United States Court of Appeals 

for the Federal Circuit ______________________

MODERNATX, INC., FKA MODERNA 

THERAPEUTICS, INC.,

Appellant

v.

ARBUTUS BIOPHARMA CORPORATION, FKA 

PROTIVA BIOTHERAPEUTICS, INC.,

Cross-Appellant

ANDREW HIRSHFELD, PERFORMING THE 

FUNCTIONS AND DUTIES OF THE UNDER 

SECRETARY OF COMMERCE FOR 

INTELLECTUAL PROPERTY AND DIRECTOR OF 

THE UNITED STATES PATENT AND TRADEMARK 

OFFICE,

Intervenor

______________________

2020-1184, 2020-1186

______________________

Appeals from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board in No. IPR2018-

00739.

______________________

Decided: December 1, 2021

______________________

AMY K. WIGMORE, Wilmer Cutler Pickering Hale and 

Dorr LLP, Washington, DC, argued for appellant. Also 

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2 MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION

represented by MARK CHRISTOPHER FLEMING, EMILY R.

WHELAN, Boston, MA.

 DAVID I. BERL, Williams & Connolly LLP, Washington, 

DC, argued for cross-appellant. Also represented by 

THOMAS S. FLETCHER, JESSICA PALMER RYEN; SONJA 

ROCHELLE GERRARD, STEVEN WILLIAM PARMELEE, MICHAEL 

T. ROSATO, Wilson Sonsini Goodrich & Rosati, Seattle, WA; 

LORA MARIE GREEN, RICHARD TORCZON, Washington, DC.

 ROBERT MCBRIDE, Office of the Solicitor, United States 

Patent and Trademark Office, Alexandria, VA, for intervenor. Also represented by THOMAS W. KRAUSE, FARHEENA 

YASMEEN RASHEED.

______________________

Before LOURIE, O’MALLEY, and STOLL, Circuit Judges.

LOURIE, Circuit Judge.

ModernaTx, Inc. (“Moderna”) appeals from the decision 

of the U.S. Patent and Trademark Office Patent Trial and 

Appeal Board (“Board”) holding that claims 7–8, 10–11, 13, 

and 16–20 of U.S. Patent 9,364,435 are not unpatentable 

as obvious. See Moderna Therapeutics, Inc. v. Protiva Biotherapeutics, Inc., IPR2018-00739, 2019 Pat. App. LEXIS 

13612 (Sept. 11, 2019) (“Board Decision”). Arbutus Biopharma Corporation (“Arbutus”)1 cross-appeals from the 

Board’s decision holding that claims 1–6, 9, 12, and 14–15 

1 At the time that this appeal was filed in November 

2019, the cross-appellant was named Protiva Biotherapeutics, Inc. (“Protiva”). Subsequently, in June 2021, Protiva

moved the court to revise the official caption to replace Protiva with Arbutus. In this opinion, unless otherwise indicated, we use “Protiva” and “Arbutus” interchangeably 

based on the relevant context to refer to the cross-appellant 

in this appeal.

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MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION 3

are unpatentable as anticipated. Id. For the reasons provided below, we dismiss Moderna’s appeal for lack of standing. Regarding Arbutus’s cross appeal, we affirm.

BACKGROUND

I. The ’435 Patent

Arbutus owns the ’435 patent directed to “stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid 

(such as one or more interfering RNA), methods of making 

the SNALP, and methods of delivering and/or administering the SNALP.” ’435 patent at Abstract. The patent, 

which issued on June 14, 2016, claims priority from a provisional application filed on April 15, 2008.

As described in the ’435 patent, RNA interference 

(“RNAi”) is a biological process in which recognition of double-stranded RNA “leads to posttranscriptional suppression of gene expression.” Id. at col. 1 ll. 39–42. That 

biological process is mediated by small interfering RNA 

(“siRNA”), “which induces specific degradation of mRNA 

through complementary base pairing.” Id. at col. 1 ll. 42–

45. The ’435 patent recognized that RNAi provided “a potential new approach to downregulate or silence the transcription and translation of a gene of interest.” Id. at col. 1

ll. 52–54.

A “safe and effective nucleic acid delivery system is required for RNAi to be therapeutically useful.” Id. at col. 1

ll. 63–64. The delivery system “should be small” and 

“should remain intact in the circulation for an extended period of time in order to achieve delivery to affected tissues.” 

