As we previously discussed, beginning in 2022, a series of patent infringement lawsuits were filed against Moderna and collaborators Pfizer+BioNTech seeking damages based on their respective sales of the Spikevax® and Comirnaty® COVID-19 vaccines.
Key suits were filed by third party mRNA and lipid pioneers that, while not having any mRNA-based products on the market themselves, leveraged their patent portfolios claiming a share of the billions of dollars in sales the vaccines have generated.
Direct competitors Moderna and Pfizer+BioNTech also clashed in patent litigation beginning in 2022, with cases initiated in the United States and later expanding abroad.
Several of the original cases, filed over three years ago, have made their way through the courts relatively efficiently and are ripe for key rulings in the coming months. This is therefore an opportune time to check in and provide an update on the mRNA/LNP litigation landscape.
Technological Background
Recall the Comirnaty® and Spikevax® mRNA-based vaccines each utilize lipid nanoparticles. The lipid nanoparticles include an mRNA “payload” encapsulated by a combination of four lipids: a (1) cationic (or ionizable) lipid; (2) conjugated lipid; (3) phospholipid; and (4) cholesterol. Each one of these lipids plays a key role in protecting the fragile mRNA molecules as the LNP travels through the body in search of a cell.
Once a cell is engaged, the configuration and charges of the lipids and LNP are crucial to ensure proper uptake of the LNP into the cytoplasm of a cell and release of the cargo once inside the cytoplasm. Once the mRNA is released, the cellular machinery reads the mRNA sequence and produces and expresses the characteristic spike protein, allowing the body’s immune system to train itself to combat the real COVID-19 virus.
Each aspect of the LNPs have been developed over decades by pioneers in both the lipid and mRNA spaces, as we have detailed in prior writings.
Accordingly, these aspects—especially the modified mRNA payload, ionizable lipids, and formulations—have been heavily protected by patents over the years. It was therefore no surprise that, and as predicted about four years ago, significant patent litigation would ensue based on the sales of these first-ever mRNA based commercial products.
Litigation Update
This section will provide an update on the key mRNA and lipid nanoparticle cases filed since 2022.
Arbutus v. Moderna; Arbutus v. Pfizer+BioNTech
In February 2022, Arbutus (patent owner) sued Moderna in the District of Delaware alleging that Moderna infringed several patents based on its sales of Spikevax®. This case, which involved Arbutus’ patented lipid nanoparticle (LNP) delivery systems, has proceeded fairly routinely since its filing, and trial is currently set for September 2025
In April 2023, Arbutus sued Pfizer and BioNTech in the District of New Jersey for infringement of certain of its LNP patents based on sales of Comirnaty®. No trial date is currently set but the case has progressed and it is possible that trial could occur this year or early next year.
In March 2025, Arbutus filed several additional patent infringement cases against Moderna abroad (again relating to the Arbutus LNP tech) including in Canada, Japan, Switzerland, and two UPC cases.
Alnylam v Moderna; Alnylam v. Pfizer+BioNTech
In March 2022, and in other later cases, Alnylam sued Moderna in the District of Delaware for infringing its patents directed to certain cationic lipids based on Moderna’s sale of Spikevax®. Alnylam filed three cases in total following grant of newly issued patents. After claim construction, the court found non-infringement in favor of Moderna, which is currently on appeal.
Alnylam similarly sued Pfizer and BioNTech in March 2022 in the District of Delaware, also in multiple suits alleging infringement of the same lipid patents. This case remains pending, and while some claims were voluntarily dismissed, the trial for the remaining claims is set for July 7, 2025.
Moderna v. Pfizer+BioNTech
In August 2022, Moderna sued Pfizer and BioNTech for infringing three of Moderna’s patents directed to mRNA and lipid technology. While Pfizer and BioNTech did not file any counterclaims for patent infringement, those defendants did challenge two of the three asserted Moderna patents before the USPTO’s Patent Trial and Appeal Board (PTAB).
In March 2025, the PTAB found all claims of the challenged Moderna patent unpatentable. Given the dollars at stake, one could assume that this ruling will likely be appealed.
Also in March 2025, the Düsseldorf Regional Court in Germany, in a patent infringement case filed in 2022, ruled in favor of Moderna that Pfizer and BioNTech infringed one of Moderna’s European patents and “should pay appropriate compensation.”
Moderna also reportedly filed cases against Pfizer and BioNTech in the UK, Ireland, the Netherlands, and Belgium from 2022 to 2023.
CureVac v. Pfizer+BioNTech
In June 2022, longstanding mRNA pioneer CureVac sued BioNTech in Germany for infringing its patents directed to mRNA and lipid technology.
In July 2022, BioNTech and Pfizer sued CureVac in the U.S. (D. Mass later transferred to E.D.V.A.) for declaratory judgment of non-infringement and invalidity of 10 CureVac patents. BioNTech and Pfizer also sued CureVac for declaratory judgment of non-infringement in England in September 2022.
In December 2023, the German court reportedly invalidated CureVac’s asserted patent. In October 2024, the UK court reportedly invalidated 2 CureVac patents.
The U.S. case has progressed and trial is set to commence in September 2025.
