Case 1:22-cv-00252-MSG Document 182 Filed 01/03/24 Page 1 of 13 PageID #: 10491
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`REDACTED - PUBLIC VERSION
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`Original filing date: December 26, 2023
`Redacted filing date: January 3, 2024
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`TABLE OF CONTENTS
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`Page
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`I.
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`INTRODUCTION.....sssssssssssssssssssessssssssssssccscscssssssssssssssssssssssesesensssssssseseesesessssssssssssasenssen 1
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`Tl. LEGAL STANDARD......csssssssssssssssssssssssssscsccecsessssssssssssssssnsnsnsevevessssesssseseesesesssssssnsesanasasens 2
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`TIL. ARGUMENT .oncccccscsssssssssssssssssssssseseesssssssesecscscssssssssssssssssssssssesesesssssssseseesesesssssssessssssenesen 3
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`TV. CONCLUSION\.u.cscsssssssssssssssssssssscssssssssssssseccescsssessssssssssssssssnsnsnvevsssssesssseceescsesesesssssesssasasene 8
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
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`Inre Avandia Mktg., Sales Pracs. & Prod. Liab. Litig.,
`924 F.3d 662 (3d Cir. 2019)... ceescsccssesccssesesenececenecaeencesesasesessseseeaesasesesanesssneaaeeneeaeeneeneees2,3
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`Bank ofAm. Nat’l Tr. & Sav. Ass’n v. Hotel Rittenhouse Assocs.,
`800 F.2d 339 (3d Cir. 1986)... ceseeseeccsseescesecsserecsecseesesacessssnersscesacenessecssenesaseaecaeeaeesssanenesanes2
`
`In re Cendant Corp.,
`260 F.3d 183 (3d Cir. 2001)... ee cscccesseescesecceecscescceesseseseneesenesaeeneeaeessnsesssesseaesaeeaesseesesaneees2
`
`Guardant Health, Inc. v. Foundation Med., Inc.,
`C.A. No. 17-1616-LPS-CJB, D.I. 447 (D. Del. Jun. 16, 2020)... eeseeeeeceeeeeeeeeeeeeseseeeneeees 6
`
`Leucadia, Inc. v. Applied Extrusion Techs., Inc.,
`998 F.2d 157 (3d Cir. 1993)... ceesscecsscsceseeecesecssesccaecacesesanesesneseeeneaeesensesssesesaeeaeeaesaeenesaneees 6
`
`Littlejohn v. Bic Corp.,
`851 F.2d 673 (3d Cir. 1988)... ceseescsccsseecesecsceseceecsecsecacessssneseseceaceneaecssesessseaecaesaeerssanenesanes2
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`Miller v. Indiana Hosp.,
`16 F.3d 549 (3d Cir. 1994)... ceeececssesceseceessecscessssecscesecseessssnesseeeaeensesesasenesaeeaeeaesaessesaneneses2
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`Mosaid Techs. Inc. v. LSI Corp.,
`878 F. Supp. 2d 503 (D. Del. 2012)... cseecssesessecceeeceeesesnenscececaeensesesssesesseeaecaecaeesesarenesaees2
`
`Nitto Denko Corp. v. Hutchinson Tech. Inc.,
`C.A. No. 16-3595 (CCC/MF), 2017 WL 2782639 (D.N.J. Mar. 3, 2017) ......ceecceseccesessreserers 6
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`Nixon v. Warner Commc’ns, Inc.,
`A35 U.S. 589 (1978)... ecesccssccssecsceceseseeeceeeccesesenevsnesaessaeescecasersssseceeseescecseevasesaeeaeeeaeesaensersneras 7
`
`Pansy v. Borough ofStroudsburg,
`23 F.3d 772 (3d Cir. 1994)... eeeeccscsscesecssesessneseseneecsnecsecesesecseesesaeeaeeaesasesesaneneeeeeeaeenseeeases2,6
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`il
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`I.
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`INTRODUCTION
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`Pursuantto the Protective Order (D.I. 91) as modified by the Court’s November14, 2023
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`Order (D.I. 155), Defendants Moderna, Inc. and ModernaTX, Inc. (“Moderna”) respectfully
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`movethis Court to seal Moderna’s sensitive and confidential information and to grant leave to
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`file partially redacted versions of the Joint Claim Construction Brief (D.I. 170) and Exhibits 77
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`and 81 in the Joint Claim Construction Appendix (D.I. 171). ! As explained in moredetail below,
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`the portions marked for redaction contain Moderna’s sensitive and confidential technical
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`information, including confidential regulatory submissionsandtrade 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,
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`Inc., who 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.
