Paper 34, April 15, 2024
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TWI PHARMACEUTICALS INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
`
`
`IPR2023-00049 (Patent 7,713,947 B2)
`
`Before ULRIKE W. JENKS, ZHENYU YANG and TINA HULSE,
`Administrative Patent Judges.
`
`JENKS, Administrative Patent Judge.
`
`PETITIONER’S OPPOSITION TO MOTION TO SEAL
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`TWI PHARMACEUTICALS INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
`
`
`IPR2023-00049 (Patent 7,713,947 B2)
`
`Before ULRIKE W. JENKS, ZHENYU YANG and TINA HULSE,
`Administrative Patent Judges.
`
`JENKS, Administrative Patent Judge.
`
`PETITIONER’S OPPOSITION TO MOTION TO SEAL
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`TABLE OF CONTENTS ........................................................................................... i
`
`TABLE OF AUTHORITIES ..................................................................................... ii
`
`EXHIBIT LIST ........................................................................................................ iii
`
`I.
`
`Introduction ........................................................................................................ 1
`
`II. Statement of Material Facts ............................................................................... 1
`
`III. Legal Standard ................................................................................................... 3
`
`IV. Relief Requested – Patent Owner’s Motion Should Be Denied ........................ 5
`
`A. Exhibit 2048 ............................................................................................... 5
`
`B. Exhibits 2049 and 2050 .............................................................................. 9
`
`C. Exhibit 2039 .............................................................................................12
`
`V. Motion for Entry of the Default Protective Order ...........................................12
`
`VI. Conclusion .......................................................................................................12
`
`
`
`
`
`
`
`– i –
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`
`Argentum Pharms. LLC v. Alcon Rsch., Ltd.,
`No. IPR2017-01053, 2018 WL 495204 (P.T.A.B. Jan. 19, 2018) ............... passim
`Corning Optical Communications RF, LLC, v. PPC Broadband, Inc.,
`No. IPR2014–00440, 2015 WL 1523712 (P.T.A.B. Apr. 6, 2015) ....................4, 6
`Garmin International, Inc. et al. v. Cuozzo Speed Technologies LLC,
`No. IPR2012-00001, 2013 WL 8696523 (P.T.A.B. March 14, 2013) ...............3, 4
`Skechers U.S.A., Inc. v. Nike, Inc.,
`No. IPR2017-00620, 2017 WL 4277684 (P.T.A.B. Sept. 25, 2017) ........... 8, 9, 11
`Westinghouse Air Brake Techs. Corp. v. Siemens Mobility, Inc.,
`Nos. IPR2017-01669, IPR2017-02044, Paper 60 (P.T.A.B. Jan. 8, 2019) ........6, 7
`Statutes
`35 U.S.C. § 316(a) ..................................................................................................... 3
`Regulations
`37 C.F.R. § 42.14 ....................................................................................................... 3
`37 C.F.R. § 42.54(a) ................................................................................................... 4
`Other Authorities
`Patent Trial and Appeal Board Consolidated Trial Practice Guide
`(November 21, 2019) ............................................................................................. 3
`
`
`
`
`
`
`– ii –
`
`
`
`EXHIBIT LIST
`
`EXHIBIT
`Ex. 1001
`
`DESCRIPTION
`US 7,713,947 B2.
`
`SHORT
`
`’947 Patent
`
`Ex. 1002
`
`Ex. 1003
`
`Ex. 1004
`
`Ex. 1005
`
`Ex. 1006
`
`Ex. 1009
`
`Ex. 1011
`
`Ex. 1012
`
`Ex. 1013
`
`Ex. 1014
`
`’903 Patent
`US 8,377,903 B2.
`’018 File
`File History for Ser. No. 11/722,018, which
`Wrapper
`issued as the ’947 patent.
`’173 File
`File History Ser. No. 12/766,173, which issued as
`Wrapper
`the ’903 patent.
