Evolve is a specialist pharmaceutical and biotechnology IP firm. Our gene therapy work is led by Rose Hughes, formerly IP Lead for biopharma cell therapy at AstraZeneca.
Related technologies: Lipid nanoparticles | In vivo CAR-T | mRNA therapeutics | CAR-T | Regenerative cell therapies
Gene therapy patents are won and lost on the science. You need attorneys who understand how the construct works and how the deal will be done. Our attorneys have doctoral research behind them in vector design and delivery, including the construction and cloning of VSV-G pseudotyped lentiviral vectors. We understand how vector, promoter and payload choices affect performance, and where the patentable innovation really sits. We have run IP diligence and negotiations on licensing deals involving gene therapy assets, and advised on how vector supply and licence terms feed into the cost of goods. We draft and prosecute with the eventual deal in mind.
Patentability and freedom to operate for a gene therapy have to be worked through component by component and in combination. We know where the dense patent thickets are and how to build your own innovation around them. Read more: Overcoming FTO and patentability challenges
Lentiviral and other viral vectors, including envelope pseudotyping, detargeting mutations, cell-specific targeting moieties and vector design. We advise therapeutics developers and vector manufacturers, from a research background in the technology.
CRISPR and base editing, ex vivo and in vivo. Ownership of the foundational editing IP is still contested, so the licence position matters as much as your own patents. Read more: Regents v Broad Institute
Lipid nanoparticles for in vivo gene editing, where the ionisable lipid, the formulation, the targeting moiety and the payload may each be claimed by a different owner. Read more: Navigating the complex LNP IP landscape
Transgenes, regulatory elements, guide RNAs and expression cassettes, with claims drafted to cover the clinical construct and the variants a competitor would try next.
Long-term follow-up now shows that a single gene therapy can work for years. Dosing, patient selection and durability findings can support valuable later filings if they are captured at the right time. Read more: The great consolidation
Regulatory exclusivity, patent term extensions and SPCs, planned alongside the patent estate so the protected period is forecast against the real competition. Read more: Patents versus regulatory exclusivity
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 gene therapy companies? Gene therapy portfolios are built on a web of vector, editing and delivery in-licences as much as on your own patents. Our patent directors bring the real-world industry experience that you only get working in-house to managing that web, and our team and AI tools to keep it aligned with the clinical plan. That is something a traditional IP firm rarely provides and a consultant working alone cannot sustain, and we do it with a global strategic approach.
For gene therapy companies that usually means managing a web of in-licences for vectors, editing tools and delivery technology alongside the company’s own filings, and keeping both aligned with the clinical plan.
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.
Often yes, but less often than companies assume, and the cost of assuming is high. Each component of a vector or a lipid nanoparticle may carry its own in-licence, and those royalties stack, so a product that is clear on paper can still be uneconomic once every licence is layered up. The better route is to follow your own science. A programme that solves a real technical problem with its own innovation usually ends up outside the crowded space, and generates something patentable in its own right.
Read more: IP strategy for cell therapy: FAQs
Possibly more than one party. The foundational CRISPR IP has been disputed for years, and in the US the first-to-invent contest between the University of California and the Broad Institute was sent back for reconsideration. Most developers rely on licences from platform owners, so the scope, field and territory of those licences need checking as carefully as your own patents.
Read more: Regents v Broad Institute
Yes, if the invention lies somewhere else. A new payload, regulatory element, targeting moiety, patient population or dosing regimen can each support claims. What matters is identifying the technical contribution and having the data to show it works, and ideally that it works better than what came before.
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 is the real advantage, a managed trade secret is usually better. Features that could be reverse engineered or reached independently are often still worth patenting, so most companies need a hybrid strategy.
Read more: Beyond the process
Patents are only one layer. Regulatory exclusivity runs from approval, independently of the patents, and patent term extensions and SPCs can add to the patent term. For a one-time and potentially curative therapy, competition from other modalities treating the same disease may matter more than the expiry date of any single patent, so we forecast the protected period against the real competition.
Read more: Patents versus regulatory exclusivity
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.
Whether the market is protected, for how long, and why a competitor cannot design around. For gene therapy they look closely at chain of title from universities and founders, at whether in-licences for vectors, editing tools and delivery technology cover the field and territory needed, and at whether the claims cover the clinical construct.
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.