Patenting stem cell therapies in the US is a difficult business, especially if your cell therapy product is defined solely by natural surface cell markers and lacks any form of genetic modification.
Evolve is a specialist pharmaceutical and biotechnology IP firm. Our regenerative medicine work is led by Rose Hughes, formerly IP Lead for AstraZeneca’s biopharma cell therapy department, covering autoimmune CAR-T and regenerative medicine programmes.
Related technologies: CAR-T | Gene therapies | Macrophages | Platform technologies
We help regenerative medicine companies with IP strategy for iPSC and ESC derived products, from the provenance of the starting cell line through to the clinical product.
Defining the product. A regenerative cell product is a heterogeneous population of living cells. If the claimed definition is too narrow, the clinical product can fall outside the markers. If it is too broad, the claim is exposed to insufficiency. We draft definitions around the release criteria and the data, using markers, function and, where they help, product-by-process features. Defining the undefinable
Subject matter eligibility. Stem cell products often face objections that they are natural products, or that they fall within exclusions for human embryos or methods of treatment. We have experience navigating these objections in patent offices around the world, and the law diverges sharply between the US and Europe. Restem v Jadi Cell | T 1259/22
Manufacturing and know-how. Differentiation protocols, banking and scale-up are often where the real advantage sits. We help decide which features to patent, which to hold as managed trade secrets and how to protect know-how with partners and CDMOs. Beyond the process
Data and filing strategy. Heterogeneous products are hard to reproduce, and so is the prior art, so we plan comparative data early and set the global filing footprint against the commercialisation plan. T 0827/23
Yes, but not as they occur in nature, and the US and Europe ask different questions.
US: naturally occurring products are not patent-eligible, so claims usually recite an isolated, modified or specifically prepared cell, and the product has to be shown to be markedly different from what exists in the body. Subject matter eligibility objections are common for unmodified stem cell products.
Europe: isolated cells can be patented, and the questions are usually novelty, sufficiency and inventive step. Inventions that require the destruction of human embryos are excluded, but human ESCs can now be obtained without destroying an embryo, so ESC-based inventions can be patented. Methods of treatment are excluded as such, so they are claimed as a product for use.
Read more: Restem v Jadi Cell | T 1259/22
With a layered claim set built around the product you will release. Marker-defined product claims and functional features come first, with product-by-process claims as a fallback where they help in the US, and method of treatment claims for the indications and regimens. In Restem v Jadi Cell the US Federal Circuit confirmed that a product-by-process claim is novel if the product itself is novel, though enforcement is a separate question. In Europe the questions are usually novelty, sufficiency and whether the claimed effect is credible.
Read more: Restem v Jadi Cell | Defining the undefinable
US: there is no specific exclusion for human embryonic stem cell inventions, and many have been patented, although claims may not be directed to or encompass a human organism, and naturally occurring products still face eligibility objections.
Europe: yes, in many cases. Europe excludes inventions that require the destruction of human embryos, but human ESCs can now be obtained without destroying an embryo, so ESC-based inventions can be patented. How and when the cells could be obtained is still checked, so the claims and the description need to be drafted with that in mind.
iPSC-based inventions avoid the embryo question altogether in both jurisdictions.
Possibly. Reprogramming methods, cell lines and differentiation reagents can each be covered by third-party rights or supplied under licence terms that restrict commercial use. We check the licence position and chain of title for the starting material early, because a partner’s diligence team will ask for it, and gaps are much harder to fix once the product is in the clinic.
Often not on its own. Process claims are designed around, become obsolete as the process improves and are hard to enforce because infringement cannot be seen in the finished product. Features that leave a detectable fingerprint in the product are often worth patenting. The rest may be better protected as a managed trade secret.
Both the US and Europe give some protection to products made by a patented process, including imports, which helps where manufacture happens elsewhere. Trade secrets are protected in both, 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, documented and actively kept secret.
Read more: Beyond the process
With data, planned early.
Europe: the EPO often asks for evidence that the invention works better than the closest prior art, but the prior art product may be even harder to reproduce and define than yours.
US: the question is whether a skilled person would have had a reason to make the product with a reasonable expectation of success, and unexpected results can rebut obviousness.
Comparative and functional data built into the development programme supports both arguments and avoids a gap that is hard to fill later.
Read more: T 0827/23
Where you will manufacture and where you will sell, weighed against the law in each place. The US and Europe treat cell products differently, from eligibility to the form of medical use claims, and Japan has led on approvals of iPSC-derived therapies. We plan the footprint around the commercialisation plan rather than a default list of countries, and draft one claim set that works across the key jurisdictions.
We are happy to have an informal conversation about your programme, with no obligation. You can read more about Rose Hughes, who leads our cell and gene therapy practice, and the rest of our team. We also write a regular newsletter on pharma and biotech IP.