Case 1:22-cv-00252-MSG Document 193 Filed 01/16/24 Page 1 of 6 PageID #: 12512
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
`
`)
`)
`)
`
`))
`
`
`) C.A. No. 22-252-MSG
`)
`
`
`))
`
`)
`
`Plaintiffs,
`
`v.
`
`MODERNA, INC. and MODERNATX, INC.,
`
`Defendants.
`
`LETTER TO THE HONORABLE MITCHELL S. GOLDBERG FROM
`NATHAN R. HOESCHEN
`
`
`John W. Shaw (No. 3362)
`Karen E. Keller (No. 4489)
`Nathan R. Hoeschen (No. 6232)
`SHAW KELLER LLP
`I.M. Pei Building
`1105 North Market Street, 12th Floor
`Wilmington, DE 19801
`(302) 298-0700
`jshaw@shawkeller.com
`kkeller@shawkeller.com
`nhoeschen@shawkeller.com
`Attorneys for Plaintiffs
`
`OF COUNSEL:
`David I. Berl
`Adam D. Harber
`Thomas S. Fletcher
`Jessica Palmer Ryen
`Shaun P. Mahaffy
`Jihad J. Komis
`Anthony H. Sheh
`Matthew W. Lachman
`Philip N. Haunschild
`Falicia Elenberg
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue S.W.
`Washington, DC 20024
`(202) 434-5000
`Attorneys for Plaintiff Genevant
`Sciences GmbH
`
`Daralyn J. Durie
`Adam R. Brausa
`Eric C. Wiener
`Annie A. Lee
`Shaelyn K. Dawson
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, CA 94105-2482
`(415) 268-6080
`
`

`

`Case 1:22-cv-00252-MSG Document 193 Filed 01/16/24 Page 2 of 6 PageID #: 12513
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`Kira A. Davis
`MORRISON & FOERSTER LLP
`707 Wilshire Boulevard
`Los Angeles, CA 90017-3543
`(213) 892-5200
`
`David N. Tan
`MORRISON & FOERSTER LLP
`2100 L Street, NW, Suite 900
`Washington, DC 20037
`(202) 887-1500
`Attorneys for Plaintiff Arbutus
`Biopharma Corporation
`
`Dated: January
`
`, 2024
`
`2
`
`

`

`Case 1:22-cv-00252-MSG Document 193 Filed 01/16/24 Page 3 of 6 PageID #: 12514
`Case 1:22-cv-00252-MSG Document 193 Filed 01/16/24 Page 3 of 6 PagelD #: 12514
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`
`
`HAW KELLER
`LLP
`
`Nathan R. Hoeschen
`
`=1105 North MarketStreet, 12Floor
`Wilmington, DE 19801
`(302) 298-0709 — Direct
`nhoeschen@shawkeller.com
`
`BY CM/ECF
`The Honorable Mitchell S. Goldberg
`HIGHLY CONFIDENTIAL -
`U.S. District Court for the Eastern District of Pennsylvania
`James A. Byrne U.S. Courthouse, Room 17614
`OUTSIDE COUNSEL EYES ONLY
`601 Market Street, Philadelphia, PA 19106-1797
`FILED UNDER SEAL
`
`Re:
`
`Arbutus Biopharma Corporation, et. al. v. Moderna,Inc., et. al. C_.A. No. 22-252-MSG
`
`Dear Judge Goldberg:
`
`Plaintiffs move for the production of three limited, relevant categories of documents.
`Plaintiffs first seek a narrow set of regulatory documents for products that use LNPs with the lipid
`molarratios in Plaintiffs’ asserted patent claims—specifically, the chemistry, manufacturing, and
`controls sections (typically contained in Module 3) of Moderna’s “Investigational New Drug”
`applications (“INDs’”) and related correspondence with the FDA. These documents, which are
`relevant
`to non-obviousness, willful
`infringement, and damages, can be produced from a
`centralized repository with minimal burden. Second, Plaintiffs seek documents concerning the
`marketing, negotiation, and contracting for batches of Modema’s COVID-19 vaccine that
`Moderna unilaterally declares are “not accused of infringement” because they were allegedly
`manufactured and used abroad. However, such batches, which are accusedof infringement, could
`have beenso/d in the U.S. underblack-letter law, and are thus subject to damagesin this action.
`Moderna cannot prevent discovery about the locus of sale for these batches based on its untested
`say-so. Third, Plaintiffs seek minutes from meetings of, and materials provided to, Moderna’s
`Board of Directors discussing the accused product. This is a narrow category of documents that
`are squarely relevant to damages, and Moderna hasnot asserted any undue burden.
`
`INDs (RFPs 163-67, Ex. 1 at 9-10). Despite criticizing Plaintiffs’ LNP technology both
`publicly and in this case, Moderna repeatedly sought FDA approval to perform humantesting
`using LNPswithin the scope of Plaintiffs’ asserted patent claims. Modemapublicly has admitted
`to performing such studies using LNPs within Plaintiffs’ claimed ratios, Ex. 2 at 1322-24; Ex. 3
`at 3327-28. The INDs seeking approval to perform these humanstudies contain detailed, non-
`public statements that discuss the patented technology, report on studies with the technology, and
`provide scientific justifications for use of Plaintiffs’ claimed lipid molarratios and components.
`
`There is no genuine dispute that Moderna’s INDsare relevant.
`
`5: Ex. 6 at 28-29. Ex. 7 at *767. And Moderna repeatedly has demandedthat Plaintiffs also produce INDs
`
`sponsoredby Plaintiffs’ predecessors. While Plaintiffs agreed to produce such documents, Ex. 8
`at 1, Moderna hassteadfastly refused to produce the requested IND excerpts, despite admitting
`that it maintains them in a centralized repository, minimizing any production burden on Moderna.
`
`Any such minimal burden is vastly outweighed by the documents’ substantial relevance.
`For example, by reflecting Moderna’s widespread copying of the patented inventions, Moderna’s
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`

