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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners
`
`Case IPR2021-00816
`Patent 9,220,631
`
`PATENT OWNERS’ FIFTH MOTION TO SEAL
`
`
`
`
`
`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`
`
`Pursuant to 37 C.F.R. §§ 42.14, 42.22, and 42.54, Patent Owners Novartis
`
`Pharma AG, Novartis Technology LLC, and Novartis Pharmaceuticals Corporation
`
`(collectively, “Novartis”) respectfully request that the Board seal portions of
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`Novartis’s Surreply to Petitioner’s Reply (“Surreply”), portions of Exhibits 2339,
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`2345, and 2347, which contain Novartis’s confidential research and development
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`information of Patent Owner, confidential research and development information
`
`of third parties, and employee personal information. Novartis also moves to seal
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`the entirety of Exhibits 2341-2344, 2346, and 2348-2352.
`
`In determining whether to grant a Motion to Seal, the Board must find “good
`
`cause” to seal the information in question and “strike a balance between the
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`public’s interest in maintaining a complete and understandable file history and the
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`parties’ interest in protecting truly sensitive information.” 37 C.F.R. § 42.54(a);
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`Consolidated Trial Practice Guide November 2019 at 19. As described in the
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`Consolidated Trial Practice Guide, the Board identifies confidential information
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`in a manner “consistent with Federal Rule of Civil Procedure 26(c)(1)(G), which
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`provides for protective orders for trade secret or other confidential research,
`
`development, or commercial information.” Id.
`
`The information that Novartis seeks to seal in this motion is subject to
`
`contractual or statutory obligations of confidentiality to third party companies or
`
`1
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`IPR2021-00816
`U.S. Patent No. 9,220,631
`individuals, as explained in more detail below. To the undersigned’s knowledge,
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`
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`the information that Novartis seeks to seal is non-public and proprietary. Public
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`disclosure of Novartis’s confidential information would competitively harm
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`Novartis’s business prospects and put Novartis at a competitive disadvantage
`
`relative to other similarly positioned companies in the same industry. In addition,
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`we are advised by Swiss counsel that public disclosure of the third party
`
`confidential information or personal information of employees could subject
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`Novartis to civil and criminal penalties under the laws of Switzerland. As such,
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`good cause exists to seal portions of Novartis’s Surreply, portions of Exhibits
`
`2339, 2345, and 2347 and the entirety of Exhibits 2341-2344, 2346, and 2348-
`
`2352
`
`Novartis’s Surreply
`
`Novartis seeks to seal the portions of its Surreply that discuss confidential
`
`information in the Exhibits that Novartis currently seeks to seal. For the same
`
`reasons that these exhibits should be sealed as disclosed below and has previously
`
`submitted, there is good cause to seal the portions of the Surreply that include
`
`confidential information appearing in at least Exhibits 2339 and 2341-2352.
`
`Exhibits 2339, 2341, 2345 and 2347-2348 (IPR Deposition Transcripts)
`
`Exhibits 2339, 2341, 2345, and 2347-2348 are cross-examination deposition
`
`transcripts of Regeneron’s witnesses taken in this IPR proceeding. Novartis seeks
`
`
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`2
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`IPR2021-00816
`U.S. Patent No. 9,220,631
`to seal portions of Ex. 2339 (Agalloco Dep. Tr.), Ex. 2345 (Kiss Dep. Tr.) and Ex.
`
`
`
`2347 (Koller Dep. Tr.), and the entirety of Ex. 2341 (Graham Dep. Tr.) and Ex.
`
`2347 (Koller Dep. Tr.).
`
`Each of Exhibits 2339, 2341, 2345, and 2347-2348 contain at least one
`
`declaration from each of these witnesses in this IPR proceeding, whereas the
`
`deposition transcripts of these witnesses discuss such declaration. See e.g., Ex.
`
`2339.005 at 16:1-4 (discussing confidential Ex. 1100); Ex. 2341.005 at 15:21-16:5
`
`(discussing confidential Ex. 1102); Ex. 2345.007 at 7:9-12 (discussing
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`confidential Ex. 1106); Ex. 2347.005 at 244:2-244:13 (discussing confidential Ex.
`
`1105); Ex. 2348.003 at 7:1-6). Accordingly, good cause exists to seal portions of
`
`Exhibits 2339, 2345, and 2347, and the entirety of 2341 and 2347.
`
`Exhibit 2346 (Becton Dickinson Witness Deposition Transcript)
`
`Exhibit 2346 is a deposition transcript of third party witness of Becton
`
`Dickinson & Co.’s (“BD”) taken in this IPR proceeding. Novartis seeks to seal
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`Exhibit 2346.
`
`This deposition discusses multiple documents that contain BD’s
`
`confidential and proprietary development, research, and sales information. These
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`documents were part of the record developed in the ITC action, and in that action,
`
`these documents were subject to a protective order requiring that these documents
`
`only be accessible by outside counsel. The parties to this IPR proceeding have
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`3
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`IPR2021-00816
`U.S. Patent No. 9,220,631
`agreed to modify the protective order in this action to extend the same level of
`
`
`
`protection for these documents as was provided in the ITC action. See Exhibit
`
`2323. Novartis relies on these exhibits to rebut Regeneron’s arguments concerning
`
`the ’631 patent claims.
