Evolve is a specialist pharmaceutical and biotechnology IP firm. Our cell and gene therapy practice is led by an advanced therapies industry-expert who was previously IP Lead for biopharma cell therapy at AstraZeneca.
Investors and partners will ask you how the market is protected. We make sure you have a good answer.
Rose Hughes leads Evolve’s cell and gene therapy practice. Rose was formerly IP Lead for biopharma cell therapy at AstraZeneca and Director of Patents. She holds a PhD in immunology from UCL on human macrophages and lentiviral vectors, and has led IP due diligence and deal negotiation on high value cell therapy transactions. She has sat on the client side of the table, communicated IP risk and opportunities to company boards and senior executives and supported successful investor interactions. Read more: Rose Hughes
We provide senior, in-house-calibre IP leadership on a flexible retainer. In practice that means supporting portfolio strategy, reporting IP risks and opportunities to the board, sitting in the R&D and regulatory conversations where filing timing is actually decided, and negotiating IP term sheets. Rose Hughes currently acts as lead IP counsel to a Nasdaq-listed clinical-stage cell therapy company, directing IP strategy.
We act as fractional in-house IP counsel, so this thinking is available from seed stage rather than only at the point of a transaction. Part of that work is making the portfolio explainable. Investors and acquirers ask how long the market is protected and why a competitor cannot simply design around. We help our clients answer both questions so that they can be successful in diligence and partnering. Read more: Fractional IP Counsel | Bridging the innovation and commercialisation gap
The competitive threat we see in cell and gene therapy is a fast follower rather than a biosimilar, and that reverses the usual patent prosecution approach used in other fields. Rather than narrow patent claims directed exact structure of the CAR or targeting molecule, the more durable IP position is usually built around the features that drive efficacy and safety. Loss of exclusivity (LoE) for a cell therapy is rarely set by patent expiry of a narrow product patent for the targeting molecule, or by the end of regulatory exclusivity. In practice it is set by competitors, whether that is another product of the same modality or a different modality reaching the same indication. Forecasting the protected period and planning the portfolio against the backdrop of the competition in the field requires a different approach to IP strategy from someone with extensive experience in the commercial realities and opportunities of advanced therapies. Read more: Patents versus regulatory exclusivity | Bridging the innovation and commercialisation gap
In cell therapy, the manufacturing process and the product are two different assets, and they need different forms of protection. Process patents filed early on may get designed around, change over time, become prior art against your own improvements, and be difficult to enforce. Innovative manufacturing at the early stage is therefore often better held as a trade secret. We work with clients on where those lines fall, separating the company know-how, the process detail worth protecting as a formal trade secret, and the features where the commercial return justifies patenting and the disclosure that comes with it. Getting that division right is also what makes the moat credible to investors and potential partners. We have extensive experience helping our clients get this right for their cell or gene therapy technologies. Read more: Beyond the process | Pitfall of manufacturing IP (T0868/23)
The hardest part of drafting a cell therapy patent is knowing how to define the product. If the definitions are too narrow, the clinical product can fall outside the claimed markers. If it is too broad, the claim is exposed to an insufficiency objection and inaccurate or outdated definitions used in patents can adversely affect validity and scope. We are scientific experts in these technologies, and we know how to align IP with the commercial, regulatory and scientific realities of an advanced therapy programme. Read more: Defining the undefinable | A new way to define T cells
CAR-T is the most clinically and commercially validated cell therapy modality, with approved products in haematological cancer, established franchises behind them and a move into autoimmune disease that widens the addressable market considerably. Seven CAR-T products have now been approved, and appetite for the next generation is visible in the deal flow, with more than seven billion dollars of in vivo CAR-T acquisitions announced in
the twelve months to February 2026 and a single option to acquire an in vivo developer valued at 2.58 billion dollars in 2026. In CAR-T cell therapy, getting the product IP right is the foundation of everything that follows. Patents on targeting molecules cover the molecule per se, so an antibody, ADC or bispecific patent on your target can block your CAR-T therapy product. Freedom to operate means clearing binder IP across every modality, plus the vehicle, the editing platform, the vector and the process. Timing matters as much as scope. A targeted search on the lead binder when the lead is chosen, followed by a full freedom-to-operate review once the construct, the formulation and the process are fixed, is more useful and less expensive than a broad early opinion t
hat has to be redone. Read more: The great consolidation | The first CAR-T for a solid tumour
A CAR-T portfolio is built from several distinct kinds of IP, and they do not all arrive at the same time. Product IP covers the construct itself, meaning the binder, the signalling and costimulatory domains, the nucleic acid, the engineered cell and the defined cell population. Clinical IP covers the treatment protocol, the conditioning and dosing regimen, methods of use, the patient subpopulations that respond and each new indication. Process IP covers the manufacturing route and the analytics that define the product, and platform IP covers whatever is reusable across more than one product. Much of the clinical and process IP is generated by the programme itself, and a good deal of it can be claimed from data a company already holds. We are experts in finding, identifying and capturing this IP. Read more: Bridging the innovation and commercialisation gap | T 1555/23
