A Primer On The RNA Patent Landscape

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

It was July 2022. I was preparing to leave for the airport to head to Boston for an mRNA conference — my first mRNA-centric event and my first in-person conference since prior to COVID. I was excited to attend several presentations during the pre-conference workshop day, but one more than the others: A panel on the increasingly circuitous patent landscape by Rothwell Figg Partner Dan Shores.
So, naturally, my flight was cancelled at the last minute. (Thanks, JetBlue...)
Fortunately, I did make it to Boston and, though I missed Shores’ presentation, I managed to cross paths with him during a coffee break, and we have been in touch ever since.
As we start out the new year here at Advancing RNA, I thought it was high time Shores and I reconnect to touch base on the current litigation landscape. Over the past few years since the commercialization of the COVID vaccines, we’ve grown increasingly familiar with just how tangled the patent litigation landscape can and has become. Of course, the litigation we read about in the news today is for the commercialized vaccines. But we also can’t discuss early-stage development without acknowledging the complications of navigating existing IP while in the throes of R&D. In the past year, I’ve heard it said multiple times that having a strong in-house legal team or a partner familiar with the legal landscape is a must for RNA biotechs today.
In the first- of this three-part article, Shores gives us an important primer on the RNA legal landscape as it stands today. As many of us are working on crafting the next generation of mRNA/RNA products and LNPs, I wanted to get his sense of how our continued scientific advancement is likely to impact the IP landscape in the long-term.
Mapping The mRNA Patent “Battlefield”
A few year ago, while writing an article on what the boardgame RISK could teach us about mRNA/RNA business strategy, I came across a figure in an article mapping out the then-current (2021) “patent network analysis” for the COVID-19 vaccines. Obviously, this chart has been updated since. But even at that time, I made the argument that it already looked like a map of the strategic movement of armies across the RISK game board.
Major litigation in the mRNA space started in 2022, something Shores himself has published on several times — for example, this piece entitled mRNA IP 2022 Year in Review: Pioneers Clash in Major Patent Litigations. As Shores reminds, because damages available under U.S. patent law generally apply to sales of infringing products, this litigation activity is centered around the two major commercialized COVID-19 vaccines products.
Throughout 2024, we continued to see additional “armies” entering the vaccines litigation fray, with GSK lobbing separate patent infringement suits at both Moderna & Pfizer/BioNTech and Northwestern University launching a suit against Moderna.
“There were a number of key pioneers that had developed mRNA and/or LNP technologies over the years,” Shores explained. “Once that technology was realized on a commercial basis, we began seeing these pioneers asserting their patents, in essence saying, “We have rights to what’s being used and sold, and this is our chance to be compensated for the use of our prior-developed technologies.’”
So far, the legal “friction” over the COVID vaccines has been related to three broad areas of innovation: The mRNA/RNA cargo; the method of use of a product (e.g., a product’s use treating specific indications); and the composition of matter for an LNP, whether it be a singular lipid or the specific combination of lipids in the formulation. (A more thorough breakdown of some of the biggest ongoing cases will be shared in a forthcoming installment — stay tuned!)
The IP Landscape: Restriction Or Freedom?
For Shores, these high-stakes litigation cases for the COVID vaccines are certainly worthy of attention, but they’re hardly the full story. In fact, as he went on to argue, they often overshadow some of the even more important scientific and technical innovations that have been happening behind the scenes for which companies are also seeking patent protection. In particular, he pointed to the work being done with active delivery to enable LNPs to target specific cell types.
“Key trends in this space include ‘decorating’ LNPs to help cargo reach specific cells,” Shores explained. “Such targeting approaches could serve to enhance potency and mitigate toxicity, potentially also widening the scope of indications successfully addressed through RNA therapeutics.” (Hello, more methods of use patents…)
It’s important to note that these newer scientific arenas will likely still have existing IP for firms to navigate; scientific novelty does not necessarily equate to a completely IP-free playing field. However, new technologies/scientific approaches — for example, a surface structure that’s novel to an LNP — are incremental advancements a company can then patent, in turn securing its own scientific and (eventually) commercial niche.
Quite often, the patent landscape is referred to as a limitation or restriction that can put us at risk of delaying a clinical trial or product launch. (In fact, I often imagine navigating existing patents being a bit like this famous “laser dance” scene from Ocean’s 12.) However, I appreciated Shores’ emphasis on the positive impact patenting can have for furthering innovation in the broader RNA space — especially during this scientifically nascent, R&D-forward age. As he explained, patenting can be an important tool for promoting scientific transparency within the field. After all, patenting an innovation is disclosing an invention to the public/other innovators.
“The bargain of the patent system is straightforward,” Shores said. “If you develop a new, useful and non-obvious invention, you can apply for a patent for that invention. As part of the deal, the government will grant you a period of years when you can exclude others from practicing your invention and, in exchange for that, you are required to publicly disclose how to make and use your invention. Once your patent term expires — 20 years from the date of filing the application — your invention is dedicated to the public.”
As he went on to explain, the patent disclosure itself becomes available to the public 18 months from the priority date so that other innovators can learn from what has been done and can build on that innovation.
“For example, perhaps there is an innovator developing a novel LNP with a specific surface structure,” he offered in conclusion. “That innovator can study third party patent applications to learn how others have decorated their LNPs to ensure the formulation is distinct from the prior art, and build on that work with new and improved approaches. They can then file patent applications of their own for those improvements. This is representative of a healthy patent system, a process that spurs future innovation.”
If you liked what you read, stay tuned: Shores and I will return in a second installment that will share a few high-level considerations for mRNA-LNP makers to consider when establishing their patenting and licensing strategies.