Case 1:22-cv-00252-MSG Document 361-2 Filed 06/21/24 Page 1 of 6 PageID #: 21779
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`C.A. No. 22-252-MSG
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`HIGHLY CONFIDENTIAL –
`OUTSIDE COUNSEL’S EYES ONLY
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`v.
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`MODERNA, INC. and MODERNATX, INC.,
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`Plaintiffs,
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`Defendants.
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`LETTER TO THE HONORABLE MITCHELL S.
`GOLDBERG REGARDING DISCOVERY DISPUTE
`
`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
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`
`
`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
`Ricardo Leyva
`Philip N. Haunschild
`Falicia Elenberg
`Kathryn Larkin
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue S.W.
`Washington, DC 20024
`(202) 434-5000
`Attorneys for Plaintiff Genevant
`Sciences GmbH
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`1
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`

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`Case 1:22-cv-00252-MSG Document 361-2 Filed 06/21/24 Page 2 of 6 PageID #: 21780
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`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
`
`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: May 30, 2024
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`2
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`Case 1:22-cv-00252-MSG Document 361-2 Filed 06/21/24 Page 3 of 6 PageID #: 21781
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`Dear Judge Goldberg:
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`Plaintiffs return to the Court to obtain discovery regarding Moderna’s U.S.-based sales of
`the Accused Product. Plaintiffs previously sought the Court’s assistance in obtaining discovery
`regarding sales of the Accused Product that Moderna unilaterally—and improperly—characterized
`as “foreign sales” solely because the product was manufactured and delivered abroad. See D.I.
`184. As the Federal Circuit has made clear, however, products “not made or used in, or imported
`into, the United States” may infringe if there is a “domestic location of sale.” Carnegie Mellon
`Univ. v. Marvell Tech. Grp., Ltd., 807 F.3d 1283, 1310 (Fed. Cir. 2015); Caltech v. Broadcom
`Ltd., 25 F.4th 976, 993 (Fed. Cir. 2022). Following argument, the Court directed Plaintiffs to:
`“propound to Defendant specific interrogatories about such sales that are narrowly-tailored to the
`factors enumerated in Halo Electronics, Inc. v. Pulse Electronics, Inc., 831 F.3d 1369 (Fed. Cir.
`2016). After review of Defendant’s responses, if Plaintiffs are able to demonstrate that a specific
`sale could be deemed a ‘U.S. Sale,’ they may renew their request for documents as to that sale.”
`D.I. 229 ¶ 5. Plaintiffs have done precisely as the Court directed. Ex. 1. Following an extensive
`meet-and-confer process, Plaintiffs identified 32 contracts—with 16 counterparties—all executed
`in June 2021 or prior, for which Plaintiffs have established a basis to pursue further discovery into
`their status as U.S. Sales. Ex. 2 (5/9/2023 Letter) at 2. Plaintiffs have requested discrete categories
`of documents concerning this limited set of agreements. Id. at 3. Plaintiffs also identified certain
`contracts for which Moderna’s interrogatory response does not provide sufficient detail.
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`Moderna continues its flat refusal to provide discovery. It contends, again, that Plaintiffs
`are not entitled to discovery because they have not proven that “substantial sales activity” occurred
`in the United States. Ex. 3 (5/23/24 Email from Moderna). Not only is that wrong—based on
`limited discovery provided to date, a majority of the Federal Circuit’s factors for determining a
`U.S. locus of sale support such a finding—but it flips the discovery process on its head and flouts
`the Court’s order. Plaintiffs need not prove at this stage that the sales at issue occurred in the United
`States. They need merely show that they could make such a finding. As set out below, there can
`be no question Plaintiffs meet this standard. Plaintiffs’ requests as to the sales in question are
`narrow and more than proportional, given that as much as
` in sales of the Accused
`Product are at issue. Unless Moderna is willing to stipulate that the sales at issue are U.S. sales, it
`cannot continue to withhold discovery in an effort to avoid this liability.
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`Discovery Suggests that the Sales at Issue are U.S. Sales. “[F]or products manufactured,
`delivered, and used entirely abroad” a “sale” may “be found to have occurred in the United States
`where a substantial level of sales activity occur[ed]” in the U.S. Ex. 4 (CalTech v. Broadcom, Ltd.,
`2:16-cv-03714 (C.D. Cal. Jan 29, 2020), D.I. 213) at Appx184, aff’d in relevant part Caltech, 25
`F.4th at 992. Determining where such “substantial activity” occurred for products manufactured
`and delivered abroad considers (1) where a contract or sale was negotiated; (2) where purchase
`orders and payments issue or are received; (3) where a contract was executed; (4) where contingent
`actions under a contract occur; (5) where specific orders are negotiated or finalized; (6) where
`marketing activities occur or are directed; and/or (7) where testing or design work underlying the
`sale occurred. See, e.g., Halo, 831 F.3d at 1378; CMU, 807 F.3d at 1308; Ex. 5 at 12–16. Based
`on the limited discovery to date, each one of these factors favors Plaintiffs for the pre-June 2021
`contracts for which Plaintiffs seek further discovery:
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`1
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`Case 1:22-cv-00252-MSG Document 361-2 Filed 06/21/24 Page 4 of 6 PageID #: 21782
`Case 1:22-cv-00252-MSG Document 361-2 Filed 06/21/24 Page 4 of 6 PagelD #: 21782
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`Current Evidence
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`
`Factor
`Contract
`of
`Location
`(1)
`Negotiation (Halo, 831 F.3d at
`1378)
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`(2) Where Purchase Orders were
`Received and Processed (Halo, 831
`F.3d at 1378
`(3) Location of Contract Execution
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`Halo, 831 F.3d at 1378
`(4) Location in which Contingent
`Actions
`im Contract Occurred
`(CMU,807 F.3d at 1311, 1308-09)
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`(5) Location Where Specific Orders
`Were Negotiated and Finalized
`CMU, 807 F.3d at 1308
`(6) Location Where Marketing
`Activities were Directed (Halo, 831
`F.3d at 1378
`(7) Location of Design Work and
`Testing (Halo, 831 F.3d at 1378)
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`
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`Moderna may dispute the implication of this evidenceat trial, but its disagreementis not a
`basis to resist discovery. See Apeldyn Corp. v. AU Optronics Corp., 2010 WL 11470585, at *1 (D.