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`Case 1:22-cv-00252-MSG Document 193 Filed 01/16/24 Page 4 of 6 PageID #: 12515
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`INDs provide “compelling evidence” nullifying its obviousness defenses, to the extent Moderna
`is not estopped from raising them in light of its failed IPRs. Adv. Display Sys., Inc. v. Kent State
`Univ., 212 F.3d 1272, 1285 (Fed. Cir. 2000). Moderna’s INDs are also relevant to willful
`infringement by demonstrating its knowledge of, and history with, the patents and patented
`technology. Georgetown Rail Equip. Co. v. Holland L.P., 867 F.3d 1229, 1245 (Fed. Cir. 2017).
`Even divorced from these legal theories, Moderna’s INDs likely contain statements directly
`commenting on the technology at issue in this case, and are plainly relevant for that reason as well.
`
`Moderna offers no valid reason the requested IND sections should not be produced. First,
`Moderna asserts that certain INDs (from 2017) are irrelevant to copying and willfulness because
`Moderna’s work was conducted pursuant to an unauthorized sublicense from Acuitas, D.I. 1 ¶¶
`32–34, or based on publicly available information. Setting aside that this argument does not
`address the full scope of non-public INDs that Plaintiffs seek, Moderna’s attorney argument does
`not render its INDs non-discoverable. Nor does the fact that certain IND studies may have been
`conducted pursuant to a license change their relevance to willful infringement here, which
`concerns activities beyond the scope of the license. Georgetown Rail, 867 F.3d at 1245. And none
`of this addresses the fact that the requested documents contain Moderna’s indisputably relevant
`statements regarding the patented technology.
`
`Moderna also objects that the INDs concern non-accused products. But the requested INDs
`include information about
`
`Exs. 2–6. Regardless, there is no rule limiting discovery to the accused product only. See, e.g.,
`Eli Lilly & Co. v. Wockhardt Ltd., 2010 WL 2605855, at *5 (S.D. Ind. June 22, 2010) (compelling
`production of IND for another formulation). “[C]ourts have allowed discovery to include non-
`accused products where a party either demonstrates the relevance of the non-accused products to
`the allegations and or their reasonable similarity to the accused product,” as Plaintiffs have done
`here, and “Delaware federal district courts . . . have concluded that discovery into non-accused
`products, particularly prior to the filing of final contentions, is permissible as long as it is narrowly
`tailored.” LKQ Corp. v. Kia Motors Am., Inc., 2023 WL 3455315, at *3 (N.D. Ill. May 15, 2023);
`Invensas Corp. v. Renesas Elecs. Corp., 287 F.R.D. 273, 283 (D. Del. 2012); Elm 3DS Innovations,
`LLC v. Samsung Elecs. Co., Ltd., 2015 WL 13902870, at *1–2 (D. Del. June 30, 2015). Moderna’s
`INDs for products using Plaintiffs’ lipid ratios are precisely the sort of “narrowly tailored,” highly
`relevant discovery that poses minimal burden, and should be compelled.
`
`Sales Discovery (RFPs 60, 64, 69, 74, 75, 81, 83, Ex. 9 at 14–18; Interrog. 11, Ex. 10).
`Moderna also refuses to produce discovery concerning sales of the batches that it unilaterally
`deems non-infringing under 35 U.S.C. § 271(a) because they were not manufactured or used in the
`U.S. Ex. 11 at 1. Moderna disregards Plaintiffs’ allegations that Moderna’s sales of these batches
`occurred in the U.S., e.g., D.I. 1 ¶¶ 50–54, 70, and defies binding precedent stating that such U.S.
`sales are infringing acts. E.g., Caltech v. Broadcom Ltd., 25 F.4th 976, 993 (Fed. Cir. 2022);
`Carnegie Mellon Univ. v. Marvell Tech. Grp., Ltd., 807 F.3d 1283, 1310 (Fed. Cir. 2015). Sales
`“for products manufactured, delivered, and used entirely abroad,” may “be found to have occurred
`in the United States”—and thus infringing under § 271(a)—“where a substantial level of sales
`activity occur[ed]” in the U.S. Ex. 12 at Appx184, aff’d in relevant part Caltech, 25 F.4th at 992.
`And products “not made or used in, or imported into, the United States” may infringe if there is a
`“domestic location of sale.” CMU, 807 F.3d at 1310. Determining where a sale occurred is a fact-
`specific inquiry, in which courts have considered (1) where a contract or sale was negotiated; (2)
`where purchase orders and payments issue or are received; (4) where a contract was executed; (5)
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`Case 1:22-cv-00252-MSG Document 193 Filed 01/16/24 Page 5 of 6 PageID #: 12516
