Case: 20-1184 Document: 135 Page: 1 Filed: 12/01/2021
`
`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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`MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION
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`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 interve-
`nor. 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 Bio-
`therapeutics, Inc., IPR2018-00739, 2019 Pat. App. LEXIS
`13612 (Sept. 11, 2019) (“Board Decision”). Arbutus Bio-
`pharma 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 Biotherapeu-
`tics, Inc. (“Protiva”). Subsequently, in June 2021, Protiva
`moved the court to revise the official caption to replace Pro-
`tiva with Arbutus. In this opinion, unless otherwise indi-
`cated, we use “Protiva” and “Arbutus” interchangeably
`based on the relevant context to refer to the cross-appellant
`in this appeal.
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`are unpatentable as anticipated. Id. For the reasons pro-
`vided below, we dismiss Moderna’s appeal for lack of stand-
`ing. Regarding Arbutus’s cross appeal, we affirm.
`BACKGROUND
`I. The ’435 Patent
`Arbutus owns the ’435 patent directed to “stable nu-
`cleic 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 administer-
`ing the SNALP.” ’435 patent at Abstract. The patent,
`which issued on June 14, 2016, claims priority from a pro-
`visional application filed on April 15, 2008.
`As described in the ’435 patent, RNA interference
`(“RNAi”) is a biological process in which recognition of dou-
`ble-stranded RNA “leads to posttranscriptional suppres-
`sion 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 po-
`tential new approach to downregulate or silence the tran-
`scription and translation of a gene of interest.” Id. at col. 1
`ll. 52–54.
`A “safe and effective nucleic acid delivery system is re-
`quired 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 pe-
`riod of time in order to achieve delivery to affected tissues.”
`Id. at col. 2 ll. 38–42. This requires a “highly stable, serum-
`resistant nucleic acid-containing particle that does not in-
`teract with cells and other components of the vascular com-
`partment.” 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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`MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION
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`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, se-
`rum-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 com-
`prised of one or more cationic lipids, one or more non-cati-
`onic 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 ad-
`vantages when used for the in vitro or in vivo delivery of an
`active agent, such as a therapeutic nucleic acid (e.g., an in-
`terfering 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 encapsu-
`lated nucleic acid (e.g., an interfering RNA such as siRNA)
`and improved tolerability of the formulations in vivo, re-
`sulting in a significant increase in the therapeutic index”
`as compared to prior art nucleic acid-lipid particle compo-
`sitions. Id. at col. 5 l. 62–col. 6 l. 2. And the particles are
`“stable in circulation, e.g., resistant to degradation by nu-
`cleases in serum, and are substantially non-toxic” to hu-
`mans. 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
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`(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 aggre-
`gation of particles comprising from 0.5
`mol % to 2 mol % of the total lipid pre-
`sent in the particle.
`Id. at col. 89 ll. 55–63. Many of the dependent claims con-
`tain 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 compo-
`nent, claims 5–8 are directed to the non-cationic lipid com-
`ponent, and claims 9–12 are directed to the conjugated
`lipid component. Id. at col. 89 l. 64–col. 91 l. 21. The re-
`maining 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 in-
`troducing a nucleic acid into a cell, in vivo delivery of a nu-
`cleic 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 com-
`bination 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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`MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION
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`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 compo-
`nents. 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 be-
`tween 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 for-
`mulation—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 Lip-
`osome-DNA Complexes, 84 Biophysical J. 3307–16 (2003).
`
`3 Ayesha Ahmad, et al., New Multivalent Cationic
`Lipids Reveal Bell Curve for Transfection Efficiency Ver-
`sus Membrane Charge Density: Lipid-DNA Complexes for
`Gene Delivery, 7 J. Gene Med. 739–48 (2005).
