`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`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
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2023-00884
`
`
`
`
`
`Pursuant to 35 U.S.C. § 316(a)(1) and 37 C.F.R. §§ 42.14 and 42.54, Patent
`
`Owner Regeneron Pharmaceuticals, Inc. moves to seal the following exhibits filed
`
`concurrently with Patent Owner’s Preliminary Response:
`
`Exhibit
`
`2001
`
`2013
`
`2015
`
`2018
`
`2019
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`
`2043
`
`2048
`
`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)
`
`
`
`1
`
`
`
`
`
`IPR2023-00884
`
`
`
`
`
`I.
`
`DOCUMENTS TO BE SEALED AND REASONS FOR SEALING
`
`The standard governing the Board’s determination of whether to grant a
`
`motion to seal is “good cause.” Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`
`IPR2012-00001, Paper 36 at 4 (April 5, 2013) (quoting 37 C.F.R. § 42.54). The
`
`Board aims 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.” Id.
`
`The documents, exhibits, and portions of exhibits that Patent Owner seeks to
`
`file under seal fall into three general categories, each of which meets the “good
`
`cause” standard to be maintained in the docket under seal and available only to the
`
`parties and Board. In each instance, the material is either the confidential
`
`information of a third party, or else consists of confidential business information
`
`that would cause competitive harm to Patent Owner were it to be disclosed
`
`publicly.
`
`A. Declaration Including Confidential Market and Pricing
`Information
`
`Exhibit 2001 is a declaration of Dr. Richard Manning, an expert witness
`
`retained by Patent Owner who addressed the commercial success of Eylea® in a
`
`related proceeding, IPR2021-00881. Dr. Manning relies on a range of confidential
`
`information in his declaration, including the following:
`
`
`
`2
`
`
`
`
`
`IPR2023-00884
`
`
`
`
`
` Confidential financial information drawn from Patent Owner’s internal
`
`business records, which contain information such as profits and costs
`
`associated with Patent Owner’s activities in connection with Eylea®.
`
`This confidential business information is not publicly available and is
`
`competitively sensitive. Its inclusion in the public docket would cause
`
`commercial harm to Patent Owner.
`
` Confidential marketing plans and information prepared and compiled by
`
`Patent Owner. These documents include and/or reference Patent
`
`Owner’s marketing plans and its Awareness Trial and Usage (“ATU”)
`
`market research for Eylea®. This information is not publicly, and public
`
`release of this information could benefit Patent Owner’s competitors and
`
`thereby cause competitive harm to Patent Owner.
`
` Confidential market metrics and projections that are compiled and
`
`provided by third party data provider Vestrum Health (“Vestrum”). These
`
`documents include data analysis related to Patent Owner’s activities in
`
`connection with Eylea®. The information contained in these exhibits is
`
`not publicly available and would cause competitive harm to Patent
`
`Owner and Vestrum if disclosed on the public docket. Patent Owner
`
`agreed with Vestrum to maintain the confidentiality this information.
`
`
`
`3
`
`
`
`
`
`IPR2023-00884
`
`
`
`
`
` Confidential market metrics and projections that are compiled and
`
`provided by third party data provider, IQVIA. These documents include
`
`data analysis related to Patent Owner’s activities in connection with
`
`Eylea®. The information contained in these exhibits is not publicly
`
`available and would cause competitive harm to Patent Owner and IQVIA
`
`if disclosed on the public docket. Patent Owner agreed with IQVIA to
`
`maintain the confidentiality of this information.
`
` Confidential information obtained from the American Society of Retina
`
`Specialists (ASRS). These documents include compiled survey
`
`information from ASRS member retina specialists. Only members of
`
`ASRS have access to this information, and the documents themselves
`
`include restrictions on their publication. The information contained in
`
`these exhibits is not publicly available and may cause competitive harm
`
`to ASRS if disclosed on the public docket.
`
`Patent Owner moves to seal the specific portions of Dr. Manning’s
`
`declaration that reveal this confidential information. Pursuant to Paragraph
`
`5(A)(ii) of the Board’s default protective order, Ex.2059, a redacted copy of Dr.
`
`Manning’s declaration is being filed publicly with the same exhibit number.
`
`
`
`4
`
`
`
`
`
`IPR2023-00884
`
`
`
`
`
`B.
`
`Patent Owner’s Clinical Development Processes and Strategic
`Decision Making
`
`Exhibits 2013, 2036, 2039, 2040, and 2041 are Patent Owner’s internal
`
`memoranda, notes, and other planning documents from 2007-2008 related to
`
`Regeneron’s development of aflibercept, and in particular to the design of
`
`aflibercept clinical trials. These documents reveal non-public aspects of Patent
`
`Owner’s strategic decision making in the development of Eylea®, including its
`
`commercial and regulatory strategies. Public release of these details could cause
`
`competitive harm to Patent Owner by giving its competitors knowledge of its
`
`clinical research operations. In the district court litigation between Regeneron and
`
`Mylan, Patent Owner produced these documents with a designation of
`
`“CONFIDENTIAL” as defined by the protective order in that case.
