Inside The mRNA–LNP Patent Wars: A Q&A With Goodwin On Litigation, Strategy, And What Comes Next

A conversation with Goodwin's Natasha Daughtrey, J.D., and William Christiansen, Ph.D.

As mRNA therapeutics expand beyond pandemic vaccines into oncology, gene editing, and rare disease, the intellectual property landscape surrounding mRNA constructs and lipid nanoparticle (LNP) delivery systems is becoming increasingly complex — and increasingly contested. Patent portfolios built during the COVID-19 vaccine race are now colliding with the next wave of RNA innovation, creating a dense web of platform technologies, overlapping claims, and high-stakes litigation. In this Q&A with Advancing RNA Executive Editor Michael Soloway, Natasha Daughtrey, J.D., partner at Goodwin, and William Christiansen, Ph.D., patent prosecution partner at the firm, discuss how the mRNA–LNP patent landscape is evolving, why delivery technologies are at the center of many disputes, and how RNA developers can build defensible IP strategies in a field where scientific breakthroughs and legal battles are advancing in parallel.

Background & Scope

ARNA: Can you describe the core work you and your team are doing in the mRNA-LNP space — both on the advisory side and in active litigation?

ND: Our work sits at the intersection of cutting-edge RNA science and high-stakes patent litigation. On the advisory side, my team and I at Goodwin advise mRNA developers, lipid technology companies, and strategic partners on building defensible IP portfolios around both mRNA constructs and LNP delivery systems. That includes prosecution strategy, freedom-to-operate assessments, licensing positioning, and preparing for the reality that platform technologies inevitably generate overlapping patent rights. It’s often the case that if you are successful in the life sciences space, someone is likely to want to sue you. So, we help our clients prepare for this and help put them in the best position for when it does happen or when they decide to enforce their own IP rights.

On the litigation and pre-litigation counseling side, we are deeply involved in disputes arising from pandemic-era vaccine commercialization and the continued expansion of mRNA into new therapeutic areas. These disputes often involve platform technologies — lipid nanoparticles, sequence optimization methods, or assays used during vaccine development — rather than a single molecule. As we’ve seen in the vaccine litigation wave generally, these disputes are typically monetary in nature, with plaintiffs seeking reasonable royalties rather than injunctions and often are part of enforcement campaigns against multiple defendants.

ARNA: How would you characterize the current patent landscape for mRNA therapeutics and LNP delivery systems? What are the biggest categories of patents being filed right now?

ND: The landscape is dense and increasingly strategic. Some of the major buckets are: (1) LNP delivery systems; (2) mRNA engineering, including sequence optimization and chemical modifications; (3) antigen or immunogen design; and (4) development technologies and tools.

One of the most aggressive filing activities today is around next-generation lipid libraries, improved tolerability and targeting, new viral based vector deliveries, and in-vivo T cell engineering.

Importantly, because some of these inventions are platform technologies, patents often have cross-product reach. That amplifies both their value and the likelihood of litigation.

Litigation Trends & Case Law

ARNA: In the cases you’re seeing, are there particular types of mRNA or LNP patents that are generating the most litigation — for example, ionizable lipid chemistry vs. manufacturing processes or analytic methods?

ND: Yes. LNP delivery patents have generated substantial litigation, particularly those claiming specific ionizable lipids or defined formulations, and because a delivery platform can be used across multiple vaccines or therapeutics, these patents can touch significant revenue streams. A recent analysis we did, looking at all the post-COVID vaccine-related patent litigation, found the following breakdown:

Across the reviewed cases, 46 patents were asserted that generally fall into four buckets: (1) LNP delivery, (2) mRNA engineering, (3) antigen/immunogen platforms, and (4) miscellaneous patents, including those around development technologies and tools.

The LNP delivery patents accounted for 62% of asserted patents, mRNA engineering for 24%, and antigen platform for 12%.

LNP delivery patents include specific ionizable lipids, LNPs with specific ratios of each component, and LNP size and structure attributes. On mRNA engineering patents, these include methods for optimizing mRNA sequences, increasing protein expression, and then specific synthetic mRNA modifications. Antigen/immunogen patents include mRNA encoding betacoronavirus spike protein and administering formulations of specific mRNA-encoded immunogens.

Interestingly, development technologies and tools patents are emerging as another asset in litigation, although they’ve only amounted to 2% of the 46 patents we looked at from the most recent wave of vaccine patent litigation. Courts have also wrestled with whether certain uses fall within the § 271(e)(1) safe harbor, and the analysis for that issue is highly fact-specific.

ARNA: Can you highlight any recent court rulings involving mRNA-LNP patents that are particularly significant? What signals do they send about how courts view patentability and infringement in this space?

