Case 1:22-cv-00252-MSG Document 211-4 Filed 02/02/24 Page 1 of 5 PageID #: 14421
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`ARBUTUS BIOPHARMA CORPORATION
`and GENEVANT SCIENCES GmbH,
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`MODERNA, INC. and MODERNATX, INC.
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`Defendants.
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`Plaintiffs,
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`
`
`v.
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`
`C.A. No. 22-252 (MSG)
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`
`CONFIDENTIAL
`FILED UNDER SEAL
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`LETTER TO THE HONORABLE MITCHELL S. GOLDBERG REGARDING
` (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
`Caitlin Dean
`N. 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
`
`
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`
`
`
`
`

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`Case 1:22-cv-00252-MSG Document 211-4 Filed 02/02/24 Page 2 of 5 PageID #: 14422
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`
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`Dear Judge Goldberg:
`discovery demands far exceed any sense of reasonable proportionality. After
`failing in their initial attempt to end-run around Delaware limit of 10 ESI custodians, D.I. 142,
`6:23-8:3, Plaintiffs have not only requested samples from all
`but
`now also seek (i) all commercial contracts and sales data, worldwide across the entire company,
`ignoring the territorial bounds of 35 U.S.C. § 271(a) and (ii) regulatory files from essentially every
`IND Moderna has ever filed. But Moderna has already produced its COVID-19 regulatory files
`and broader R&D documents. Likewise,
`:
`Moderna agreed to produce relevant documents provided Plaintiffs do the same. And Moderna
`has already produced more than 1.35 million pages
`than 525,000 pages. Plaintiffs are extreme in their demands, arguing tenuous relevance grounds
`that in no way justify their ever-
`denied.
`INDs for All Products. This case involves one accused product
`COVID-19
`vaccine
`and patents limited to certain lipid formulations. Yet Plaintiffs seek
`all
`[IND] Applications submitted by Moderna to the [FDA] wherein the proposed product comprised
`i.e.,
`pre-commercial pipeline, which spans dozens
`of potential medicines and treatments (e.g., for HIV, cancer, Lyme disease). Ex. A, RFP Nos. 166-
`167.
` of proportionality. And despite having no asserted claims
`to manufacturing methods, Plaintiffs, in particular, demand the manufacturing sections in those
`applications. Mot. at 1; Ex. A, RFP No. 166.
`Plaintiffs have the discovery needed for the claims and defenses in this case. Moderna has
`already complied with arguably overbroad demands for regulatory documents concerning its
`COVID-19 vaccine: producing more than 400,000 pages of filings, more than 220,000 pages of
`which comprised the COVID-19 IND.1 Moreover, a
`terms
`hitting on over 300,000 documents
`including those related
`platform, several of which were applied to a decade of ESI from all 10 custodians, whose
`responsibilities were not limited to the COVID vaccine. Ex. C, terms III-02 & III-06; Ex. D at 2.
`-commercial pipeline products is not
`warranted. First, the unaccused product cases Plaintiffs cite focus almost entirely on discovery to
`determine whether other products infringe.2 Plaintiffs admit that is not their goal (nor could it be
`under the § 271(e)(1) safe harbor), instead arguing that the requested INDs are relevant to copying,
`willfulness, and/or damages. This is insufficient to establish relevance. LKQ Corp. v. Gen. Motors
`Co., 2021 WL 4127326, at *1-2 (N.D. Ill. Sept. 9, 2021) (denying discovery into unaccused parts
`where alleged relevance
`and distinguishing from Invensas). Second, Plaintiffs cite no evidence as to
`, which is pure speculation. Mot. at 1, 2. Nor do Plaintiffs explain why
`the INDs would have relevant information that is not present in the COVID IND. Either Plaintiffs
`are contending that the requested INDs contain the same relevant information present in the
`COVID-19 IND and thus seek duplicative discovery
`or Plaintiffs are merely seeking leave for
`, which is an insufficient
`basis to warrant discovery. Micro Motion, Inc. v. Kane Steel Co., 894 F.2d 1318, 1326-28 (Fed.
`
`1 Yet Plaintiffs refuse to confirm when (or if) they will produce a single regulatory filing. Ex. B.
`2 The remaining case (Eli Lilly) focused on how the unaccused product differed from the accused
`product, not discovery into features that could be gleaned from discovery into the accused product.
`
`1
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`Case 1:22-cv-00252-MSG Document 211-4 Filed 02/02/24 Page 3 of 5 PageID #: 14423
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`Cir. 1990); Ethicon LLC v. Intuitive Surgical, 2018 WL 1392341, at *3 (D. Del. Feb. 12, 2018);
`Hologram USA, Inc. v. Pulse Evolution Corp., 2015 WL 13238450, at *4 (D. Nev. Dec. 18, 2015)
`carte blanche
`. Plaintiffs
`cases regarding
`Adv. Display and Georgetown Rail) are inapposite.
`Neither addresses production of regulatory files, let alone unaccused products.
`
`The question of
`burden rests on what is required to produce the material and must be weighed against relevance.
`Moderna has at least 35 pipeline products currently in clinical development, each with at least
`one IND. Ex. E. Moderna would need to review each document to assign a confidentiality level
`and separately confirm whether they contain third-party confidential information requiring third-
`party notice or consent for production, which Plaintiffs have relied on to refuse discovery. Ex. F
`at 4 (
`). Plaintiffs cite no precedent for their request for all of
`. Their (at best) speculative relevance basis cannot justify this undue burden.
`OUS Discovery. First, Plaintiffs ignore black-letter law. Courts consistently note the
`Halo Elecs., Inc. v. Pulse
`Elecs., Inc., 831 F.3d 1369, 1376 (Fed. Cir. 2016) (no direct infringement because OUS products
`Cal. Inst. of Tech. v. Broadcom
`dispute that [U.S. infringement] laws apply only
`Ltd., 25 F.4th 976, 992-
`Carnegie Mellon Univ. v. Marvell Tech. Grp., Ltd., 807 F.3d 1283, 1310-11 (Fed.
`Cir. 2015) (vacating damages for products not made, used in, or imported into U.S.); 35 U.S.C.
`§ 271(a). Plaintiffs do not and cannot deny that activities occurring wholly outside the U.S.
`speculation alone
`is enough to require Moderna to provide voluminous, burdensome discovery just so Plaintiffs can
`-
`Yet by demanding this production,
`Plaintiffs are effectively shifting their burden onto Moderna to prove that OUS activity is not
`actually OUS.
`is not proportional to the needs of the case. For example, Moderna
`OUS contracts,
`
` for which would take months.
`
`and
`intervene if warranted. Requiring Moderna to undergo this exercise hundreds of times is a burden
`that is not outweighed by any likely benefit. If Plaintiffs were correct, every case would open up
`defendants to worldwide discovery without a shred
`are U.S. sales. Doing so would extend the scope of §
`
`Halo, 831 F.3d at 1379.
`
`Second, Plaint
`contention, Moderna already provided discovery about OUS batches that were subsequently
`imported into the U.S. as well as U.S. manufactured batches released for distribution abroad. Ex.
`G; Ex. H.
`
`requests. Nor is their quest for information that objectively cannot be infringement a valid basis.
`Kajeet, Inc. v. Qustodio, LLC, 2019 WL 8060078, at *13 (C.D. Cal. Oct. 22, 2019) (denying
`
`Tessera, Inc. v. Broadcom Corp., 2017 WL 4876215, at *1 (D. Del. Oct. 24, 2017) (denying
`
`2
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`

