IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`Accord Healthcare Inc., USA, Accord Healthcare, Inc., Intas
`Pharmaceuticals Ltd., Amneal Pharmaceuticals LLC, Amneal
`Pharmaceuticals of New York, LLC, Amneal Pharmaceuticals Co. India
`Pvt. Ltd., Apotex Corp., Apotex Inc., Dr. Reddy’s Laboratories, Ltd., Dr.
`Reddy’s Laboratories, Inc., Glenmark Generics Inc., USA, Glenmark
`Generics Ltd., Glenmark Pharmaceuticals Ltd., Panacea Biotec Ltd., Sun
`Pharma Global FZE, Teva Pharmaceuticals USA, Inc., Zydus
`Pharmaceuticals USA, Inc., and Cadila Healthcare Ltd.
`Petitioners
`
`v.
`
`Daiichi Sankyo Company, Limited, and Ube Industries, Ltd.
`Patent Owners
`
`U.S. Patent No. 8,569,325 B2 to Asai et al.
`Issue Date: October 29, 2013
`Title: Method of Treatment with Coadministration of
`Aspirin and Prasugrel
`_____________________
`
`Inter Partes Review No.: IPR2015-00865
`_____________________
`
`Petitioners’ Motion to Seal
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`Accord Healthcare Inc., USA, Accord Healthcare, Inc., Intas
`Pharmaceuticals Ltd., Amneal Pharmaceuticals LLC, Amneal
`Pharmaceuticals of New York, LLC, Amneal Pharmaceuticals Co. India
`Pvt. Ltd., Apotex Corp., Apotex Inc., Dr. Reddy’s Laboratories, Ltd., Dr.
`Reddy’s Laboratories, Inc., Glenmark Generics Inc., USA, Glenmark
`Generics Ltd., Glenmark Pharmaceuticals Ltd., Panacea Biotec Ltd., Sun
`Pharma Global FZE, Teva Pharmaceuticals USA, Inc., Zydus
`Pharmaceuticals USA, Inc., and Cadila Healthcare Ltd.
`Petitioners
`
`v.
`
`Daiichi Sankyo Company, Limited, and Ube Industries, Ltd.
`Patent Owners
`
`U.S. Patent No. 8,569,325 B2 to Asai et al.
`Issue Date: October 29, 2013
`Title: Method of Treatment with Coadministration of
`Aspirin and Prasugrel
`_____________________
`
`Inter Partes Review No.: IPR2015-00865
`_____________________
`
`Petitioners’ Motion to Seal
`
`
`
`
`Mail Stop "PATENT BOARD"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`USPN 8,404,325 B2 (IPR2015-00865)
`
`Pursuant to 37 C.F.R. § 42.54, Petitioners respectfully move to seal portions
`
`of Petitioners’ Authorized Reply Brief to Patent Owners’ Preliminary Response
`
`(“the Brief”), portions of the Declaration of Kevin Zive (Exhibit 1049, “the
`
`Declaration”), and the entirety of Exhibits 1050, 1051, 1052, 1055, 1056, 1057,
`
`and 1058 (“the Confidential Exhibits”), which Petitioners are filing concurrently
`
`with this motion. Counsel for Petitioners have conferred with counsel for Patent
`
`Owners, who have agreed to entry of the Board’s Default Protective Order
`
`(Appendix A), and, pursuant to Section 4(A)(ii) of that Order, Petitioners are also
`
`filing partially-redacted public versions of the Brief and the Declaration.
`
`I.
`
`Good cause exists for sealing Petitioners’ confidential information.
`
`The Office Patent Trial Practice Guide provides that “the rules aim to strike
`
`a balance between
`
`the public’s
`
`interest
`
`in maintaining a complete and
`
`understandable file history and the parties’ interest in protecting truly sensitive
`
`information.” 77 Fed. Reg. 48,756, 48,760 (Aug. 14, 2012). Under the Board’s
`
`Rules, “confidential information [is identified] in a manner consistent with Federal
`
`Rule of Civil Procedure 26(c)(1)(G), which provides for protective orders for trade
`
`secret or other confidential research, development, or commercial information.”
