UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
`
`
`
`Case IPR2023-00050
`U.S. Patent 8,377,903
`
`
`PATENT OWNER’S REPLY TO PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO SEAL AND FOR ENTRY OF
`DEFAULT PROTECTIVE ORDER
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`v.
`MERCK SERONO SA,
`Patent Owner.
`
`
`
`Case IPR2023-00050
`U.S. Patent 8,377,903
`
`
`PATENT OWNER’S REPLY TO PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO SEAL AND FOR ENTRY OF
`DEFAULT PROTECTIVE ORDER
`
`
`
`
`
`
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`
`Introduction
`Patent Owner satisfied its burden to establish that the contents of Exhibits
`
`I.
`
`2048-2050 are “truly confidential.” Moreover, good cause exists to protect and
`
`seal that material. The Motion to Seal should be granted.
`
`II. There is Good Cause to Seal the JRA (Exhibit 2048), Briefing Document
`(Exhibit 2049), and Internal Business Notes (Exhibit 2050)
`Good cause to seal material is determined on the balance of four factors.
`
`Paper 26 (Patent Owner’s Motion to Seal) at 3-4. Petitioner’s opposition
`
`challenges only one: whether the sealed material is “truly confidential.” But Patent
`
`Owner satisfied this factor by explaining that these documents contain confidential
`
`technical, financial, and commercial information. See id. at 4-10.
`
`The documents Petitioner seeks to unseal relate to its challenge under
`
`§102(e) and help to establish the disclosure set out in the Bodor reference on which
`
`Petitioner relies is not “by another.” These materials are not publicly available and
`
`contain sensitive business, licensing, commercial, and research and development
`
`information of Patent Owner, Patent Owner’s predecessor, and third parties. See
`
`Paper 26 at 3-8. These types of documents are routinely considered confidential
`
`and sealed. See, e.g., Mylan Lab’ys Ltd. v. Aventis Pharm. S.A., IPR2016-00712,
`
`Paper 35 at 3 (granting motions to seal exhibits containing market analyses and
`
`meeting minutes related to regulatory plans and clinical trials); Associated British
`
`Foods PLC et al. v. Cornell Rsch. Found., IPR2019-00577, Paper 129 at 3-4
`- 1 -
`
`
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`
`(granting motion to seal “grant applications, a record of invention, and license
`
`agreements”); Celltrion, Inc. v. Genentech, Inc., IPR2016-01667, Paper 20 at 3
`
`(granting motion to seal exhibits including “‘non-public research and development
`
`information in the form of proprietary clinical and scientific data concerning [the
`
`drug product], and confidential information about drug development and
`
`regulatory approval strategies.’”).
`
`Turning first to the confidential Joint Research Agreement (“JRA”) in
`
`Exhibit 2048, that document establishes the relationship between Patent Owner’s
`
`predecessor and third parties that led to the disclosure upon which Petitioner relies.
`
`On its face, the JRA establishes why it is appropriately sealed in this proceeding:
`
`It explicitly states that the parties can neither disclose the JRA nor its performance
`
`without permission. See Exhibit 2048 at 29. It further demands that the
`
`involvement of certain entities may not be disclosed. Id. The JRA further includes
`
`confidential information related to commercial business information (e.g., research
`
`and development information, financial data, and licensing terms and practices)
`
`that could have significant value to competitors of both Patent Owner and third
`
`parties to the agreement. Good cause therefore exists to seal this material. The
`
`Board has granted motions to seal similar agreements on similar grounds. See,
`
`e.g., Westinghouse Air Brake Techs. Corp. v. Siemens Mobility, Inc., IPR2017-
`
`01669, Paper 60.
`
`
`
`- 2 -
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`
`Next, turning to Exhibits 2049 and 2050, these documents were created
`
`pursuant to the performance outlined in the confidential JRA. Contrary to
`
`Petitioner’s argument, the JRA expressly contemplates treating documents like
`
`Exhibits 2049 and 2050, which trigger the contractual obligation, as confidential
`
`information. See Exhibit 2048 at 3 (stating that one of two categories of
`
`confidential material include “any information that, by the nature of the
`
`information or the circumstances surrounding its disclosure, ought, in good faith,
`
`to be treated as confidential.”). Because these documents concern research and
`
`development efforts, marketing plans, regulatory plans, and licensing practices of
`
`third parties and of Patent Owner’s predecessor, they satisfy the JRA’s confidential
`
`information definition. Specifically, Exhibit 2049 is a draft of a document for
`
`confidential submission before the Swedish Medical Products Authority. The
`
`contents include confidential business information and research and development
`
`information of both Patent Owner’s predecessor and third parties. These
`
`categories of confidential information should be sealed. See Activision Blizzard,
`
`Inc. et al. v. Acceleration Bay, LLC, IPR2015-01951, Paper 108 at 3-4 (granting
`
`motion to seal “confidential information regarding internal research and
`
`development efforts of a third party” and “licensing practices of a third party”).