ND: Claim construction has been outcome-determinative in some cases. For example, courts have construed “cationic lipid” and “branched alkyl” in ways that foreclosed infringement findings. This underscores how much these cases can turn on precise chemical definitions. In other cases, the courts have given terms very broad scope to expand potential damages exposure and influence settlement leverage. Related to claim construction sometimes is that courts are grappling with whether the claims encompass uses that were not really contemplated at the time of the invention, so it’s a mixed question of whether there are sufficient enablement and written description to allow a broader claim scope that would encompass later discovered inventions to be infringing.  

Another notable pattern is the heavy use of inter partes review (IPR) prior to the new procedures related to institution put in place in 2025 by Director Squires. District courts frequently stay cases after Patent Trial and Appeal Board (PTAB) institution, meaning PTAB strategy often drives litigation timelines. Under the new procedures, there is likely to be less focus on IPRs as a way to resolve these disputes.

ARNA: Are there emerging areas of contention — such as priority disputes, obvious challenges, or enablement issues — that are becoming more common in mRNA-LNP litigation?

ND: We are seeing increased emphasis on inventorship disputes. As illustrated by recent LNP-related cases, correcting inventorship can create joint ownership rights and independent licensing authority. That is a powerful strategic lever. In the 23 complaints filed since October 2020 involving vaccine patent rights, 9% sought a declaratory judgment of co-inventorship.

Enablement and written description challenges are also front and center, particularly for broad genus claims covering large lipid libraries or sequence variants.

Strategic IP Decisions & R&D Impact

ARNA: From a strategic standpoint, how are RNA developers balancing broad vs. narrow patent claims in a space that is evolving so quickly? Are we seeing a shift in claim drafting strategies?

WC: There hasn’t been a huge change in overall claim strategy, but generally we try to include picture claims, given it is such a tight space. From a 112 perspective, we’ve also seen it is generally easier to claim mRNA delivery with generic LNP claims than it was previously. In addition, claim drafting strategy in the U.S. verse ex-U.S. can differ. For example, every sequence-specific claim in the U.S. tends to go through examination easily with the assumption that there is novelty. Outside the U.S., such as in the EP, broader claims are easier to achieve as long as the specific target isn’t known or you have some hook as to why you are better than what has come before.

ARNA: How do patent strategies around mRNA chemistry versus delivery system design differ, and what lessons are being learned from litigation about which approach offers stronger protection?

WC: In the earlier generation of inventions directed at vaccine‑style mRNA–LNP platforms, there was a focus on stabilizing mRNA chemistry to get longer expression. Now we are seeing more companies embracing mRNA’s inherent transience rather than trying to engineer around it. For example, Capstan has an approach using short‑lived mRNA with more targeted LNPs to engineer T cells in vivo, and then relying on repeat dosing instead of pushing for a longer half‑life from a single dose. That being said, most of the old strategies for capping and modifying RNA for stability are mostly off-patent or will be short and can be used freely for therapeutic product development. For delivery systems, LNPs and engineered viruses still have some broad patents out there. The delivery systems today, if novel, offer the broadest protection as most RNA sequences are known. Nevertheless, we see the most defensible positions come from combining various breadth of delivery vehicles and their content. In a broader sense, we expect to see the in vivo T cell engineering space heat up, including LNP programs, but obviously also including viral-based vector deliveries.

ARNA: What role are trade secrets playing in mRNA-LNP innovation, especially where patents may be difficult to obtain or enforce?

WC: Trade secrets are increasingly important in manufacturing scale-up, lipid synthesis processes, and formulation know-how. Like other areas of life sciences where reverse engineering is difficult (biologic and biosimilar pharmaceuticals), companies may prefer secrecy over patent disclosure.

That said, trade secrets require rigorous internal controls. And in a collaborative ecosystem — where CDMOs, suppliers, and partners are deeply involved — maintaining secrecy can be challenging. It is very important, if a company decides to maintain certain things as trade secret, that they have undertaken “reasonable efforts” to maintain secrecy.

Regulatory & Global Market Interactions

ARNA: Have you seen differences in how international jurisdictions are handling mRNA-LNP IP disputes — for example, in Europe, Japan, or China — compared to the U.S.? What does this mean for global strategy?

ND: The U.S. remains the epicenter of vaccine patent litigation, particularly in Delaware. Previously, the availability of IPR proceedings added a distinctive strategic layer, but that is lessening with the changes in IPR/PTAB rules.

While less than the U.S., Europe still has seen its share of IP-related vaccine cases. There have been suits between major players including Pfizer/BioNTech, Moderna, and CureVac. Europe presents a different dynamic, particularly with the Unified Patent Court now active. The potential for pan-European injunctions changes leverage, even if vaccine cases to date have largely focused on royalties.

To date, China and Japan have not seen a comparable wave of public mRNA vaccine patent litigation like that observed in the United States, likely reflecting differences in commercialization and strategic enforcement considerations.