Id. at col. 2 ll. 38–42. This requires a “highly stable, serumresistant nucleic acid-containing particle that does not interact with cells and other components of the vascular compartment.” Id. at col. 2 ll. 42–45. The particle should also 

“readily interact with target cells at a disease site in order 

to facilitate intracellular delivery of a desired nucleic acid.” 

Id. at col. 2 ll. 45–47. The ’435 patent thus recognized that 

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4 MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION

there remained “a strong need in the art for novel and more 

efficient methods and compositions for introducing nucleic 

acids such as siRNA into cells.” Id. at col. 2 l. 66–col. 3 l. 1.

The ’435 patent describes the invention as “novel, serum-stable lipid particles comprising one or more active 

agents or therapeutic agents, methods of making the lipid 

particles, and methods of delivering and/or administering 

the lipid particles (e.g., for the treatment of a disease or 

disorder).” Id. at col. 3 ll. 9–13. The lipid particles are comprised of one or more cationic lipids, one or more non-cationic lipids, and one or more conjugated lipids. See id. at 

col. 3 ll. 22–31. As described in the patent, “[t]he present 

invention is based, in part, upon the surprising discovery 

that lipid particles comprising from about 50 mol % to 

about 85 mol % of a cationic lipid, from about 13 mol % to 

about 49.5 mol % of a non-cationic lipid, and from about 0.5 

mol % to about 2 mol % of a lipid conjugate provide advantages when used for the in vitro or in vivo delivery of an 

active agent, such as a therapeutic nucleic acid (e.g., an interfering RNA).” Id. at col. 5 ll. 55–62. The ’435 patent 

further states that the stable nucleic acid-lipid particles 

“advantageously impart increased activity of the encapsulated nucleic acid (e.g., an interfering RNA such as siRNA) 

and improved tolerability of the formulations in vivo, resulting in a significant increase in the therapeutic index” 

as compared to prior art nucleic acid-lipid particle compositions. Id. at col. 5 l. 62–col. 6 l. 2. And the particles are 

“stable in circulation, e.g., resistant to degradation by nucleases in serum, and are substantially non-toxic” to humans. Id. at col. 6 ll. 2–5

The ’435 patent contains 20 claims. Claim 1, the only 

independent claim, recites:

1. A nucleic acid-lipid particle comprising:

(a) a nucleic acid;

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MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION 5

(b) a cationic lipid comprising from 50 mol 

% to 85 mol % of the total lipid present 

in the particle;

(c) a non-cationic lipid comprising from 13 

mol % to 49.5 mol % of the total lipid 

present in the particle; and

(d) a conjugated lipid that inhibits aggregation of particles comprising from 0.5 

mol % to 2 mol % of the total lipid present in the particle.

Id. at col. 89 ll. 55–63. Many of the dependent claims contain additional limitations directed to one of the various 

components in the nucleic acid-lipid particle of claim 1. For 

example, claims 2 and 3 are directed to the nucleic acid 

component, claim 4 is directed to the cationic lipid component, claims 5–8 are directed to the non-cationic lipid component, and claims 9–12 are directed to the conjugated 

lipid component. Id. at col. 89 l. 64–col. 91 l. 21. The remaining dependent claims pertain to the encapsulation of 

the nucleic acid within the particle, id. at col. 91 ll. 22–24 

(claim 13), pharmaceutical compositions comprising the 

particle, id. at col. 92 ll. 1–3 (claim 14), and methods for introducing a nucleic acid into a cell, in vivo delivery of a nucleic acid, and treatment using the particle, id. at col. 92

ll. 4–22 (claims 15–20).

II. Inter Partes Review of the ’435 Patent

Moderna petitioned for inter partes review of the ’435 

patent. In its petition, Moderna asserted three grounds 

challenging all claims of the ’435 patent. In the first 

ground, Moderna alleged that all claims of the ’435 patent 

would have been obvious under 35 U.S.C. § 103 over a combination of International Pat. Publ. WO 2005/007196 (“the 

’196 PCT”) and U.S. Pat. Publ. 2006/0134189 (“the ’189 

publication”). In the second ground, Moderna alleged that 

all claims of the ’435 patent would have been obvious over 

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6 MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION

a combination of the ’196 PCT, the ’189 publication, Lin,2

and Ahmad.3 In the third ground, Moderna alleged that 

all claims of the ’435 patent were anticipated by U.S. Pat. 