`
`Exhibit 2050 is a copy of internal meeting notes that discuss business-
`
`sensitive marketing plans, research and development plans, and regulatory
`
`
`
`- 3 -
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`strategy. Such information is generally understood to be confidential and known to
`
`potentially cause harm by its disclosure. The Board has withheld similar
`
`confidential information from public disclosure before. See, e.g., Mylan, IPR2016-
`
`00712, Paper 35 at 3 (granting motion to seal business notes related to confidential
`
`FDA submissions, marketing plans, and regulatory strategy); British Foods,
`
`IPR2019-00577, Paper 129 at 3-4 (same). Accordingly, good cause exists to seal
`
`the confidential information in all three documents.
`
`III. Reference in Patent Owner Response Does Not Extinguish the
`Documents’ Entire Confidentiality
`Beyond pointing to the material cited in the Patent Owner Response
`
`(“POR”), Petitioner does not point to any specific material that is public. That is
`
`because there is none. Patent Owner acknowledges that its POR quotes and
`
`references a handful of sentences out of numerous pages of the challenged
`
`Exhibits. But such quotes and references do not extinguish the documents’
`
`confidentiality—and certainly should not result in public disclosure of the
`
`confidential documents’ entire contents. Exhibit 2048-2050 are referenced in the
`
`POR in conjunction with other unsealed and public exhibits. See Paper 27 (POR)
`
`at 12-15. The POR introduces the existence of these confidential documents and
`
`points to precise instances where they help establish Patent Owner’s predecessor’s
`
`involvement in the disclosure found in Petitioner’s Bodor reference. See id. The
`
`
`
`- 4 -
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`
`POR does not disclose the totality of the confidential material discussed above.
`
`Nevertheless, to address any concerns, Patent Owner has filed redacted Exhibits, as
`
`Exhibits 2077-2079, redacting only non-public information which has not been
`
`quoted or referenced in any papers in these proceedings, and which is clearly
`
`confidential and should be shielded from the public.1
`
`IV. Patent Owner Has Filed Public-Facing Versions
`Petitioner’s opposition noted that Patent Owner had not yet filed a public
`
`version of the challenged Exhibits. But as of this Reply, Patent Owner has filed
`
`public versions of these Exhibits, as Exhibits 2077-2079, with the redactions
`
`discussed above. That filing should cure any concerns Petitioner has regarding
`
`proper public disclosure of non-confidential information.
`
`For the above reasons, the Motion to Seal should be granted.
`
`Dated: May 15, 2024
`
`Respectfully Submitted,
`
`/Emily R. Whelan/
`Emily R. Whelan (Reg. No. 50,391)
`Counsel for Patent Owner
`Wilmer Cutler Pickering
` Hale and Dorr LLP
`60 State Street
`Boston, MA 02109
`Tel. (617) 526-6567
`E-mail: Emily.Whelan@wilmerhale.com
`
`
`
`
`
`
`
`1 To the extent necessary, Patent Owner is willing to file a new motion to seal.
`- 5 -
`
`
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`Description
`
`Exhibit
`No.
`2001 Declaration of David B. Bassett in Support of Motion for Admission
`Pro Hac Vice
`2002 Declaration of Vinita Ferrera in Support of Motion for Admission Pro
`Hac Vice
`2003 Declaration of Mary Pheng in Support of Motion for Admission Pro
`Hac Vice
`
`2004
`
`J. C. Sipe et al., Cladribine in Treatment of Chronic Progressive
`Multiple Sclerosis, 344 THE LANCET 9 (1994)
`
`2005
`
`2006
`
`B. M. Greenberg et al., Multiple Sclerosis, in PHARMACOLOGY AND
`THERAPEUTICS: PRINCIPLES TO PRACTICE 685 (S. A. Waldman & A.
