Arbutus Biopharma Corporation (ABUS) - Overview of the Summary Judgment Motions in Arbutus' Case Against Moderna

***Please note that the information below was delivered to clients on Sepetember 26, 2025 prior to the Court's Rulings on these Motions on February 2, 2026. Past performace may not be indicative of future results.***

Note that MDC Financial Research currently plans on attending the upcoming March 9th Trial in Arbutus' Case against Moderna and providing updates to our clients. Please contact us if you are interesting in learning more about this situation and our service.

Previously, we distributed an email to our clients (on September 5, 2025), which covered the Opening Briefs for these Summary Judgment Motions. This post provides an overview of the Response Briefs of each of the Parties' respective Motions and provides our thoughts.  The Parties have now filed their Sur-Reply Briefs (as of September 23, 2025), and as such, we currently believe that we are in the window in which the Court may issue an Order at Any Time, or more likely, schedule a Hearing on these Motions prior to issuing an Order.  

Overall, we currently believe that the direction of the Court's Order on the § 1498 (government contract) Summary Judgment Motion will strongly indicate the direction of the trade in shares of Arbutus Biopharma Corporation (ABUS).  We currently believe that the Orders on the other Motions will either enhance or diminish the magnitude of the overall move, but that the "government contract" Summary Judgment Decision will set the direction.  Beyond the § 1498 issue, Moderna's Motion seeks Judgment that Arbutus' Claims for Infringement under the "Doctrine of Equivalents" of three of the four asserted Patents (the "LNP" Patents - see the table below) are estopped.  Moderna separately seeks Judgment that the other Asserted Patent (the '651 Patent) is Indefinite.  As such, it would appear to us that an Order favorable to Moderna on those two aspects (estoppel and indefiniteness) would not be Case Dispositive - it would just appear to us that Arbutus would only have the "LNP Patents" to Assert, and that Arbutus would only have Literal Infringement of the "LNP Patents" as a theory.  Arbutus has filed its own Summary Judgment Motion (D.E. 518), which seeks Judgment on three of Moderna's Defenses.  It would appear to us that an Order on this Motion could be impactful as it may limit or eliminate Moderna's INVALIDITY Defenses going into Trial but note that Arbutus will still have to prove Infringement.  Arbutus also filed a CROSS Motion for Summary Judgment (D.E. 562), which directly contests Moderna's Summary Judgment Motion in that Arbutus seeks Judgement that § 1498 does not apply and that the Claims are not Indefinite.  So, absent any questions of fact, we believe that an Order from the Court will address whether § 1498 does or does not apply, whether infringement claims under the doctrine of equivalents (“DOE”) for the LNP Patents (the ’435, ’359, and ’378 Patents) are barred, and whether the Claims of the '651 are Indefinite or not.  It is worth noting that while Moderna does not appear to challenge the definiteness of the "LNP Patents" in its own Summary Judgment Motion, Arbutus does argue for Summary Judgment declaring the "LNP" Patents Definite.  Taken together it does not appear that an Order on these Motion would be Case Dispositive, and it would appear that the § 1498 issue may provide the greatest certainty of trading direction as an Order will determine if Damages requested will be reduced from $5 billion down to $2.6 billion (unless the Court simply Denies the Motion finding that a question of fact still exists).

Note that the Court has not yet scheduled a Hearing on the Summary Judgment Motions or the Daubert Motions (which are scheduled to be filed on November 14th, and briefing is scheduled to conclude December 12, 2025).  While we believe that it is more likely that the Court will schedule a Hearing on the Summary Judgment Motions (and also potentially the Daubert Motions at some point in December or January), we have found instances in which Judge Wolson issued a Decision on Summary Judgement without holding a Hearing on the Motions.  Based on the statistics below as to time to Decision, we believe that if the Court decides a Hearing is unnecessary, then Judge Wolson may issue an Order on these Summary Judgment Motions (that were fully briefed on September 23, 2025) at the earliest in early December - although we stress that we would be incredibly surprised if Judge Wolson issued a Decision on these Motions without the benefit of Oral Arguments. 

