Case 1:22-cv-00252-MSG Document 195 Filed 01/16/24 Page 1 of 13 PageID #: 13329
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`Plaintiffs,
`
`v.
`
`MODERNA, INC. and MODERNATX, INC.
`
`Defendants.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`C.A. No. 22-252 (MSG)
`
`REDACTED - PUBLIC VERSION
`
`DEFENDANTS’ BRIEF IN SUPPORT OF THEIR MOTION TO SEAL
`PORTIONS OF PLAINTIFFS’ MOTION TO COMPEL (D.I. 184)
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`Travis J. Murray (#6882)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`tmurray@morrisnichols.com
`
`Attorneys for Defendants
`
`OF COUNSEL:
`
`Patricia A. Carson, Ph.D.
`Jeanna M. Wacker, P.C.
`Mark C. McLennan
`Yan-Xin Li
`Caitlin Dean
`Nancy Kaye Horstman
`Shaoyao Yu
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4800
`
`Alina Afinogenova
`KIRKLAND & ELLIS LLP
`200 Clarendon Street
`Boston, MA 02116
`(617) 385-7500
`
`Yan-Xin Li
`KIRKLAND & ELLIS LLP
`555 California Street, 27th Floor
`San Francisco, CA 94104
`(415) 439-1400
`
`Original filing date: January 12, 2024
`Redacted filing date: January 16, 2024
`
`

`

`Case 1:22-cv-00252-MSG Document 195 Filed 01/16/24 Page 2 of 13 PageID #: 13330
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`TABLE OF CONTENTS
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`Page
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`I.
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`II.
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`III.
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`IV.
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`INTRODUCTION ............................................................................................................... 1
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`LEGAL STANDARD .......................................................................................................... 1
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`ARGUMENT ....................................................................................................................... 2
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`CONCLUSION .................................................................................................................... 7
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`i
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`

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`Case 1:22-cv-00252-MSG Document 195 Filed 01/16/24 Page 3 of 13 PageID #: 13331
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`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`In re Avandia Mktg., Sales Pracs. & Prod. Liab. Litig.,
`924 F.3d 662 (3d Cir. 2019)...............................................................................................1, 2, 3
`
`Bank of Am. Nat’l Tr. & Sav. Ass’n v. Hotel Rittenhouse Assocs.,
`800 F.2d 339 (3d Cir. 1986).......................................................................................................2
`
`In re Cendant Corp.,
`260 F.3d 183 (3d Cir. 2001).......................................................................................................2
`
`Guardant Health, Inc. v. Foundation Med., Inc.,
`C.A. No. 17-1616-LPS-CJB, D.I. 447 (D. Del. Jun. 16, 2020) .................................................6
`
`Leucadia, Inc. v. Applied Extrusion Techs., Inc.,
`998 F.2d 157 (3d Cir. 1993).......................................................................................................6
`
`Littlejohn v. Bic Corp.,
`851 F.2d 673 (3d Cir. 1988).......................................................................................................2
`
`Miller v. Indiana Hosp.,
`16 F.3d 549 (3d Cir. 1994).........................................................................................................2
`
`Mosaid Techs. Inc. v. LSI Corp.,
`878 F. Supp. 2d 503 (D. Del. 2012) ...........................................................................................2
`
`Nitto Denko Corp. v. Hutchinson Tech. Inc.,
`C.A. No. 16-3595 (CCC/MF), 2017 WL 2782639 (D.N.J. Mar. 3, 2017) ................................5
`
`Nixon v. Warner Commc’ns, Inc.,
`435 U.S. 589 (1978) ...................................................................................................................6
`
`Pansy v. Borough of Stroudsburg,
`23 F.3d 772 (3d Cir. 1994).....................................................................................................2, 6
`
`ii
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`