We expect that the U.S. will continue to be the focus for vaccine litigation given its market dominance and availability of damages and the potential for injunctive relief (even if rarely sought).

ARNA: How does regulatory exclusivity (e.g., data exclusivity periods) interact with patent enforcement strategies in the mRNA space? Are sponsors relying more on regulatory barriers or patent fences?

ND: Regulatory exclusivity provides a backstop but rarely replaces patents. For innovative vaccines, data exclusivity periods are meaningful, but patents usually exceed any regulatory exclusivity so still are viewed as superior mechanisms to maintain market share.

In the mRNA space, we see companies rely on both: building patent fences while also leveraging regulatory barriers. In practice, many of the patent disputes have been around other branded competitors and not biosimilars/generics, so the IP litigation is occurring well before regulatory exclusivity expires.

Future Outlook

ARNA: Looking ahead, what do you see as the most important IP or litigation issues that could shape the next three to five years of mRNA-LNP development?

ND: Three themes stand out. First, PTAB practice (and whether recent changes in PTAB practice continue) will shape district court litigation timelines and settlement leverage.

Second, as non-COVID mRNA products mature (oncology vaccines, individualized neoantigen platforms, rare disease therapeutics), litigation will expand beyond infectious disease.

Third, damages modeling will grow more complex as royalty stacking concerns intensify and multiple platform patent holders seek compensation.

ARNA: Are there specific technology areas — such as novel ionizable lipid libraries, AI-designed delivery systems, or modular manufacturing platforms — where you expect IP battles to intensify?

ND: We see specific targeting as where the novelty and battles lie. For more traditional vaccines, they can live with high off-target and/or liver accumulation of LNPs, while other applications (e.g., gene-editing) are really trying to avoid off-target effects and will find novelty there. In vivo editing and AI-designed capsids and targeted delivery technologies will continue to be hot.

ARNA: If you were advising a biotech CEO today on building an IP strategy for an mRNA-LNP program, what would be your top three priorities?

ND:

1. Get your freedom to operate completed early. Be aware of potential future third-party directions and plan accordingly.
2. Scope out the maximum breadth for the LNP and the mRNA pieces independently.
3. Revise your portfolio to focus on leads as soon as you are aware of them.

In terms of questions to ask yourself, there are a lot of parallels between LNP and the CRISPR space over the past decade:

• Can you wait for ongoing litigation to play out for what claims remain valid?
• Do first-generation LNPs work for your purposes, or do you need an LNP system that overcomes known issues?
• Do you want your company to get into the platform delivery improvement space optimized for your mRNA or try to piggy-back off what may be available to license?

About The Experts:

Natasha Daughtrey, J.D., partner, is nationally known for her expertise on intellectual property litigation. A partner of Goodwin’s IP Litigation practice and member of the firm's Life Sciences Disputes group, she has a special focus on patents, trade secrets, and trademarks to deliver wins for her clients. Fighting in court for Teva in patent infringement litigation against Eli Lilly related to Eli Lilly's migraine treatment Emgality (galcanezumab), Daughtrey and her team secured an initial jury verdict of more than $176 million, which is currently on appeal.

Daughtrey earned her J.D., cum laude, from the University of San Diego School of Law. In 2024, the Legal 500 US named Natasha a Recommended Lawyer for Patent Litigation, and in 2020 Patexia named her a top ANDA litigator.

She is co-chair of the Women@Goodwin Los Angeles chapter, where she works to hire, retain, and promote women lawyers. Daughtrey also serves as editor-in-chief of Goodwin’s award-winning blog Big Molecule Watch, covering biosimilars and biologics, and is a key contributor to the firm’s online resource Founders Workbench, a hub for startups and emerging companies.

Bill Christiansen, Ph.D., is a partner in Goodwin’s Life Sciences group. He advises pharmaceutical, biotechnology, clean energy, and medical device companies, as well as universities, non-profit research institutions, and investors, with respect to complex intellectual property matters and market exclusivity strategies.

Christiansen specializes in patent matters, with particular emphasis on worldwide patent procurement, strategic management of patent portfolios, investment due diligence, early-stage company counseling, competitive patent position analysis, and intellectual property value creation. He also advises litigation teams on technical and patent-specific issues. Christiansen has extensive experience in a variety of technologies, including biology-based clean energy, small molecule therapeutics, immunology, gene therapy, stem cell therapeutics, formulations, re-formulations, drug delivery, RNAi, miRNA, antisense, gene regulation, epigenetics, diagnostics, diagnostic and therapeutic polypeptides, polynucleotides, and antibodies, vaccines, genomics, and bioinformatics.

Christiansen has published numerous legal and scientific articles, has extensive teaching and research experience, and is recognized by leading legal directories including Chambers, Best Lawyers, IAM Patent 1000, LMG Life Sciences, and Super Lawyers.