Publ. 2006/0240554 (“the ’554 publication”) under 

35 U.S.C. § 102, and alternatively that the claims would 

have been obvious over the ’554 publication.

Moderna’s obviousness arguments with respect to all 

grounds centered on alleged overlapping ranges of components. For example, claim 1 of the ’435 patent recites a 

composition range for the cationic lipid that is “from 50 

mol % to 85 mol % of the total lipid present in the particle.” 

See ’435 patent at col. 89 ll. 57–58. In comparison, the ’196 

PCT and the ’189 publication each disclose a range of between 2 mol % and 60 mol % for the cationic lipid. See 

’196 PCT ¶ 88; ’189 publication ¶ 152. According to 

Moderna, the range for each lipid component in the 

claims—i.e., the cationic lipid, the non-cationic lipid, and 

the conjugated lipid—overlaps with the range for that lipid 

component taught by the prior art.

Moderna’s anticipation argument was based on one formulation—the “L054 formulation”—disclosed in the ’554 

publication. Moderna argued that the L054 formulation 

contained all of the claimed components in amounts within 

the claimed ranges of the ’435 patent. Specifically, 

Moderna contended that the L054 formulation contained 

50 mol % cationic lipid (which is within the 50–85 mol % 

range of claim 1), 48 mol % non-cationic lipid (which is 

2 Alison J. Lin, et al., Three-Dimensional Imaging of 

Lipid Gene-Carriers: Membrane Charge Density Controls 

Universal Transfection Behavior in Lamellar Cationic Liposome-DNA Complexes, 84 Biophysical J. 3307–16 (2003).

3 Ayesha Ahmad, et al., New Multivalent Cationic 

Lipids Reveal Bell Curve for Transfection Efficiency Versus Membrane Charge Density: Lipid-DNA Complexes for 

Gene Delivery, 7 J. Gene Med. 739–48 (2005).

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MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION 7

within the 13–49.5 mol % range of claim 1), and 2 mol % 

conjugated lipid (which is within the 0.5–2 mol % range of 

claim 1).

The Board found that Moderna proved by a preponderance of the evidence that claims 1–6, 9, 12, and 14–15 were 

anticipated by the L054 formulation in the ’554 publication. However, the Board found that Moderna failed to 

prove that the remaining claims were anticipated, or that 

those claims would have been obvious over the prior art.

Moderna appealed from the Board’s decision that it had 

failed to show that claims 7–8, 10–11, 13, and 16–20 were 

not anticipated and/or would not have been obvious. Protiva cross-appealed from the Board’s decision that 

claims 1–6, 9, 12, and 14–15 were anticipated. Subject to 

the parties’ dispute about Moderna’s standing to pursue its 

appeal, which we discuss further below, we have jurisdiction pursuant to 28 U.S.C. § 1295(a)(4).

DISCUSSION

I. Moderna’s Appeal

Before we consider Moderna’s arguments on the merits 

of the Board’s decision upholding claims of the ’435 patent, 

we must first determine whether Moderna has standing to 

pursue its appeal. After all, “no principle is more fundamental to the judiciary’s proper role in our system of government than the constitutional limitation of federal-court 

jurisdiction to actual cases or controversies.” DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 341–42 (2006)

(quoting Raines v. Byrd, 521 U.S. 811, 818 (1997)).

Since the America Invents Act took effect nearly a decade ago, we have had a number of occasions to consider the 

question of standing in appeals from Board decisions in 

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8 MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION

IPR proceedings.4 Our precedent generally makes clear 

that, as in all appeals before this court, an appellant seeking review of a Board decision in an IPR must have “(1) suffered an injury in fact, (2) that is fairly traceable to the 

challenged conduct of the [appellee], (3) that is likely to be 

redressed by a favorable judicial decision.” Phigenix, 845 

F.3d at 1171–72 (Fed. Cir. 2017) (quoting Spokeo, Inc. v. 

Robbins, 136 S. Ct. 1540, 1547 (2016)).