`
`Id. (citing 37 C.F.R. § 42.54).
`
`As explained in the Brief, Petitioners identified all real parties-in-interest to
`
`this proceeding in their Petition (Paper 10). Patent Owners allege that another
`
`
`
`
`
`
`
`USPN 8,404,325 B2 (IPR2015-00865)
`
`entity, Apotex Holdings Inc., is a real party-in-interest. See Paper 17. On June 24,
`
`2015, by email, the Board authorized Petitioners to file a 10-page reply brief to
`
`Patent Owners’ Preliminary Response by July 8, 2015. Petitioners are submitting
`
`the Brief, the Declaration, and related Exhibits in response to the Board’s June 24,
`
`2015, order. The Brief and the Declaration delineate and discuss in detail the
`
`evidence that shows that the Apotex Petitioners (Apotex Inc. and Apotex Corp.)
`
`control the prosecution, direction, and funding of this proceeding on their own
`
`behalf, and that Apotex Holdings has not had, and will not have, any involvement,
`
`control, or influence in this proceeding. See, e.g., TRW Auto. US LLC v. Magna
`
`Elecs. Inc., IPR2014-01497, Paper 7, at 8-11 (PTAB Mar. 19, 2015).
`
`The narrowly-tailored excerpts of the Brief and the Declaration that
`
`Petitioners seek to seal, and the Confidential Exhibits, contain confidential and
`
`business-sensitive details of the Apotex Petitioners’ organizational structure,
`
`business processes, financing, and corporate and legal operations. The Apotex
`
`Petitioners have a strong interest in maintaining the confidentiality of this
`
`information. Conversely, there is no countervailing interest that would counsel
`
`against granting the present motion. Patent Owners do not oppose entry of the
`
`default protective order. And, the sealed information has nothing to do with the
`
`underlying substantive matters and questions at issue in the underlying Petition.
`
`Therefore, granting the present motion will have no effect on the public’s interest
`
`2
`
`
`
`USPN 8,404,325 B2 (IPR2015-00865)
`
`in “maintaining a complete and understandable file history.” 77 Fed. Reg. at
`
`48,760. On the contrary, the confidential portions of the Brief and the Declaration,
`
`and the Confidential Exhibits, relate only to the non-public internal operations of
`
`the Apotex Petitioners.
`
`II. Certification of non-publication
`On behalf of Petitioners, undersigned counsel certifies that the information
`
`identified as confidential and sought to be sealed has not, to their knowledge, been
`
`published or otherwise made public.
`
`III. Certification of conference with Patent Owners
`Pursuant to 37 C.F.R. § 42.54 and the Default Protective Order, counsel for
`
`Petitioners have conferred in good faith with counsel for Patent Owners, and the
`
`parties have agreed to entry of the Board’s Default Protective Order, attached as
`
`Appendix A.
`
`IV. Conclusion
`For the foregoing reasons, Petitioners respectfully request that the Board seal
`
`the confidential versions of the Brief and the Declaration (Exhibit 1049), and
`
`Exhibits 1050, 1051, 1052, 1055, 1056, 1057, and 1058, which Petitioners are
`
`filing concurrently with this motion.
