As research and development efforts move forward in relation to Chimeric antigen receptor CAR-T cells, it is interesting to understand the main patentability issues of these technologies in order to obtain patent protection quickly and in a manner that satisfies the commercial interests of companies.

In Brazil, parts of natural living beings are excluded from patent protection, even if modified/recombinant, which means that human cells are not considered to be patentable in Brazil. By this rationale, the current Brazilian IP law excludes from patent protection CAR-T cells per se. On the other hand, it is possible to obtain patent protection for compositions/formulations comprising said CAR-T cells and at least one further component (excipient/carrier) that does not represent a mere dilution of said cells (such additional component in the composition should be different from water or saline, for instance).

To illustrate this understanding, please see below a concrete example of the Brazilian PTO’s examination regarding claims directed to human cells and composition comprising only said cells:

Claims BPTO’s comments

X. An isolated T cell (…), characterised by comprising at least one gene that encodes a component of the T cell receptor (TCR) (…).

Y. Pharmaceutical composition, characterised by comprising at least one isolated T cell, as defined in claim X.

The subject matter of claim X refers to a variety of plant or animals, which is not patentable, as it falls within the provisions of Article 18 (III) of the Brazilian IP law. T cells are encompassed here. Compositions with 1 cell are the cell itself.

Besides the information provided above, companies interested in seeking patent protection for CAR-T cell-related technologies in Brazil should keep in mind that therapeutic methods and methods comprising invasive steps are not considered to be inventions in Brazil. Specifically, Article 10 (VIII) of the Brazilian IP law establishes that therapeutic, surgical and diagnostic methods applied to the human or animal body are not considered to be inventions, that is, methods having at least one invasive/administration step and/or methods with purposes of cure, prophylaxis or diagnosis are usually non-patentable.

In this case, the steps of obtaining the patient’s blood and infusing back the CAR-T cells into patient’s body should not be accepted by the Brazilian PTO, based on the allegation that they are invasive steps to the human body.

There are alternatives to deal with the non-patentability of therapeutic methods, for instance. It is possible to obtain protection for the therapeutic use of these cells through claims drafted in the Swiss-type format (use of a compound X characterised in that it is in the manufacture of a medicament to treat a disease Y), which is the claim format currently accepted by the Brazilian PTO. Special attention should be paid to the fact that features related to administration steps and dosage regimen are usually interpreted by the Brazilian PTO as associated to therapeutic methods and, therefore, not considered an invention, as exemplified below:

Claim (emphasis added) BPTO’s comments
X. Use of cyclophosphamide, characterised in that it is in the manufacture of a medicament and/or a kit and/or a composition to prepare a patient with a tumour for treatment with genetically engineered T cells that express a chimeric antigen receptor (CAR-T cells), wherein the cyclophosphamide is administered to the patient at doses of 500 mg/m²/day to 600 mg/m²/day for 3 days with fludarabine before treatment of the tumour with CAR T cells. Despite the fact that the claims are intended to protect the use of cyclophosphamide to manufacture a product for treatment, they include therapy or drug administration steps, including mentioning doses and administration regimens employed, which ends up configuring a therapeutic method for application in the human or animal body, which is not considered to be an invention, according to Article 10 (VIII) of Brazilian IP law.

Finally, considering that most patent applications directed to CAR-T cell-related technologies were filed in recent years, the Brazilian PTO has not yet had the opportunity to carry out the technical examination of most of these cases. However, since the obstacles mentioned above are provided by the current IP law, it is expected that these provisions are applied during the examination of these cases and thus, it is crucial to delimit a scope of protection that covers the Applicant’s interests in Brazil and, in parallel, does not fall within the legal prohibitions.

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