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`Case 1:22-cv-00252-MSG Document 195 Filed 01/16/24 Page 4 of 13 PageID #: 13332
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`I.
`
`INTRODUCTION
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`Pursuant to the Protective Order (D.I. 91) as modified by the Court’s November 14, 2023
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`Order (D.I. 155), Defendants Moderna, Inc. and ModernaTX, Inc. (“Moderna”) respectfully
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`move this Court to seal Moderna’s sensitive and confidential information and to grant leave to
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`file partially redacted versions of Plaintiffs’ Motion to Compel (D.I. 184) and Exhibits 1, 7, and
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`10-11 thereto. As explained in more detail below, the portions marked for redaction contain
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`Moderna’s sensitive and confidential technical information, including confidential regulatory
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`submissions and trade secrets.
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`In support of this motion, Moderna attaches as Exhibit A the Declaration of Peter
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`Wojciechowski, CMC Knowledge Management Lead at ModernaTX, Inc., who
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`is
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`knowledgeable about Moderna’s confidential information that Moderna seeks to seal and is
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`familiar with its sensitivity. Moderna seeks to redact portions of Plaintiffs’ Motion and Exhibits 1,
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`7, and 10-11 thereto (collectively, the “Confidential Materials”).
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`The Confidential Materials contain Moderna’s highly confidential information, and the
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`Court should maintain that material under seal to prevent serious and real harm to Moderna.
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`Release of Moderna’s highly confidential information to the public and Moderna’s competitors
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`would create a clearly defined and serious injury to Moderna, as discussed in detail below.
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`II.
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`LEGAL STANDARD
`
`Third Circuit common law presumes a public right of access to judicial records, however
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`it also protects business and financial information when access would cause economic harm,
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`including competitive harm. In re Avandia Mktg., Sales Pracs. & Prod. Liab. Litig., 924 F.3d
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`662, 672 (3d Cir. 2019). “Although the common law right to public access is a recognized and
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`venerated principle, courts have also recognized the accompanying principle that the right is not
`
`1
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`

