Case 2:22-cv-00263-JRG-RSP Document 49-1 Filed 03/28/23 Page 1 of 3 PageID #: 1661
`Case 2:22-cv-00263-JRG-RSP Document 49-1 Filed 03/28/23 Page 1 of 3 PagelD #: 1661
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`EXHIBIT A
`EXHIBIT A
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`Case 2:22-cv-00263-JRG-RSP Document 49-1 Filed 03/28/23 Page 2 of 3 PageID #: 1662
`Arbutus Biopharma Corporation v. Moderna, Inc., Slip Copy (2023)
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`2023 WL 2455979
`Only the Westlaw citation is currently available.
`United States District Court, D. Delaware.
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`ARBUTUS BIOPHARMA CORPORATION
`and Genevant Sciences GmbH, Plaintiffs,
`v.
`MODERNA, INC. and Modernatx, Inc.,
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`CIVIL ACTION NO. 22-252
`|
`Filed March 10, 2023
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`Attorneys and Law Firms
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`John W. Shaw, Nathan Roger Hoeschen, Karen Elizabeth
`Keller, Shaw Keller LLP, Wilmington, DE, Eric C. Wiener,
`Pro Hac Vice, Durham, NC, Kira A. Davis, Pro Hac Vice, San
`Francisco, CA, for Plaintiff Arbutus Biopharma Corporation.
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`John W. Shaw, Karen Elizabeth Keller, Shaw Keller LLP,
`Wilmington, DE, Adam D. Harber, Pro Hac Vice, Anthony
`H. Sheh, Pro Hac Vice, David I. Berl, Pro Hac Vice, Jessica
`Palmer Ryen, Pro Hac Vice, Lydia B. Cash, Pro Hac Vice,
`Shaun P. Mahaffy, Pro Hac Vice, Thomas S. Fletcher, Pro Hac
`Vice, Washington, DC, Daralyn J. Durie, Pro Hac Vice, San
`Francisco, CA, Denis R. Hurley, Pro Hac Vice, Latham, NY,
`for Plaintiff Genevant Sciences GmbH.
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`Brian P. Egan, Jack B. Blumenfeld, Morris, Nichols, Arsht
`& Tunnell LLP, Wilmington, DE, James F. Hurst, Pro Hac
`Vice, Chicago, IL, Jeanna M. Wacker, Pro Hac Vice, Mark C.
`McLennan, Pro Hac Vice, Patricia A. Carson, Pro Hac Vice,
`New York, NY, for Moderna, Inc., Modernatx, Inc.
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`MEMORANDUM OPINION
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`Goldberg, District Judge
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`*1 Context is important. This is particularly so in litigation
`and in considering the stage of a proceeding. In the patent
`infringement matter before me, which is at the pleading stage,
`the parties, now joined by the United States and several
`Amici Curiae, hotly contest the application of 28 U.S.C. §
`1498(a). This statute instructs that whenever it is alleged that
`a patent has been used by the United States in an infringing
`manner, litigation shall occur in the United States Court of
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`Federal Claims, which is where Defendants Moderna, Inc.
`and Modernatx, Inc. (collectively, “Moderna”) urge that a
`majority of this case must be decided.
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`It is well settled that an accused infringer, such as Moderna,
`bears the burden of establishing under § 1498(a) that
`the infringing use is “for the Government” and “with
`authorization and consent of the Government.” Sevenson
`Envt'l Servs., Inc. v. Shaw Envt'l, Inc., 477 F.3d 1361, 1365
`(Fed. Cir. 2007). These standards clearly implicate factual
`considerations, and in the context of the pleading stage of this
`case, where I am obligated to assume the veracity of the facts
`pled in the Complaint, weighing facts is inappropriate. Burtch
`v. Milberg Factors, Inc., 662 F.3d 212, 221 (3d Cir. 2011).
`Consequently, the Government's recently filed Statement of
`Interest does not change my view that Moderna's request to
`transfer a portion of this matter to the Federal Claims Court is
`premature and must be denied at this time. My brief reasoning
`follows.
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`Most of the necessary background regarding § 1498(a) is
`set forth in my November 2, 2022 Opinion that addressed
`Moderna's partial motion to dismiss. That motion asserted
`that some of Plaintiff's patent infringement claims should
`proceed in the Court of Federal Claims pursuant to 28 U.S.C.