`Declaration of Dr. Benjamin M. Greenberg, M.D. Greenberg
`Decl.
`Curriculum Vitae of Dr. Benjamin M. Greenberg,
`Greenberg CV
`M.D.
`Bodor ‘WO
`Ex. 1007 WO 2004/087101 A2.
`101
`Ex. 1008
`Rice, George P.A., Massimo Filippi, and
`Giancarlo Comi. “Cladribine and progressive MS:
`clinical and MRI outcomes of a multicenter
`controlled trial.” Neurology Vol. 54, no. 5 (2000)
`pp. 1145–1155.
`Liliemark, Jan. “The clinical pharmacokinetics of
`cladribine.” Clinical pharmacokinetics Vol. 32,
`no. 2 (1997) pp. 120–131.
`Ex. 1010 Merck KGaA et al v. Accord Healthcare, Inc. et al
`1-22-cv-00974 (DDE) Complaint.
`EMD Serano Inc., Mavenclad® (Cladribine)
`Package Insert, Mar. 2019
`Lublin FD, Reingold SC. Defining the clinical
`course of multiple sclerosis: results of an
`international survey. Neurology 1996;46:907–
`911.
`National Multiple Sclerosis Society, What is MS,
`Types of MS,
`https://www.nationalmssociety.org/What-is-
`MS/Types-of-MS, retrieved Sept. 20, 2022.
`National Multiple Sclerosis Society, What is MS,
`Types of MS, Secondary Progressive MS,
`https://www.nationalmssociety.org/What-is-
`
`Rice 2000 or
`Rice
`
`Liliemark 1997
`
`Merck
`Complaint
`Mavenclad
`Package Insert
`
`Lublin 1996
`
`
`
`
`
`– iii –
`
`
`
`EXHIBIT
`
`Ex. 1015
`
`Ex. 1016
`
`Ex. 1017
`
`Ex. 1018
`
`Ex. 1019
`
`Ex. 1020
`
`Ex. 1021
`
`Ex. 1022
`
`Ex. 1023
`
`Ex. 1024
`
`Ex. 1025
`
`DESCRIPTION
`MS/Types-of-MS/Secondary-progressive-MS.
`Casanova, B., et al. “High clinical inflammatory
`activity prior to the development of secondary
`progression: a prospective 5-year follow-up
`study,” Multiple Sclerosis Journal, Feb. 2002, pp.
`59-63, vol. 8.
`Romine, J. et al. “A Double-Blind, Placebo-
`Controlled, Randomized Trial of Cladribine in
`Relapsing-Remitting Multiple Sclerosis,”
`Proceedings of the Association of American
`Physicians, Jan./Feb. 1999, pp. 35-44, vol. 111,
`No. 1.
`Immunex Corporation, Novantrone®
`(Mixantrone) Package Insert, Oct. 13, 2000
`(“Novantrone® Package Insert”).
`Langtry, H. et al. “Cladribine: A Review of its
`Use in Multiple Sclerosis,” Biodrugs, May 1998,
`pp. 419-433, vol. 9, No. 3.
`Biogen Idec Inc., Tysarbi® (natazlizumab)
`Package Insert, Nov. 2004.
`Chiron Corporation, Betaseron® (Interferon beta-
`lb) Package Insert, 1993.
`Biogen, Inc., Avonex™ (Interferon Beta-1a)
`Package Insert, Nov. 1996.
`Teva Pharms USA, Copaxone® (glatiramer
`acetate for injection) Package Insert, 2001.
`Serano, Inc., Rebif® (Interferon Beta-1a) Package
`Insert, May 2003.
`Cursiefen, Simone, et al. “Escalating
`immunotherapy with mitoxantrone in patients
`with very active relapsing-remitting or
`progressive multiple sclerosis,” European
`neurology, Apr. 2000, pp. 186–187, vol. 43, No.
`3.