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`Case 1:22-cv-00252-MSG Document 195 Filed 01/16/24 Page 5 of 13 PageID #: 13333
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`absolute.” In re Cendant Corp., 260 F.3d 183, 194 (3d Cir. 2001) (citations and quotations
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`omitted); see also Littlejohn v. Bic Corp., 851 F.2d 673, 678 (3d Cir. 1988) (“Despite the
`
`presumption, courts may deny access to judicial records, for example, where they are sources of
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`business information that might harm a litigant’s competitive standing.”).
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`This presumption is overcome where a movant shows “that the interest in secrecy
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`outweighs the presumption.” In re Avandia Mktg., 924 F.3d at 672 (quoting Bank of Am. Nat’l
`
`Tr. & Sav. Ass’n v. Hotel Rittenhouse Assocs., 800 F.2d 339, 344 (3d Cir. 1986)). This showing
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`may be made by demonstrating that disclosure will work a clearly defined and serious injury to
`
`the movant and that the material is the kind of information that courts will protect. See In re
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`Avandia Mktg., 924 F.3d at 672 (citing Miller v. Indiana Hosp., 16 F.3d 549, 551 (3d Cir. 1994)).
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`The Court will apply a “good cause” standard justifying sealing or redacting judicial records,
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`requiring a “balancing process, in which courts weigh the harm of disclosing information against
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`the importance of disclosure to the public.” Mosaid Techs. Inc. v. LSI Corp., 878 F. Supp. 2d
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`503, 507-08 (D. Del. 2012) (citing Pansy v. Borough of Stroudsburg, 23 F.3d 772, 787 (3d Cir.
`
`1994)).
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`III. ARGUMENT
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`Good cause exists here to seal the Confidential Materials because the Confidential
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`Materials contain Moderna’s highly confidential technical and business information. Disclosure
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`of such information would cause real and serious competitive harm to Moderna and the
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`information does not need to be disclosed to the public to understand the filings at issue.
`
`Although the public’s presumptive common law right of access to judicial records
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`attaches to materials filed in connection with a pretrial motion of a non-discovery nature, this
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`right is “not absolute” and may be overcome by a showing that the material sought to be sealed
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`2
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`Case 1:22-cv-00252-MSG Document 195 Filed 01/16/24 Page 6 of 13 PageID #: 13334
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`“is the kind of information that courts will protect and … will work a clearly defined and serious
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`injury to the party seeking closure.” In re Avandia Mktg., 924 at 672 (citation omitted). Here,
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`the Confidential Materials are all the types of limited information of the kind that courts in the
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`Third Circuit have recognized as protectable, namely highly sensitive and confidential technical
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`information regarding Moderna’s proprietary and trade secret manufacturing methods for its
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`COVID-19 Vaccine, including steps in the manufacturing process and parameters for those
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`steps.
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`The harms caused by revealing Moderna’s confidential information are discussed below,
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`and further in the attached declaration of Peter Wojciechowski (Exhibit A), a CMC Knowledge
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`Management Lead at ModernaTX, Inc., who is familiar with this information and its sensitivity.
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`As Mr. Wojciechowski explains, there is significant competition between established vaccine
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`suppliers, including suppliers with mRNA-based vaccines, like Moderna, and any information
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`about one of these competitors, even seemingly minor information, may prove competitively
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`advantageous. Ex. A, ¶ 7.
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`Moderna seeks only to partially seal the Confidential Materials at issue in this motion.
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`As described briefly below, and further explained in the Declaration of Peter Wojciechowski,
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`attached hereto as Exhibit A, the Confidential Materials contain Moderna’s confidential
`
`information. The Confidential Materials contain highly confidential and sensitive information
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`regarding Moderna’s proprietary technology relating to its manufacturing methods for its
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`COVID-19 Vaccine, known as mRNA-1273 or “SpikeVax.” Ex. A, ¶ 6. SpikeVax is comprised
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`of messenger RNA (mRNA) which is delivered using lipid nanoparticles (LNPs). Ex. A, ¶ 3.
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`Moderna’s proprietary LNP is comprised of four lipid components including SM-102,
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`cholesterol, phospholipid, and PEGDMG-2000. Ex. A, ¶ 3. With respect to Moderna’s
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`3
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`Case 1:22-cv-00252-MSG Document 195 Filed 01/16/24 Page 7 of 13 PageID #: 13335
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`formulation, Moderna considers its precise formulation, including the specific quantities of
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`ingredients, a trade secret, which is not public knowledge. Ex. A, ¶ 8. With respect to Moderna’s
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`manufacturing process for SpikeVax, Moderna considers its process-as-a-whole a trade secret,
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`including the steps in the process, the records of each step, the parameters or specification for
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`each step (such as timing, sequence, amount and kind of raw materials, temperatures,
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`measurements, equipment used etc.). Ex. A, ¶ 9. Moderna has not publicly disclosed its
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`proprietary manufacturing process. Ex. A, ¶ 9.
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`Moderna has not publicly disclosed information within Plaintiffs’ Motion and Exhibits
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`1, 7, and 10-11 which refer to, quote, summarize, or otherwise disclose Moderna’s sensitive and
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`confidential technical information. Specifically, the information on the following pages of
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`Moderna’s Opposition and Exhibits disclose specific information concerning the composition
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`of Moderna’s COVID-19 Vaccine (and other pipeline products) and Moderna’s proprietary and
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`trade secret manufacturing methods for its COVID-19 Vaccine (and other pipeline products)
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`including steps in the manufacturing process and parameters for those steps:
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` Plaintiffs’ Motion at page 1, lines 30-35; page 2, line 19;
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` Exhibit 1 at page 9, lines 12-15;
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` Exhibit 7 (confidential regulatory filing);
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` Exhibit 10 at page 2, lines 6, 13-14; and
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` Exhibit 11, page 4, line 11; page 8, lines 4-13; page 11, line 26; page 13, lines 1-4, 12-
`13.
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`Because of the highly competitive nature of the vaccine supplier market, Moderna has
`
`spent significant effort and resources to develop these manufacturing methods and formulations
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`and the release of such information to the public, including Moderna’s competitors, would harm
`
`Moderna. Ex. A, ¶ 7. Because there are so few competitors in the vaccine supplier market, the
`
`4
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`Case 1:22-cv-00252-MSG Document 195 Filed 01/16/24 Page 8 of 13 PageID #: 13336
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`market is highly competitive, and any information about one of the competitors, even seemingly
`
`minor information, may prove competitively advantageous. Ex. A, ¶ 7. Additionally, there are
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`companies considering entering the vaccine market and companies developing mRNA-based
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`vaccines and therapeutics for other diseases or developing lipid nanoparticles for mRNA-based
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`products. Ex. A, ¶ 7.
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`The Confidential Materials also include highly confidential business information
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`regarding Moderna’s COVID-19 Vaccine. Ex. A, ¶ 6. If the confidential information were made
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`public, Moderna’s competitors would be able to potentially replicate Moderna’s products,
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`features within Moderna’s products, and methods of making mRNA-LNP products, or make
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`decisions about where, when, and how to offer directly competitive goods with full knowledge
`
`of Moderna’s technology. Ex. A, ¶ 10. Moderna’s competitors would gain a significant
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`advantage in creating their own business strategies, which would put Moderna at a significant
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`competitive disadvantage, causing it real and serious harm. Ex. A, ¶ 10. Moderna’s competitors
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`may also seek patent claims to cover Moderna’s technology. Ex. A, ¶ 10.
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`Moderna has always taken extensive measures to maintain the confidentiality of its
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`technical information. Ex. A, ¶ 5. Moderna has been extremely concerned about the protection
`
`of its confidential information during this litigation and has been very careful to always protect
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`this information. Ex. A, ¶5. Moderna has invested significant resources to develop this
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`information as well, Ex. A, ¶ 7, and this information is of the type that courts have recognized
`
`as protectable. See, e.g., Nitto Denko Corp. v. Hutchinson Tech. Inc., C.A. No. 16-3595
`
`(CCC/MF), 2017 WL 2782639, at *2 (D.N.J. Mar. 3, 2017) (granting motion to seal
`
`“confidential technical information” where such information “was not intended to be seen by
`
`competitors . . . for review and potential use against the parties” and parties were in a “highly
`
`5
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`

