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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`SLAYBACK PHARMA LLC,
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`Petitioner,
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`v.
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`EYE THERAPIES, LLC,
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`Patent Owner.
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`__________________
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`Case IPR2022-00142
`U.S. Patent No. 8,293,742
`__________________
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`PATENT OWNER’S SECOND MOTION TO SEAL
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`1
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`I.
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`Introduction
`Patent Owner Eye Therapies, LLC (“Patent Owner”) renews its request to seal
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`the confidential version of its Patent Owner Response, exhibits containing excerpts
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`of regulatory documents related to the commercial product Lumify, and certain
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`exhibits filed with Petitioner’s Reply, pursuant to the Board’s February 1, 2023,
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`Order, which denied without prejudice the portion of Patent Owner’s motion to seal
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`related to these documents, each of which contain Bausch & Lomb’s (Patent
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`Owner’s RPI) confidential information. As requested by the Board, this motion
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`specifically addresses the Argentum factors, including how and why public
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`disclosure of the information sought to be sealed would cause concrete harm to
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`Patent Owner and Bausch & Lomb.
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`II. Governing Rules: The Argentum Factors
`A party moving to seal a document must show “good cause” for the relief
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`requested. 37 C.F.R. §§ 42.20(c), 42.54. The “good cause” standard “reflects the
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`strong public policy for making all information in an inter partes review open to the
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`public.” See Argentum Pharms. LLC v. Alcon Research, Ltd., IPR2017-01053, Paper
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`27 at 3 (PTAB Jan. 19, 2018) (informative). The moving party must show that:
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`(1) the information sought to be sealed is truly confidential,
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`(2) a concrete harm would result upon public disclosure,
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`2
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`(3) there exists a genuine need to rely in the trial on the specific
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`information sought to be sealed, and
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`(4) on balance, an interest in maintaining confidentiality outweighs the
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`strong public interest in having an open record.
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`Id. at 4.
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`III.
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`Identification of Confidential Information
`This motion refers to confidential information in two categories, both of
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`which relate to sensitive, confidential information of Bausch & Lomb. Bausch &
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`Lomb is the exclusive licensee of the ’742 patent, the registered holder of the IND
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`and NDA for the commercial product Lumify, and a real-party-in interest in this
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`proceeding. The categories are summarized below:
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`(1) Non-public Bausch & Lomb regulatory documents and discussions
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`thereof, reflecting Bausch & Lomb’s confidential research and development.
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`This information is contained in the following documents:
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`• Patent Owner’s Response, pages 43, 63-65
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`• Exhibit 2020 (Declaration of Robert J. Noecker), ¶¶ 149, 172, 190,
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`198, 245, 275, 287-301, 304, 305, 309, 312
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`• Exhibit 2021 (Declaration of Robert O. Williams, III, Ph.D.), ¶ 43
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`3
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`
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`• Documentary Exhibits 2028, 2166-2168, 21961
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`(2) Non-public discussion of Bausch & Lomb’s sensitive commercial and
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`financial information. This information is contained in the following
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`documents:
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`• Exhibit 1047 (Declaration of Ivan T. Hofmann), ¶¶ 25, 33, 44-47
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`(including footnote 55), 52
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`• Exhibit 1051 (Deposition Transcript of John Ferris), 22:14-22:15,
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`22:18-23:7, 24:10-27:18, 27:21-29:2, 29:7-29:11, 29:13-29:21, 30:4-
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`8, 30:11-31:2, 31:4-31:17, 31:20-32:3, 32:5-32:16, 32:19, 32:21-
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`35:16, 40:10-40:13, 40:16-40:17, 40:19-40:20, 41:2-41:5, 41:8-41:17,
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`43:2-43:4, 43:6-43:7, 43:12-43:17, 43:19-44:19, 44:22-45:9, 45:12-
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`45:22, 46:2-46:5, 46:7-46:8, 46:11-47:8, 47:10-47:16, 47:18, 48:3-
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`48:6, 48:9-48:12, 48:14-48:15, 48:18-48:22, 49:2-50:17, 50:19-52:4,
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`54:11-53:6, 53:18-54:12, 59:5-59:6, 59:9-60:16, 60:18-61:2, 61:5-
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`61:10, 61:12, 61:15-62:22, 63:10-63:12, 63:15-63:18, 63:20-64:13,
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`1 In the related district court proceeding, Patent Owner designated these documents
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`“COUNSEL’S EYES ONLY – SUBJECT TO DISCOVERY CONFIDENTIALITY
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`ORDER.” Patent Owner provided an unstamped version of the documents in this
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`proceeding for legibility purposes.