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`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 preponder-
`ance of the evidence that claims 1–6, 9, 12, and 14–15 were
`anticipated by the L054 formulation in the ’554 publica-
`tion. 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. Pro-
`tiva 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 jurisdic-
`tion 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 funda-
`mental to the judiciary’s proper role in our system of gov-
`ernment than the constitutional limitation of federal-court
`jurisdiction to actual cases or controversies.” Daim-
`lerChrysler 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 dec-
`ade ago, we have had a number of occasions to consider the
`question of standing in appeals from Board decisions in
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`MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION
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`IPR proceedings.4 Our precedent generally makes clear
`that, as in all appeals before this court, an appellant seek-
`ing review of a Board decision in an IPR must have “(1) suf-
`fered 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 require-
`ment 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 redressabil-
`ity 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 deci-
`sion 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] pa-
`tent, 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 in-
`jury.” See JTEKT, 898 F.3d at 1220. Moreover, Moderna
`must show that standing existed at the time it filed its ap-
`peal 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 Novem-
`ber 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 nonspecula-
`tively 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 ex-
`pressly stated in January 2020 that it did “not base its Ar-
`ticle III standing on the threat of an
`impending
`infringement suit or Protiva’s accusations of infringe-
`ment.” 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 tar-
`gets . . . with actual monetary obligations . . . that are im-
`pacted 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 Pro-
`tiva’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 de-
`scribed information relating to Moderna’s status as a
`
`
`6 The non-confidential version of Moderna’s respon-
`
`sive brief is Dkt. 28. Moderna filed the confidential version
`of its brief as Dkt. 30.
`
`filed
`7 For confidentiality purposes, Moderna
`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 confiden-
`tial 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 at-
`tested 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 technol-
`ogy for four viral targets, one of which was Respiratory
`Syncytial Virus (“RSV”). Mr. Ryan further stated that, un-
`der its rights from the Acuitas sublicenses, Moderna was
`engaged in an active development program for the RSV vi-
`ral 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 mile-
`stone obligations owed to Acuitas for the use of the ’435 pa-
`tent 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 re-
`sponse to Moderna’s assertions of standing. Protiva Resp.
`Br. at 5–9. Protiva argued that the mere existence of a li-
`cense 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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`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 declara-
`tion more than a year earlier. With its motion to supple-
`ment, 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 devel-
`opment 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 subli-
`censes were being pursued to further phases, though he
`noted that they had not been fully abandoned. Im-
`portantly, Mr. Ryan did not provide an approximate date
`on which that RSV development program had been termi-
`nated, nor did he describe any concrete plans to further
`pursue development programs for any of the four viral tar-
`gets.
`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 supple-
`
`mental declaration also purports to contain confidential in-
`formation. Again, we reference only material from the
`supplemental declaration that Moderna has made public.
`Moreover, attached to Mr. Ryan’s supplemental declara-
`tion in this appeal was a supplemental declaration that he
`submitted on the same day in Appeal No. 20-2329. For pur-
`poses of this opinion, we treat these two supplemental dec-
`larations 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 authoriza-
`tion 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, cre-
`ated 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 argu-
`ing 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 deter-
`mination of patent validity,” id. at 2:27. Counsel repeat-
`edly 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 as-
`pect 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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`MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION
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`from the evidence that Moderna presented on its “specula-
`tive” 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 subli-
`censes, and that Moderna had not shown how its payment
`obligations would change if the ’435 patent were to be in-
`validated. 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 re-
`garding “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 bur-
`dens from the validity of that patent is too speculative.
`Notwithstanding Moderna’s counsel’s repeated characteri-
`zation 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 dec-
`laration states only that Moderna would have to make an
`additional milestone payment “if and when” a future mile-
`stone is reached. On this evidence, Moderna falls short of
`its burden to demonstrate that at the time it filed this ap-
`peal, 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 pa-
`tents were licensed, the appellant had provided evidence
`demonstrating that the express terms of the contract struc-
`tured 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 stand-
`ing 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 con-
`tractual 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 pa-
`tent declared invalid while the remaining licensed patents
`continue to exist. Thus, Moderna has failed to meet its bur-
`den of demonstrating that it suffers an injury from the ex-
`istence 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 through-
`out 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 ev-
`idence 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 devel-
`opment 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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`Case: 20-1184 Document: 135 Page: 16 Filed: 12/01/2021
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`16
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`& Co. v. Synvina C.V., 904 F.3d 996, 1004–05 (Fed. Cir.
`2018).
`As the appellant, Moderna bears the burden on the is-
`sue 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 sub-
`licenses 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 rec-
`ognize 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 demon-
`strated that a person of ordinary skill in the art would have
`expected the composition of components in a final lipid par-
`ticle 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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`fabrication process would skew the L054 formulation’s fi-
`nal 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 specif-
`ically considered Arbutus’s argument that the L054 formu-
`lation 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 for-
`mulation. The Board further relied on the disclosures of
`the prior art and the ’435 patent itself, as well as the testi-
`mony of expert w