`
`
`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
`______________________
`PATENT OWNER’S MOTION FOR ENTRY OF STIPULATED
`PROTECTIVE ORDER AND TO SEAL DOCUMENTS
`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
`
` 1
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`
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`with this proceeding.
`
`
`
`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`
`Pursuant to 37 C.F.R. § 42.54, Patent Owner Novartis AG respectfully
`
`
`
`submits this motion for entry of a stipulated protective order and to seal Exhibits
`
`2057 and 2063-66, which contain Novartis’s confidential information. In addition,
`
`Novartis moves to seal the portions of its Patent Owner’s Response and
`
`accompanying declarations (Exs. 2022, 2024-26) containing substantive reference
`
`to the above exhibits. Novartis has filed public, redacted versions of those
`
`documents and is serving Petitioners with both versions of each document.
`
`I. Motion for Entry of a Stipulated Protective Order
`Novartis moves for entry of a Stipulated Protective Order (Ex. 2074), which
`
`is an amended version of the Default Protective Order provided in Appendix B of
`
`the Trial Practice Guide, 77 Fed. Reg. 48756, 48771 (Aug. 14, 2012). A redlined
`
`version of the Default Protective Order showing where modifications have been
`
`made is attached hereto as Exhibit 2075. After conferring with Novartis, counsel for
`
`the Apotex Petitioners agreed to entry of the Stipulated Protective Order via email
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`on November 10, 2017.
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`The Stipulated Protective Order differs from the Default Protective Order by
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`addition of a category of confidential material to be marked “OUTSIDE
`
`ATTORNEY’S EYES ONLY – PROTECTIVE ORDER MATERIAL.” Access to
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`such material is restricted to outside counsel, experts, one in-house counsel of a
`
`party, and support personnel. (Ex. 2074 at 5.) An identical protective order was
`
`2
`
`
`
`
`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`
`
`entered by a similarly constituted panel of the Board in Torrent Pharms. Ltd. et al v.
`
`Novartis AG et al, IPR2014-00784, Paper 41 (May 7, 2015).
`
`Novartis is submitting one Exhibit with redactions required by Swiss law.
`
`Novartis has corresponded with Petitioners and if Petitioners wish to see the redacted
`
`information, Novartis reserves the right to seek confidentiality protections beyond
`
`those in the attached protective order before revealing that information to Petitioners.
`
`II. Motion to Seal
`Novartis seeks to file the documents under seal because they contain or make
`
`reference to non-public, sensitive business information. In the case of Exhibit 2057,
`
`the document describes the methods and results of confidential Novartis research
`
`that has not been publicly disclosed. Exhibits 2063-66 represent confidential
`
`communications with the FDA and/or disclose proprietary information regarding the
`
`design and execution of Novartis clinical trials. Novartis holds the information
`
`contained in these exhibits as confidential and takes precaution to prevent their
`
`distribution. Additionally, at least Exhibit 2057 contains redactions of specific
`
`personal information that is subject to Swiss Privacy Law and may not be distributed
`
`outside of Novartis. As a result, public disclosure of these documents could cause
`
`competitive business harm and good cause exists to seal them.
`
`As summarized below Exhibits 2057 and 2063-66 contain Novartis’s sensitive
`
`confidential information that Novartis maintains an interest in protecting:
`
`3
`
`
`
`
`
`Document Summary of Contents Good Cause for Filing Under Seal
`
`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`
`
`
`Ex. 2057
`
`Internal Novartis report
`summarizing highly
`confidential research
`
`Ex. 2063
`
`Ex. 2064
`
`Ex. 2065
`
`Ex. 2066
`
`Email between
`Novartis and clinical
`investigators discussing
`clinical trial strategy.
`Letter from Novartis to
`FDA communicating
`confidential clinical
`trial strategy.
`Email between
`Novartis and clinical
`investigators discussing
`clinical trial strategy.
`Letter from Novartis
`regulatory personnel to
`clinical investigators
`conveying confidential
`minutes from meetings
`with FDA.
`
`Constitutes sensitive technical research
`and development information, including
`test methods and data, and has been
`marked “Confidential” internally at
`Novartis.
`Constitutes confidential communications
`with potential investigators about
`confidential aspects of Novartis clinical
`trials.
`Constitutes information regarding clinical
`trial design and strategy as reflected in
`confidential regulatory communication.
`
`Constitutes confidential communications
`with potential investigators about
`confidential aspects of Novartis clinical
`trials.
`Constitutes confidential clinical trial
`design and strategy as reflected in
`confidential regulatory communication.
`
`In addition, Patent Owner moves to seal the portions of the Patent Owner’s
`
`Response and accompanying declarations of Lawrence Steinman (Ex. 2022),
`
`William Jusko (Ex. 2024), Fred Lublin (Ex. 2025), and Christian Schnell (Ex. 2026)
`
`containing substantive reference to the above exhibits.
`
`4
`
`
`
`
`
`
`
`CONCLUSION
`
`IPR2017-00854
`U.S. Patent No. 9,187,405
`
`
`For the foregoing reasons, the Novartis respectfully requests that the Board
`
`seal the aforementioned exhibits, and the unredacted versions of documents in which
`
`they are described, to protect the confidential information of the parties.
`
`
`
`Dated: November 13, 2017
`
`Respectfully submitted,
`
`/Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`Lead Counsel for Patent Owner
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue
`New York, New York 10166-0193
`jlove@gibsondunn.com
`Tel: 212-351-3922
`
`
`
`5
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on November 13, 2017,
`
`a true and accurate copy of PATENT OWNER’S MOTION FOR ENTRY OF
`
`STIPULATED PROTECTIVE ORDER AND TO SEAL DOCUMENTS was
`
`served via electronic mail on the following counsel of record for Petitioners:
`
`For Apotex:
`
`For Argentum:
`
`
`
`Steven W. Parmelee: sparmelee@wsgr.com
`Michael T. Rosato: mrosato@wsgr.com
`Jad A. Mills: jmills@wsgr.com
`
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`Telephone: 206-883-2542
`
`
`Teresa Stanek Rea: trea@crowell.com
`Deborah H. Yellin: dyellin@crowell.com
`Shannon M. Lentz: slentz@crowell.com
`Tyler C. Liu: TLiu@agpharm.com
`
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, NW
`Washington, DC 20004-2595
`(202) 624-2620
`
` 1
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`
`
`
`
`
`
`
`
`
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`For Sun:
`
`
`For Teva:
`
`Samuel Park: SPark@winston.com
`Charles B. Klein: CKlein@winston.com
`Sharick Naqi: SNaqi@winston.com
`
`Winston & Strawn LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
`
`
`
`
`Dated: November 13, 2017
`
`Amanda Hollis: amanda.hollis@kirkland.com
`Eugene Goryunov: egoryunov@kirkland.com
`Gregory Springsted: gregory.springsted@kirkland.com
`
`Kirkland & Ellis LLP
`300 North LaSalle
`Chicago, IL 60654
`Telephone: (312) 862-2000
`(202) 624-2620
`
`/Jane M. Love, Ph.D./
`Jane M. Love, Ph.D.
`Reg. No. 42,812
`Lead Counsel for Patent Owner
`Gibson, Dunn & Crutcher LLP
`200 Park Avenue
`New York, New York 10166-0193
`jlove@gibsondunn.com
`Tel: 212-351-3922
`
`2
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`
`
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