`Terzic eds., 2009)
`
`C. Krishnan et al., Reduction of Disease Activity and Disability With
`High-Dose Cyclophosphamide in Patients With Aggressive Multiple
`Sclerosis, 65 ARCHIVES OF NEUROLOGY 1044 (2008)
`
`2007
`
`B. Greenberg & E. M. Frohman, Defining Success in Multiple
`Sclerosis: Treatment Failures and Nonresponders, 8 PROCEEDINGS,
`JOHNS HOPKINS ADVANCED STUDIES IN MEDICINE 274 (2008)
`2008 B. M. Greenberg et al., Current and Emerging Multiple Sclerosis
`Therapeutics, 16 CONTINUUM 58 (2010)
`
`2009 Transcript of Deposition of Benjamin Greenberg (Feb. 26, 2024)
`
`2010
`
`A. E. Miller & R. M. Herndon, Treatment Issues, in MULTIPLE
`SCLEROSIS: THE QUESTIONS YOU HAVE—THE ANSWERS YOU NEED 43
`(R. C. Kalb ed., 2nd Ed. 2000)
`
`
`
`- 6 -
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`
`Exhibit
`No.
`
`2011
`
`Description
`
`J. Noseworthy et al., Disease-Modifying Treatments in Multiple
`Sclerosis, in MCALPINE’S MULTIPLE SCLEROSIS 729 (A. Compston et
`al. eds., 4th ed. 2005)
`
`2012
`
`H. El-Moslimany & A. E. Miller, Escape Therapies and Management
`of Multiple Sclerosis, in MULTIPLE SCLEROSIS: A COMPREHENSIVE
`TEXT 333 (C. S. Raine et al. eds., 2008)
`2013 F. Lublin, History of Modern Multiple Sclerosis Therapy, 252 JOURNAL
`OF NEUROLOGY III/3 (2005)
`2014 D. S. Goodin et al., Disease Modifying Therapies in Multiple Sclerosis,
`58 NEUROLOGY 169 (2002)
`
`2015
`
`2016
`
`G. Giovannoni et al., Long-Term Follow-Up of Patients with Relapsing
`Multiple Sclerosis From the CLARITY/CLARITY Extension Cohort of
`CLASSIC-MS: An Ambispective Study, 29 MULTIPLE SCLEROSIS
`JOURNAL 719 (2023)
`
`M. Filippi et al., The Effect of Cladribine on T1 ‘Black Hole’ Changes
`in Progressive MS, 176 JOURNAL OF THE NEUROLOGICAL SCIENCES 42
`(2000)
`
`2017
`
`J. E. Joy & R. B. Johnston, Jr., MULTIPLE SCLEROSIS: CURRENT STATUS
`AND STRATEGIES FOR THE FUTURE 17 (2001)
`
`2018
`
`O. Neuhaus et al., Immunomodulation in Multiple Sclerosis: From
`Immunosuppression to Neuroprotection, 24 TRENDS IN
`PHARMACOLOGICAL SCIENCES 131 (2003)
`
`2019 Declaration of Fred Lublin, M.D.
`2020 L. Durelli, Dose and Frequency of Interferon Treatment Matter, 250
`JOURNAL OF NEUROLOGY IV/9 (2003)
`
`
`
`- 7 -
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`
`Exhibit
`No.
`
`Description
`
`2021
`
`R. Rudick & A. Sandrock, Natalizumab: 4-Integrin Antagonist
`Selective Adhesion Molecule Inhibitors for MS, 4 EXPERT REVIEW OF
`NEUROTHERAPEUTICS 571 (2004)
`2022 D. S. Alberts et al., Disposition of Mitoxantrone in Cancer Patients, 45
`CANCER RESEARCH 1879 (1985)
`
`2023
`
`K. Rammohan et al., The Development of Cladribine Tablets for the
`Treatment of Multiple Sclerosis: A Comprehensive Review, 80 DRUGS
`1901 (2020)
`
`2024
`
`J. F. Kurtzke, Rating Neurologic Impairment in Multiple Sclerosis: An
`Expanded Disability Status Scale (EDSS), 33 NEUROLOGY 1444 (1983)
`
`2025
`
`2026
`
`2027
`
`2028
`
`M. J. Tullman et al., Immunotherapy of Multiple Sclerosis—Current
`Practice and Future Directions, 39 JOURNAL OF REHABILITATION
`RESEARCH AND DEVELOPMENT 273 (2002)
`
`G. Giovannoni et al., A Placebo-Controlled Trial of Oral Cladribine
`for Relapsing Multiple Sclerosis, 362 NEW ENGLAND JOURNAL OF
`MEDICINE 416 (2010)
`
`Supplementary Appendix to G. Giovannoni et al., A Placebo-
`Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis,
`362 NEW ENGLAND JOURNAL OF MEDICINE 416 (2010) (Exhibit 2026)
`
`G. Giovannoni et al., Safety and Efficacy of Cladribine Tablets in
`Patients with Relapsing–Remitting Multiple Sclerosis: Results from the
`Randomized Extension Trial of the CLARITY Study, 24 MULTIPLE
`SCLEROSIS JOURNAL 1594 (2018)
`
`2029 US Patent No. 8,785,415
`2030 Serono Press Release, Serono and Ivax to Develop Oral Therapy for
`Multiple Sclerosis (Oct. 30, 2002)
`
`
`
`- 8 -
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`
`Exhibit
`No.