`
`
`
`3
`
`
`
`USPN 8,404,325 B2 (IPR2015-00865)
`
`
`
`Respectfully submitted,
`
`
` /Samuel S. Park/
`Samuel S. Park
`Reg. No. 59,656
`Lead Counsel for Petitioners
`
`Dated: July 8, 2015
`
`
`
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
`Fax: (312) 558-5700
`Email: Prasugrel-IPR@winston.com
`
`
`
`
`
`
`
`
`
` CERTIFICATION OF SERVICE ON PATENT OWNERS
`
`I certify that, on July 8, 2015, I caused to be served true and correct copies
`
`of the foregoing “Petitioners’ Motion to Seal” through the Patent Review
`
`Processing System and electronic mail on the following attorneys:
`
`
`Dov P. Grossman
`Reg. No. 72,525
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`Washington, D.C. 20005
`202-434-5812 (Telephone)
`202-434-5029 (Facsimile)
`dgrossman@wc.com
`Effient-IPR@wc.com
`
`Lead Counsel for Patent Owners
`
`
`
`
`
`
`Dated: July 8, 2015
`
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
`Fax: (312) 558-5700
`Email: Prasugrel-IPR@winston.com
`
`Andrew V. Trask
`Reg. No. 59,239
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`Washington, D.C. 20005
`202-434-5098 (Telephone)
`202-434-5029 (Facsimile)
`atrask@wc.com
`Effient-IPR@wc.com
`
`Backup Counsel for Patent Owners
`
`Respectfully submitted,
`
` /Samuel S. Park/
`Samuel S. Park
`Reg. No. 59,656
`
`Lead Counsel for Petitioners
`
`
`
`
`
`
`
`
`
`
`
`
`
`APPENDIX A
`
`APPENDIX A
`
`DEFAULT PROTECTIVE ORDER
`
`DEFAULT PROTECTIVE ORDER
`
`77 Fed. Reg. 48,756, 48,771 (Aug. 14, 2012)
`77 Fed. Reg. 48,756, 48,771 (Aug. 14, 2012)
`
`
`
`
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`Accord Healthcare Inc., USA, Accord Healthcare, Inc., Intas
`Pharmaceuticals Ltd., Amneal Pharmaceuticals LLC, Amneal
`Pharmaceuticals of New York, LLC, Amneal Pharmaceuticals Co. India
`Pvt. Ltd., Apotex Corp., Apotex Inc., Dr. Reddy’s Laboratories, Ltd., Dr.
`Reddy’s Laboratories, Inc., Glenmark Generics Inc., USA, Glenmark
`Generics Ltd., Glenmark Pharmaceuticals Ltd., Panacea Biotec Ltd., Sun
`Pharma Global FZE, Teva Pharmaceuticals USA, Inc., Zydus
`Pharmaceuticals USA, Inc., and Cadila Healthcare Ltd.
`Petitioners
`
`v.
`
`Daiichi Sankyo Company, Limited, and Ube Industries, Ltd.
`Patent Owners
`
`U.S. Patent No. 8,569,325 B2 to Asai et al.
`Issue Date: October 29, 2013
`Title: Method of Treatment with Coadministration of
`Aspirin and Prasugrel
`_____________________
`
`Inter Partes Review No.: IPR2015-00865
`_____________________
`
`Protective Order
`
`Finding good cause exists to enter a Protective Order governing the
`
`disclosure and treatment of confidential information produced in this inter partes
`
`review, it is ordered:
`
`1. Confidential information shall be clearly marked “PROTECTIVE
`A1
`
`
`
`
`
`
`
`ORDER MATERIAL.”
`
`2. 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.
`
`(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 person shall have
`
`the burden of proving that such person should be restricted from access to
`
`confidential information.
`
`
`
`A2
`
`
`
`
`
`(F) The Office. Employees and representatives of the Office who have a
`
`need for access to the confidential information shall have such access without the
`
`requirement to sign an Acknowledgement. Such employees and representatives
`
`shall include the Director, members of the Board and their clerical staff, other
`
`support personnel, court reporters, and other persons acting on behalf of the Office.
`
`(G) Support Personnel. Administrative assistants, clerical staff, court
`
`reporters and other support personnel of the foregoing persons who are reasonably
`
`necessary to assist those persons in the proceeding shall not be required to sign an
`
`Acknowledgement, but shall be informed of the terms and requirements of the
`
`Protective Order by the person they are supporting who receives confidential
`
`information.