`Del. Apr. 12, 2010) (Plaintiffs “not required to prove [their] case before being entitled to such
`discovery.”). Moderna’s own cases cited previously confirm that “the question [] is not whether
`[Defendant] has somefacts on its side that it can later use to argue the ultimate issue .
`.
`. [nJoris
`the question here whether [Plaintiff] can now definitively prove that these sales are U.S.-based
`sales.” Tessera, Inc. v. Broadcom Corp., No. CV 16-380-LPS-CJB, 2017 WL 4876215, at *3 (D.
`Del. Oct. 24, 2017) (cited in Ex. 3 at 1). Rather, “the question is whether [Plaintiff] has made a
`sufficient record to demonstrate relevance.” Jd. Nor does the “presumption against extraterritorial
`application of United States law” limit further discovery. See Ex. 5 at 18. The Federal Circuit
`already has
`rejected that precise argument, concluding that “the presumption against
`extraterritorial applicationis [] inapplicable” to the determination of whether specific transactions
`“were domestic or extraterritorial in nature.” Caltech, 25 F.4th at 992.
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`The Requested Discovery Is Limited and Proportional. Plaintiffs seek two categories of
`materials. First, after recerving Moderna’s Court-ordered interrogatory response, Plaintiffs made
`every effort to identify
`a targeted set ofdocuments for Moderna’s pre-June 2021 sales that occurred
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`beforeOO To that end, for each ofthe 32 contracts at
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`issue, to the extent Moderna continuesto dispute that the U.S. is a situs of sale, Plaintiffs requested
`30(b)(6) corporate testimony regarding these sales, together with the following documents:
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`Case 1:22-cv-00252-MSG Document 361-2 Filed 06/21/24 Page 5 of 6 PageID #: 21783
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`• Copies of the agreements: Copies of Moderna’s contracts are relevant to establish the price
`for which Moderna sold the Accused Product, the timing of Moderna’s sales, and to assess
`other contractual provisions establishing a U.S. situs of sale, such as the location of the law
`applied under the agreement, parent guaranties with Moderna’s U.S. affiliate, and may include
`U.S. locations for notice and/or payment.
`• Negotiation communications: Moderna’s discussions concerning the negotiation of each
`agreement are relevant to assessing the location from which Moderna’s negotiations were
`performed, unless stipulated.
`• Sales orders: Moderna’s sales orders are relevant to confirm the location in which they were
`processed together with the dates of specific sales.
`• Financial, distribution, and genealogical information about the doses sold pursuant to those
`agreements (to the extent not already produced): Plaintiffs are entitled to the information
`relevant to assess infringement and damages on a lot-by-lot basis (as Moderna contests) to
`prove their case for each infringing sale.
`• Identification of new “part numbers” placed at issue for doses sold under these contracts so
`that Moderna may produce samples under the existing sample production protocol, D.I. 225.
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`Each of these limited categories relates directly to the Halo factors and Plaintiffs’ burden to prove
`infringement for the product sales at issue.
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`Second, for the post-2021 contracts identified in Moderna’s interrogatory response,
`Plaintiffs request that the Court Order Moderna to supplement its response to provide information
`broken down by specific contract, so Plaintiffs can assess concretely whether specific sales are
`U.S. sales, and whether further targeted discovery is warranted as to specific contracts. As it stands,
`Moderna has lumped together its responses in a way that prevents the necessary contract-by-
`contract analysis. For example, Moderna lists all U.S. and foreign sales employees without
`identifying which employees worked on which contracts, or their respective roles. Ex. 5 at 21.
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`Moderna contends that providing the above discovery would be burdensome, given the
`notice and confidentiality obligations Moderna owes to its counterparties. Ex. 3 at 1; Ex. 6 at 17–
`18. But the burden that Moderna has previously asserted—providing notices of disclosures for
`more than 100 agreements—no longer applies to Plaintiffs’ current request for contracts with just
`16 counterparties—a total of 32 agreements. Ex. 2 at 3. Moreover, Moderna has already selectively
`produced at least six of these agreements, thereby requiring additional notice obligations to just 10
`counterparties. See Exs. 7–12. Moderna, moreover, may avoid some of the additional burden of
`producing its negotiation communications if it is willing to stipulate that the contracts at issue were
`negotiated entirely from the U.S. Absent such a stipulation, the documents Plaintiffs request are
`plainly proportional given Moderna’s position that as much as
` in sales may be in
`dispute. Ex. 15 (3/15/24 8th Supp R&Os) at 97. Any additional discovery would not affect the
`case schedule. If Moderna produces the requested information promptly before expert reports, it
`can be incorporated on the current schedule or handled with prompt, targeted supplements.
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`Plaintiffs respectfully request that Moderna be ordered to provide the requested discovery
`within two weeks of the Court’s order.
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`3
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`Case 1:22-cv-00252-MSG Document 361-2 Filed 06/21/24 Page 6 of 6 PageID #: 21784
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`Respectfully submitted,
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`/s/ Nathan R. Hoeschen
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`Nathan R. Hoeschen (No. 6232)
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`Enclosures
`cc:
`Clerk of the Court (via Hand Delivery)
`All Counsel of Record (via Email)
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`4
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