`
`Description
`
`2031 Serono Form 20-F (2003)
`
`2032
`
`C. Sargent, Serono Purchases Rights to Experimental MS Drug, WALL
`STREET JOURNAL (Oct. 31, 2002),
`https://www.wsj.com/articles/SB1035995148253461151 (accessed
`Dec. 14, 2023)
`
`2033 Reserved
`
`2034
`
`P. S. Rommer et al., Requirement for Safety Monitoring for Approved
`Multiple Sclerosis Therapies: An Overview, 175 CLINICAL AND
`EXPERIMENTAL IMMUNOLOGY 397 (2013)
`
`2035 Reserved
`
`2036 LEUSTATIN® (cladribine) Package Insert (2002)
`
`2037
`
`Merck Receives Complete Response Letter from FDA on Cladribine
`Tablets New Drug Application, FIERCEBIOTECH.COM (Mar. 2, 2011),
`https://www.fiercebiotech.com/biotech/merck-receives-complete-
`response-letter-from-fda-on-cladribine-tablets-new-drug-application
`(accessed Mar. 12, 2024)
`
`2038
`
`M. Hoffman, Interview of K. Rammohan: Short-Term Dosing Regimen
`Gives Cladribine an Advantage in MS, NEUROLOGYLIVE.COM (Jul. 1,
`2020), https://www.neurologylive.com/view/short-commitment-
`dosing-regimen-gives-cladribine-an-advantage-in-ms (accessed Nov.
`10, 2023)
`2039 Transcript of Deposition of Nicholas Bodor in IPR2023-00480 &
`IPR2023-00481 (PROTECTIVE ORDER MATERIAL)
`
`2040
`
`J. C. Sipe et al., Development of Cladribine Treatment in Multiple
`Sclerosis, 1 MULTIPLE SCLEROSIS 343 (1996)
`
`
`
`- 9 -
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`
`Exhibit
`No.
`2041 Transcript of Deposition of Nicholas Bodor in IPR2023-00480 &
`IPR2023-00481 [Public, Redacted]
`
`Description
`
`2042 Reserved
`
`2043
`
`FDA News Release: FDA Approves New Oral Treatment for Multiple
`Sclerosis (Mar. 29, 2019), https://www.fda.gov/news-events/press-
`announcements/fda-approves-new-oral-treatment-multiple-sclerosis
`(accessed on Nov. 25, 2023)
`
`2044 U.S. Provisional Patent Application No. 60/458,922
`
`2045 U.S. Provisional Patent Application No. 60/484,756
`
`2046 U.S. Provisional Patent Application No. 60/541,247
`2047 Amendment and Reply to Rule 312 Communication (Jun. 12, 2014), in
`File History for U.S. Patent No. 8,785,415
`
`2048
`
`The 2002 Product Development and License Agreement between
`IVAX International GMBH and Ares Trading S. A. (PROTECTIVE
`ORDER MATERIAL)
`2049 December 17, 2003 Email and Cladribine Briefing Document
`(PROTECTIVE ORDER MATERIAL)
`2050 August 27, 2003 Minutes for the Oral Cladribine for MS Project Joint
`Meeting (PROTECTIVE ORDER MATERIAL)
`
`2051
`
`Video: A. E. Miller, What You Need to Know About Mavenclad®
`(https://www.nationalmssociety.org/Treating-
`MS/Medications/Mavenclad) (2019)
`2052 Transcript of Video: A. E. Miller, What You Need to Know About
`Mavenclad® (2019)
`
`
`
`- 10 -
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`
`Exhibit
`No.
`
`Description
`
`2053 Declaration of Alain Munafo, Ph.D.
`
`2054 Declaration of Nicholas Bodor, Ph.D., D.Sc., d.h.c.
`
`2055 Declaration of Yogesh Dandiker, Ph.D.