`
`3. Persons receiving confidential information shall use reasonable efforts to
`
`maintain the confidentiality of the information, including:
`
`(A) Maintaining such information in a secure location to which persons not
`
`authorized to receive the information shall not have access;
`
`(B) Otherwise using reasonable efforts to maintain the confidentiality of the
`
`information, which efforts shall be no less rigorous than those the recipient uses to
`
`maintain the confidentiality of information not received from the disclosing party;
`
`(C) Ensuring that support personnel of the recipient who have access to the
`
`confidential information understand and abide by the obligation to maintain the
`
`
`
`A3
`
`
`
`
`
`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.
`
`4. Persons receiving confidential information shall use the following
`
`procedures to maintain the confidentiality of the information:
`
`(A) Documents and Information Filed With the Board.
`
`(i) A party may file documents or information with the Board under seal,
`
`together with a non-confidential description of the nature of the confidential
`
`information that is under seal and the reasons why the information is confidential
`
`and should not be made available to the public. The submission shall be treated as
`
`confidential and remain under seal, unless, upon motion of a party and after a
`
`hearing on the issue, or sua sponte, the Board determines that the documents or
`
`information do not to qualify for confidential treatment.
`
`(ii) Where confidentiality is alleged as to some but not all of the information
`
`submitted to the Board, the submitting party shall file confidential and non-
`
`confidential 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 non-confidential version of the submission shall clearly indicate the
`
`
`
`A4
`
`
`
`
`
`locations of information that has been redacted. The confidential version of the
`
`submission shall be filed under seal. The redacted information shall remain under
`
`seal unless, upon motion of a party and after a hearing on the issue, or sua sponte,
`
`the Board determines that some or all of the redacted information does not qualify
`
`for confidential treatment.
`
`(B)
`
` Documents and Information Exchanged Among
`
`the Parties.
`
`Information designated as confidential that is disclosed to another party during
`
`discovery or other proceedings before the Board shall be clearly marked as
`
`“PROTECTIVE ORDER MATERIAL” and shall be produced in a manner that
`
`maintains its confidentiality.
`
`(j) Standard Acknowledgement of Protective Order. The following form
`
`may be used to acknowledge a protective order and gain access to information
`
`covered by the protective order:
`
`
`
`
`
`[ACKNOWLEDGMENT FORM ON NEXT PAGE]
`
`A5
`
`
`
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`Accord Healthcare Inc., USA, Accord Healthcare, Inc., Intas
`Pharmaceuticals Ltd., Amneal Pharmaceuticals LLC, Amneal
`Pharmaceuticals of New York, LLC, Amneal Pharmaceuticals Co. India
`Pvt. Ltd., Apotex Corp., Apotex Inc., Dr. Reddy’s Laboratories, Ltd., Dr.
`Reddy’s Laboratories, Inc., Glenmark Generics Inc., USA, Glenmark
`Generics Ltd., Glenmark Pharmaceuticals Ltd., Panacea Biotec Ltd., Sun
`Pharma Global FZE, Teva Pharmaceuticals USA, Inc., Zydus
`Pharmaceuticals USA, Inc., and Cadila Healthcare Ltd.
`Petitioners
`
`v.
`
`Daiichi Sankyo Company, Limited, and Ube Industries, Ltd.
`Patent Owners
`
`U.S. Patent No. 8,569,325 B2 to Asai et al.
`Issue Date: October 29, 2013
`Title: Method of Treatment with Coadministration of
`Aspirin and Prasugrel
`_____________________
`
`Inter Partes Review No.: IPR2015-00865
`_____________________
`
`Acknowledgment 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
`
`
`
`A6
`
`
`
`
`
`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:
`
`Name:
`
`Date:
`
`
`
`
`
`
`
`
`
`A7
`
`
`
`
`
`
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