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`Modernaseeksto redact portions of the following:
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`e
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`Joint Claim Construction Brief (D.I. 170) (sealed);
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`e Exhibit 77 in the Joint Claim Construction Appendix (D.I. 171) (sealed); and
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`e Exhibit 81 in the Joint Claim Construction Appendix (D.I. 171) (sealed)
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`(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 in order to prevent serious and real harm to
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`Moderna. Release of Moderna’s highly confidential information tothe public and Moderna’s
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`1
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`All other exhibits in the Joint Claim Construction Appendix (D.I. 171) will be filed
`publicly.
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`competitors would create a clearly defined and serious injury to Moderna,as discussed in detail
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`below.
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`Il.
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`LEGAL STANDARD
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`Third Circuit common law presumesa 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. Jn re Avandia Mktg., Sales Pracs. & Prod. Liab. Litig., 924 F.3d
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`662, 672 (3d Cir. 2019). “Although the commonlaw right to public access is a recognized and
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`venerated principle, courts have also recognized the accompanyingprinciple that the rightis not
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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 vy. Bic Corp., 851 F.2d 673, 678 (3d Cir. 1988) (“Despite the
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`presumption, courts may deny accessto judicial records, for example, where they are sources of
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`business information that might harmalitigant’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.” Jn re Avandia Mktg., 924 F.3d at 672 (quoting Bank ofAm. Nat’l
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`Tr. & Sav. Ass’n y. 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
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`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 ofdisclosing 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 ofStroudsburg, 23 F.3d 772, 787 (3d Cir.
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`1994)).
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`Hl.
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`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 doesnot need to be disclosed to the public to understandthefilingsat issue.
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`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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`“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 forits
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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., whois familiar with this information andits 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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`Modernaseeksonly to partially seal the Confidential Materials at issue in this motion.
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`Asdescribed briefly below, and further explained in the Declaration of Peter Wojciechowski,
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`attached hereto as Exhibit A,
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`the Confidential Materials contain Moderna’s confidential
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`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, J 6. SpikeVax is comprised
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`of messenger RNA (mRNA) whichis 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, 4 3. With respect
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`to Moderna’s
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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,
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`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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`Specifically,
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`information within Moderna’s Answering portion of the Joint Claim
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`Construction Brief and Exhibits 77 and 81 in the Joint Claim Construction Appendix which
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`refer to, quote, summarize, or otherwise disclose Moderna’s sensitive and confidential technical
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`information. Specifically, (1) the information on page 25, lines 15-18 and page 29,lines 1-3 of
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`the Joint Claim Construction Brief refers to the composition of Moderna’s COVID-19 Vaccine
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`which indirectly references the quantities of the components, which Moderna maintains as
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`confidential, and (2) the information on page 3, lines 6-7; page 25, lines 15-18; page 28, lines
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`3-15; page 29,
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`lines 1-3 (including the figure); page 34,
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`lines 17-21 of the Joint Claim
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`Construction Brief and Exhibits 77 and 81 in the Joint Claim Construction Appendix (which are
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`confidential regulatory submissions to the FDA) disclose specific information concerning
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`Moderna’s proprietary and trade secret manufacturing methods for its COVID-19 Vaccine
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`including steps in the manufacturing process and parametersfor those steps.
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`Because of the highly competitive nature of the vaccine supplier market, Moderna has
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`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
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`Moderna. Ex. A, § 7. Because there are so few competitors in the vaccine supplier market, the
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`market is highly competitive, and any information about one of the competitors, even seemingly
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`minor information, may prove competitively advantageous. Ex. A, J 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, JJ 4, 6. If the confidential information were
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`made 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-LNPproducts, or make
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`decisions about where, when, and how to offer directly competitive goods with full knowledge
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`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 Modernaat a significant
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`competitive disadvantage, causing it real and serious harm. Ex. A, J 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
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`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
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`as protectable. See, e.g., Nitto Denko Corp. v. Hutchinson Tech. Inc., C.A. No. 16-3595
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`(CCC/MF), 2017 WL 2782639, at *2 (D.N.J. Mar. 3, 2017)
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`(granting motion to seal
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`“confidential technical information” where such information “was not intended to be seen by
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`competitors .
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`.
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`. for review and potential use against the parties” and parties were in a “highly
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`competitive [] industry”); Guardant Health, Inc. v. Foundation Med., Inc., C.A. No. 17-1616-
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`LPS-CJB, D.I. 447 (D. Del. Jun. 16, 2020) (granting motion to redact confidential information
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`concerning defendant’s confidential technical information).