Table of Past Decisions by Judge Wolson:

The following Motions have now been filed and briefed in Arbutus' Case against Moderna (the Motions highlighted in yellow are the focus of this email): 

• Moderna's Motion for Summary Judgment (D.E. 507 - filed August 1, 2025);
• Moderna's Motion to Preclude Mr. Pitt's and Mr. Brill's Expert Reports (D.E. 510 - filed August 1, 2025);
• Arbutus' Motion for Summary Judgment (D.E. 518 - filed August 1, 2025);
• Arbutus' Motion to Exclude Certain Expert Testimony of Drs. Anderson and Prud'homme (D.E. 522 - filed August 1, 2025);
• Arbutus' Motion to Exclude Certain Expert Testimony of Rutherford, Vellturo and Prud'homme (D.E. 558 - filed August 29, 2025);
• Arbutus' Cross-Motion for Summary Judgment & Response in Opposition to Moderna's Summary Judgment Motion (D.E. 562 - filed August 29, 2025).

The Following Patents are asserted in this Case and relevant to the above Motions:

As a reminder, Moderna addresses the following three main points in its Motion for Summary Judgment (D.E. 507):

1. Whether approximately $2.4 billion of Plaintiffs’ Damages claim against Moderna is barred under § 1498, because those vaccines were expressly made for the Federal Government, as the Government contract makes clear; 
2. Whether Plaintiffs’ infringement claims under the doctrine of equivalents (“DOE”) for the LNP Patents (the ’435, ’359, and ’378 Patents) are barred by prosecution history estoppel, because Plaintiffs expressly narrowed their claims to disclaim the compositions they now contend infringe; and 
3. Whether the expired ’651 Patent is Indefinite, because the Claims require distinguishing “full encapsulation” of mRNA from “partial encapsulation,” and there is no way to do that.

In its Response Brief & in Support of its own Cross Motion for Summary Judgment (D.E. 572 - attached), Arbutus seeks Summary Judgment on its Cross Motion regarding Moderna's Section 1498 Affirmative Defense. Arbutus argues that the purchase of the COVID-19 vaccine was not "for the government," it was "for millions of Americans." They argue that Moderna asserts a World War 1 era statute that was designed to encouraged military contractors to provide materials for the war effort. Arbutus argues that NO COURT has ever shifted liability whenever a government's contracts are for the public's benefit. Arbutus notes that: "As this Court correctly recognized in rejecting Moderna’s motion to dismiss, § 1498(a) applies only to infringing articles that are 'for the Government.'"

Note that we wrote the following in our March 10, 2023, email distributing the Court's Order on the Motion to Dismiss:

Please note that in its Order, the Court is essentially adopting Arbutus' position that "on behalf of the government" is a two-prong approach requiring analysis as to whether infringement was 1) for the government and 2) under the Government authorization and consent.  Please note that we found the following quote from Arbutus' Brief in Response to the United States Statement of Interest Interesting: "The reason that the Government’s Statement ... urges this Court to erase the “for the Government” prong of the § 1498(a) inquiry, is that medical treatments and Interventions, such as Moderna’s COVID-19 vaccine, fail to satisfy that prong. The law could not be clearer: “Medical care is provided for the benefit of the patient, not the government.” Larson, 26 Cl. Ct. at 369. Moderna’s inability to satisfy § 1498(a) is no reason to change it outside of the proper legislative avenue."

In Today's Memorandum Opinion, the Court wrote:

"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 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. ..."