4. Acuitas v. Arbutus; Acuitas v. Alnylam; Acuitas v. GSK; Acuitas v. Arbutus; Acuitas v. CureVac
Lipid pioneer Acuitas has filed numerous lawsuits since 2022, all of which were for declaratory judgment. Recall that Acuitas has certain collaborations with BioNTech and Comirnaty® utilizing Acuitas lipids.
In March 2022, Acuitas sued Arbutus for declaratory judgement of non-infringement and invalidity of nine Arbutus patents in the Southern District of New York. That case was voluntarily dismissed and re-filed in the District of New Jersey. In May 2024, that case was dismissed for lack of standing as Acuitas was allegedly never accused of infringement.
In November 2023, Acuitas sued CureVac for correction of inventorship of 4 CureVac patents in the Eastern District of Delaware. That case settled in June 2024 with prejudice.
In July 2024, Acuitas sued Alnylam for correction of inventorship of seven Alnylam patents in the District of Delaware. This case is pending and in its early stages.
In January 2025, Acuitas sued GSK for declaratory judgement of non-infringement and invalidity of five GSK patents. This case is pending and in its early stages.
GSK v. Pfizer+BioNTech
GSK entered the fray last year, lodging suits against Moderna and Pfizer+BioNTech. Specifically, in April 2024, GSK sued Pfizer and BioNTech for infringing five GSK patents in the District of Delaware. Then, in October 2024, GSK filed two patent infringement lawsuits against Moderna also in the District of Delaware, one suit involving six GSK patents and the other seven GSK patents. All of these cases are pending and in their early stages.
Other Cases
A number of other cases have been filed that are not detailed above. For example, in June 2023, Promosome sued each of Moderna and Pfizer+BioNTech for patent infringement in the Southern District of California (both cases settled in 2023); in August 2024, UPenn sued BioNTech for breach of contract in the Eastern District of Pennsylvania (case settled for $467 million in December 2024); and Northwestern sued Moderna for patent infringement in August 2024 (case in its early stages with a Moderna motion to dismiss pending).
Also, based on its alleged contributions to both vaccines, NIH has had ongoing disputes with each of Moderna and BioNTech over ownership and licensing rights. At least aspects of these disputes have reportedly been settled, with Moderna agreeing to pay NIH $400 million and BioNTech agreeing to pay NIH $791.5 million, with each deal reportedly also including low single digit royalties on vaccine sales going forward.
Recap
Over the past three years, mRNA and LNP patent litigation activity has grown and persisted.
Lipid pioneer Arbutus has pursued patent infringement claims against Moderna and Pfizer+BioNTech in the U.S. and now (at least for Moderna) abroad, with its U.S. case against Moderna set for trial in September 2025 and the Pfizer+BioNTech trial possibly following soon thereafter.
Alnylam has similarly done so, asserting newly granted lipid patents, against Moderna and Pfizer+BioNTech with the Pfizer+BioNTech trial currently set for July this year and Moderna’s claim construction and non-infringement wins on appeal.
For its part, Moderna has asserted certain of its patents against its direct competitors Pfizer+BioNTech in the United States and abroad, scoring a recent victory in Germany with a finding of infringement, but also (in the same week) suffering defeats at the PTAB with two of the patents it asserted against Pfizer+BioNTech in the U.S. case being found unpatentable.
GSK entered the arena in 2024, lodging suits against Moderna and Pfizer+BioNTech, adding to an increasingly complex litigation landscape, with those cases in their very early stages.
The stakes for the above cases are significant, with possibly greater than $100 billion in combined Spikevax® and Comirnaty® COVID vaccines sales to use as a basis for reasonable royalty and other damages calculations. There have already been sizable payouts, with Moderna paying NIH $400 million and BioNTech paying NIH $791.5 million and the University of Pennsylvania $467 million. At stake for the parties asserting infringement include invalidation of asserted patents which, for companies that leverage certain of their portfolios for licensing revenues (like Arbutus/Genevant), ostensibly carries its share of risks.
CureVac took a few losses abroad with German and UK courts invalidating some of its patents, but its U.S. case with Pfizer+BioNTech remains alive with trial set for September this year.
Acuitas – in its DJ suits against Arbutus – fell short in its standing arguments resulting in dismissal, but that process could have served to mitigate the risk that Arbutus would pull Acuitas into the Pfizer+BioNTech case, and a similar notion may apply with regard to rationale behind Acuitas’ DJ suit against GSK.
As for Acuitas’ correction of inventorship cases, the one against CureVac settled quickly, but the one against Alnylam remains on track. While it is not entirely clear about the precise reason for these correction cases, joint inventorship of patent claims confers joint ownership of those claims, and a successful outcome for Acuitas could do just that as applied to the patents in question.
Players in the mRNA and LNP space should continue to watch these cases very closely as they progress.
Note: This landscape is in a constant state of flux. The information in this post is as of March 2025.
Disclaimer: The information contained in this posting does not, and is not intended to, constitute legal advice or express any opinion to be relied upon legally, for investment purposes or otherwise. If you would like to obtain legal advice relating to the subject matter addressed in this posting, please consult with your attorney. The information in this post is also based upon publicly available information, presents opinions, and does not represent in any way whatsoever the opinions or official positions of the entities or individuals referenced herein.