Under the IPR statute, there is no standing requirement for petitioners to request institution of IPR by the 

Board. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 

2131, 2143–44 (2016) (“Parties that initiate [IPRs] need not 

have a concrete stake in the outcome; indeed, they may lack 

constitutional standing.”). And we recognize that where a 

statute grants judicial review, as the IPR statute does, see 

35 U.S.C. § 319, the criteria of immediacy and redressability may be “relaxed.” See Momenta, 915 F.3d at 768. But 

we have always maintained that a party’s participation in 

the underlying IPR before the Board is insufficient by itself 

to confer standing on that party to appeal the Board’s decision to this Article III court. See Phigenix, 845 F.3d 

at 1175; see also Momenta, 915 F.3d at 768 (“Although the 

statutory grant of judicial review may ‘relax’ the Article III 

criteria, judicial review of agency action remains subject to 

the constitutional foundation of injury-in-fact, lest the 

court occupy only an advisory role.”); JTEKT, 898 F.3d 

at 1219 (“[T]he statute cannot be read to dispense with the 

4 See, e.g., Apple Inc. v. Qualcomm Inc., 992 F.3d 

1378 (Fed. Cir. 2021); Samsung Elecs. Co. v. Infobridge Pte. 

Ltd., 929 F.3d 1363 (Fed. Cir. 2019); Momenta Pharms., 

Inc. v. Bristol-Myers Squibb Co., 915 F.3d 764 (Fed. Cir. 

2019); JTEKT Corp. v. GKN Auto. Ltd., 898 F.3d 1217 

(Fed. Cir. 2018); Phigenix, Inc. v. Immunogen, Inc., 845 

F.3d 1168 (Fed. Cir. 2017); Consumer Watchdog v. Wis. 

Alumni Research Found., 753 F.3d 1258 (Fed. Cir. 2014).

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Article III injury-in-fact requirement for appeal to this 

court.”). Accordingly, even when an appellant is “sharply 

opposed to the Board’s decision and the existence of [a] patent, that is not enough to make th[e] dispute justiciable.” 

Consumer Watchdog, 753 F.3d at 1263.

As the party seeking judicial review, Moderna “has the 

burden of establishing that it possesses the requisite injury.” See JTEKT, 898 F.3d at 1220. Moreover, Moderna 

must show that standing existed at the time it filed its appeal and has continued to exist at all times throughout the 

appeal. See Steffel v. Thompson, 415 U.S. 452, 459 n.10 

(1974) (“[A]n actual controversy must be extant at all 

stages of review, not merely at the time the complaint is 

filed.”); Momenta, 915 F.3d at 770 (“[I]t is established that 

jurisdiction must exist throughout the judicial review, and 

an intervening abandonment of the controversy produces 

loss of jurisdiction.”).

Shortly after Moderna filed this appeal in November 2019, Protiva moved to dismiss for lack of standing. 

Protiva argued that Moderna had never established that it 

suffered an injury in fact. See Protiva Opening Standing 

Br.5 at 1. Protiva emphasized that it had never initiated a 

patent infringement action or directly accused Moderna of 

infringing its patents, and thus Moderna could only show 

standing to appeal the Board’s decision if it were “currently 

using claimed features” of the ’435 patent “or nonspeculatively planning to do so.” Id. at 4 (citing Fischer & Paykel 

Healthcare Ltd. v. ResMed Ltd., No. 2018-2262 (Fed. Cir. 

Nov. 27, 2019) (Order, non-precedential)). Indeed, Protiva 

argued, Moderna had consistently taken the position that

it was not using Protiva’s patented technology and did not 

intend to do so. Id. at 5.

5 Dkt. 22.

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In opposing Protiva’s motion to dismiss, Moderna expressly stated in January 2020 that it did “not base its Article III standing on the threat of an impending 

infringement suit or Protiva’s accusations of infringement.” Moderna Resp. Standing Br.6 at 3. Rather, 

Moderna argued, its standing was based on its status as a 

“current licensee to the ’435 patent for four viral targets . . . with actual monetary obligations . . . that are impacted by the Board’s validity determinations.” Id. at 3–4. 

