Evolve is a specialist pharmaceutical and biotechnology IP firm. Our team includes scientific experts in every technology that goes into an mRNA medicine: nucleic acids and sequence design, lipid and polymer chemistry, biochemistry, immunology and vector biology.
Related technologies: Lipid nanoparticles | Gene therapies | In vivo CAR-T | Platform technologies
We help RNA developers clear freedom to operate on their formulation and build a patent estate of their own around it that stands up to investor scrutiny. We have experts in each of the technologies involved, from nucleic acid chemistry and cargo design to lipid and polymer chemistry, biochemistry and immunology, so we can follow an invention wherever it sits in the stack.
Formulation. Lipid nanoparticles combine an ionisable lipid, a PEGylated lipid, a sterol and a helper lipid, and the molar ratios between them tune size, stability and charge. Each ingredient, the ratios and the combination can be claimed separately, often by different owners. Navigating the complex LNP IP landscape
Cargo and targeting. Nucleotide modifications, untranslated regions, sequence design and formats such as circular RNA, and targeting moieties that take particles beyond the liver to specific cells, including T cells for in vivo CAR-T. These are some of the most active filing areas in the field. The universal cell therapy revolution
Disputes and risk. LNP and RNA delivery is one of the most heavily litigated landscapes in advanced therapies, and trade secret disputes are emerging alongside patent cases. We follow the disputes closely so our clients understand the risks and can build their own innovation around them. Navigating the complex LNP IP landscape
Supply, manufacturing and know-how. GMP-grade ionisable lipid supply is concentrated in fewer than ten manufacturers worldwide, and scalable LNP manufacture remains a challenge. We help decide which features to patent, which to keep as managed trade secrets, and how to protect know-how with suppliers and CDMOs.
Often yes, but less often than companies assume. Each component of 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. 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. Licence scope needs checking for each territory, because patent families are rarely identical across the US, Europe, China and Japan.
Read more: Navigating the complex LNP IP landscape
Less than they were. Many of the foundational formulation patents are approaching expiry, and many disputed claims have been narrowed to particular products and formulations. A product that is years from launch can often avoid them. Newer families on lipids, targeting and manufacturing are a different matter, and the position can differ between the US and Europe, where the same family may have been granted with different claims or decided differently by the courts.
Yes, in both the US and Europe. The cargo sequence, the specific formulation, the targeting, the therapeutic use and the dosing regimen can each support claims. Onpattro, for example, is protected both by a US patent on its siRNA sequence and by a US patent on a method of treatment using lipid nanoparticles containing it. In Europe the use is claimed as a product for use rather than a method of treatment, and the EPO will look for data showing the effect is credible.
With claims at several levels: the novel lipid, the formulation with defined components and ratios, the formulated product with its cargo, and its use. In the US, broad functional or genus claims face strict written description and enablement requirements, and definitions in the description can narrow the claims. At the EPO, selections of ranges and ratios must be clearly disclosed in the application as filed, so fallback positions need to be written in from the start.
Read more: Navigating the complex LNP IP landscape
Usually a mix. Formulation features that can be identified in the product are generally worth patenting. Manufacturing know-how that cannot be detected may be better held as a trade secret, protected under the Defend Trade Secrets Act in the US and national laws implementing the Trade Secrets Directive in Europe, provided it is identified, documented and actively kept secret. Trade secret claims are now appearing alongside patent litigation in this field.
Once the cargo, the formulation and the process are fixed and the product is heading into the clinic, covering every territory where you will manufacture or sell. Before that point, a landscape of competitor technologies, updated as the programme moves, is far more useful and far less expensive.
Read more: FTO versus patentability | Overcoming FTO and patentability challenges
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.