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`Disclosure of Moderna’s confidential information regarding either the technical details
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`of Moderna’s precise formulation and the proprietary manufacturing process for SpikeVax
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`would “work a clearly defined and serious injury” to Moderna,as such disclosure would provide
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`Moderna’s competitors, customers, and potential
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`licensors or
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`licensees with otherwise
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`confidential information regarding Moderna’s products andstrategies, as well as a competitive
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`advantage in both the vaccine supplier market and in negotiations with Moderna. See Pansy, 23
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`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. Jd. at 788.
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`Under such circumstances, Moderna’s interest in maintaining the confidentiality ofthe proposed
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`redacted information outweighs any countervailing public interest. See id. (“[I]f a case involves
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`private litigants, and concerns mattersoflittle legitimate public interest, that should be a factor
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`weighing in favor of granting or maintaining an order of confidentiality.”); Leucadia, Inc. v.
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`Applied Extrusion Techs., Inc., 998 F.2d 157, 166 (3d Cir. 1993) (“Documents containing trade
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`secrets or other confidential business information may be protected from disclosure” and
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`explaining that the court has “framed the inquiry as whether the need for secrecy outweighs the
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`presumption of access that normally attaches to such documents”); Nixon v. Warner Commc’ns,
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`Inc., 435 U.S. 589, 598 (1978) (“[C]ourts have refused to permittheir files to serve as ... sources
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`of business information that might harmalitigant’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
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`manufacturing process. Moderna’s proposed redactions redact the specific confidential material
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`at issue, leaving the remainderofthe Joint Claim Construction Briefunredacted. These proposed
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`redactions are narrow such that the public’s ability to understand the claim construction
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`arguments is not impaired any less than necessary to prevent the release of Moderna’s most
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`sensitive technical informationto its competitors, preventing clear competitive harm. Moderna’s
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`proposed redactions are narrow in scope and refer only to Moderna’s confidential, sensitive
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`technical or business information to prevent the serious harm to Moderna which would be
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`causedbyits public release as outlined in Mr. Wojciechowski’s Declaration. Exhibits 77 and 81
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`of the Joint Claim Construction Appendix are confidential regulatory submissions to the FDA
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`and disclose specific information concerning Moderna’s proprietary and trade secret
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`manufacturing methodsfor its COVID-19 Vaccine including steps in the manufacturing process
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`and parameters for those steps. Likewise, sealing Exhibits 77 and 81 does not impair the public’s
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`ability to understand the claim construction arguments any more than necessary to prevent the
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`release of Moderna’s most sensitive technical information to its competitors, preventing clear
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`competitive harm.
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`IV.
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`CONCLUSION
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`For the foregoing reasons, Moderna respectfully requests the Court grant Moderna’s
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`Motion to Seal with respect to Moderna’s highly confidential information.
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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
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`Attorneys for Defendants
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`OF COUNSEL:
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`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 ClarendonStreet
`Boston, MA 02116
`(617) 385-7500
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`December26, 2023
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`

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`CERTIFICATE OF SERVICE
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`I hereby certify that on December26, 2023, I caused the foregoingto 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
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`registered participants.
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`I further certify that I caused copies of the foregoing document to be served on December
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`26, 2023, upon the following in the mannerindicated:
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`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
`Attorneysfor 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 MarketStreet
`San Francisco, CA 94105-2482
`Attorneysfor PlaintiffArbutus Biopharma
`Corporation
`
`Kira A. Davis, Esquire
`MorRISON & FOERSTER LLP
`707 Wilshire Boulevard
`Los Angeles, CA 90017-3543
`Attorneysfor PlaintiffArbutus Biopharma
`Corporation
`
`VIA ELECTRONIC MAIL
`
`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
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`VIA ELECTRONIC MAIL
`
`VIA ELECTRONIC MAIL
`
`David N. Tan, Esquire
`MorRISON & FOERSTER LLP
`2100 L Street, NW, Suite 900
`Washington, DC 20037
`Attorneysfor PlaintiffArbutus Biopharma
`Corporation
`
`David I. Berl, Esquire
`Adam D. Harber, Esquire
`ThomasS. 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 AvenueS.W.
`Washington, DC 20024
`Attorneysfor PlaintiffGenevant Sciences GmbH
`
`/s/ Travis J. Murray
`
`Travis J. Murray (#6882)
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`