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`Case 1:22-cv-00252-MSG Document 195 Filed 01/16/24 Page 9 of 13 PageID #: 13337
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`competitive [] industry”); Guardant Health, Inc. v. Foundation Med., Inc., C.A. No. 17-1616-
`
`LPS-CJB, D.I. 447 (D. Del. Jun. 16, 2020) (granting motion to redact confidential information
`
`concerning defendant’s confidential technical information).
`
`Disclosure of Moderna’s confidential information regarding either the technical details
`
`of Moderna’s precise formulation and the proprietary manufacturing process for SpikeVax
`
`would “work a clearly defined and serious injury” to Moderna, as such disclosure would provide
`
`Moderna’s competitors, customers, and potential licensors or licensees with otherwise
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`confidential information regarding Moderna’s products and strategies, as well as a competitive
`
`advantage in both the vaccine supplier market and in negotiations with Moderna. See Pansy, 23
`
`F.3d at 786. Moreover, because this “case involves private litigants” and their confidential
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`information, there is “little legitimate public interest” in the proposed redactions. Id. at 788.
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`Under such circumstances, Moderna’s interest in maintaining the confidentiality of the proposed
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`redacted information outweighs any countervailing public interest. See id. (“[I]f a case involves
`
`private litigants, and concerns matters of little legitimate public interest, that should be a factor
`
`weighing in favor of granting or maintaining an order of confidentiality.”); Leucadia, Inc. v.
`
`Applied Extrusion Techs., Inc., 998 F.2d 157, 166 (3d Cir. 1993) (“Documents containing trade
`
`secrets or other confidential business information may be protected from disclosure” and
`
`explaining that the court has “framed the inquiry as whether the need for secrecy outweighs the
`
`presumption of access that normally attaches to such documents”); Nixon v. Warner Commc’ns,
`
`Inc., 435 U.S. 589, 598 (1978) (“[C]ourts have refused to permit their files to serve as … sources
`
`of business information that might harm a litigant’s competitive standing”).
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`As explained above, the Confidential Materials identified contain technical details
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`regarding Moderna’s proprietary LNP formulation in SpikeVax and the related proprietary
`
`6
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`

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`Case 1:22-cv-00252-MSG Document 195 Filed 01/16/24 Page 10 of 13 PageID #: 13338
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`manufacturing process. Moderna’s proposed redactions redact the specific confidential material
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`at issue, leaving the remainder of Plaintiffs’ Motion unredacted. These proposed redactions are
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`narrow such that the public’s ability to understand the claim construction arguments is not
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`impaired any less than necessary to prevent the release of Moderna’s most sensitive technical
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`information to its competitors, preventing clear competitive harm. Moderna’s proposed
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`redactions are narrow in scope and refer only to Moderna’s confidential, sensitive technical or
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`business information to prevent the serious harm to Moderna which would be caused by its
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`public release as outlined in Mr. Wojciechowski’s Declaration. Exhibits 7 to Plaintiffs’ Motion
`
`is a confidential regulatory submission to the FDA and discloses specific information
`
`concerning Moderna’s proprietary and trade secret manufacturing methods for its COVID-19
`
`Vaccine including steps in the manufacturing process and parameters for those steps. Likewise,
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`sealing Exhibit 7 does not impair the public’s ability to understand the arguments any more than
`
`necessary to prevent the release of Moderna’s most sensitive technical information to its
`
`competitors, preventing clear competitive harm.
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`IV. CONCLUSION
`
`For the foregoing reasons, Moderna respectfully requests the Court grant Moderna’s
`
`Motion to Seal with respect to Moderna’s highly confidential information.
`
`7
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`