`Burt, Richard K., et al. “Treatment of
`autoimmune disease by intense
`immunosuppressive conditioning and autologous
`hematopoietic stem cell transplantation,” Blood,
`The Journal of the American Society of
`Hematology, Nov. 1998, pp. 3505–3514, vol. 92,
`No. 10.
`
`– iv –
`
`SHORT
`
`
`Casanova 2002
`
`Romine 1999
`
`Novantrone
`Package Insert
`
`Langtry 1998
`
`Tysabri
`Package Insert
`Betaseron
`Package Insert
`Avonex
`Package Insert
`Copaxone
`Package Insert
`Rebif Package
`Insert
`
`Cursiefen 2000
`
`Burt 1998
`
`
`
`EXHIBIT
`Ex. 1026
`
`Ex. 1027
`
`Ex. 1028
`
`Ex. 1029
`Ex. 1030
`
`Ex. 1031
`
`DESCRIPTION
`Tortorella, Carla, et al. “Cladribine. Ortho
`Biotech Inc.” Current Opinion in Investigational
`Drugs, Dec. 2001, pp. 1751–1756, vol. 2, no. 12.
`Beutler, E. et al. “The treatment of chronic
`progressive multiple sclerosis with cladribine,”
`Proc. Natl. Acad. Sci. USA, Feb. 1996, pp. 1716–
`1720, vol. 93.
`Coles, Alasdair, et al. “Campath-1H treatment of
`multiple sclerosis: lessons from the bedside for
`the bench,” Clinical neurology and neurosurgery,
`June 2004, pp. 270–274, vol. 106, no. 3.
`U.S. Patent No. 7,888,328
`Center for Disease Control, Office of Enterprise
`Communication, Press Release, Oct. 27, 2004,
`https://www.cdc.gov/media/pressrel/r041027.htm.
`Selby, R. et al. “Safety and Tolerability of
`Subcutaneous Cladribine Therapy in Progressive
`Multiple Sclerosis,” Can. J. Neurol. Sci., 1998,
`pp. 295-299, vol. 25.
`Docket Navigator Printout of Case Activity for
`Merck KGaA et al v. Accord Healthcare, Inc. et al
`Food and Drug Administration, Orange Book:
`Approved Drug Products with Therapeutic
`Equivalence Evaluations, Patent and Exclusivity
`for: N022561,
`https://www.accessdata.fda.gov/scripts/cder/ob/pa
`tent_info.cfm?Product_No=001&Appl_No=0225
`61&Appl_type=N, retrieved Oct. 5, 2022.
`Ex. 1034 Merck KGaA et al v. Accord Healthcare, Inc. et al
`1-22-cv-00974 (DDE) Answer.
`Declaration of A. Lauren Hitchens
`(exhibit not filed)
`Declaration of Don J. Mizerk
`Ex. 1036
`Ex. 1037 March 2024 Email chain between Counsel for
`Petitioner and Counsel for Patent Owner
`Ex. 1038 Westinghouse Air Brake Techs. Corp. v. Siemens
`Mobility, Inc., Nos. IPR2017-01669, IPR2017-
`02044, Paper 60 (P.T.A.B. Jan. 8, 2019)
`
`Ex. 1032
`
`Ex. 1033
`
`Ex. 1035
`
`
`
`SHORT
`
`Tortorella 2001
`
`Beutler 1996
`
`Coles 2004
`
`Bodor ’328
`CDC Press
`Release
`
`Selby 1998
`
`
`
`
`
`Accord
`Complaint
`
`
`
`
`
`
`
`– v –
`
`
`
`I.