`
`2056
`
`J. H. Noseworthy et al., Multiple Sclerosis, 343 THE NEW ENGLAND
`JOURNAL OF MEDICINE 938 (2000)
`2057 R. A. Rudick et al., Management of Multiple Sclerosis, 337 THE NEW
`ENGLAND JOURNAL OF MEDICINE 1604 (A. J. J. Wood ed., 1997)
`
`2058
`
`R. A. Rudick et al., Natalizumab plus Interferon Beta-1a for Relapsing
`Multiple Sclerosis, 354 THE NEW ENGLAND JOURNAL OF MEDICINE 911
`(2006)
`
`2059
`
`M. Caporro et al., Two Decades of Subcutaneous Glatiramer Acetate
`Injection: Current Role of the Standard Dose, and New High-Dose
`Low-Frequency Glatiramer Acetate in Relapsing–Remitting Multiple
`Sclerosis Treatment, 8 PATIENT PREFERENCE AND ADHERENCE 1123
`(2014)
`
`2060 COPAXONE® (glatiramer acetate) Package Insert (2014)
`
`2061 Reserved
`
`2062
`
`A. Liu, Better 8 Years Late than Never: Merck KGaA Nabs FDA Nod
`for MS Drug Mavenclad, FIERCEBIOTECH.COM (Apr. 1, 2019),
`https://www.fiercepharma.com/pharma/better-8-years-late-than-never-
`merck-kgaa-nabs-fda-nod-for-ms-drug-mavenclad (accessed Dec. 18,
`2023)
`
`
`
`- 11 -
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`
`Exhibit
`No.
`
`2063
`
`Description
`
`ClinicalTrials.gov Publication and Record History, NCT00213135, A
`Safety and Efficacy Study of Oral Cladribine in Subjects With
`Relapsing-Remitting Multiple Sclerosis (RRMS) (CLARITY) (2014),
`https://clinicaltrials.gov/study/NCT00213135;
`https://clinicaltrials.gov/study/NCT00213135?tab=history&a=13,
`(accessed Nov. 25, 2023)
`
`2064
`
`Safety & Side Effects: Learn About the Possible Risks of
`MAVENCLAD,
`https://web.archive.org/web/20231004232146/https://www.mavenclad.
`com/en/home/why-mavenclad/safety-and-side-effects.html (last
`updated Nov. 2022) (accessed Dec. 19, 2023)
`2065 M. Filippi et al., Whole Brain Volume Changes in Patients with
`Progressive MS Treated with Cladribine, 55 NEUROLOGY 1714 (2000)
`
`2066 Declaration of Asher S. McGuffin
`
`2067 Declaration of Willem de Weerd
`
`2068 Declaration of Cindy Kan
`
`2069 Reserved
`
`2070 Reserved
`
`2071 Reserved
`2072 Reply and Amendment (Oct. 3, 2008), in File History for U.S. Patent
`No. 7,888,328
`2073 Declaration of Gillian Farrell in Support of Motion for Admission Pro
`Hac Vice
`
`2074 Supplemental Declaration of Cindy Kan (service only)
`
`
`
`- 12 -
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`
`Exhibit
`No.
`
`Description
`
`2075
`
`J. C. Sipe et al., Cladribine in Treatment of Chronic Progressive
`Multiple Sclerosis, 344 THE LANCET 9 (1994) (service only)
`
`2076
`
`The 2002 Product Development and License Agreement between
`IVAX International GMBH and Ares Trading S.A. (PROTECTIVE
`ORDER MATERIAL) (service only)
`
`2077
`
`The 2002 Product Development and License Agreement between
`IVAX International GMBH and Ares Trading S. A. (REDACTED -
`PUBLIC)
`2078 December 17, 2003 Email and Cladribine Briefing Document
`(REDACTED - PUBLIC)
`2079 August 27, 2003 Minutes for the Oral Cladribine for MS Project Joint
`Meeting (REDACTED - PUBLIC)
`
`
`
`- 13 -
`
`
`
`IPR2023-00050
`Reply to Opposition to Motion to Seal and for Entry of Default Protective Order
`
`
`CERTIFICATE OF SERVICE
`I hereby certify that on May 15, 2024, I caused true and correct copies of the
`
`following documents:
`
`
`
`
`
`
`
`
`
`Patent Owner’s Reply to Petitioner’s Opposition to Patent Owner’s
`
`Motion to Seal and for Entry of Default Protective Order
`
`Exhibit No. 2077
`
`Exhibit No. 2078
`
`Exhibit No. 2079
`
`to be served via e-mail, as consented to by Petitioner, on the following attorneys of
`record:
`
`Philip.Segrest@huschblackwell.com
`Nathan.Sportel@huschblackwell.com
`Steve.Howe@huschblackwell.com
`Don.Mizerk@huschblackwell.com
`
`By: /Cindy Kan/
`Cindy Kan (Reg. No. 76,385)
`Wilmer Cutler Pickering
` Hale and Dorr LLP
`7 World Trade Center
`50 Greenwich Street
`New York, NY 10007
`Tel: (212) 295-6470
`E-mail: Cindy.Kan@wilmerhale.com
`
`- 14 -
`
`
`
`
`
`
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