`
`Exhibits 2037 and 2038 are Patent Owner’s internal summaries of the status
`
`of planned, ongoing, and completed clinical trials and planned regulatory
`
`submissions in 2010. They reveal non-public details of Patent Owner’s clinical
`
`development for Eylea® and aspects of Patent Owner’s regulatory and commercial
`
`strategies. Public release of these details could cause competitive harm to Patent
`
`Owner by giving its competitors knowledge of its clinical research operations. In
`
`the district court litigation between Regeneron and Mylan, Patent Owner produced
`
`these documents with a designation of “OUTSIDE COUNSEL’S EYES ONLY” as
`
`defined by the protective order in that case.
`
`
`
`5
`
`
`
`
`
`IPR2023-00884
`
`
`
`
`
`C. Confidential Clinical Trial Protocols and Results
`
`Exhibits 2015, 2019, and 2043 are Patent Owner’s internal summaries of its
`
`DA VINCI and VIEW clinical trial results. These documents reveal non-public
`
`data and data analysis. Public release of these details could cause competitive
`
`harm to Patent Owner. Further, these exhibits report patient-level demographic
`
`information as well as details of these patients’ adverse events and treatment
`
`outcomes. Disclosure of this information would compromise the confidentiality of
`
`the clinical trial subjects. In the district court litigation between Regeneron and
`
`Mylan, Patent Owner produced these documents with a designation of
`
`“CONFIDENTIAL” as defined by the protective order in that case. These exhibits
`
`report a combination of published and unpublished data and data analysis, and
`
`Patent Owner moves to seal the specific portions of these exhibits that reveal
`
`unpublished data and data analysis. Pursuant to Paragraph 5(A)(ii) of the Board’s
`
`default protective order, a redacted copy of these exhibits is being filed publicly
`
`with the same exhibit number.
`
`Exhibit 2018 is a detailed report of Patent Owner’s DA VINCI clinical trial
`
`results. It reveals non-public details of the protocol, results, and data analysis that
`
`have not been made public. Public release of these details could cause competitive
`
`harm to Patent Owner. Further, these exhibits report patient-level demographic
`
`information as well as details of these patients’ adverse events and treatment
`
`
`
`6
`
`
`
`
`
`IPR2023-00884
`
`
`
`
`
`outcomes. Disclosure of this information would compromise the confidentiality of
`
`the clinical trial subjects. In the district court litigation between Regeneron and
`
`Mylan, Patent Owner produced this document with a designation of
`
`“CONFIDENTIAL” as defined by the protective order in that case.
`
`Exhibit 2048 is a detailed clinical trial protocol for the DA VINCI trial. It
`
`reveals non-public details about Patent Owner’s clinical trial protocol, data
`
`analysis, and the product used in the clinical trial, and it implicates Patent Owner’s
`
`commercial and regulatory strategies. Public release of these details could cause
`
`competitive harm to Patent Owner by giving its competitors knowledge of its
`
`clinical research operations. As reflected on the first page, this document was
`
`designated as confidential to the Institutional Review Board and those involved in
`
`the conduct of the clinical trial.
`
`II.
`
`PROTECTIVE ORDER
`
`Concurrently with the present motion, Regeneron filed an unopposed
`
`Motion for Protective Order requesting entry of the Board’s default protective
`
`order, Ex.2059.
`
`III. CERTIFICATION
`
`Pursuant to 37 CFR § 42.54, Patent Owner certifies that it has conferred with
`
`Petitioner regarding this motion to seal. Petitioner does not object to the motion.
`
`
`
`7
`
`
`
`
`
`IPR2023-00884
`
`
`
`
`Dated: August 25, 2023
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`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
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`8
`
`
`
`
`
`IPR2023-00884
`
`
`
`
`
`Certificate of Service (37 C.F.R. § 42.6(e)(4))
`
`I hereby certify that the attached MOTION TO FILE CONFIDENTIAL
`
`DOCUMENTS UNDER SEAL PURSUANT TO 37 C.F.R. §§ 42.14 AND 42.54
`
`was served as of the below date on the Petitioner via e-mail (by agreement) to the
`
`following counsel of record:
`
`
`
`
`
`
`
`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
`
`
`
`Dated: August 25, 2023
`
`
`
` /Adam R. Brausa/
`Adam R. Brausa, Reg. No. 60,287
`
`
`9
`
`
`
`