`
`Introduction
`Petitioner TWi Pharmaceuticals Inc. (“Petitioner”) hereby opposes, in part,
`
`Patent Owner Merck Serono SA’s (“Patent Owner”) Motion to Seal and for Entry of
`
`Default Protective Order (the “Motion”) relating to certain materials submitted in
`
`connection with Patent Owner’s Response. Specifically, Petitioner opposes Patent
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`Owner’s request to seal Exhibits 2048, 2049, and 2050. Patent Owner has failed to
`
`demonstrate that any of the material contained in either document is truly
`
`confidential, and thus has not met its burden to maintain any portions thereof under
`
`seal. Moreover, Patent Owner did not file redacted public versions of either exhibit,
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`and instead seeks to seal the documents in their entirety, despite its acknowledgment
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`that much of the material contained therein is indeed not confidential and appropriate
`
`for public access.
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`Petitioner does not oppose Patent Owner’s request to seal Exhibit 2039, which
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`was filed with an accompanying redacted public version (Exhibit 2041). Petitioner
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`notes however that Patent Owner has not submitted evidence showing that the
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`material it seeks to seal is truly confidential, and therefore has not met its burden
`
`with respect thereto.
`
`II.
`
`Statement of Material Facts
`On February 29, 2024, counsel for Patent Owner emailed counsel for
`
`Petitioner, and indicated that it intended to submit certain materials in connection
`
`– 1 –
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`
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`with its Patent Owner Response in IPR2023-00049 and -00050 which it contends to
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`be confidential. Ex. 1037 at 3. In that correspondence, Patent Owner stated that it
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`intended to “move to seal certain documents and for entry of a protective order,” and
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`inquired as to whether Petitioner opposed the request. Id. Patent Owner did not
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`identify the materials it intended to seal, or otherwise provide any information that
`
`would permit a meaningful meet and confer on the issue. See id.
`
`Petitioner responded to Patent Owner’s request, noting that Patent Owner: (1)
`
`had not identified the materials it intended to move to seal; (2) had not identified its
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`need to rely on said materials; (3) had not explained why said materials were truly
`
`confidential; (4) had not explained what adverse consequences would result from
`
`public disclosure thereof; (5) had not shown that on balance and interest in
`
`maintaining confidentiality outweighs the strong public interest in having an open
`
`record; and (6) that Patent Owner had therefore demonstrated that good cause existed
`
`to seal the unnamed materials. Id. at 2. Accordingly, Petitioner explained that it
`
`“therefore does not agree to the filing of the unidentified information under seal,”
`
`but that it would not object to the use of the Default Protective Order from the
`
`Consolidated Trial Practice Guide, Appendix B, “[i]f Patent Owner sufficiently
`
`shows good cause for filing materials under seal.” Id.
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`– 2 –
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`
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`Patent Owner responded on March 8, 2024, identifying only Exhibits 2048,
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`2049, and 2050 (but not 2039), as exhibits it intended to move to seal, and explaining
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`that the bases therefore were the same as those asserted in IPR2023-00480. Id. at 1.
`
`III. Legal Standard
`“There is a strong public policy for making all information filed in a
`
`quasijudicial administrative proceeding open to the public, especially in an inter
`
`partes review which determines the patentability of claims in an issued patent and
`
`therefore affects the rights of the public.” Garmin Int’l, Inc. v. Cuozzo Speed Techs.
