The upcoming Federal Circuit hearing in the case between Arbutus Biopharma Corp. and Moderna Inc., scheduled for November 5, 2026, is poised to address several pivotal issues that could significantly influence patent law and the biotechnology sector. The dispute centers on allegations that Moderna’s COVID-19 vaccine infringed upon Arbutus’s lipid nanoparticle (LNP) technology patents, with potential damages amounting to $1.3 billion.
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Government Contractor Defense Under 28 U.S.C. § 1498
A central issue is whether Moderna’s production of the vaccine under government contracts during the pandemic shields it from liability under 28 U.S.C. § 1498. This statute can transfer patent infringement liability to the U.S. government when a product is manufactured “for the Government.” Moderna contends that, due to its federal contracts, any infringement claims should be directed at the government. Conversely, Arbutus argues that this defense should not apply to doses distributed to the general public. The Department of Justice has also weighed in, suggesting that the government should face the claims instead of Moderna. ([mlex.com](https://www.mlex.com/healthcare-authority/other/articles/2492097/gov-t-says-it-should-face-vax-ip-claims-not-moderna?utm_source=openai))
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Validity of Arbutus’s Patents
The court will examine the validity of the patents in question. Moderna has previously challenged these patents on grounds of obviousness and derivation. However, earlier rulings have limited Moderna’s ability to argue obviousness due to prior inter partes review proceedings and dismissed the derivation defense for lack of evidence. The enablement defense remains a point of contention, with Moderna asserting that the patents do not sufficiently enable the claimed inventions. ([law.justia.com](https://law.justia.com/cases/federal/district-courts/delaware/dedce/1%3A2022cv00252/78146/743/?utm_source=openai))
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Scope of Infringement and Damages
Determining the extent of alleged infringement and the corresponding damages is crucial. Arbutus claims that Moderna’s vaccine utilizes its patented LNP technology without authorization. The court will need to assess whether Moderna’s vaccine falls within the scope of Arbutus’s patents and, if so, calculate appropriate damages, which could reach up to $1.3 billion. ([legalclarity.org](https://legalclarity.org/moderna-lawsuit-all-major-patent-cases-explained/?utm_source=openai))
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Implications for Future Government Contracts
The outcome may set a precedent regarding the application of § 1498 in situations where private companies produce products under government contracts but distribute them broadly. This could influence how companies approach government contracts and manage patent risks in future public health emergencies. ([news.bgov.com](https://news.bgov.com/ip-law/moderna-vaccine-appeal-poised-to-set-patent-liability-benchmark?utm_source=openai))
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Impact on Biotechnology Patent Landscape
This case could have broader implications for patent enforcement in the biotechnology industry, particularly concerning foundational technologies like LNPs. A ruling favoring Arbutus might encourage more rigorous patent enforcement, while a decision for Moderna could lead to increased scrutiny of patent validity and the scope of patent protections in rapidly evolving fields. ([legalclarity.org](https://legalclarity.org/moderna-lawsuit-all-major-patent-cases-explained/?utm_source=openai))
As the Federal Circuit prepares to hear arguments, stakeholders across the legal and biotechnology sectors are closely monitoring the proceedings, anticipating that the court’s decisions will provide clarity on these complex issues.