Courtroom Clash: Inside The High-Stakes World Of mRNA Patent Litigation
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
Since the launch of the mRNA COVID vaccines in 2022, things have gotten a bit litigious. In fact, having started my career covering the court room drama also known as the biosimilars industry, the burgeoning legal news in the RNA space sometimes makes me feel as though I’m reliving the arrival of biosimilars onto the U.S. market.
Obviously, establishing an IP portfolio is an essential concern for every biotech striving to bring a competitive innovation to market. But quite often, IP seems to be a topic that inspires a collective shiver to run throughout the RNA space, regardless of an expert’s expertise/functional area. I’ve had conversations over the past year on a variety of different topics ranging from supply chain to process development to manufacturing, all of which have emphasized just how complicated innovation can be when you’re trying to avoid infringing other companies’ innovations.
In two previous articles for Advancing RNA, Rothwell Figg Partner Dan Shores shared a high-level overview of the current RNA litigation landscape, as well as the strategies companies can employ today to course correct and/or proactively protect themselves in the face of any potential patent infringements. However, as we’ve continued to see big headlines about new litigants to the already convoluted COVID vaccine litigation “map,” I also thought it was a good time to highlight a few of the biggest ongoing legal cases worth noting and following in the year(s) ahead.
Here, Shores provides the “who’s who” and “what’s what” behind some of the hottest legal cases to hit the headlines in the mRNA space to-date, as well as why these cases are or could be significant to companies commercializing mRNA products in the future.
Understanding The Current World of mRNA Patent Litigation
As Shores clarified in part 1 of this series, the litigation news appearing in headlines today is in relation to the commercialized mRNA products. Though companies in preclinical and clinical development are also filing for their own patents and/or establishing licensing agreements to cover their legal bases, most of the lawsuits we’re hearing about in the mRNA space today have been sparked by sales of Moderna and Pfizer’s vaccines. As sales of the COVID vaccines continue to accrue, third-party companies are coming forward seeking compensation for rights to innovations for which they allegedly weren’t compensated. These innovations predominantly fall into three different camps — the mRNA cargo; the product’s method of use (i.e., the target indication); and/or the LNP’s composition of matter.
Even though most of us here in the Advancing RNA community are not lawyers, these lawsuits — and namely, the courts’ rulings on these lawsuits — can provide us with much more than just delightful drama befitting movie theatre popcorn (protip: with layered butter). Whittling down an innovator’s patent “thicket” and/or reinforcing the validity of an innovator’s patent(s) are both significant developments that can provide a clearer path to market for future innovators, as well as opportunities for companies to file their own patents/create their own IP portfolios.
However, as Shores also acknowledged, it’s rare to see litigation go to a jury trial. In most cases, patent litigation is settled.
“This ultimately means that the patents will stay in play due to the fact that settlements almost always maintain the status quo in terms of patent rights,” he added. “As such, the patent landscape remains as ‘thick’ as it is now because the risk of infringement remains. Obviously, Pfizer/BioNTech and Moderna have large patent portfolios, but certain smaller players have growing portfolios, too. So that’s the big challenge: How do biotechs navigate this properly while mitigating their exposure and cost?”
Below, Shores outlines several of the most noteworthy patent suits from recent years — both resolved or ongoing. It should go without saying that this is far from an exhaustive list. But overall, each of these cases provides some important context on the innovations that, at present, have multiple industry parties mimicking everyone’s favorite (albeit quite demanding) seagulls from Pixar’s Finding Nemo.
Notable mRNA Patent Disputes: A Closer Look
Following is a summary of some of the early key cases that were filed in 2022 and 2023 that are now coming to fruition, which, as Shores said, will likely make 2025 a very notable year for this litigation activity.
1. Arbutus v. Moderna and Arbutus v. Pfizer/BioNTech
In February 2022, Arbutus (patent owner) sued Moderna alleging that Moderna infringed several patents directed to lipid nanoparticle (LNP) delivery systems based on its sales of Spikevax®. The case has proceeded routinely since its filing, and trial is currently set for September 2025.
Over a year later, in April 2023, Arbutus sued Pfizer and BioNTech for infringement of certain of its LNP patents based on sales of Comirnaty®. Shores said no trial date is currently set but the case has progressed and it is possible that trial could occur this year also.
“Each case is high stakes with a large risk profile for both parties especially if the cases go to trial since both damages and patent validity are at issue, and how a jury will side is inherently unpredictable,” Shores said.
2. Alnylam v Moderna and Alnylam v. Pfizer/BioNTech
In March 2022, and in other later cases, Alnylam sued Moderna for infringing its patents directed to certain cationic lipids based on Moderna’s sale of Spikevax®. That case progressed fairly quickly in which the district court ruled in favor of Moderna. That ruling is currently on appeal.
Alnylam also sued Pfizer and BioNTech in March 2022 and in other later cases, also alleging infringement of the same lipid patents. This case remains pending at the district court level, and while some claims were voluntarily dismissed, the trial for the remaining claims is set for July 7, 2025.
“The Alnylam cases are intriguing as well,” Shores said. “Alnylam is an early pioneer in the lipid space, and these rulings will test whether the lipids used in today’s commercial products fall outside of Alnylam’s foundational lipid technology.”
3. Moderna v. Pfizer and BioNTech
In August 2022, Moderna sued Pfizer and BioNTech for infringing three of Moderna’s patents directed to mRNA and lipid technology.
“This was a significant move by Moderna,” Shores added. “On the one hand you have Moderna and Pfizer both being sued by third parties, but toward the end of 2022, you see the first lawsuit between the direct competitors in the space which broadened the stakes across the entire litigation landscape.”
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 these IPRs, Pfizer/BioNTech argued that Moderna’s patents in question are “unimaginably broad” and represent “a basic idea that was known long before” their invention.
The PTAB proceeding has been pending for over a year, and a decision on whether Moderna’s patents will survive the PTAB challenge could come “any day now,” said Shores. Once that ruling comes in, there will be a process for appeal to the Federal Circuit, and eventually those outcomes will come back to bear in the district court case.
“The results of these IPRs will have a significant impact on the entire Moderna vs. Pfizer & BioNTech dispute and will ultimately strengthen one of these player’s positions,” Shores added.
4. CureVac v. Pfizer and BioNTech
In June 2022, CureVac sued BioNTech for infringement of patents directed to mRNA and lipid technology in Germany, and BioNTech then quickly sued CureVac in the U.S. for a declaratory judgment of non-infringement.
“A declaratory judgment action for non-infringement is a preemptive action by an accused infringer to request that the court declare it does not infringe and, in many cases, that the asserted patents are not valid,” Shores clarified.
This case has progressed and the U.S. trial is set to commence on March 3, 2025.
As Shores explained, “This is a key case between two longstanding, German-based, mRNA pioneers. The result of this trial will be closely watched by the entire mRNA ecosystem.”
5. Other Cases
A number of other cases have been filed that are not detailed here. For example, according to Shores, Acuitas sued Arbutus for declaratory judgment of non-infringement in 2022; UPenn sued BioNTech for breach of contract in 2023; GSK sued Pfizer and BioNTech for patent infringement in 2024; Acuitas sued CureVac and Alnylam separately for correction of inventorship in 2024; and Northwestern sued Moderna for infringement in 2024.
“This activity may not seem appealing to participants in a space that prides itself on seeking cures for human disease using innovative mRNA therapeutics,” Shores said. “But for patent lawyers, infringement actions have been going on for centuries, and this activity is simple blocking and tackling. But what makes this all unique is that it is occurring in the emergent mRNA space which did not exist commercially before the pandemic. It will be very interesting to see how this will all play out.”