Note that the above Order was issued by Chief Judge Goldberg - who is no longer assigned to this Case.  Arbutus reiterates in its Brief that Moderna does not meet the prong of "for the government," because the majority of doses were provided for third parties (private pharmacies and state and local governments.  Arbutus reiterates that Chief Judge Goldberg wrote that the Government grant DOES NOT mean that the use was necessarily "for the Government."  Arbutus continues by arguing that the very Case that Moderna cites for ignoring the "for the government" prong, used a two-prong approach in which the Court looked at: 1) for the government; and 2) authorization and consent.  Arbutus states that Moderna provides no evidence beyond the contract itself - which Judge Goldberg has already found does not include "for the benefit of the government." 

Arbutus then cites Chief Judge Goldberg, stating: "I find this Case more akin to Larson than Advanced Software Design or Saint-Gobain Ceramics. ... [M]edical care is provided for the benefit of the patient, not the government."  Arbutus notes that Moderna seeks to distinguish Larson based on the type of medical care noting that vaccines "have effects far beyond individual recipients, including prevention of widespread severe infections of others across the nation and globally.  In the Alternative, Arbutus argues that (at most) ONLY the limited doses that were used by the Federal Government may be considered "for the government" - Arbutus notes that this is about 3% of the C-100 contract; however, most of those doses delivered to the government were donated or delivered to foreign governments.

Separately, Arbutus argues that even if Section 1498 applies - it cannot make tax payors liable for Moderna's INDIRECT infringement.  Thus, they argue that the Government would not be responsible for Moderna's indirect infringement, and Arbutus is therefore entitled to Summary Judgement as to Moderna's defense as it relates to Indirect Infringement.  

Arguing for a Denial of Moderna's Summary Judgment based on questions of fact, Arbutus argues that Moderna fraudulently told the Government that it did not Infringe the Patent family asserted in this Case in an effort to secure the government contract (along with authorization and consent).  Arbutus provides evidence as to why they believe that Moderna knew it was Infringing at the time (which included test results). Arbutus concludes this section by stating: "Moderna also covered up evidence that it was infringing. For example, a 2019 email ordered one scientist to remove references to the role of the MC3 lipid (which Moderna had used in conjunction with the patented formulations) from scientific presentations: ... There is no indication that the Government has ever been aware of any of this evidence. As a result, there is a live factual dispute at to whether the Government would have provided its authorization and consent in the C-100 contract if it had known of Moderna’s willful infringement." 

Turning to Moderna's argument #2 - "Whether Plaintiffs’ infringement claims under the doctrine of equivalents (“DOE”) for the LNP Patents (the ’435, ’359, and ’378 Patents) are barred by prosecution history estoppel, because Plaintiffs expressly narrowed their claims to disclaim the compositions they now contend infringe," Arbutus argues that Moderna's argument as to Amendment based Estoppel is meritless, because Judge Goldberg rejected this argument during Claim Construction.  Specifically, Arbutus states that Moderna argued that the removal of the term "about" during prosecution of the Patent disclaimed broader ranges - and according to Arbutus, the Court found that the amendment ONLY disclaims these broader ranges. Arbutus argues that Moderna misconstrues the context of Plaintiff's amendment.  Arbutus states that Moderna believes that the prior art disclosed up to 50 mol% and Arbutus removed "about" to eliminate the overlap of the range.  Arbutus states that this is not true as "... just because a reference discloses a range of 2-60 mol % cationic lipid, as MacLachlan does, does not mean that it anticipates every point within that range, or even the end points. ... Rather, the prior art anticipates the claimed range only if it describes the claimed range with sufficient specificity such that a reasonable fact finder could conclude that there is no reasonable difference in how the invention operates over the ranges."  Arbutus states that the examiner found that without "about" in the claimed ranges, MacLachlan no longer disclosed the claimed ranges with "sufficient specificity."  Arbutus therefore argues that it did not disclaim the percentages just outside the range. 