Moderna relied on our case law for the proposition that 

“[t]he risk of a future infringement suit is not the only way 

an IPR petitioner can show injury-in-fact.” Id. at 4 (citing 

Gen. Elec. Co. v. United Techs. Corp., 928 F.3d 1349, 1357 

(Fed. Cir. 2019)). Moderna repeatedly cited our decision in 

Samsung Electronics Co. v. Infobridge Pte. Ltd., to support 

its position that financial impacts to an appellant based on 

licensing obligations can be an independent means by 

which to establish an injury-in-fact supporting standing. 

See Moderna Resp. Standing Br. at 4, 8–9 (citing Samsung, 

929 F.3d at 1368).

In support of its responsive brief in opposition to Protiva’s motion to dismiss, Moderna submitted a declaration 

from Shaun Ryan, who was its Senior Vice President and 

Deputy General Counsel.7 In his declaration, Mr. Ryan described information relating to Moderna’s status as a 

6 The non-confidential version of Moderna’s responsive brief is Dkt. 28. Moderna filed the confidential version 

of its brief as Dkt. 30.

7 For confidentiality purposes, Moderna filed 

Mr. Ryan’s declaration under seal with the confidential 

version of its responsive brief in Dkt. 30. In this opinion, 

to the extent we reference information from that confidential declaration, we reference only material that Moderna 

has subsequently made public through its briefing and oral 

argument in this appeal.

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sublicensee of the ’435 patent. Specifically, Mr. Ryan attested that Protiva had licensed the ’435 patent among 

other patents to a company called Acuitas Biotherapeutics 

(“Acuitas”), and that Acuitas had, in turn, granted a series 

of sublicenses to Moderna to practice the patented technology for four viral targets, one of which was Respiratory 

Syncytial Virus (“RSV”). Mr. Ryan further stated that, under its rights from the Acuitas sublicenses, Moderna was 

engaged in an active development program for the RSV viral target. According to Mr. Ryan, Moderna had already 

made one milestone payment to Acuitas, and potentially 

could have additional milestone and royalty obligations in 

the future. Thus, Moderna argued, the royalty and milestone obligations owed to Acuitas for the use of the ’435 patent caused harm to Moderna by increasing the financial 

burdens on Moderna’s RSV development program.

We denied Protiva’s motion, but we specifically noted 

that our denial was without prejudice to allow Protiva to 

raise its standing argument in its merits brief. See Dkt. 35. 

Shortly thereafter, Moderna filed its opening brief on the 

merits, relying in its jurisdictional statement mainly on the 

same arguments and evidence it had presented in opposing 

Protiva’s motion to dismiss. Moderna Opening Br. at 6–9. 

Protiva then filed its responsive brief, including its response to Moderna’s assertions of standing. Protiva Resp. 

Br. at 5–9. Protiva argued that the mere existence of a license is not sufficient to support Article III standing, and 

that Moderna’s alleged “obligations” were “nothing but 

rank speculation, which even Moderna characterizes as an 

if and when proposition.” Id. at 5. Protiva noted that the 

last milestone payment Moderna had made to Acuitas was 

on or before February 2016, and emphasized that Moderna 

“fail[ed] to identify any recent milestone payment or any 

such payment reasonably forthcoming.” Id. at 7.

In March 2021, approximately nine months after 

Moderna had filed its opening brief on the merits, Moderna

filed a motion to supplement the record to provide 

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12 MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION

additional evidence of standing. In that motion, Moderna 

argued that “new facts supporting Moderna’s ongoing 

standing to appeal have arisen, and the existing facts have 

continued to develop.” Moderna Mot. to Suppl.8 at 3.

The “existing facts” to which Moderna referred were 

those that Mr. Ryan had described in his original declaration more than a year earlier. With its motion to supplement, Moderna submitted a supplemental declaration from 

Mr. Ryan,9 in which he stated that Moderna had, at some 

point during the previous year, terminated the RSV development program that had been active at the time that the 

appeal was filed. He also admitted that none of the four 

viral targets that were covered under the Acuitas sublicenses were being pursued to further phases, though he 

noted that they had not been fully abandoned. Importantly, Mr. Ryan did not provide an approximate date 

on which that RSV development program had been terminated, nor did he describe any concrete plans to further 

pursue development programs for any of the four viral targets.

The “new facts” to which Moderna referred related to 

Moderna’s ongoing development of a vaccine for COVID-19. 