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`Case 1:22-cv-00252-MSG Document 195 Filed 01/16/24 Page 11 of 13 PageID #: 13339
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`
`
`
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`/s/ Travis J. Murray
`
`
`
`
`Jack B. Blumenfeld (#1014)
`Brian P. Egan (#6227)
`Travis J. Murray (#6882)
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@morrisnichols.com
`began@morrisnichols.com
`tmurray@morrisnichols.com
`
`Attorneys for Defendants
`
`
`
`
`
`
`OF COUNSEL:
`
`Patricia A. Carson, Ph.D.
`Jeanna M. Wacker, P.C.
`Mark C. McLennan
`Caitlin Dean
`Nancy Kaye Horstman
`Shaoyao Yu
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, NY 10022
`(212) 446-4800
`
`Alina Afinogenova
`KIRKLAND & ELLIS LLP
`200 Clarendon Street
`Boston, MA 02116
`(617) 385-7500
`
`Yan-Xin Li
`KIRKLAND & ELLIS LLP
`555 California Street, 27th Floor
`San Francisco, CA 94104
`(415) 439-1400
`
`January 12, 2024
`
`
`8
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`

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`Case 1:22-cv-00252-MSG Document 195 Filed 01/16/24 Page 12 of 13 PageID #: 13340
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`CERTIFICATE OF SERVICE
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`I hereby certify that on January 12, 2024, I caused the foregoing to be electronically filed
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`with the Clerk of the Court using CM/ECF, which will send notification of such filing to all
`
`registered participants.
`
`I further certify that I caused copies of the foregoing document to be served on
`
`January 12, 2024, upon the following in the manner indicated:
`
`John W. Shaw, Esquire
`Karen E. Keller, Esquire
`Nathan R. Hoeschen, Esquire
`Emily S. DiBenedetto, Esquire
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`Attorneys for Plaintiffs Arbutus Biopharma
`Corporation and Genevant Sciences GmbH
`
`Daralyn J. Durie, Esquire
`Adam R. Brausa, Esquire
`Eric C. Wiener, Esquire
`Annie A. Lee, Esquire
`Shaelyn K. Dawson, Esquire
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, CA 94105-2482
`Attorneys for Plaintiff Arbutus Biopharma
`Corporation
`
`Kira A. Davis, Esquire
`MORRISON & FOERSTER LLP
`707 Wilshire Boulevard
`Los Angeles, CA 90017-3543
`Attorneys for Plaintiff Arbutus Biopharma
`Corporation
`
`
`
`
`
`VIA ELECTRONIC MAIL
`
`VIA ELECTRONIC MAIL
`
`VIA ELECTRONIC MAIL
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`

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`Case 1:22-cv-00252-MSG Document 195 Filed 01/16/24 Page 13 of 13 PageID #: 13341
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`VIA ELECTRONIC MAIL
`
`VIA ELECTRONIC MAIL
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`David N. Tan, Esquire
`MORRISON & FOERSTER LLP
`2100 L Street, NW, Suite 900
`Washington, DC 20037
`Attorneys for Plaintiff Arbutus Biopharma
`Corporation
`
`David I. Berl, Esquire
`Adam D. Harber, Esquire
`Thomas S. Fletcher, Esquire
`Jessica Palmer Ryen, Esquire
`Shaun P. Mahaffy, Esquire
`Anthony H. Sheh, Esquire
`Philip N. Haunschild, Esquire
`Jihad J. Komis, Esquire
`Matthew W. Lachman, Esquire
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue S.W.
`Washington, DC 20024
`Attorneys for Plaintiff Genevant Sciences GmbH
`
`/s/ Travis J. Murray
`
`Travis J. Murray (#6882)
`
`2
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`