`
`For example, Ex. 2346.005 at 17:3-9 discusses a communication between
`
`BD and a third party relating to BD’s confidential and technical information. At
`
`Ex. 2346.011 at 40:15-21 discuses at declaration of a BD employee describing
`
`BD’s confidential information related to certain BD products.
`
`Public information in Exhibit 2346 would harm BD, a third party, because
`
`insights to BD’s technical and business information would provide a competitive
`
`advantage to BD’s competitors to its detriment. For example, such information
`
`could also be used by a competitor to improve its products. Therefore, good cause
`
`exists to seal Exhibit 2346.
`
`Exhibits 2342-2344, 2349-2352 (Regeneron Confidential Documents)
`
`Exhibits 2342-2344 and 2349-2352 are Regeneron internal documents
`
`containing its confidential and proprietary research, development, manufacture,
`
`and business information. Exhibits 2342-2343 and 2349-2352 were part of the
`
`record developed in the ITC action, and in that action, these documents were
`
`subject to a protective order requiring that these documents only be accessible to
`
`outside counsel. The parties to this IPR proceeding have agreed to modify the
`
`
`
`4
`
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`
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`IPR2021-00816
`U.S. Patent No. 9,220,631
`protective order in this action to extend the same kind of level of protection for
`
`
`
`these documents as was provided in the ITC action. See Exhibit 2323. Novartis
`
`relies on these exhibits to rebut Regeneron’s arguments concerning the claims of
`
`the ’631 patent. Exhibit 2344 was part of the record developed in the SDNY
`
`action, and in that action, this document was subject to a protective order requiring
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`that this document be kept confidential.
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`Specifically Exhibits 2342-2344 and 2349-2352 include confidential
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`biologics license application information for the EYLEA product and related
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`communications with the FDA and internal Regeneron communications. These
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`exhibits include Regeneron’s confidential technical and regulatory information.
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`Exhibit 2342 is correspondence between Regeneron and the FDA concerning the
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`development of the EYLEA product and includes confidential development and
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`technical information. Exhibit 2343 is an internal Regeneron report detailing the
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`development and technical specifications of the EYLEA product. Exhibits 2344
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`and 2349-2351 are Regeneron internal and third party communications discussing
`
`the development and technical specifications of the EYLEA product. Exhibit
`
`2352 is a summary of a meeting between Regeneron and a third party discussing
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`the development and technical specifications of the EYLEA product.
`
`Regeneron has asserted that documents with similar information, if not
`
`sealed, “would substantially harm Rogerson’s competitive position in the pre-
`
`
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`5
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`IPR2021-00816
`U.S. Patent No. 9,220,631
`filled syringe industry” and “would provide competitors with valuable information
`
`
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`regarding confidential research and development projects.” (Paper 71 (filed April
`
`15) at 11-13.) Therefore, good cause exists to seal Exhibits 2342-2344 and 2349-
`
`2352.
`
`Accordingly, Novartis respectfully requests that the Board grant Patent
`
`Owners’ Fifth Motion to Seal.
`
`Dated: May 26, 2022
`
`By:
`
`
`/Elizabeth J. Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
`Lead Counsel for Patent Owners
`ALLEN & OVERY LLP
`1221 Avenue of the Americas
`New York, NY 10020 Phone:
`(212) 610-6300
`elizabeth.holland@allenovery.com
`
`6
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`IPR2021-00816
`U.S. Patent No. 9,220,631
`CERTIFICATE OF SERVICE
`A copy of this Patent Owners’ Fifth Motion to Seal has been served on
`
`Petitioner’s attorneys of record as follows via electronic mail:
`
`Elizabeth Stotland Weiswasser
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8022
`F: 212-310-8007
`elizabeth.weiswasser@weil.com
`USPTO Reg. No. 55,721
`Anish R. Desai
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8730
`F: 212-310-8007
`anish.desai@weil.com
`USPTO Reg. No. 73,760
`
`Natalie Kennedy
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8730
`F: 212-310-8007
`natalie.kennedy@weil.com
`USPTO Reg. No. 68,511
`Andrew Gesior
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8730
`F: 212-310-8007
`andrew.gesior@weil.com
`
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`IPR2021-00816
`U.S. Patent No. 9,220,631
`
`USPTO Reg. No. 76,588
`
`Brian E. Ferguson
`Weil, Gotshal & Manges LLP
`2001 M Street, N.W., Suite 600
`Washington, D.C. 20036
`T: 202-682-7000
`F: 202-857-0940
`brian.ferguson@weil.com
`USPTO Reg. No. 36,801
`
`Christopher M. Pepe
`Weil, Gotshal & Manges LLP
`2001 M Street, N.W., Suite 600
`Washington, D.C. 20036
`T: 202-682-7000
`F: 202-857-0940
`christopher.pepe@weil.com
`USPTO Reg. No. 73,851
`
`Regeneron.IPR.Service@weil.com
`
`Attorneys for Regeneron Pharmaceuticals, Inc.
`Dated: May 26, 2022
`By:
`
`/Elizabeth J. Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
`Lead Counsel for Patent Owners
`ALLEN & OVERY LLP
`1221 Avenue of the Americas
`New York, NY 10020
`Tel: (212) 610-6300
`elizabeth.holland@allenovery.com
`
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