Filings also need to look forward. A payload and a targeting moiety developed for an autologous CAR-T will usually carry value into other indications and other modalities, from allogeneic products through to in vivo CAR-T, and claims drafted only to the construct in the clinic today give that away for nothing. Read more: IP strategy for the universal cell therapy revolution | Juno v Kite
Lentiviral vector IP and freedom to operate
Lentiviral vectors remain the workhorse of ex vivo gene delivery, and vector performance, titre and stability drive both the science and the cost of goods of every product built on them. Every currently approved ex vivo CAR-T product depends on a viral vector to deliver the construct, and vector supply, performance and licence terms are all negotiated against that dependency. We advise on lentiviral vector IP strategy for therapeutics developers and for vector manufacturers, and we do it from a research background in the technology. Our cell therapy IP experts are scientific specialists in the field, with doctoral research behind them in vector design and delivery, including the construction and cloning of VSV-G pseudotyped lentiviral vectors. Read more: IP strategy for the universal cell therapy revolution
A lentivector particle for cell and gene therapy can be an assembly of separately owned parts, so freedom to operate and patentability both have to be worked through component by component, as well as in combination. Each of those parts may carry its own in-licence or IP risk. The envelope and its pseudotyping, the mutations that detarget it, the cell-specific targeting moiety, the payload and the surrounding vector design each sit in a different and densely filed landscape. We help clients build a patent estate of their own that captures their innovation, steers around third party rights and avoids licences they do not need to take. Read more: Overcoming freedom to operate and patentability challenges
Lipid nanoparticles are the delivery platform that made RNA medicines viable at scale, and the same chemistry now underpins in vivo gene editing and in vivo cell engineering, which is why the formulation itself carries so much of the commercial value. The stakes were made plain by a more than 2 billion dollar global settlement over LNP delivery patents, and supply remains concentrated in fewer than ten GMP-grade ionisable lipid manufacturers worldwide. For RNA and gene therapy developers, our lipid nanoparticle work covers both sides of the problem, clearing freedom to operate on the formulation and building a patent estate around it that stands up to investor scrutiny. Ownership of the underlying technology is just as fragmented here as it is for viral vectors, but the pressure points are different. Clearance and patentability turn on the formulation as a whole and on every ingredient within it. The ionisable lipid, the PEGylated lipid and the rest of the lipid mix, any targeting moiety, the payload, the manufacturing method and the indication are each claimed separately, frequently by different owners, and the combination is often claimed again over the top. Read more: Navigating the complex LNP IP landscape | Overcoming freedom to operate and patentability challenges
Lipid nanoparticle delivery is also the most heavily litigated landscape in advanced therapies. The disputes are instructive and we monitor the litigation landscape closely so that our clients stay informed about the risks. Our role is to help our client navigate the complexities of the landscape, protect their own innovation, and make the resulting position attractive to investors and partners.
Read more: Navigating the complex LNP IP landscape | The great consolidation
iPSC and ESC derived cells offer something autologous therapy cannot, a renewable and bankable starting material that turns a bespoke treatment into a manufacturable product with a real cost base. In February 2026 Japan granted the world’s first conditional approvals for iPSC-derived therapies, one in Parkinson’s disease and one in severe heart failure, which moves the field from research promise into a commercial market with real competitors. Read more: Beyond the process | The great consolidation
We help regenerative medicine companies with the IP strategy for iPSC and ESC derived products, from the provenance of the starting cell line through to the clinical product itself. Read more: Defining the undefinable | T 0827/23
The law on iPSC-derived products diverges sharply between the US and Europe. We work out a patent strategy that actually holds in each jurisdiction before filing. We also advise clients on their global patent filing footprint for regenerative technologies, based on the commercialization plan and evolving patent law. Read more: Restem v Jadi Cell | T 1259/22
Macrophages reach solid tumours and inflamed tissue that engineered T cells struggle to enter, which is the scientific reason the field exists and the commercial reason it attracts investment while still at an early stage. The first-in-human CAR-macrophage trial, in fourteen patients with HER2-overexpressing solid tumours, reported safety and manufacturing feasibility in Nature Medicine in 2025, and that single dataset is carrying much of the field’s investment case. We are proud experts in macrophage biology. Our cell therapy expert, Rose Hughes, holds a PhD thesis was directed to human macrophage, and we are excited by the potential of these cells to be the next big thing in cell therapy. The IP opportunities in this space are huge. Read more: CAR-Macrophage (CAR-M) cell therapy | Defining the undefinable