`
`LLC, No. IPR2012-00001, Paper 34 at 1-2, 2013 WL 8696523 (P.T.A.B. March 14,
`
`2013) (Representative Order). “Under 35 U.S.C. § 316(a)(1), the default rule is that
`
`all papers filed in an inter partes review are open and available for access by the
`
`public; . . . [i]t is, however, only ‘confidential information’ that is protected from
`
`disclosure.” Id. at 2 (citing 35 U.S.C. § 316(a)(7)). “The rules aim to strike a balance
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`between the public’s interest in maintaining a complete and understandable file
`
`history and the parties’ interest in protecting truly sensitive information. . . . The
`
`record of a proceeding, including documents and things, shall be made available to
`
`the public, except as otherwise ordered. 37 C.F.R. § 42.14.” Patent Trial and Appeal
`
`Board Consolidated Trial Practice Guide (November 21, 2019). See Argentum
`
`Pharms. LLC v. Alcon Rsch., Ltd., No. IPR2017-01053, 2018 WL 495204, at *1
`
`(P.T.A.B. Jan. 19, 2018) (“We are mindful that, in district court, a party routinely
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`– 3 –
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`
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`will determine (by marking or stamping a document ‘confidential’) whether a
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`document is produced under the terms of a district court protective order. By
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`contrast, in an inter partes review, ‘the default rule is that all papers ... are open and
`
`available for access by the public.’”) (quoting Garmin Int’l, Paper 34 at 2); Corning
`
`Optical Communications RF, LLC, v. PPC Broadband, Inc., No. IPR2014–00440,
`
`Paper 46 at 3, 2015 WL 1523712 (P.T.A.B. Apr. 6, 2015) (“With respect to Exhibits
`
`2106, 2107, and 2108, the Motion to Seal states merely that Patent Owner has
`
`identified the information as subject to a protective order in either a Civil Action
`
`before a U.S. District Court or an Investigation before the U.S. International Trade
`
`Commission (ITC).…That is insufficient. The parties do not represent that the
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`District Court or the ITC has ruled that any such information would be presented for
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`trial in a “sealed” status. We already are at trial.”).
`
`A party moving to seal must show “good cause” for the relief requested.
`
`Argentum, 2018 WL 495204, at *1. To establish “good cause” for sealing, a movant
`
`must demonstrate adequately that (1) the information sought to be sealed is truly
`
`confidential, (2) a concrete harm would result upon public disclosure, (3) there exists
`
`a genuine need to rely in the trial on the specific information sought to be sealed,
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`and (4), on balance, an interest in maintaining confidentiality outweighs the strong
`
`public interest in having an open record. Id. (quoting Corning, Paper 47 at 2–3, 2015
`
`WL 1888338, Paper 49 at 2, 2015 WL 1745114); 37 C.F.R. § 42.54(a).
`
`– 4 –
`
`
`
`IV. Relief Requested – Patent Owner’s Motion Should Be Denied
`A. Exhibit 2048
`Patent Owner seeks to seal the entirety of Exhibit 2048, which is purportedly
`
`a joint development agreement between Ares Trading S.A. and IVAX International
`
`GmbH (the “Agreement”). Motion at 6; Exhibit 2048. Patent Owner seeks to seal
`
`this document on the basis that it allegedly contains certain confidential commercial
`
`terms concerning joint development and research obligations, as well as a purported
`
`confidentiality clause restricting disclosure of the Agreement itself. Motion at 6.
`
`Despite these conclusory assertions however, Patent Owner’s Motion, and indeed
`
`the exhibit itself, fails to demonstrate that anything contained therein, much less the
`
`entirety of the document, is truly confidential, as is required to justify withholding
`
`this document from the public. See Argentum, 2018 WL 495204, at *1–2.
`
`
`
`First, although Patent Owner asserts
`
`that
`
`the agreement “contains
`
`confidentiality provisions requiring Ares Trading S.A. and its affiliate, Patent
`
`Owner, to maintain the confidentiality of the agreement term,” Patent Owner fails to
`
`cite to any specific provision of the agreement containing such a requirement.
`
`Indeed, a review of this document demonstrates that there is no such confidentiality
`
`provision covering the terms of the agreement itself. See Exhibit 2048 generally.
`
`
`
`Patent Owner’s second argument in support of sealing Exhibit 2048—that it
`
`contains confidential commercial terms—is also insufficient to justify Patent
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`– 5 –
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`
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`Owner’s request. Patent Owner has not identified what specific information therein
`
`constitutes truly confidential information, or why the alleged highly confidential
`
`commercial terms concerning the joint research and development obligations
`
`themselves are truly confidential. Instead, Patent Owner has merely listed a broad
`
`category of information, and asserted, in conclusory manner, that it is confidential.
