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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
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`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,
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`Petitioners,
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` v.
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`NOVARTIS AG,
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`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
`
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` 1 Cases IPR2017-01550, IPR2017-01946, and IPR2017-01929 have been joined
`with this proceeding.
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`Apotex v. Novartis
`IPR2017-00854
`NOVARTIS 2074
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`The following Protective Order governs the treatment and filing of
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`confidential information, including documents and testimony in the instituted Inter
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`Partes Review captioned above.
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`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
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`or contains (i) confidential, proprietary, or commercially sensitive information; or
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`(ii) confidential information of a non-party that the producing party is bound to
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`maintain in confidence pursuant to a separate confidentiality agreement or court
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`order and 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,
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`marketing, financial, pricing, or sales information; (ii) any confidential,
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`proprietary, or commercially sensitive information that the producing party
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`believes in good faith will result in significant risk of competitive disadvantage or
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`harm if disclosed to another party without restriction upon use or further
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`disclosure, or that affords the producing party an actual or potential economic
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`advantage over others; or (iii) third party settlement agreements and
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`communications, including discussions or negotiations regarding potential
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`settlements.
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`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) Parties. Persons who are owners of a patent involved in the proceeding
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`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 in the proceeding who sign the
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`Acknowledgement (attached).
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`(D) 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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`performing work for a party, other than in-house counsel and in-house counsel’s
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`support staff, who sign the Acknowledgement shall be extended access to
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`confidential information only upon agreement of the parties or by order of the
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`Board upon a motion brought by the party seeking to disclose confidential
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`information to that person. The party opposing disclosure to that person shall have
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`the burden of proving that such person should be restricted from access to
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`confidential information.
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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) 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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`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
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`need 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
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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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`6.
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`Persons receiving confidential information shall use reasonable efforts
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`to maintain the confidentiality of the information, including:
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`(A) Maintaining such information in a secure location to which persons not
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`authorized to receive the information shall not have access;
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`(B) Otherwise using reasonable efforts to maintain the confidentiality of the
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`information, which efforts shall be no less rigorous than those the recipient uses to
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`maintain the confidentiality of information not received from the disclosing party;
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`(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) Limiting the copying of confidential information to a reasonable number
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`of copies needed for conduct of the proceeding and maintaining a record of the
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`locations of such copies.
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`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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`(A) Documents and Information Filed With the Board.
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`(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) Where confidentiality is alleged as to some but not all of the information
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`submitted to the Board, the submitting party shall file confidential and non-
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`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
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`the 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,
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`the Board determines that some or all of the redacted information does not qualify
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`for confidential treatment.
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`(B) Documents and Information Exchanged Among the Parties. Information
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`designated as confidential that is disclosed to another party during discovery or
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`other proceedings before the Board shall be clearly marked as “PROTECTIVE
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`ORDER MATERIAL” or “OUTSIDE ATTORNEYS’ EYES ONLY –
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`PROTECTIVE ORDER MATERIAL” and shall be produced in a manner that
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`maintains its confidentiality.
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`8. Nothing herein shall bar or otherwise restrict counsel from rendering
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`advice to his or her client with respect to this Inter Partes Review, and in the course
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`thereof, from generally referring to or relying upon PROTECTIVE ORDER
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`MATERIAL or OUTSIDE ATTORNEYS’ EYES ONLY – PROTECTIVE
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`ORDER MATERIAL. In rendering advice or otherwise communicating with his
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`or her client, counsel shall not disclose the specific content of any PROTECTIVE
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`ORDER MATERIAL or OUTSIDE ATTORNEYS’ EYES ONLY –
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`PROTECTIVE ORDER MATERIAL where such disclosure would not otherwise
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`be permitted under the terms of this Protective Order.
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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
`____________________________
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`STANDARD ACKNOWLEDGEMENT FOR
`ACCESS TO PROTECTIVE ORDER MATERIAL
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` _____________________, affirm that I have read the Protective Order; that I will
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` I
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`abide by its terms; that I will use the confidential information only in connection
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`with this proceeding and for no other purpose; that I will only allow access to
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`support staff who are reasonably necessary to assist me in this proceeding; that
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`prior 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
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`District of Virginia for purposes of enforcing the terms of the Protective Order and
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`providing remedies for its breach.
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`__________________________
`Signature
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`__________________________
`Date
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`10
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