`
`UNITED STATES PATENT AND TRADEMARK OFFICE
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`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________
`
`
`HOPEWELL PHARMA VENTURES, INC.,
`Petitioner
`v.
`MERCK SERONO S.A.,
`Patent Owner
`
`___________________
`
`Case IPR2023-00481
`U.S. Patent No. 8,377,903
`___________________
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`PETITIONER HOPEWELL PHARMA VENTURES, INC.’S
`MOTION TO SEAL EXHIBITS 1059, 1060, 1063, 1080, 1084, AND
`PETITIONER’S REPLY
`
`
`
`
`
`
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`Case IPR2023-00481
`U.S. Patent No. 8,377,903
`TABLE OF CONTENTS
`
`I.
`II.
`III.
`
`INTRODUCTION ....................................................................................... 1
`GOVERNING RULES AND PTAB GUIDANCE....................................... 1
`IDENTIFICATION OF CONFIDENTIAL DOCUMENTS ......................... 2
`A.
`Exhibits 1059, 1060, and 1063 ........................................................... 3
`B.
`Exhibits 1080 and 1084 ..................................................................... 3
`C.
`Hopewell’s Reply .............................................................................. 4
`IV. GOOD CAUSE EXISTS FOR SEALING THE CONFIDENTIAL
`INFORMATION. ........................................................................................ 4
`RELIEF REQUESTED ................................................................................ 6
`V.
`VI. CONCLUSION ........................................................................................... 6
`
`
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`Case IPR2023-00481
`U.S. Patent No. 8,377,903
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`I.
`
`INTRODUCTION
`Pursuant to 37 C.F.R. §§ 42.14 and 42.54, Petitioner Hopewell Pharma
`
`Ventures, Inc. (“Hopewell”) respectfully submits this Motion to Seal Exhibits
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`1059, 1060, 1063, 1080, 1084, and the Petitioner’s Reply (collectively “the
`
`Confidential Documents”). The parties have met and conferred regarding the
`
`Motion to Seal, as required by 37 C.F.R. § 42.54(a), and Patent Owner Merck
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`Serono, S.A. (“Merck”) has stated it will not oppose this motion.
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`All of the confidential material submitted in this proceeding belongs to
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`Merck. Good cause to seal exists because Merck has represented to Hopewell that
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`certain information in the Confidential Documents is “highly confidential,
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`competitively sensitive information.” Mot. To Seal And For Entry of Default
`
`Protective Order, 2, Hopewell Pharma Ventures, Inc. v. Merck Serono SA,
`
`IPR2023-00481 (P.T.A.B. Dec. 21, 2023) (“Paper 19”). Hopewell therefore
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`submits this Motion to Seal under the Default Protective Order in this case. See
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`Paper 19.
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`II. GOVERNING RULES AND PTAB GUIDANCE
`While under 35 U.S.C. § 316(a)(1), papers filed in an inter partes review are
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`generally open and available for access by the public, a party may file a concurrent
`
`Motion to Seal to protect public disclosure of certain confidential information,
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`which has the effect of sealing the information at issue pending resolution of the
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`Case IPR2023-00481
`U.S. Patent No. 8,377,903
`motion. In determining whether to grant a Motion to Seal, the Board must find
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`“good cause,” 37 C.F.R. § 42.54(a), and “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,” Consolidated Trial Practice
`
`Guide, November 2019 (“TPG”), 19. The Board identifies confidential information
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`in a manner “consistent with Federal Rule of Civil Procedure 26(c)(1)(G), which
`
`provides for protective orders for … confidential research, development, or
`
`commercial information.” TPG, 19.
`
`Based on the procedure set forth in the TPG, Hopewell seeks to prevent the
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`disclosure of sensitive information that Merck has represented is contained in the
`
`Confidential Documents.
`
`III.