Mr. Ryan’s supplemental declaration described Moderna’s

8 The non-confidential version of Moderna’s motion 

is Dkt. 111. Moderna filed the confidential version of its 

brief as Dkt. 112.

9 Like his original declaration, Mr. Ryan’s supplemental declaration also purports to contain confidential information. Again, we reference only material from the 

supplemental declaration that Moderna has made public. 

Moreover, attached to Mr. Ryan’s supplemental declaration in this appeal was a supplemental declaration that he 

submitted on the same day in Appeal No. 20-2329. For purposes of this opinion, we treat these two supplemental declarations as one.

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work that led to its concrete plans as of September 2020 to 

release a COVID-19 vaccine, its emergency use authorization as of December 2020, and its subsequent commercial 

shipments of the vaccine. Mr. Ryan also described a series 

of public statements made by Arbutus in 2017 regarding 

the alleged extensive scope of its patents. According to Mr. 

Ryan, those aggressive public statements by Arbutus, in 

combination with Arbutus’s refusal to grant Moderna a 

covenant not to sue and Arbutus’s consistent insistence 

that Moderna requires a license to Arbutus’s patents, created a significant risk that Arbutus would sue for patent 

infringement.

During oral argument, counsel for Moderna explained 

its position that “Moderna had and continues to have 

standing to pursue this appeal.” Oral Arg. at 1:32, 

https://oralarguments.cafc.uscourts.gov/default.aspx?fl=20

-1184_10072021.mp3. Moderna’s counsel began by arguing that the basis for Moderna’s standing “at the outset 

when this appeal was filed in November of 2019,” id. at 

1:38, was “contractual rights that are affected by a determination of patent validity,” id. at 2:27. Counsel repeatedly emphasized the “active” status of Moderna’s RSV 

development program at that time, which had resulted in 

one milestone payment and potentially could have resulted 

in future milestone and royalty obligations. But Moderna’s 

counsel then argued that “the situation has evolved,” id. 

at 6:53, and the “evolution keeps this controversy alive,” id. 

at 8:24. Specifically, counsel conceded that “over 

time, . . . that particular RSV program was not pursued,” 

id. at 8:36, but “at the same time, the COVID vaccine was 

developed and ultimately [] delivered to the market and 

commercialized,” id. at 8:53.

Arbutus’s counsel responded by challenging each aspect of Moderna’s standing timeline, as well as the timeline 

as a whole. Counsel began by arguing, regarding 

Moderna’s position on standing at the time the appeal was 

filed, that “any notion of immediacy is entirely absent”

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from the evidence that Moderna presented on its “speculative” licensing obligations. Id. at 16:50. Arbutus’s counsel 

also insisted that it was crucial that the ’435 patent was 

only one of many patents licensed under the Acuitas sublicenses, and that Moderna had not shown how its payment 

obligations would change if the ’435 patent were to be invalidated. Next, Arbutus’s counsel turned to Moderna’s 

concession that the RSV development program had at some 

point been abandoned, focusing on the lack of evidence regarding “when that happened versus when their COVID 

vaccine came into being and recreated” standing. Id. at 

23:33.

We agree with Arbutus that Moderna lacked standing 

at the time the appeal was filed. Even if the ’435 patent 

was the only patent that Moderna had licensed under the 

Acuitas sublicenses, Moderna’s evidence of financial burdens from the validity of that patent is too speculative. 

Notwithstanding Moderna’s counsel’s repeated characterization of the RSV development program as “active” at the 

time this appeal was filed, Moderna concedes that the last 

milestone payment it made under the Acuitas sublicenses 

was approximately five years earlier, and Mr. Ryan’s declaration states only that Moderna would have to make an 

additional milestone payment “if and when” a future milestone is reached. On this evidence, Moderna falls short of 

its burden to demonstrate that at the time it filed this appeal, it had suffered or was suffering a “concrete” injury 

from the existence of the ’435 patent. See Phigenix, 845 

F.3d at 1171 (“To constitute a ‘concrete’ injury, the harm 

must ‘actually exist’ or appear ‘imminent’—a ‘conjectural 

or hypothetical’ injury will not suffice.” (internal citations 

omitted)).