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`4
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`
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`64:17-65:5, 67:5-67:8, 67:17-67:21, 68:11-68:18, 68:20-70:4, 70:7-
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`71:19, 72:1-72:10, 72:13-72:14, 72:16-72:19, 72:21-74:7, 75:11-
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`75:14, 76:7-78:9, 79:7-79:9, 79:12-79:15, 79:17-79:20, 80:1, 80:3-
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`80:5, 80:8-81:17, 81:20-82:4, 82:7-82:11, 82:13-82:14, 82:19-83:18,
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`83:21, 84:3-84:19, 85:1-85:4, 85:6-85:7, 85:9-85:20, 86:2-86:9, 86:11-
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`87:2, 87:11-13
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`IV. Good Cause Exists for Sealing the Confidential Information
`Good cause exists for sealing all of the above, as all four Argentum factors are
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`met. Each category of documents is addressed below.
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`A. Good Cause Exists for Sealing the Regulatory Documents and
`Discussions Thereof (Category 1)
`First, there is no question that the Lumify regulatory documents (i.e.,
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`Investigational New Drug (IND) and New Drug Application (NDA) files) are truly
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`confidential.
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` They were confidentially submitted to the FDA, and that
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`confidentiality has been maintained since submission.
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`Second, concrete harm would result upon public disclosure. As background,
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`Lumify is a patent-protected commercial product, which was approved in late 2018
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`and launched in 2019—just about four years ago. Thus, although some of the
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`referenced documents are seemingly a decade old, the reality is that they relate to
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`the approval of a relatively new commercial product. Moreover, Bausch & Lomb
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`has publicly announced that it has Lumify-related products in its pipeline that likely
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`5
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`also implicate these same categories of documents. Additionally, at least two
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`generic drug manufacturers have already filed abbreviated new drug applications
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`(ANDAs) seeking approval for generic copies of Lumify—meaning that competitors
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`are interested in this product and would improperly benefit from disclosure of
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`Bausch & Lomb’s proprietary information, and thus harming Bausch & Lomb.
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`At a high level, the information Patent Owner seeks to seal contains
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`confidential development and technical information, identifying, among other
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`things, internal specifications, suppliers, etc. For ease, a summary of each exhibit,
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`along with an example of the harm to Bausch & Lomb upon disclosure, is provided
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`below. For all of the same reasons provided below, disclosure of the redacted
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`portions of the Patent Owner’s Response, EX-2020 (Noecker Declaration), and EX-
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`2021 (Williams Declaration), would result in the same harm, for each of those
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`documents discussed these exhibits.
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`
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`Exhibit
`EX-2028
`(3.2.P.5.6
`Justification of
`Specifications)
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`Description
`This exhibit is an excerpt from
`the Lumify NDA containing,
`e.g., not only the Lumify drug
`product specifications
`(including, e.g., methods used)
`but also the justifications for
`those specifications.
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`Summary of Harm
`Disclosure would put Bausch
`& Lomb at a competitive
`disadvantage as it would give
`competitors access to its
`internal specifications,
`methods, and justifications,
`allowing competitors to
`circumvent traditional R&D
`processes by using Bausch &
`Lomb’s proprietary
`information.
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`6
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`EX-2196 (2.3.P
`Drug Product)
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`The exhibit is an excerpt from
`the Lumify NDA containing,
`e.g., the full qualitative and
`quantitative composition of
`Lumify, including reference to
`quality standards.
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`EX-2166, 2167,
`2168 (Clinical
`Study Reports)
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`These exhibits contain
`excerpts from the clinical
`study reports for three studies
`submitted in connection with
`the approval of the Lumify
`NDA.
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`Disclosure would put Bausch
`& Lomb at a competitive
`disadvantage as it would give
`competitors access to the
`entirety of the drug product
`formulation, allowing
`competitors to circumvent
`traditional R&D processes by
`using Bausch & Lomb’s
`proprietary information.
`Disclosure would put Bausch
`& Lomb at a competitive
`disadvantage as it would give
`competitors access to, e.g.,
`information not only about
`the commercially approved
`dosage of Lumify, but also
`additional dosages (not
`currently commercialized).
`Moreover, the Clinical Study
`Reports provide detailed,
`proprietary clinical protocols
`and procedures, disclosure of
`which would allow
`competitors to circumvent
`traditional R&D processes by
`using Bausch & Lomb’s
`proprietary information.
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`Third, there exists a genuine need to rely on the specific information sought
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`to be sealed. Indeed, Patent Owner has relied on these documents in connection with
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`its claim construction and non-obviousness arguments. See Patent Owner’s
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`Response at 43, 63-65.
