The loss of market share we are already seeing for on-market cell therapy products is a result of in-class competitors for the same target and indication from rival innovator companies, not copycat products with identical CAR sequences.
Evolve is a specialist pharmaceutical and biotechnology IP firm. Our team includes scientific experts in every technology that goes into an in vivo CAR-T product: immunology and T cell biology, viral vectors, lipid and polymer chemistry, nucleic acids and biochemistry.
Related technologies: CAR-T | Lipid nanoparticles | Gene therapies | Macrophages | T cell engagers
Cell therapy has always been limited by logistics and scale. The approved CAR-T therapies are autologous: each patient’s own cells are engineered ex vivo and reinfused, with vein-to-vein times of around two weeks and list prices often above $400,000. Allogeneic, off-the-shelf cells were the first answer. In vivo CAR-T goes further. It engineers the patient’s own T cells inside the body, using lentiviral vectors or lipid nanoparticles (LNPs), and removes ex vivo manufacturing altogether. It has been hailed as potentially revolutionary for the field, particularly as CAR-T moves into autoimmune disease, where the limits of autologous manufacturing will be felt most.
AbbVie’s $2.1 billion acquisition of Capstan Therapeutics, AstraZeneca’s acquisition of EsoBiotec for up to $1 billion, Gilead and Kite’s $350 million acquisition of Interius BioTherapeutics and Eli Lilly’s agreement to acquire Kelonia Therapeutics for up to $7 billion all point the same way. Large pharma is buying proprietary delivery platforms that can generate a pipeline of products, rather than single drugs (Evolve Insights).
Capstan began a Phase 1 trial of its LNP-delivered CPTX2309 in SLE and RA in June 2025. MagicRNA published the first clinical data for an mRNA-based in vivo CAR-T in The New England Journal of Medicine in September 2025, reporting complete depletion of circulating B cells and reduced disease activity in refractory SLE, without lymphodepletion. Vivacta Bio, Grit Biotherapeutics and Starna Therapeutics have also reported encouraging early results in lymphoma and SLE (Evolve Insights).
The IP landscape for in vivo cell therapy is still being written, which creates a huge opportunity for innovators. The focus is shifting from the CAR to the delivery mechanism, although both still matter. Whether the product uses engineered lentivectors or targeted LNPs, the delivery technology is the key enabling component, and protecting it is paramount.
Delivery vehicles overlap with vaccines and gene therapy, so their landscapes are already crowded. The strongest position usually comes from protecting what is specific to cell therapy, such as targeting the vector to the right cells while avoiding off-target effects.
Existing CAR IP still matters. Many CAR patents cover the molecule regardless of how the cell is made, and some are very broad. A core patent for Breyanzi, for example, defines an anti-CD19 CAR only by the sequence of its CD3ζ signalling domain (US 9856322). In Europe, a new CAR against an established target will usually need data showing it works better than the prior art (Evolve Insights). As always, the best IP strategy follows the science. Truly innovative solutions are more likely to be patentable and to fall outside older, broader patents.
An in vivo CAR-T product combines a delivery vehicle, a targeting moiety, a cargo and a CAR, and each has its own crowded landscape. We help you protect what is yours in each, clear what is not, and build an estate that supports the deal.
Delivery. In vivo CAR-T is delivered either by targeted lipid nanoparticles carrying RNA or by engineered lentiviral particles. We have experts in both, so we understand the science behind the ionisable lipids, formulations and targeting moieties on one side, and the envelopes, detargeting mutations and payloads on the other (Evolve Insights).
Competitive intelligence, patentability and FTO. New filings, clinical data and deals arrive every month, much of it from China. We keep landscapes current so that patentability and freedom to operate decisions for the delivery technology, the targeting, the cargo and the CAR are made on today’s picture (Evolve Insights).
Platform versus product claims. We help ring-fence platform IP from product IP, so that each can be licensed, partnered or sold on its own terms in licensing and acquisition deals (Evolve Insights).
Speed and positioning. We help you file quickly and in the right order, capture clinical IP such as dosing without lymphodepletion and repeat dosing as the data emerges, and shape the portfolio so that it is attractive to the investors, partners and acquirers buying in vivo platforms. Our team has handled the IP work on an in vivo CAR-T licence for a Nasdaq-listed clinical-stage biotech (Evolve Insights).
Read the full article on IP strategy for the universal cell therapy revolution
At the moment the choice is a scientific one, not a legal one. Both routes are densely patented in the US and Europe, and each brings its own landscape. Pick the route your science supports, then build the IP around your own innovation within it.
Read more: Navigating the complex LNP IP landscape
Not automatically. The binder clearance still applies, but an in vivo product brings the delivery vehicle, the cargo format, the targeting moiety and the dosing regimen into play, and each has its own landscape. Patent families are rarely identical across the US, Europe, China and other markets, so clearance has to be checked in each territory where you will manufacture or sell.
Read more: Overcoming FTO and patentability challenges
Yes, if the claims rest on what is new: the targeting of the delivery vehicle, the cargo design, the expression profile, treatment without lymphodepletion or a new dosing regimen, supported by data.
Europe: the EPO will often expect evidence that the invention works better than the closest prior art, not only that it works.
US: the question is whether a skilled person would have had a reason to make it with a reasonable expectation of success, and unexpected results can rebut obviousness.
Into separate, clearly defined families where possible. Platform claims to the delivery system or engineering approach, and product claims to each construct and clinical candidate, can then be licensed, partnered or sold on their own terms. US continuation practice and European divisional applications both allow claims to be pursued in stages, but the support for each has to be in the application as filed.
Read more: The great consolidation
Before anything is presented. Early observations such as the depth of B cell depletion, the dosing schedule or the absence of lymphodepletion can support valuable filings. The US gives a one-year grace period for your own disclosures, but Europe does not, so a conference abstract or press release before filing can destroy novelty in Europe even where the US filing is still possible.
They look at whether the platform can generate more than one product, whether the company owns or securely licenses every component, how long the protection runs and whether it holds in both the US and Europe. Recent deals show big pharma buying technology platforms rather than single drugs, so a platform estate that is clearly explained is worth more.
Read more: The great consolidation
Yes. Trade secret claims are now being brought alongside patent litigation in this field. Know who has had access to what, keep records of independent development, and make sure collaboration and supplier agreements deal with know-how expressly. Trade secrets are protected under the Defend Trade Secrets Act in the US and national laws implementing the Trade Secrets Directive in Europe, but only if they are identified and actively kept secret.
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