In a simplified way, the production of CAR-T cells works as follows:
- The patient's blood is collected and processed to separate the patient's T cells, which are the most important cells in the human defence system
- The patient's T-cells are genetically engineered to insert the Chimeric Antigen Receptor (CAR) into the cells
- The CAR-T cells are multiplied according to the patient’s need; and
- The CAR-T cells are infused back into patient’s body.
CAR-T cell therapy brings hope to patients who no longer respond to conventional cancer treatments, where T-cells lose the ability to see and attack cancer cells, as they regain this property and may recognise and kill cancer cells.
Approved drugs and ongoing clinical trials
Currently, there are seven FDA-approved treatments using CAR-T cells[1], namely: Axicabtagene ciloleucel (Yescarta™); Brexucabtagene autoleucel (Tecartus®); Ciltacabtagene autoleucel (Carvykti™); Idecabtagene vicleucel (Abecma®); Lisocabtagene maraleucel (Breyanzi®); Tisagenlecleucel (Kymriah®); and Tocilizumab (Actemra®). In parallel, several clinical trials are ongoing in the world.
In Brazil, the Cell Therapy Center of Fundação Hemocentro de Ribeirão Preto is the national pioneer in the production of CAR-T cells for the treatment of cancer patients. Currently, in partnership with the Federal University of São Paulo and the Butantan Institute, clinical trials are ongoing and have shown promising results: so far, 14 patients have been treated with this therapy and all of them had remission of at least 60% of the tumours[2].
Because it is a personalised cell therapy that uses extremely complex technology, the costs of the therapy are very high, which makes it difficult for the population to access it. A great differentiator in Brazil is the fact that this treatment, through the clinical trials mentioned above, is funded by the federal government through the Unified Health System (SUS).
The development of the CAR-T cells technology x Intellectual Property
A global vision of how this technology is developing in a patent scenario shows that the United States, China and Europe are the territories where the most patents related to CAR-T cells are filed, indicating that these are the places where research/clinical tests are being developed more actively.
CAR-T cell therapy is a recent and promising technology, which is evidenced by the considerable increase in the number of patents filed from 2018 onwards.
Going deeper in the patent scenario, results from searches in specific patent databases show that almost all (96%) patents related to T-CAR cells refer to the treatment of cancer, with few occurrences within the microbial/fungal/biofilm, as well as pet/animal/livestock technical fields.
Additionally, the Applicants who filed more patent applications related to this technology are Juno Therapeutics INC and KITE PHARMA INC. Other companies seem to be developing technologies related to the CAR-T cells, such as HANGZHOU DAC BIOTECH and CRISPR Therapeutics AG.
Looking at the Brazilian scenario, we identified in the Brazilian PTO’s database a little more than 30 patent applications whose title or summary includes the expression "CAR-T Cells", with most of these filings being from 2019 onwards. Brazil will certainly follow the exponential growth in the area, reflecting not only domestic investment but also the commercial interests of foreign clients.
Although therapies based on CAR-T cells are already a reality, much research and many improvements are still needed in relation to the technology used, to reduce risks and side effects during their use. The several ongoing clinical trials will certainly contribute to an even more effective and accessible therapy, and it is expected that the inventions associated with these improvements will continue to grow in the coming years, reflecting in a greater number of patent applications directed to this technological area.
FICPI's view and involvement
FICPI uniquely combines education and advocacy on topics around patents and trade marks, with a focus on developing the professional excellence of its individual members. FICPI Forums, Congress, committees and meetings are opportunities to gather insights from the international IP attorney community on any issue, whether it be practice-related or topics of patent and trade mark law.
Next steps
- Search for FICPI members in Brazil by navigating to the FICPI member directory and searching by country.
- Events such as FICPI’s 2023 Open Forum (4-7 October, London) offer the opportunity to attend technical sessions, and to meet and further discussions in congenial surroundings.