How to protect therapeutic methods in Brazil

Brazil’s patent law does not allow methods of treatment to be patented, but there are other means of getting protection, according to Kene Gallois and Samantha Salim of Daniel Law.

“It is possible to draft therapeutic method claims into Swiss-type format in order to obtain protection for medical inventions in Brazil.”

Unlike US patent law, which does not exclude therapeutic methods from patent protection, Brazil’s patent system follows a similar rationale to Europe’s: that “methods of treatment” are not patentable.

The non-acceptance of therapeutic method claims in Brazil is grounded in the provisions of article 10(VIII) of Brazilian IP Law # 9,279/96, which establishes that therapeutic, surgical and diagnostic methods applied to the human or animal body are not considered to be inventions.

Therefore, methods having at least one invasive/administration step and/or methods with the purpose of cure, prophylaxis or diagnosis are usually non-patentable in Brazil.

Different types of claim language are used to protect medical inventions, depending on the legislation and the patent office’s guidelines for examination.

Protecting therapeutic medical inventions

Although therapeutic methods are not patentable in Brazil, a substance or composition may be patented for a specific therapeutic use through so-called Swiss-type use claims.

According to the Brazilian Patent and Trademark Office’s (INPI) Rule 169/2016 (Guidelines for the examination of Brazilian patent applications), the format currently accepted for second medical use claims is the Swiss-type one, as follows: “Use of a compound of formula X characterised by being in the manufacture of a medicament to treat the disease Y”.

There is an important difference between Brazil and Europe: “product for use” claims (“Substance X characterised by being for use in the treatment of, or for treating, a disorder Y”) currently accepted in Europe are considered therapeutic methods by INPI and, therefore, are not eligible for patent protection.

On the other hand, as is the case in Europe, “use for treating” claims (“Use of the compound X characterised by being for treating a medical condition Y”) are also interpreted by INPI as therapeutic methods.

The main aspects for assessment of patentability requirements of medical use claims in Brazil are: novelty, inventive activity, sufficiency of disclosure, and accuracy, are summarised in Table 1.

Table 1: Patentability requirements of medical use claims in Brazil

Novelty

Inventive activity Sufficiency of disclosure Accuracy
The therapeutic purpose should be different from the one already disclosed in the prior art when using the already known product.

Features related to the use of the compound, such as therapeutic regimen (dosage, administration/application form, dosage interval) and/or group of patients in the claims, when present in the claims, do not confer novelty to the known use of the compound (Rule 208/2017 – Chemical guidelines for the examination of patent application).

The mechanism of action of the compound involved in the new use should not be inferred from its mechanism of action for the medical use already disclosed in the prior art;

The new use should relate to the treatment of a disease the etiology of which is different from that of the prior art;

The new use cannot be deduced from the structure-activity relationship of the drug compared to structurally related molecules, ie, from the structural analogy with other compounds, which exhibit the same activity claimed therein, already disclosed in the prior art;

The new use cannot be deduced from the disclosure of adverse effects of the known drug of the prior art; and

The new use cannot be deduced from the use of the compound for the treatment of a symptom of a disease already disclosed in the prior art, even if the claimed use refers to a different disease.

The specification of a patent application as originally filed must disclose evidences that prove the new claimed medical use.

INPI understands that it is not always possible to extrapolate the results of in vitro assays for an actual therapeutic application without complementary data regarding the equivalency of the effect. For studies performed in animal bodies, the models adopted should present the possibility of extrapolation for the humans or animals to be treated.

The submission of additional evidence is acceptable during the technical examination if it is intended solely to supplement the information already comprised in the application as originally filed.

Common objections on lack of accuracy of medical use claims raised by INPI refer to the lack of an accurate definition of the disease(s) to be treated.

For example, new use claims referring to broad terms including “disorders”, “syndromes”, “symptoms” or any other generic terms, such as “gastrointestinal disorders” or “respiratory syndromes”, without specifying the names of the diseases/disorders are usually objected under the allegation that they are imprecise.

Moreover, the definition of the disease to be treated by the mechanism of action (such as “use of the compound X for preparing a Y-receptor inhibitory medicament”), as well as features related to therapeutic scheme (“administering the medicament three times a day orally”) are also considered by INPI as lacking accuracy.

 

Product claims including therapeutic features

Although “product for use” claims are considered to be therapeutic methods by INPI, it is possible to draft product claims including therapeutic features, provided that the product is already defined accurately by its components.

For instance, therapeutic features can be present in an independent composition claim that already defines the components thereof (“Composition characterised by comprising A, B and C, and wherein it is for the treatment of a disease X”), or in dependent claims in which the components are already precisely defined in the respective independent claim (such as: “1. Composition characterised by comprising A, B and C”; and “2. Composition, according to claim 1, characterised in that it is for the treatment of a disease X”).

In this case, the therapeutic feature will be considered as an additional definition of the claimed product and will not be considered relevant to assess the novelty requirement of the compound, which is evaluated based on the components thereof.

Although methods of treatment are not considered to be inventions in Brazil, medical inventions related to therapeutic purposes are patentable if drafted according to Brazilian practice and if they fulfil the patentability requirements.

Applicants should be aware that there are significant differences regarding the claim format for medical inventions related to therapeutic purposes accepted by different patent offices, so it may be necessary to adapt the claims if the application is initially prosecuted via the Patent Corporation Treaty and then continued to a national phase.

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