UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
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`v.
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` REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Patent No. 11,253,572
`
`
`Inter Partes Review No. IPR2023-00884
`
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`MOTION TO FILE CONFIDENTIAL DOCUMENTS UNDER
`SEAL PURSUANT TO 37 C.F.R. §§ 42.14 AND 42.54
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`SAMSUNG BIOEPIS CO., LTD.,
`Petitioner,
`
`v.
`
` REGENERON PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Patent No. 11,253,572
`
`
`Inter Partes Review No. IPR2023-00884
`
`
`MOTION TO FILE CONFIDENTIAL DOCUMENTS UNDER
`SEAL PURSUANT TO 37 C.F.R. §§ 42.14 AND 42.54
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`IPR2023-00884
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`Pursuant to 35 U.S.C. § 316(a)(1) and 37 C.F.R. §§ 42.14 and 42.54, Patent
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`Owner Regeneron Pharmaceuticals, Inc. moves to seal the following exhibits filed
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`concurrently with Patent Owner’s Preliminary Response:
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`Exhibit
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`2001
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`2013
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`2015
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`2018
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`2019
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`2036
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`2037
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`2038
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`2039
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`2040
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`2041
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`2043
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`2048
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`Description
`Expert Declaration of Richard Manning, Ph.D., Mylan Pharms. Inc.
`v. Regeneron Pharms., Inc., IPR2021-00881, Ex. No. 2052 (Feb. 11,
`2022)
`Regeneron, Clinical Study Concept - Ophthalmology-Diabetic
`Macular Edema-Phase 2-IVT-VGFT-OD-0706 (updated May 19,
`2008)
`DA VINCI – DME And VEGF Trap-Eye: Investigation of Clinical
`Impact: One Year Data (Dec. 8, 2010) (attachment to Ex.2024)
`Regeneron Pharmaceuticals, Inc., VGFT-OD-0706 Week 24 Topline
`Results (Feb. 1, 2010) (attachment to Ex.2017)
`DRAFT – DA VINCI – 6-Month Primary Endpoint (Feb. 1, 2010)
`(attachment to Ex.2017)
`DME Target Product Profile - VEGF Trap-Eye (Sept. 26, 2007)
`Clinical Development & Regulatory Affairs Weekly Update (Oct.
`29, 2010)
`Clinical Development & Regulatory Affairs Weekly Update (Dec. 3,
`2010)
`Email from George Yancopoulos re DME PLANS & FDA meeting
`pre-discussion (Jan. 9, 2008)
`MEMO re Guidance From Bayer/ REGN Sr. Management Regarding
`Additional Indications in Ophthalmology from George Yancopoulos
`to Bayer/REGN Joint Development Group (Mar. 28, 2008)
`Action Items by GD Yancopoulos - Bayer/REGN JSC (Feb. 15,
`2008)
`Vascular Endothelial Growth Factor (VEGF): Investigation of
`Efficacy and Safety in Wet Age-Related Macular Degeneration
`(AMD)—VIEW 1 + VIEW 2: 1-Year Results (Nov. 20, 2010)
`(Attachment to Ex.2042)
`Regeneron Pharmaceuticals, Inc., A Double-Masked, Randomized,
`Controlled Study of the Safety, Tolerability and Biological Effect of
`Repeated Intravitreal Administration of VEGF Trap-Eye in Patients
`with Diabetic Macular Edema (DME) (Issued Jan. 28, 2009)
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`IPR2023-00884
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`I.
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`DOCUMENTS TO BE SEALED AND REASONS FOR SEALING
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`The standard governing the Board’s determination of whether to grant a
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`motion to seal is “good cause.” Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
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`IPR2012-00001, Paper 36 at 4 (April 5, 2013) (quoting 37 C.F.R. § 42.54). The
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`Board aims to “strike a balance between the public’s interest in maintaining a
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`complete and understandable file history and the parties’ interest in protecting truly
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`sensitive information.” Id.