`§ 1498(a). I denied that request on November 2, 2022, finding
`that Moderna's Rule 12(b)(6) motion was not an appropriate
`vehicle to resolve the § 1498(a) issue. Arbutus Biopharma
`Corp. v. Moderna, Inc., No. 22-cv-252, 2022 WL 16635341,
`at *7–8 (D. Del. Nov. 2, 2022). Following submission of
`the parties’ Answers and Counterclaims, I set a Rule 16
`scheduling conference to be held on February 16, 2023.
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`Two days prior to that conference, the United States
`Government filed a Statement of Interest, asserting that
`any doses of the vaccine produced by Moderna pursuant
`to the terms of Contract No. W911QY-20-0100 (the
`’-0100 Contract) were “for the Government” and “with
`the authorization and consent of the Government.” During
`the Rule 16 conference, counsel for the parties and the
`Government (who I invited to participate) addressed the
`import of this Statement of Interest. Letter briefs, including
`those of Amici, have subsequently been submitted and
`considered.
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`As set out in my November 2, 2022 Opinion, § 1498(a)
`establishes an affirmative defense, not a jurisdictional bar.
`Manville Sales Corp. v. Paramount Sys., Inc., 917 F.2d
`544, 554 (Fed. Cir. 1990). Importantly, I also noted that
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` © 2023 Thomson Reuters. No claim to original U.S. Government Works.
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`Case 2:22-cv-00263-JRG-RSP Document 49-1 Filed 03/28/23 Page 3 of 3 PageID #: 1663
`Arbutus Biopharma Corporation v. Moderna, Inc., Slip Copy (2023)
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`a § 1498(a) affirmative defense presents a highly factual
`determination. Toxgon Corp. v. BNFL, Inc., 312 F.3d 1379,
`1382–83 (Fed. Cir. 2002). Viewing as true the well-pled facts
`in the Complaint, I found that Moderna had not established as
`a matter of law that § 1498(a) applied, and that the issue was
`best resolved after discovery.
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`*2 Moderna continues to press its point that § 1498(a)
`requires transfer of part of this case to the Court of Federal
`Claims. Now, heavily relying on the recently filed Statement
`of Interest, Moderna urges that, “the Government is in the
`best position to decide what is for its benefit.” (Moderna
`Letter brief, p. 2.) But neither the Government nor Moderna
`have provided any authority suggesting that the Government's
`interpretation of § 1498(a) trumps a court's analysis of this
`issue. And I note that the very contract that Moderna relies
`upon also states that vaccine was to be developed to “improve
`patient care,” thereby “mitigating the impact of COVID-19
`on the nation and its people.” (D.I. 17-1, Ex. A (emphasis
`added)); see Larson v. United States, 26 Cl. Ct. 365 (Cl.
`Ct. 1992) (“[M]edical care is provided for the benefit of the
`patient, not the government.”).
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`While the Statement of Interest does point to certain
`evidence that Moderna's sales under the ’-0100 Contract
`may have been with the “authorization and consent” of the
`Government, Moderna offers no evidence that sales were “for
`the Government” which is also a necessary factor under §
`1498(a). But in any event, examination of evidence in the
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`context of Fed. R. Civ. P. 12(b)(6) is not proper. Rather, I will
`consider the § 1498(a) issue after both parties have engaged
`in discovery, which will provide Plaintiff an opportunity to
`review the entire unredacted version of the ’-0100 Contract
`and discover facts regarding that Contract.
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`The recent submissions by the parties underscore why
`discovery on this issue is needed. Moderna originally moved
`to dismiss Plaintiffs’ claims as to all of its sales of COVID-19
`vaccine doses to the U.S. Government. But now, both the
`Government and Moderna acknowledge that claims regarding
`sales under a second Government contract (W58P05-22-
`C-0017 (the ‘-0017 Contract)) were not with the authorization
`and consent of the Government and should not be dismissed.
`Had I granted the relief Moderna sought in its original motion
`to dismiss, this fact would not have come to light and the relief
`ordered could have been incorrect. Discovery is necessary
`to ensure that any application of § 1498(a) is based upon
`developed facts and not solely on the Government's say-so.
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`I reaffirm the analysis and conclusions set forth in my
`November 2, 2022 Memorandum Opinion and again conclude
`that the Complaint should not be partially dismissed based on
`28 U.S.C. § 1498(a). An appropriate Order follows.
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`All Citations
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`Slip Copy, 2023 WL 2455979
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`End of Document
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`© 2023 Thomson Reuters. No claim to original U.S.
`Government Works.
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` © 2023 Thomson Reuters. No claim to original U.S. Government Works.
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