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`where contingent actions under a contract occur; (6) where specific orders are negotiated or
`finalized; (7) where marketing activities occur or are directed; and/or (8) where testing or design
`work underlying the sale occurred. See, e.g., Caltech, 25 F.4th at 976; Halo Elecs., Inc. v. Pulse
`Elecs., Inc., 831 F.3d 1369, 1378 (Fed. Cir. 2016); CMU, 807 F.3d at 1308; Ex. 13.
`
`Moderna ignores this precedent, and refuses discovery, by baldly declaring its sales
`occurred abroad. Ex. 14 at 1. Moderna improperly confuses its unilateral view of the merits of
`infringement with discoverability. Plaintiffs are not obligated to accept Moderna’s untested
`assertions, but are “entitled to discover the extent to which [Moderna] has engaged in foreign sales
`activities” to determine if sales of products made and used abroad in fact “occurred within the
`U.S.” McGinley v. Luv N’Care, Ltd., 2018 WL 9814589, at *5 (W.D. La. Sept. 10, 2018).
`Plaintiffs are “not required to prove [their] case” for infringing sales “before being entitled to such
`discovery.” Apeldyn Corp. v. AU Optronics Corp., 2010 WL 11470585, at *1 (D. Del. Apr. 12,
`2010) (compelling “worldwide sales data”); Pos. Techs., Inc. v. Sony Elecs., Inc., 2013 WL
`707914, at *6 (N.D. Cal. Feb. 26, 2013) (“It would be improper under Rule 26 to expect Plaintiff
`to show that the discovery it seeks is admissible when it has not yet obtained the discovery.”).
`Moderna cannot dispute that significant sales activities occurred at its U.S. headquarters, key
`testing and design work occurred in the U.S., and employees executed contracts in the U.S.
`Moderna should be compelled to produce documents and information concerning the sales of its
`COVID-19 vaccine that it contends were for batches manufactured and used abroad, and not to
`limit discovery to batches manufactured or used in the U.S, as it has in response to each of
`Plaintiffs’ requests.1
`
`Board Materials (RFP 130, Ex. 1 at 2). Moderna refuses to produce minutes of meetings
`of, and materials provided to, its Board of Directors discussing the accused product. Moderna has
`acknowledged that this request “is narrowly circumscribed,” Ex. 15 at 7, and has not disputed
`relevance. Nor could it. Such materials are directly relevant to damages, as planning and strategy
`around the accused product are evidence about the hypothetical negotiation. Indeed, Moderna’s
`CEO testified before Congress that its Board made strategic sales decisions, including agreeing to
`give an unsolicited $2.9 billion discount to the U.S. Government. Ex. 16, 54:5-22, 83:9. Moderna
`also has not asserted burden, as such materials generally are centrally stored. Ex. 15 at 10.
`
`Moderna’s sole basis to resist production has been shifting counter-demands. Plaintiffs
`agreed to produce the same scope of Board materials requested from Moderna, plus more. Ex. 15
`at 4. So Moderna demanded yet more: first that Plaintiffs produce their and their predecessors’
`board materials concerning not just the accused product, but effectively every LNP made in their
`two-decade-plus history. Then, Moderna demanded that Plaintiffs and non-party Roivant produce
`documents discussing lipid molar ratios and the asserted patents. Ex. 15 at 2. This conditioning
`is improper. Genentech, Inc. v. Trustees of Univ. of Pa., 2011 WL 7074208, at *1 (N.D. Cal. June
`10, 2011). The documents Plaintiffs seek are targeted and plainly relevant to damages. Courts
`routinely compel defendants in patent litigation to produce board materials regarding the accused
`product, and Plaintiffs respectfully request the Court follow suit here. E.g., Vasudevan Software,
`Inc. v. MicroStrategy Inc., 2013 WL 597655, at *1 (N.D. Cal. Feb. 15, 2013) (ordering production
`of board minutes); Unilin Beheer B.V. v. NSL Trading Corp., 2015 WL 12698382, at *9 (C.D. Cal.
`Feb. 27, 2015) (ordering investigation into board minutes and other financial documents).
`
`1 Plaintiffs have also sought samples of such batches. D.I. 161.
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`

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`Case 1:22-cv-00252-MSG Document 193 Filed 01/16/24 Page 6 of 6 PageID #: 12517
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`Respectfully submitted,
`/s/ Nathan R. Hoeschen
`Nathan R. Hoeschen (No. 6232)
`
`cc:
`
`Clerk of the Court (by CM/ECF)
`All counsel of record (by CM/ECF & e-mail)
`
`