`
`IDENTIFICATION OF CONFIDENTIAL DOCUMENTS
`The Confidential Documents at issue here comprise Exhibits 1059, 1060,
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`1063, 1080, 1084, and Hopewell’s Reply, which quotes and characterizes those
`
`exhibits and the exhibits previously filed under seal by Merck (Exhibits 2048,
`
`2049, and 2050). Paper 19, 4–7. Under the terms of the Default Protective Order
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`filed by Merck in this case on December 21, 2023, documents so designated must
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`be filed under seal. Default Protective Order, ¶5(A)(i).
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`Case IPR2023-00481
`U.S. Patent No. 8,377,903
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`A. Exhibits 1059, 1060, and 1063
`Exhibits 1059, 1060, and 1063 are the deposition transcripts of Drs.
`
`Nicholas Bodor, Yogesh Dandiker, and Alain Munafo, respectively. Merck
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`designated and marked Exhibits 1059, 1060, and 1063 as “CONFIDENTIAL”
`
`under the proposed Default Protective Order in this proceeding. Default Protective
`
`Order, ¶5(A)(i)-(ii).
`
`With respect to Exhibit 1059, Merck served a redacted copy identifying the
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`portions of the testimony to which a claim of confidentiality is to be maintained, as
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`required by the terms of the Default Protective Order, Appendix B, Section (d)6.
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`Merck did not indicate why these portions of testimony disclosed confidential
`
`protective order material. This redacted copy will be made publicly available.
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`Hopewell only moves to file the unredacted copy of Exhibit 1059 under seal.
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`Default Protective Order, ¶5(A)(ii).
`
`With regard to Exhibits 1060 and 1063 (Dandiker and Munafo deposition
`
`transcripts), Merck has agreed to Hopewell to filing Exhibits 1060 and 1063 under
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`seal in their entirety.
`
`Exhibits 1080 and 1084
`B.
`Exhibits 1080 and 1084 are the declarations of Dr. Rodolfo Pinal and Dr.
`
`Aaron Miller, respectively. Exhibits 1080 and 1084 cite the Confidential
`
`Documents. Merck has agreed to Hopewell filing Exhibits 1080 and 1084 under
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`Case IPR2023-00481
`U.S. Patent No. 8,377,903
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`seal in their entirety.
`
`C. Hopewell’s Reply
`Hopewell has, to the best of its ability, limited material in its Reply to non-
`
`confidential information. However, it nonetheless is necessary for the Reply to
`
`quote and characterize Exhibits 1059, 1060, 1063, 1080, and 1084, as well as
`
`Merck’s sealed Exhibits 2048, 2049, 2050. Merck has agreed to Hopewell filing
`
`the Reply under seal in its entirety.
`
`*
`
`*
`
`*
`
`To the best of Hopewell’s knowledge, and based on Merck’s representation
`
`that the Confidential Documents and the information contained therein are indeed
`
`confidential, the information sought to be sealed has not been published or
`
`otherwise made public.
`
`IV. GOOD CAUSE EXISTS FOR SEALING THE CONFIDENTIAL
`INFORMATION.
`The standard for granting a motion to seal is “good cause.” Garmin Int’l,
`
`Inc. v. Cuozzo Speed Techs. LLC, IPR2012-00001, Paper 34 at 3 (P.T.A.B. Mar.
`
`14, 2013). This requires the Board 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.” Garmin International, Inc. et al. v.
`
`Cuozzo Speed Technologies LLC, IPR2012-00001, Paper 36 at 4 (P.T.A.B. Apr. 5,
`
`2013). Good cause can be established by demonstrating that (1) the information
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`Case IPR2023-00481
`U.S. Patent No. 8,377,903
`sought to be sealed is truly confidential, (2) concrete harm would result upon
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`public disclosure, (3) there exists a genuine need to rely in the trial on the specific
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`information sought to be sealed, and (4) on balance, the interest in maintaining
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`confidentiality outweighs the strong public interest in having an open record. See
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`Argentum Pharms. LLC v. Alcon Research, Ltd., IPR2017-01053, Paper 27 at 4
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`(P.T.A.B. Jan. 19, 2018).