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`The documents, exhibits, and portions of exhibits that Patent Owner seeks to
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`file under seal fall into three general categories, each of which meets the “good
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`cause” standard to be maintained in the docket under seal and available only to the
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`parties and Board. In each instance, the material is either the confidential
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`information of a third party, or else consists of confidential business information
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`that would cause competitive harm to Patent Owner were it to be disclosed
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`publicly.
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`A. Declaration Including Confidential Market and Pricing
`Information
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`Exhibit 2001 is a declaration of Dr. Richard Manning, an expert witness
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`retained by Patent Owner who addressed the commercial success of Eylea® in a
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`related proceeding, IPR2021-00881. Dr. Manning relies on a range of confidential
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`information in his declaration, including the following:
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`IPR2023-00884
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` Confidential financial information drawn from Patent Owner’s internal
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`business records, which contain information such as profits and costs
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`associated with Patent Owner’s activities in connection with Eylea®.
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`This confidential business information is not publicly available and is
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`competitively sensitive. Its inclusion in the public docket would cause
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`commercial harm to Patent Owner.
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` Confidential marketing plans and information prepared and compiled by
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`Patent Owner. These documents include and/or reference Patent
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`Owner’s marketing plans and its Awareness Trial and Usage (“ATU”)
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`market research for Eylea®. This information is not publicly, and public
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`release of this information could benefit Patent Owner’s competitors and
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`thereby cause competitive harm to Patent Owner.
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` Confidential market metrics and projections that are compiled and
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`provided by third party data provider Vestrum Health (“Vestrum”). These
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`documents include data analysis related to Patent Owner’s activities in
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`connection with Eylea®. The information contained in these exhibits is
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`not publicly available and would cause competitive harm to Patent
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`Owner and Vestrum if disclosed on the public docket. Patent Owner
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`agreed with Vestrum to maintain the confidentiality this information.
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`IPR2023-00884
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` Confidential market metrics and projections that are compiled and
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`provided by third party data provider, IQVIA. These documents include
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`data analysis related to Patent Owner’s activities in connection with
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`Eylea®. The information contained in these exhibits is not publicly
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`available and would cause competitive harm to Patent Owner and IQVIA
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`if disclosed on the public docket. Patent Owner agreed with IQVIA to
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`maintain the confidentiality of this information.
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` Confidential information obtained from the American Society of Retina
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`Specialists (ASRS). These documents include compiled survey
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`information from ASRS member retina specialists. Only members of
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`ASRS have access to this information, and the documents themselves
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`include restrictions on their publication. The information contained in
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`these exhibits is not publicly available and may cause competitive harm
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`to ASRS if disclosed on the public docket.
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`Patent Owner moves to seal the specific portions of Dr. Manning’s
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`declaration that reveal this confidential information. Pursuant to Paragraph
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`5(A)(ii) of the Board’s default protective order, Ex.2059, a redacted copy of Dr.
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`Manning’s declaration is being filed publicly with the same exhibit number.
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`IPR2023-00884
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`B.
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`Patent Owner’s Clinical Development Processes and Strategic
`Decision Making
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`Exhibits 2013, 2036, 2039, 2040, and 2041 are Patent Owner’s internal
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`memoranda, notes, and other planning documents from 2007-2008 related to
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`Regeneron’s development of aflibercept, and in particular to the design of
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`aflibercept clinical trials. These documents reveal non-public aspects of Patent
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`Owner’s strategic decision making in the development of Eylea®, including its
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`commercial and regulatory strategies. Public release of these details could cause
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`competitive harm to Patent Owner by giving its competitors knowledge of its
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`clinical research operations. In the district court litigation between Regeneron and
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`Mylan, Patent Owner produced these documents with a designation of
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`“CONFIDENTIAL” as defined by the protective order in that case.
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`Exhibits 2037 and 2038 are Patent Owner’s internal summaries of the status
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`of planned, ongoing, and completed clinical trials and planned regulatory
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`submissions in 2010. They reveal non-public details of Patent Owner’s clinical
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`development for Eylea® and aspects of Patent Owner’s regulatory and commercial
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`strategies. Public release of these details could cause competitive harm to Patent
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`Owner by giving its competitors knowledge of its clinical research operations. In
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`the district court litigation between Regeneron and Mylan, Patent Owner produced
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`these documents with a designation of “OUTSIDE COUNSEL’S EYES ONLY” as
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`defined by the protective order in that case.
