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 CAR-T practice is led by Rose Hughes, formerly 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.
Related technologies: In vivo CAR-T | Macrophages | T cell engagers | Antibodies | Gene therapies
A CAR-T product is a binder, a receptor architecture, a vector, an engineered cell population and a manufacturing process. A generalist sees a patent. We see the product. Our cell therapy attorneys have doctoral research behind them in immunology and vector design, including the construction and cloning of VSV-G pseudotyped lentiviral vectors. We read your data, talk to your scientists in their own language and see the claim the data will actually support. We have led cell therapy IP inside big pharma, reported IP risk to boards and run diligence on high-value cell therapy deals. We draft and prosecute with the commercial questions in mind: how long is the market protected, and why can a competitor not simply design around?
There is no biosimilar pathway for CAR-T. Market erosion comes from in-class competitors with different sequences, so a portfolio built only on the exact CAR sequence will not stop them. We build protection around the features that drive efficacy and safety. Read more: Thinking beyond the sequence
The binder, the signalling and costimulatory domains, the nucleic acid, the engineered cell and the defined cell population. The hard part is defining the product so the clinical product falls inside the claims without exposing them to an insufficiency attack. Read more: Defining the undefinable | A new way to define T cells
Treatment protocols, conditioning and dosing regimens, safety management, responding patient subpopulations and each new indication. Much of this can be claimed from data a company already holds. Read more: T 1555/23 | Bridging the innovation and commercialisation gap
Process patents get designed around, can become prior art against your own improvements and are hard to enforce. We help you decide what to patent and what to hold as a managed trade secret. Read more: Beyond the process | T 0868/23
Patents on targeting molecules cover the molecule per se, so an antibody, ADC or bispecific patent on your target can block your CAR-T. We clear the binder across every modality, plus the vector, editing platform and process, timed so you pay for a full opinion once the product is fixed. Read more: Overcoming FTO and patentability challenges
Every approved ex vivo CAR-T product depends on a viral vector. A lentivector can be an assembly of separately owned parts, so we work through patentability and freedom to operate component by component, for therapeutics developers and for vector manufacturers.
A payload or targeting moiety developed for an autologous product usually carries value into allogeneic, in vivo and CAR-macrophage approaches. We draft so that value is not given away. Read more: The universal cell therapy revolution | CAR-M cell therapy
As fractional in-house IP counsel we support portfolio strategy, report IP risks and opportunities to the board, sit in the R&D and regulatory conversations where filing timing is actually decided, and negotiate IP term sheets. Rose Hughes currently acts as lead IP counsel to a Nasdaq-listed clinical-stage cell therapy company, directing its IP strategy.
Why fractional IP counsel for CAR-T companies? CAR-T companies face fast followers, crowded binder landscapes and investors who want to know how the market is protected. Our patent directors have led cell therapy IP in-house, so they bring the real-world industry experience that you only get working in-house to those questions, with the support of a specialist cell therapy team and our own AI tools that a lone consultant cannot offer. A traditional IP firm can file for your CAR, but rarely sits in the room when the clinical and manufacturing decisions are made. We do, with a global strategic approach.
Part of the job is making the portfolio explainable. When investors and acquirers ask how long the market is protected and why a competitor cannot design around, we make sure you have an answer that survives diligence.
Built by our own patent attorneys for pharma and biotech work. The tools do the groundwork. The analysis, and the advice, are ours. Our fractional IP clients have access to the whole Evolve AI ecosystem as standard. Every output is reviewed by the attorney responsible for your work, and no client data is used to train models. See our AI tools.
Not necessarily. Novelty asks whether anyone has published your construct before. Freedom to operate asks whether making, using or selling it falls within someone else’s claims, and a genuinely novel CAR can still sit inside a broader granted right. Patents on targeting molecules cover the molecule per se, so an antibody, ADC or bispecific patent on your target can block you even though that patentee never contemplated a cell therapy. The vector, the payload, the editing platform, the process and the cell source each need clearing too, in every territory where you will manufacture or sell.
Read more: IP strategy for cell therapy: FAQs
Once the product is finalised and heading into the clinic. An opinion on a construct, a vector and a process that are all still moving will be out of date before it is delivered. Before that point, a targeted search on the lead binder when the lead is chosen, and a landscape of competitor technologies, is far more useful and far less expensive.
Rarely. There is no biosimilar pathway for CAR-T, and the competition comes from in-class products with different binders aimed at the same target and indication. Sequence-limited claims do not reach those products. We are now seeing broad, non-sequence-limited claims asserted between CAR-T competitors at the Unified Patent Court, which shows where the value lies.
Read more: Thinking beyond the sequence | Patents versus regulatory exclusivity
Often not on its own. Process claims are designed around, become obsolete as the process changes and are hard to enforce because infringement cannot be seen in the finished product. Where the process really is the advantage, a managed trade secret is usually better. Features a competitor could arrive at independently, or that can be reverse engineered, are often still worth patenting, so most companies need a hybrid strategy.
Read more: Pitfalls of cell therapy manufacturing IP
When the data supports the claim you want, and not before. Filing too early produces an application that cannot be enabled across its scope. Filing too late risks a competitor publication, or your own conference abstract, becoming prior art. We align filings with the clinical programme and time later filings against regulatory interactions, when release criteria and markers are settled.
Yes, in important ways. In Juno v Kite the US Federal Circuit applied a strict written description requirement to a CAR-T claim covering a broad genus of binders, and the claim fell. The EPO asks whether the data make the claimed effect credible across the scope of the claim. China, now a major source of CAR-T innovation and approvals, and Japan apply their own standards too. A claim set has to be drafted to survive in every market that matters.
Read more: Juno v Kite
Whether the market is protected, for how long, and why a competitor cannot simply design around. They also test whether the company owns what it says it owns, whether in-licences cover the field and territory needed, whether the claims cover the clinical product rather than an earlier construct, and whether manufacturing know-how is documented and actually kept secret.
We are happy to have an informal conversation about your programme, with no obligation. You can read more about our team, and we also write a regular newsletter on pharma and biotech IP.