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`Fourth, the interest in maintaining confidentiality outweighs the strong public
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`interest of having an open record. See Sandoz, Inc. v. EKR Therapeutics, LLC,
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`7
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`
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`IPR2015-00005, Paper 21 (PTAB April 24, 2015) (granting motion to seal relating
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`to ANDA documents). Indeed, if this confidential information is made public,
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`Bausch & Lomb’s competitors could exploit this confidential information and gain
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`an unfair competitive advantage over Bausch & Lomb. Moreover, the public’s
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`interest in Bausch & Lomb’s confidential regulatory information (i.e., specifics as
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`to formulation, development, and clinical trials) is minimal, particularly because the
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`highly detailed information set forth in the materials sought to be sealed is not
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`relevant to the patentability of the claims.
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`B. Good Cause Exists for Sealing the Sensitive Commercial
`Discussions (Category 2)
`First, there is no question Bausch & Lomb’s sensitive commercial
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`information (including that discussed in Exhibits 1047 and 1051) is confidential.
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`These materials discuss Bausch & Lomb’s market analysis, business strategy, and
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`financial information relating to Lumify—a commercial embodiment of the patented
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`invention. Bausch & Lomb treats these materials as confidential in the ordinary
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`course of business, and these materials have been treated as confidential in this
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`matter pursuant to the terms of the Stipulated Protective Order entered in this action.
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`See Paper 56.
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`Second, concrete harm would result upon public disclosure. Simply put,
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`details about Bausch & Lomb’s sensitive business information, including
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`competitive market analysis, business strategy, and other information that provides
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`8
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`insight into the inter-workings of Bausch & Lomb’s business, would be valuable to
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`Bausch & Lomb’s competitors and harmful to Bausch & Lomb if made public.
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`Indeed, Bausch & Lomb exists in a highly competitive commercial landscape; thus,
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`maintaining confidentiality of sensitive business information is highly important.
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`Third, there exists a genuine need to rely on the specific information sought
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`to be sealed. Indeed, both Patent Owner and Petitioner have relied on the
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`information sought to be sealed in their Papers.
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`Fourth, the interest in maintaining confidentiality outweighs the strong public
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`interest of having an open record, as the Board has already acknowledged by
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`granting Patent Owner’s [First] Motion to Seal for this same category of documents
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`(i.e., “Bausch & Lomb’s business and financial information”). See Paper 56.
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`Indeed, good cause exists to seal because the information includes details about
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`Bausch & Lomb’s sensitive business information, including Bausch & Lomb’s
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`competitive market analysis and business strategy, would be valuable to Bausch &
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`Lomb’s competitors and harmful to Bausch & Lomb if made public. Indeed, if this
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`confidential information is made public, Bausch & Lomb’s competitors could
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`exploit this confidential information and gain an unfair competitive advantage over
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`Bausch & Lomb.
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`9
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`III. CERTIFICATION OF NON-PUBLICATION
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`
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`The undersigned counsel certifies the information sought to be sealed by this
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`Motion to Seal has not, to their knowledge, been published or otherwise made public.
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`Patent Owner has made efforts to maintain the confidentiality of this information in
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`a related district court proceeding. In that district court proceeding, certain of the
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`information that the parties presently move to seal has been produced and designated
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`“COUNSELS’ EYES ONLY – SUBJECT TO DISCOVERY CONFIDENTIALITY
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`ORDER.” While the other information has not yet been produced, if it is produced
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`in the district court proceeding, it will be produced “COUNSELS’ EYES ONLY –
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`SUBJECT TO DISCOVERY CONFIDENTIALITY ORDER” pursuant to a
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`Protective Order agreed upon by the Parties.
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`IV. CONCLUSION
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`For the reasons set forth above, the parties respectfully request the Board grant
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`Patent Owner’s Second Motion to Seal.
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`Respectfully submitted,
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`Dated: February 10, 2023
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`/Bryan C. Diner/
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`
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`Bryan C. Diner, Reg. No. 32,409
`Counsel for the Patent Owner
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`10
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`
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`Case No. IPR2022-00142
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`CERTIFICATE OF SERVICE
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`
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`I hereby certify that on this 10th day of February, 2023, a copy of this
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`PATENT OWNER’S SECOND MOTION TO SEAL including all attachments and
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`exhibits was served electronically via email on February 10, 2023, in its entirety on
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`the following:
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`Linnea P. Cipriano
`Goodwin Proctor LLP
`620 Eight Avenue
`New York, NY 10018
`lcipriano@goodwinlaw.com
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`Louis H. Weinstein
`Patrick G. Pollard
`Windels Marx Lane & Mittendorf, LLC
`1 Giralda Farms
`Madison, NJ 07940
`lweinstein@windelsmarx.com
`ppollard@windelsmarx.com
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`Robert Frederickson III
`Goodwin Proctor LLP
`100 Northern Avenue
`Boston, MA 02210
`rfrederickson@goodwinlaw.com
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`The Petitioner has consented to service by electronic mail.
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`
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` Respectfully submitted,
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`Date: February 10, 2023
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`/Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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`
`
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