Even more problematic for Moderna, the ’435 patent is 

not the only patent licensed under the Acuitas sublicenses, 

but rather it is one of many licensed patents. On this point, 

the parties appear to agree that the two crucial cases are 

Samsung and Apple. In Samsung, we held that the 

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appellant had standing because, even though multiple patents were licensed, the appellant had provided evidence 

demonstrating that the express terms of the contract structured the patent pool in such a way that invalidation of the 

patent at issue in the underlying IPR would have changed 

the amount of royalties. Samsung, 929 F.3d at 1368. In 

contrast, in Apple we held that the appellant lacked standing because multiple patents had been licensed, and the 

appellant failed to present evidence that invalidation of the 

particular patents it was challenging would affect its contractual rights by changing its royalty obligations. Apple, 

992 F.3d at 1383.

The facts here resemble those in Apple, not those in 

Samsung. Moderna has provided no evidence as to how, if 

at all, its obligations under the Acuitas sublicenses would 

change if it is successful in its attempts to have the ’435 patent declared invalid while the remaining licensed patents 

continue to exist. Thus, Moderna has failed to meet its burden of demonstrating that it suffers an injury from the existence of the ’435 patent, or that any such injury would be 

redressed by invalidation of that patent. See id. at 1383–

84. Accordingly, we agree with Arbutus that Moderna 

lacked standing at the time this appeal was filed.

We also agree with Arbutus that, even if Moderna had 

standing at the time it filed this appeal, Moderna has failed 

to demonstrate that it continuously had standing throughout the pendency of the appeal. Under our precedent, an 

“intervening abandonment of the controversy produces loss 

of jurisdiction.” Momenta, 915 F.3d at 770. Moderna’s evidence fails to show an approximate date when the RSV 

development program was terminated. Thus, on the record 

before us, it is impossible to determine whether, by the 

time the RSV development program was terminated, 

Moderna was already sufficiently underway with its development of a COVID-19 vaccine to “create[] a substantial 

risk of future infringement or likely cause the patentee to 

assert a claim of infringement.” E.I. DuPont de Nemours 

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16 MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION

& Co. v. Synvina C.V., 904 F.3d 996, 1004–05 (Fed. Cir. 

2018).

As the appellant, Moderna bears the burden on the issue of standing, JTEKT, 898 F.3d at 1220, including the 

burden to demonstrate that there has been no gap in its 

standing while this appeal has been pending, Momenta,

915 F.3d at 770. In view of Moderna’s concession that the 

basis for its standing shifted during the pendency of this 

appeal—i.e., from the financial burdens of the Acuitas sublicenses to a potential infringement suit for the COVID-19 

vaccine—Moderna had to come forth with evidence to 

demonstrate the necessary continuity of jurisdiction. 

Moderna failed to do so.

For the reasons explained above, we find that Moderna 

has failed to meet its burden on its standing to pursue this 

appeal. Therefore, Moderna’s appeal must be dismissed.

II. Arbutus’s Cross-Appeal

With respect to the cross appeal, there is no dispute 

that Arbutus, as the patent owner, has standing to appeal 

the Board’s decision that claims 1–6, 9, 12, and 14–15 are 

unpatentable. Thus, we proceed to the merits.

Arbutus argues that the Board erred by failing to recognize a critical distinction between starting ingredients 

versus a final product. Arbutus contends that the claims 

of the ’435 patent are directed to completed lipid particles 

of defined composition. In contrast, Arbutus argues, the 

L054 formulation disclosed in the ’554 publication is a lipid 

mixture of starting ingredients for making lipid particles, 

not a completed lipid particle itself. According to Arbutus, 

expert testimony and corroborating literature demonstrated that a person of ordinary skill in the art would have 

expected the composition of components in a final lipid particle to deviate from the composition of components in the 

mixture of starting ingredients. Arbutus further argues 

that its expert provided evidence that the ’554 publication’s 

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MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION 17

fabrication process would skew the L054 formulation’s final lipid particle such that the final composition would fall 

outside the range of the ’435 patent claims.