`
`But this is insufficient to meet Patent Owner’s burden here, and its request must
`
`therefore fail. Corning, 2015 WL 1523712 (“The Motion to Seal is conclusory. It
`
`contains essentially no presentation of specific facts for meaningful analysis. For
`
`instance, it states simply that Petitioner has identified certain information as
`
`disclosing confidential financial records relating to Petitioner's commercial
`
`activities, or that Petitioner has identified a certain document as disclosing
`
`confidential compensation information. A movant bears a burden of prove. Merely
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`identifying information that a movant believes should be sealed on the basis of
`
`confidential information does not establish entitlement to the relief requested.”
`
`(internal citations omitted).) Patent Owner has provided nothing beyond mere
`
`attorney argument. Patent Owner could have, if it desired and if declarants were
`
`willing to so testify, submitted a sworn declaration or other evidence demonstrating
`
`the alleged confidential nature of this information, but it did not. Notably, Patent
`
`Owner’s citation to the Westinghouse inter partes review does not counsel otherwise.
`
`There, both parties moved to seal certain materials, and neither contested what Patent
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`– 6 –
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`
`
`Owner asserted in support of confidentiality. See Westinghouse Air Brake
`
`Technologies Corporation v. Siemens Mobility, Inc., IPR2017-01669, Paper 60 at 4
`
`(P.T.A.B. January 8, 2019) (“Petitioner did not file an opposition to Patent Owner’s
`
`Motion to Seal Exhibit 2017 and Patent Owner’s Submission of Supplemental
`
`Information.”) The alleged facts underlying Patent Owner’s motion were, in effect
`
`stipulated by the parties. In contrast, here, Petitioner disputes Patent Owner’s
`
`assertions, and moreover has demonstrated that Patent Owner has failed to meet its
`
`burden of proof. Westinghouse is thus distinguishable.
`
`Patent Owner’s final argument in support of sealing this document is that it
`
`was designated as “PROTECTIVE ORDER MATERIAL” under the Protective
`
`Order in IPR2023-00480 and -00481, and that it moved, unopposed, to seal this
`
`document therein. Motion at 4. But case law is clear, that mere marking of a
`
`document as confidential pursuant to a protective order in another matter is
`
`insufficient, on its own, to warrant sealing. Argentum, 2018 WL 495204, at *1. Nor
`
`has there been a determination in that matter that said material actually warrants
`
`sealing—Patent Owner merely obtained consent from the Petitioner in that matter,
`
`not the Board.
`
`
`
`Moreover, Patent Owner’s entire argument here is a tacit admission that the
`
`request to seal the document itself is improper. As asserted by Patent Owner, the
`
`agreement “contains” allegedly confidential commercial terms. Motion at 6. Patent
`
`– 7 –
`
`
`
`Owner does not assert, however, that those terms constitute the entirety of the
`
`Agreement. And a simple review of the agreement proves that it contains much more
`
`than the alleged confidential terms. See Exhibit 2048 generally. Even Patent Owner
`
`would have to agree here, as it quoted directly from the Agreement in its Response,
`
`without seeking to seal the quoted statements. Patent Owner Response at 13. Despite
`
`the foregoing, Patent Owner has provided no justification for seeking to seal the
`
`document in its entirety, as opposed to merely redacting the alleged confidential
`
`commercial terms, 1 , 2 other than, as discussed above, its legally and factually
`
`incorrect assertion that the Agreement contains a confidentiality provision covering
`
`the entirety of the document. Patent Owner’s request to seal must therefore be denied
`
`for the additional reason that it has not provided a public version of Exhibit 2048
`
`redacting only the information it deems truly confidential, or otherwise established
`
`good cause for sealing the document in its entirety. See Argentum, 2018 WL 495204,
`
`at *2; Skechers U.S.A., Inc. v. Nike, Inc., No. IPR2017-00620, 2017 WL 4277684,
`
`
`1 PO has not identified which specific clauses of the agreement this assertion relates
`
`to. Petitioner therefore does not consent to the redaction thereof.