`
`Merck previously submitted Exhibits 2048, 2049, and 2050 under seal,
`
`stating that they contained “confidential technical information regarding drug
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`development and/or financial and business information of [Merck] and non-
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`parties” in this proceeding, which are “subject to non-party confidentiality
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`obligations.” Paper 19, 4. The Confidential Documents relate at least in part to
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`Exhibits 2048, 2049, and 2050, which Merck has stated would cause “competitive
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`business harm” to Merck if publicly disclosed. Id., 4-5. To the best of Hopewell’s
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`knowledge, the same risk of concrete harm to non-parties applies to Exhibits 1059,
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`1060, 1063, 1080, 1083, and Petitioner’s Reply. Further, because of the nature and
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`extent of the Confidential Documents, there is a genuine need for Hopewell to
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`quote and characterize the Confidential Documents throughout Hopewell’s Reply.
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`But due to the competitive harm that Merck has asserted, which Petitioner
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`currently has no reason to doubt extends to the Confidential Documents, the
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`interest in maintaining confidentiality outweighs the strong public interest in
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`Case IPR2023-00481
`U.S. Patent No. 8,377,903
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`maintaining a public record.
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`V. RELIEF REQUESTED
`For the reasons stated above, Hopewell requests that the Board seal and
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`protect the Confidential Documents according to the proposed Default Protective
`
`Order in this case.
`
`VI. CONCLUSION
`For the foregoing reasons, Hopewell respectfully requests that the Board seal
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`Exhibits 1059, 1060, 1063, 1080, 1084, and the Petitioner’s Reply according to the
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`Default Protective Order.
`
`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & FOX PLLC
`
`/Eldora L. Ellison/
`
`Eldora L. Ellison, Ph.D., Esq.
`Registration No. 39,967
`Lead Attorney for Petitioner
`
`Date: April 5, 2024
`1101 K Street, NW, 10th Floor
`Washington, DC 20005
`(202) 371-2600
`
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`Case IPR2023-00481
`U.S. Patent No. 8,377,903
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`I certify that the above-captioned PETITIONER HOPEWELL PHARMA
`
`VENTURES, INC.’S MOTION TO SEAL EXHIBITS 1059, 1060, 1063, 1080,
`
`1084, AND THE PETITIONER’S REPLY was served in its entirety on April 5,
`
`2024, upon the following parties via electronic mail:
`
`
`
`Emily R. Whelan (Lead Counsel) Emily.Whelan@wilmerhale.com
`Deric Geng (Back-up Counsel) Deric.Geng@wilmerhale.com
`Cindy Kan (Back-up Counsel) Cindy.Kan@wilmerhale.com
`David B. Bassett (Back-up Counsel) David.Bassett@wilmerhale.com
`Vinita Ferrera (Back-up Counsel) Vinita.Ferrera@wilmerhale.com
`David Mlaver (Back-up Counsel) David.Mlaver@wilmerhale.com
`Mary.Pheng (Back-up Counsel) Mary.Pheng@wilmerhale.com
`Asher McGuffin (Back-up Counsel) Asher.McGuffin@wilmerhale.com
`WILMER CUTLER PICKERING HALE AND DORR LLP
`WHMerckMavencladIPRs@wilmerhale.com
`
`Respectfully submitted,
`
`STERNE, KESSLER, GOLDSTEIN & FOX PLLC
`
`/Eldora L. Ellison/
`
`Eldora L. Ellison, Ph.D., Esq.
`Registration No. 39,967
`Lead Attorney for Petitioner
`
`Date: April 5, 2024
`1101 K Street, NW, 10th Floor
`Washington, DC 20005
`(202) 371-2600
`
`
`22149456.1
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`
`
`
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