Evolve is a specialist pharmaceutical and biotechnology IP firm. Our team includes scientific experts in every technology that goes into an LNP medicine: lipid and polymer chemistry, nucleic acids and cargo design, biochemistry and immunology.
Related technologies: mRNA therapeutics | In vivo CAR-T | Gene therapies | Platform technologies | Formulations
As the disputes over the COVID-19 vaccines wind down, how should companies developing the next wave of LNP-based products in cell and gene therapy navigate the IP landscape?
LNPs are nanoscale delivery vehicles that carry genetic cargo, such as mRNA or DNA, into target cells. They protect the cargo from degradation in the bloodstream and help it cross the cell membrane.
An LNP generally has four components. Ionisable cationic lipids bind the negatively charged cargo. They stay neutral at physiological pH, which reduces toxicity, but become positively charged in the acidic endosome after the particle is taken up. This disrupts the endosomal membrane and releases the cargo into the cytoplasm. Pegylated lipids control particle size and reduce aggregation and immune clearance. Sterols, typically cholesterol, stabilise the particle, and helper phospholipids support structural integrity and cellular uptake.
The molar ratios of these components must be optimised to tune particle size, stability and surface charge, which together dictate biological performance. Efficient and scalable manufacture also remains a challenge.
LNP technology pre-dates the pandemic. The early products delivered RNA to silence gene expression, and Alnylam won approval for the first siRNA LNP, patisiran (Onpattro), in 2018. During COVID-19, the industry and governments took a gamble on LNP vaccines for the first time, to avoid the slow manufacture of traditional viral vector vaccines. The results were Pfizer and BioNTech’s Comirnaty and Moderna’s Spikevax, each with its own LNP formulation and ionisable lipids.
Building on the success of the vaccines, the industry is now applying LNPs to in vivo cell therapy. Instead of extracting and engineering a patient’s cells in a laboratory, a targeted LNP delivers genetic instructions that reprogram circulating cells inside the body to attack cancer or autoimmune disease. The aim, in both cancer and autoimmune disease, is full remission. Traditional ex vivo cell therapy can deliver this, but its cost and manufacturing burden restrict it to a small number of patients, mostly as an end-of-the-line treatment for incurable cancer. In vivo approaches seek to solve that problem.
Commercial interest has been huge, reflecting a wider shift by big pharma towards acquiring whole technology platforms rather than single drug candidates. Key deals include AbbVie’s 2.1 billion dollar acquisition of Capstan Therapeutics.
Clinical data is now emerging. Capstan began a Phase 1 trial of CPTX2309 in SLE and RA in June 2025 (NCT06917742). Its platform uses an ionisable lipid designed to reduce off-target liver accumulation and minimise reactogenicity, and the trial is expected to read out in 2026. MagicRNA published the first clinical data for an mRNA-based in vivo CAR-T in The New England Journal of Medicine in September 2025. Its targeted LNP, HN2301, given without lymphodepletion to 5 patients with refractory SLE, depleted circulating B cells for up to 10 days and substantially reduced disease severity scores.
Vivacta Bio and Grit Biotherapeutics have also reported early data in relapsed or refractory non-Hodgkin lymphoma. Two patients received repeated doses of a targeted mRNA-LNP without lymphodepleting chemotherapy, the therapy was generally well tolerated, and expansion was durable and repeatable after each dose. In China, Starna Therapeutics reports that a single low-dose infusion eliminated circulating B cells within 72 hours in patients with SLE and non-Hodgkin lymphoma, and it is now starting a clinical trial in lymphoma (NCT07245251).
LNPs are not the only option. In April 2026, Eli Lilly agreed to acquire Kelonia Therapeutics, which uses engineered lentiviral particles to transduce T cells in vivo, for up to seven billion dollars. Which delivery technology wins will, for now, be a scientific decision rather than a legal one.
LNP platforms and products are protected by multiple layers of patents and trade secrets. Patents cover the ionisable, pegylated and helper lipids and other components, LNP formulations and manufacturing methods, cargo formats such as circular RNA, and ways of targeting LNPs to specific cells and tissues. The cargo itself can also be protected. Onpattro, for example, is covered by patents to the siRNA sequence (US 8168775 B2) and to a method of treatment with LNPs comprising it (US 9101643 B2).
The commercial value of LNPs has produced a complex web of multi-jurisdictional disputes. Arbutus Biopharma and Genevant Sciences, which control foundational patents to the four-component LNP architecture and its manufacture, sued Moderna over Spikevax and mRESVIA on patents including US 8058069, US 9364435 and US 11141378 (Arbutus v Moderna) and Pfizer and BioNTech over Comirnaty on a similar family, including US 11298320 and US 11318098 (Arbutus v Pfizer).
Alnylam asserted composition of matter patents to specific biodegradable cationic lipids, including US 11246933, US 11590229 and US 11633479, against Moderna’s SM-102 and Pfizer’s ALC-0315. In Alnylam v Moderna, the Federal Circuit held that a restrictive definition of “branched alkyl” in the description narrowed the claims, a clear lesson in careful drafting (Evolve Insights). Alnylam has since withdrawn its parallel suit against Pfizer and BioNTech.
Moderna has itself sued Pfizer and BioNTech in several jurisdictions on patents combining mRNA modifications with LNP delivery, including US 10702600, US 10933127 and EP 3718565. Pfizer and BioNTech invalidated the two US patents at the PTAB, arguing that their “unimaginably broad claims” covered mRNA concepts already known before the 2015 priority date (see IPwatchdog), while a German court found infringement of the European patents. GSK has also sued Pfizer, and Acuitas has brought inventorship claims against Alnylam and CureVac, seeking co-ownership of their patents.
The landscape is starting to calm. Many foundational patents are nearing expiry and matter little for products that are years from launch. Arbutus and Genevant reached a global settlement with Moderna in March 2026, and many of the disputed patents have been narrowed to specific vaccine products and their LNP formulations. The original vaccines cannot now change their lipids or formulations, but companies developing new LNP-based products can design around these patents.
New disputes are already emerging, however, and trade secrets are becoming a key battleground. In September 2025, Arcturus Therapeutics sued AbbVie, alleging that Capstan misappropriated LNP trade secrets through a former employee and a consultant and then used them in a patent application naming those individuals as inventors. Arcturus claims that the main value of the Capstan acquisition lies in these trade secrets. Trade secret disputes are clearly not only a tech industry problem. With trade secrets increasingly central to biotech IP strategy, this is a case to watch.
The LNP landscape can feel daunting, but most active disputes concern IP that is old or irrelevant to the next wave of products. The volume of litigation reflects the commercial success of the vaccines as much as the underlying IP. The future of LNP IP strategy will be about building layers of protection for complex, multi-layered products.
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