`
`2 Exhibit 2048, which PO seeks to seal in its entirety, already contains redactions for
`
`information Patent Owner asserts to constitute “highly sensitive” monetary
`
`information. Motion at 6.
`
`– 8 –
`
`
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`at *1 (P.T.A.B. Sept. 25, 2017) (“Any such motion, however, must be accompanied
`
`by the filing of redacted (public) versions of Exhibits 2002–2008 that provides
`
`public access to any non-confidential information contained in those documents. For
`
`each exhibit, in the event no public version is filed, Petitioner is directed to provide
`
`in its motion a justification sufficient to establish good cause for sealing the exhibit
`
`in its entirety.”)
`
`Exhibits 2049 and 2050
`B.
`Patent Owner also seeks to seal, in their entirety, Exhibits 2049 and 2050.
`
`According to Patent Owner, these documents consist of an email communication and
`
`meeting minutes from 2003 concerning the aforementioned development agreement
`
`between IVAX and Serono. Motion at 7-8. These documents purportedly contain
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`highly confidential information “concerning Serono’s development plan for an oral
`
`cladribine drug product,” as well as joint development efforts, data, and prospective
`
`research relating thereto. Id. None of these conclusory assertions are sufficient to
`
`justify sealing however, as Patent Owner has not provided any evidence that the
`
`information at issue is truly confidential. For example, although Patent Owner
`
`asserts that the information contained within these documents is subject to non-party
`
`confidentiality obligations, such as the Agreement of Exhibit 2048, Patent Owner
`
`has failed to demonstrate that the information in either exhibit meets the definition
`
`– 9 –
`
`
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`of confidential information contained therein. 3 Neither document is marked as
`
`confidential on its face, and Patent Owner has not provided any evidence that, by the
`
`nature of the information itself, the parties to the Agreement must, in good faith, treat
`
`it as confidential. See Exhibit 2048 at 3; Exhibits 2049 and 2050 generally. Thus,
`
`Patent Owner’s argument that the Agreement itself requires sealing of these
`
`materials is without support.
`
`Patent Owner has also failed to demonstrate that the entirety of the
`
`information contained in Exhibits 2049 and 2050 is truly confidential for any other
`
`reason. As with the Agreement itself, Patent Owner opted not to submit a sworn
`
`declaration from anyone at either IVAX or Serono stating that they considered this
`
`information proprietary or confidential. Instead, Patent Owner relies solely on
`
`unsworn attorney argument. And as discussed above, conclusory assertions without
`
`supporting evidence is insufficient to meet the standard required to justify sealing
`
`the documents and withholding them from public view, particularly in light of the
`
`
`3 Patent Owner misleadingly refers to the Agreement as the “IVAX-Serono
`
`Agreement”. By its explicit terms however, the parties to the agreement are “IVAX
`
`International GmbH” and “Ares Trading S.A.” Motion at 7; Exhibit 2048 at 4. In
`
`contrast, Exhibits 2049 and 2050 constitute email correspondence and meeting
`
`minutes between IVAX and Serono. Exhibit 2049; Exhibit 2050.
`
`– 10 –
`
`
`
`strong public policy favoring making information filed in an inter partes review
`
`open to the public. This is especially notable here, as the information in question is
`
`more than twenty years old, and thus any value its alleged secrecy may have had in
`
`the past is almost certainly non-existent today, if it is even maintained as such
`
`anymore.