Finally, Arbutus addresses Moderna's argument on Indefiniteness (#3 above).  Arbutus argues that the scope of the Lipid Composition Claims is unambiguous.  Arbutus states that the Claims require a SINGLE particle with the required components, and although Moderna's expert insists that it's impossible to measure the composition on an individual particle, Arbutus argues that the test for Indefiniteness does not depend on a potential Infringer's ability to ascertain the nature of its own accused product.  Additionally, Arbutus argues that Moderna's Expert's Opinion that different measurements may produce different data does not render a claim Indefinite - and different techniques have still consistently shown infringement.  Arbutus argues for Summary Judgment in its favor on Moderna's Lipid Composition Patents Indefiniteness Argument.

As to the '651 Patent, Arbutus argues that the Court should also Grant Summary Judgment in Arbutus' favor on Moderna's Indefiniteness Argument.  Moderna's argument relates to mRNA strands being fully encapsulated vs partially encapsulated. Arbutus states that the Court resolved any ambiguity in its Claim Construction Order.  Arbutus states: "[The Court] held that mRNA strands 'fully contained inside the vesicle' fall within the claims, ... whereas strands that are 'part-in-part-out' or unencapsulated do not. That decision is dispositive."  According to Arbutus, Moderna's Experts now assert that "fully encapsulated" has no defined meaning.  Arbutus argues that conclusory expert assertions cannot raise triable issues of fact, and regardless, Moderna's Expert that asserts that there is no accepted meaning of full encapsulation has his own Patent that uses the term (according to Arbutus).  Arbutus argues that at the very least, the Court should Deny Moderna's Summary Judgment Motion.  

Next, we turn to Moderna's Response (D.E. 556) in Opposition to Arbutus' Motion for Summary Judgment (D.E. 518).  As a reminder, Arbutus' Motion for Summary Judgment requests Judgment on three of Moderna's Defenses:

1. Non-Obviousness - which Arbutus states that the PTO has already rejected as to the '069 and '435 Patents, and Moderna is therefore estopped.  Additionally, Arbutus argues that the Federal Circuit Affirmed the Validity of the '069 Patent, which has preclusive effect on Moderna's arguments. 
2. Enablement - Arbutus argues that Moderna's Opinion relies on the introduction of properties that the Claims do not recite or require. 
3. Derivation - Arbutus argues that logic precludes Moderna's "derivation" claim as the '651 has a priority date of 2002, a decade before the Patent that Moderna claims Arbutus derived its Patent from. 

Moderna argues that it is not Estopped from raising Obviousness issues (#1 above) on the LNP Patents that have never been fully litigated.  Moderna argues that Arbutus relies on a flawed argument that these Patents present identical obviousness issues as the previously dropped '069 Patent (which Moderna argues is much narrower than the LNP Patents).  Moderna argues that Arbutus has failed to show that the issues are "identical."  Moderna argues that the Patents recite different amounts and types of Lipids.  Secondly, Moderna argues that Arbutus' attempt to argue IPR estoppel is misplaced as the PTAB Decision on the '435 Patent was never subject to Article III judicial review (including appellate review) - which, they argue, allows them to assert their Invalidity defense.  Note that Moderna writes the following regarding its lack of Appellate rights for the '435 IPR: "... the Federal Circuit found Moderna lacked standing to appeal the ’435 IPR after Plaintiffs argued there was no imminent threat of suit." 

As to Enablement (#2 above), Moderna argues that Arbutus is relying on out of context Expert Statements in its Summary Judgment Motion to suggest that Moderna "... relies on unclaimed limitations and conclusory expert opinions."  Moderna argues that at a minimum, the competing Expert opinions prove that Summary Judgment is not appropriate. 

Lastly, as to Derivation (#3 above), Moderna argues that Arbutus derived the '651 Patent Claims from Moderna. It argues that Plaintiff's original application in 2002 focused on lipid formulations to encapsulate pDNA, and Arbutus did not start research into mRNA delivery until 2012.  Moderna argues that it was not until Arbutus started monitoring Moderna that Arbutus filed the '651 in 2014, and whether the 2002 Application disclosed the subject matter of the '651 Patent is a "hotly disputed issue," and therefore not ripe for Summary Judgment.