shall be filed under seal. The redacted information shall remain under
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`seal unless, upon motion of a party and after a hearing on the issue, or sua sponte, the
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`Board determines that some or all of the redacted information does not qualify for
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`confidential treatment.
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`7
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`(B) (B) Documents and Information Exchanged Among the Parties.
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`Information designated as confidential that is disclosed to another party during
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`discovery or other proceedings before the Board shall be clearly marked as
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`“PROTECTIVE ORDER MATERIAL” or “OUTSIDE ATTORNEYS’ EYES
`
`ONLY – PROTECTIVE ORDER MATERIAL” and shall be produced in a manner
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`that maintains its confidentiality.
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`(j) Standard Acknowledgement of Protective Order. The following form may be used to
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`acknowledge a protective order and gain access to information covered by the protective
`
`order:
`
`[CAPTION]
`8. Nothing herein shall bar or otherwise restrict counsel from rendering advice
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`to his or her client with respect to this Inter Partes Review, and in the course thereof,
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`from generally referring to or relying upon PROTECTIVE ORDER MATERIAL or
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`OUTSIDE ATTORNEYS’ EYES ONLY – PROTECTIVE ORDER MATERIAL.
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`In rendering advice or otherwise communicating with his or her client, counsel shall
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`not disclose the specific content of any PROTECTIVE ORDER MATERIAL or
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`OUTSIDE ATTORNEYS’ EYES ONLY – PROTECTIVE ORDER MATERIAL
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`where such disclosure would not otherwise be permitted under the terms of this
`
`Protective Order.
`
`8
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`APOTEX INC., APOTEX CORP., ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA PHARMACEUTICALS USA, INC., SUN
`PHARMACEUTICAL INDUSTRIES, LTD., SUN PHARMACEUTICAL
`INDUSTRIES, INC., AND SUN PHARMA GLOBAL FZE,
`
`Petitioners,
`
`v.
`
`NOVARTIS AG,
`
`Patent Owner.
`______________________
`Case IPR2017-00854
`U.S. Patent No. 9,187,405
`____________________________
`
`Standard Acknowledgment for Access to Protective Order Material
`STANDARD ACKNOWLEDGEMENT FOR
`ACCESS TO PROTECTIVE ORDER MATERIAL
`
`I _____________________, affirm that I have read the Protective Order; that I will
`
`abide by its terms; that I will use the confidential information only in connection
`
`with this proceeding and for no other purpose; that I will only allow access to
`
`support staff who are reasonably necessary to assist me in this proceeding; that prior
`
`9
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`to any disclosure to such support staff I informed or will inform them of the
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`requirements of the Protective Order; that I am personally responsible for the
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`requirements of the terms of the Protective Order and I agree to submit to the
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`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
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`remedies for its breach.
`
`__________________________
`[Signature]
`
`__________________________
`Date
`
`10
`
`