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`Case 1:22-cv-00252-MSG Document 211-4 Filed 02/02/24 Page 4 of 5 PageID #: 14424
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`-shifting positions on OUS discovery is untenable. Ex. 11, Ex. 14;
`Third,
`Ex. I; Ex. G. After loosely raising the issue in May, Plaintiffs ignored it until November. Ex. 11 at
`11; Ex. J at 4; Ex. P at 6. Then Plaintiffs pivoted from seeking all OUS analytical data to all OUS
`
`3
`
`shifting positions are the definition of a fishing expedition. Apex Fin. Options, LLC v. Gilbertson,
`2021 WL 5206104, at *2 (D. Del. Nov. 9, 202
`-19 vaccine wholly manufactured and used OUS should be denied.
`Board Materials. This unripe dispute should be denied Moderna has not refused to
`produce Board documents. Moderna offered
`-privileged Board documents which
`
`discovery
`
`premature motion. Indeed, just one day before filing, Plaintiffs for the first time confirmed that
`they possess Board documents, indicating both parties were still investigating these requests.4
`the
`Moderna offered a scope of documents focused on issues relevant to this litigation
`lipid molar ratio of the Accused Product (the subject of the Asserted Patents). Contrary to
`of RFP No. 130 because
`all
`
`it essentially demands all
`COVID-
`
`O at 2. For example, clinical trial information is irrelevant because
`the asserted claims are not to methods of use.
`is burdensome, and courts have denied such broad requests. Osucha v. Alden State Bank, 2020 WL
`3055790, *6
`
`Moderna proposed a compromise to reduce
`permitting relevance redactions for Board
`
`scope and burden which Plaintiffs ignored
`documents
`sensitivity in certain circumstances. Ex. F at 2. To the extent the Court orders the parties to
`produce certain Board Materials, courts have permitted redactions
`Holley v. Gilead Scis., Inc., 2020 WL 2097602, at *3 (N.D.
`Cal. May 1, 2020), and Moderna would request such redactions be permitted here.
`Moderna respectfully requests that the Court d
`
`3
`
`McGinley
`
`whether sales occurred in U.S.); Apeldyn, 2010 WL 11470585, at *1
`
`Positive Techs.,
`2013 WL 707914, at *4 (denying protective order barring discovery of sales information for non-
`accused accessories and services sold with accused e-readers on the basis of convoyed sales).
`4 Moreover, Plaintiffs and Roivant have likewise refused to produce Board documents requested
`by Moderna, including documents related to the Asserted Patents that are highly relevant. Roivant
`is not a disinterested third-party as Plaintiffs suggest; it
`Ex. K at 5; Exs. L-N.
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`3
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`

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`Case 1:22-cv-00252-MSG Document 211-4 Filed 02/02/24 Page 5 of 5 PageID #: 14425
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`Respectfully,
`
`/s/ Travis J. Murray
`
`Travis J. Murray (#6882)
`
`
`TJM:lo
`Enclosures
`cc:
`All Counsel of Record (via CM/ECF and electronic mail)
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`4
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