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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`REGENERON PHARMACEUTICALS, INC.,
`Petitioner
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`v.
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`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owners
`
`Case IPR2021-00816
`Patent 9,220,631
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`PATENT OWNERS’ FOURTH MOTION TO SEAL
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`U.S. Patent No. 9,220,631
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`Pursuant to 37 C.F.R. §§ 42.14, 42.22, and 42.54, Patent Owners Novartis
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`Pharma AG, Novartis Technology LLC, and Novartis Pharmaceuticals Corporation
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`(collectively, “Novartis”) respectfully request that the Board seal Exhibits 2337
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`and 2338, filed herewith, which contain Novartis’s confidential research and
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`development information of Patent Owner, confidential research and development
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`information of third parties, and employee personal information.
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`In determining whether to grant a Motion to Seal, the Board must find “good
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`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,
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`development, or commercial information.” Id.
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`The information that Novartis seeks to seal in this motion is subject to
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`contractual or statutory obligations of confidentiality to third party companies or
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`individuals, as explained in more detail below. To the undersigned’s knowledge,
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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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`U.S. Patent No. 9,220,631
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`Novartis’s business prospects and put Novartis at a competitive disadvantage
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`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
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`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 Exhibits 2337, and 2338.
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`Exhibit 2337
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`Exhibit 2337 is the deposition transcript of Regeneron’s expert witness,
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`James Agallaco, taken in the related International Trade Commission (“ITC”)
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`investigation regarding the ’631 patent. See Certain Pre-Filled Syringes for
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`Intravitreal Injection and Components Thereof, Inv. No. 337-TA-1207. Novartis
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`relies on this document to rebut Regeneron’s arguments concerning the claims of
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`the ’631 Patent.
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`Exhibit 2337 contains information on Novartis’s business relationships with
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`third parties as well as third party confidential business information. This
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`document contains details on collaboration efforts on pre-filled syringe design and
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`manufacture (See e.g., 2337.0018) and contractual agreements between Novartis
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`and third party business partners. Id.
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`This document was part of the record developed in the ITC action, and in
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`that action, these documents were subject to a protective order requiring that these
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`3
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`U.S. Patent No. 9,220,631
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`documents only be accessible by outside counsel. The parties to this IPR
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`proceeding have agreed to modify the protective order in this action to extend the
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`same level of protection for these documents as was provided in the ITC action.
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`Exhibit 2323.
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`Therefore, good cause exists to seal exhibit 2337 due to the presence of
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`information regarding Novartis and its third party business partners because
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`Novartis’s competitors would gain insight into Novartis’s business approaches and
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`commercial interests when collaborating with third parties, thereby placing
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`Novartis at a competitive disadvantage.
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`Exhibits 2338
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`Exhibit 2338 is Novartis document produced in the related ITC case.
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`Novartis relies on these documents to rebut Regeneron’s arguments concerning
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`the claims of the ’631 Patent.
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`Exhibit 2338 contains Novartis internal communications pertaining to
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`research and development activities related to the subject matter of the ’631
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`patent, and are therefore, “confidential research [and] development…information”
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`pursuant to Fed. R. Civ. P. 26(c)(1)(G). Exhibit 2337 contains proprietary
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`information regarding details on Novartis’s research strategy, such as the
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`evaluation of physiochemical properties of the drug products and discussions on
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`project feedback. See e.g., 2338.001–.003. Exhibit 2337 also contains personal
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`4
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`U.S. Patent No. 9,220,631
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`information of Novartis and third party employees, including the identities of
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`Novartis and third party employees and their roles and responsibilities. As
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`discussed above, Novartis is legally obligated to prevent the public disclosure of
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`employee information, and public disclosure of this information may expose
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`Novartis to criminal sanctions and civil liability.
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`This documents was part of the record developed in the ITC action, and in
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`that action, these documents were subject to a protective order requiring that these
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`documents only be accessible by outside counsel. The parties to this IPR
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`proceeding have agreed to modify the protective order in this action to extend the
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`same level of protection for these documents as was provided in the ITC action.
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`Exhibit 2323.
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`Therefore, good cause exists to seal exhibit 2338 due to the presence of
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`Novartis’s confidential information and confidential information from a third
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`party, the disclosure of which would put Novartis and the third party at a
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`competitive disadvantage. There is also good cause to seal the personal
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`information of individuals employed by Novartis and third parties based on
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`obligations under Swiss privacy laws.
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`Accordingly, Novartis respectfully requests that the Board grant Patent
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`Owners’ Fourth Motion to Seal.
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`5
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`Dated: May 11, 2022
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`By:
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`U.S. Patent No. 9,220,631
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`
`/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
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`6
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`U.S. Patent No. 9,220,631
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`CERTIFICATE OF SERVICE
`A copy of this Patent Owners’ Motion to Seal has been served on
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`Petitioner’s attorneys of record as follows via electronic mail:
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`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
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`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
`USPTO Reg. No. 76,588
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`7
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`U.S. Patent No. 9,220,631
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`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
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`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
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`Regeneron.IPR.Service@weil.com
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`Attorneys for Regeneron Pharmaceuticals, Inc.
`Dated: May 11, 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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`8
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