Moderna responds that substantial evidence supports 

the Board’s factual findings regarding the disclosures of 

the ’554 publication. Moderna notes that the Board specifically considered Arbutus’s argument that the L054 formulation failed to teach the composition of the final lipid 

particle, but the Board rejected that argument. Moderna 

argues that after weighing the evidence, the Board found 

that it was standard practice in the field to describe lipid 

particles by the composition of components in the input formulation. The Board further relied on the disclosures of 

the prior art and the ’435 patent itself, as well as the testimony of expert witnesses.

We review the Board’s legal determinations de novo, In 

re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), but we review the Board’s factual findings underlying those determinations for substantial evidence, In re Gartside, 203 F.3d 

1305, 1316 (Fed. Cir. 2000). A finding is supported by substantial evidence if a reasonable mind might accept the evidence as adequate to support the finding. Consol. Edison 

Co. v. NLRB, 305 U.S. 197, 229 (1938).

“Anticipation is a question of fact that we review for 

substantial evidence.” Blue Calypso, LLC v. Groupon, Inc., 

815 F.3d 1331, 1341 (Fed. Cir. 2016) (citing Kennametal, 

Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. 

Cir. 2015)). A prior art reference anticipates a claim if it

discloses “each and every element of the claimed invention 

. . . arranged or combined in the same way as in the claim.”

Id. (quoting In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 

2009)).

We agree with Moderna that substantial evidence supports the Board’s decision. Arbutus’s arguments pertain to 

whether a person of ordinary skill in the art would have 

reasonably understood from the disclosure in a prior art 

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18 MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION

reference that every element of the claims is disclosed, 

which is the “dispositive question regarding anticipation.” 

See AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1055 

(Fed. Cir. 2010). In evaluating that question, the Board 

first considered the substantial evidence that Moderna presented that a person of ordinary skill would understand 

that the mol % of each component in the L054 formulation 

would result in lipid particles within the claimed ranges of 

the ’435 patent, which also describes lipid particles in 

terms of mol % of the formulation. Board Decision, 2019 

Pat. App. LEXIS 13612, at *23. Thus, the Board turned to 

Arbutus’s evidence and found that it, at best, suggested 

that there would be some variation in the final compositions of the lipid particles fabricated from the L054 formulation. See id. at *23–24. But the Board rejected as 

speculative Arbutus’s expert’s opinion that all of the particles formed from L054 formulation would fall outside the 

claimed ranges. Id. at *24–27. And the Board noted that 

anticipation “does not require that all of the formed particles from the L054 formulation . . . be within the claimed 

ranges . . . . Anticipation merely requires that a composition within the claimed ranges be disclosed.” Id. at *28 (citing Titanium Metals Corp. v. Banner, 778 F.2d 775, 782

(Fed. Cir. 1985)).

The Board’s legal conclusions regarding the requirements of anticipation were correct. “When a patent claims 

a range, as in this case, that range is anticipated by a prior 

art reference if the reference discloses a point within the 

range.” Ineos USA LLC v. Berry Plastics Corp., 783 F.3d 

865, 869 (Fed. Cir. 2015) (citing Titanium Metals, 778 F.2d 

at 782). Furthermore, an anticipating reference need not 

show that every disclosed compound anticipates; rather it 

is sufficient that it contains a disclosure of “at least one 

compound which anticipates.” See In re Sasse, 629 F.2d 

675, 682 (Fed. Cir. 1980). Thus, to anticipate the claims of 

the ’435 patent, the question for the Board was whether the 

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MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION 19

’554 publication discloses at least one composition that falls 

within the claimed ranges.

The Board weighed the evidence and found, as a factual 

matter, that the ’554 publication disclosed at least one composition that anticipates the claims. In challenging that 

factual determination in this appeal, Arbutus relies on the 

same evidence and argument that failed to convince the 

Board that the L054 formulation does not anticipate the 

completed lipid particles of the ’435 patent claims. But Arbutus fails to persuade us that Moderna’s evidence was insufficient to allow the Board to find that the L054 

formulation does anticipate. Substantial evidence supports the Board’s decision.

CONCLUSION

We have considered the parties’ remaining arguments 

but we find them unpersuasive. Accordingly, we dismiss 

Moderna’s appeal for lack of standing. We affirm the 

Board’s final written decision that claims 1–6, 9, 12, and 

14–15 are unpatentable as anticipated.

DISMISSED-IN-PART, AFFIRMED-IN-PART

COSTS

No costs.

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