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`IPR2023-00884
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`C. Confidential Clinical Trial Protocols and Results
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`Exhibits 2015, 2019, and 2043 are Patent Owner’s internal summaries of its
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`DA VINCI and VIEW clinical trial results. These documents reveal non-public
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`data and data analysis. Public release of these details could cause competitive
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`harm to Patent Owner. Further, these exhibits report patient-level demographic
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`information as well as details of these patients’ adverse events and treatment
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`outcomes. Disclosure of this information would compromise the confidentiality of
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`the clinical trial subjects. In the district court litigation between Regeneron and
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`Mylan, Patent Owner produced these documents with a designation of
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`“CONFIDENTIAL” as defined by the protective order in that case. These exhibits
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`report a combination of published and unpublished data and data analysis, and
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`Patent Owner moves to seal the specific portions of these exhibits that reveal
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`unpublished data and data analysis. Pursuant to Paragraph 5(A)(ii) of the Board’s
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`default protective order, a redacted copy of these exhibits is being filed publicly
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`with the same exhibit number.
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`Exhibit 2018 is a detailed report of Patent Owner’s DA VINCI clinical trial
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`results. It reveals non-public details of the protocol, results, and data analysis that
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`have not been made public. Public release of these details could cause competitive
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`harm to Patent Owner. Further, these exhibits report patient-level demographic
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`information as well as details of these patients’ adverse events and treatment
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`IPR2023-00884
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`outcomes. Disclosure of this information would compromise the confidentiality of
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`the clinical trial subjects. In the district court litigation between Regeneron and
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`Mylan, Patent Owner produced this document with a designation of
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`“CONFIDENTIAL” as defined by the protective order in that case.
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`Exhibit 2048 is a detailed clinical trial protocol for the DA VINCI trial. It
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`reveals non-public details about Patent Owner’s clinical trial protocol, data
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`analysis, and the product used in the clinical trial, and it implicates Patent Owner’s
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`commercial and regulatory strategies. Public release of these details could cause
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`competitive harm to Patent Owner by giving its competitors knowledge of its
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`clinical research operations. As reflected on the first page, this document was
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`designated as confidential to the Institutional Review Board and those involved in
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`the conduct of the clinical trial.
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`II.
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`PROTECTIVE ORDER
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`Concurrently with the present motion, Regeneron filed an unopposed
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`Motion for Protective Order requesting entry of the Board’s default protective
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`order, Ex.2059.
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`III. CERTIFICATION
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`Pursuant to 37 CFR § 42.54, Patent Owner certifies that it has conferred with
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`Petitioner regarding this motion to seal. Petitioner does not object to the motion.
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`IPR2023-00884
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`Dated: August 25, 2023
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`Respectfully submitted,
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`By /Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, California 94105
`Tel: (415) 268-6053
`ABrausa@mofo.com
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`8
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`IPR2023-00884
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`Certificate of Service (37 C.F.R. § 42.6(e)(4))
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`I hereby certify that the attached MOTION TO FILE CONFIDENTIAL
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`DOCUMENTS UNDER SEAL PURSUANT TO 37 C.F.R. §§ 42.14 AND 42.54
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`was served as of the below date on the Petitioner via e-mail (by agreement) to the
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`following counsel of record:
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`Raymond N. Nimrod (Reg. No. 31,987)
`Matthew A. Traupman (Reg. No. 50,832)
`Landon Andrew Smith (Reg. No. 79,248)
`QUINN EMANUEL URQUHART
`& SULLIVAN, LLP
`51 Madison Ave., 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Direct Tel: (212) 849-7322
`Fax: (212) 849-7100
`raynimrod@quinnemanuel.com
`matthewtraupman@quinnemanuel.com
`landonsmith@quinnemanuel.com
`qe-samsungbioepis@quinnemanuel.com
`
`
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`Dated: August 25, 2023
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`
`
` /Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
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`9
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