`
`Even if Patent Owner had submitted evidence that some of the information
`
`contained in Exhibits 2049 and 2050 is truly confidential, which it has not, that
`
`would fail to support sealing the documents in their entirety as requested, as opposed
`
`to submitting redacted public versions disclosing the non-confidential version. See
`
`Argentum, 2018 WL 495204, at *1–2; Skechers, 2017 WL 4277684, at *1. And
`
`Patent Owner would certainly have to agree that there is a significant amount of non-
`
`confidential material contained within each document, as it discussed the substance
`
`of each in detail in its Response, without requesting those portions of its Response
`
`to be sealed. Patent Owner Response at 13-15 (disclosing the substance of the
`
`briefing document (Exhibit 2049); disclosing the substance of what was said at the
`
`August 2003 meeting (Exhibit 2050). Patent Owner cannot plausibly assert that these
`
`materials need to be sealed in their entirety when they themselves have publicly
`
`disclosed portions thereof. Patent Owner’s request to seal Exhibits 2049 and 2050
`
`must therefore be denied.
`
`– 11 –
`
`
`
`C. Exhibit 2039
`Exhibit 2039 is the deposition transcript of Nicholas Bodor, taken on February
`
`15, 2024, in IPR2023-00480 and -00481. Unlike the previous exhibits, Patent Owner
`
`has at least attempted to limit the scope of its request to seal this document, and has
`
`submitted a redacted version of the exhibit for public access. Petitioner has reviewed
`
`the portions of this exhibit that Patent Owner seeks to seal, and does not oppose the
`
`request. Petitioner notes however that here, as with the previously discussed exhibits,
`
`Patent Owner has neglected to submit any evidence demonstrating that the material
`
`it seeks to seal in Exhibit 2039 is truly confidential. Instead, it bases its entire
`
`position on mere attorney argument. Motion at 5-6. Thus, while Petitioner does not
`
`oppose Patent Owner’s request to seal Exhibit 2039, Petitioner does not believe
`
`Patent Owner to have met its burden relating thereto.
`
`V. Motion for Entry of the Default Protective Order
`Petitioner does not oppose entry of a protective order modelled on the Default
`
`Protective Order, as set forth in Appendix B of the Consolidated Trial Practice Guide,
`
`provided that it is formatted appropriately for entry in these specific proceedings.
`
`VI. Conclusion
`For the foregoing reasons, Petitioner respectfully requests that the Board deny
`
`Patent Owner’s Motion to Seal Exhibits 2048, 2049, and 2050 submitted with Patent
`
`Owner’s Response.
`
`
`
`– 12 –
`
`
`
`April 15, 2024
`
`
`
`
`
`Respectfully submitted,
`/Philip D. Segrest, Jr./
`Philip D. Segrest, Jr. (Reg. No. 39,021)
`philip.segrest@huschblackwell.com
`Lead Counsel for Petitioner
`
`Nathan P. Sportel
` Stephen R. Howe
`Backup Counsel for Petitioner
`HUSCH BLACKWELL LLP
`120 South Riverside Plaza, Suite 2200
`Chicago, IL 60606
`Tel. 312-655-1500
`Fax. 312-644-1501
`
`
`
`– 13 –
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.105, Petitioner certifies that the foregoing
`
`document was served via electronic mail to the attorneys of record in this proceeding
`
`at the following:
`
`Emily R. Whelan (Reg. No. 50,391)
`Emily.Whelan@wilmerhale.com
`Deric X. Geng, Ph.D. (Reg. No. 73,434)
`Deric.Geng@wilmerhale.com
`Cindy Kan (Reg. No. 76,385)
`Cindy.Kan@wilmerhale.com
`
`WILMER CUTLER PICKERING HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`
`Counsel for Patent Owner
`
`April 15, 2024
`
`/Philip D. Segrest, Jr./
`Philip D. Segrest, Jr. (Reg. No. 39,021)
`philip.segrest@huschblackwell.com
`Lead Counsel for Petitioner
`
`Nathan P. Sportel
`Stephen R. Howe
`Backup Counsel for Petitioner
`HUSCH BLACKWELL LLP
`120 South Riverside Plaza, Suite 2200
`Chicago, IL 60606
`Tel. 312-655-1500
`Fax. 312-644-1501
`
`
`
`– 14 –
`
`
`
`
`
`
`
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