Second medical use in Brazil

6 March 2024

Second medical use in Brazil considering the particularities of the Brazilian Industrial Property Law and the regulations issued by the BPTO.

6 March 2024

The importance of research into other uses of known molecules is growing enormously, as the search for new molecules for pharmaceutical inventions has become very expensive, from initial research to the sale of the final product to the consumer.

Thus, new therapeutic effects have become vitally important in research, and therefore, patent protection is absolutely necessary as an incentive for clinical tests and Research and Development.

It is important to highlight that, in the development of a new molecule, there are several lines of research, one being main and the others secondary.

The granting of patents for the second medical use has the great merit of serving as a stimulus for secondary lines to be developed and, in several cases, the secondary lines become the main lines.

These are new inventions and not random “discoveries”, since with the inventions of known medicines for the treatment of other diseases, there are entirely different circumstances that will have to be deeply researched and properly tested (the new use arising of research, analysis and investments) and not mere chance.

Research is protected and remunerated as inventive, non-obvious work with clear industrial utility.

The possibility of patenting new uses opens up opportunities for research into new cures based on greater availability of capital, both for large international conglomerates and the national pharmaceutical industry, in collaboration with national research and teaching centers.

The granting of protection for second use favors local industry, which finds an opportunity to develop patentable solutions, without having to resort to the synthesis of new substances, an activity that would require much more significant investments.

The BPTO admits second medical use patents in Brazil

However, considering the particularities of the Brazilian Industrial Property Law and the regulations issued by the BPTO, it is very important to take into account the restrictions to be successful in requesting this protection, highlighting that in Brazil only the Swiss Formula format is accepted.

Second use patents are patents that protect new uses of an already known substance.

The TRIPS Agreement defines that member countries are free to decide on the patentability of the uses of already known products, but the Brazilian Industrial Property Law (Law nº 9,279/96) did not incorporate this flexibility.

Although it did not prohibit the patenting of new uses, the Brazilian Industrial Property Law inserted criteria in the Patent Application Examination Guidelines issued by the BPTO.

The Examination Guidelines – Block I (Resolution No. 124/2013) define that, in the pharmaceutical area, claims involving the use of chemical-pharmaceutical products for the treatment of a new disease must use the Swiss Formula format:

  • “Use of a compound of formula X, characterized by being to prepare a medicine to treat disease Y”

It should be noted that this type of claim provides protection for the use, but does not provide protection for the therapeutic method, which is not considered an invention in Brazil.

The Examination Guidelines in the Chemical Area (Resolution nº 208/2017) consider that, to be considered new, the invention of a new medical use must reveal the application of the already known product to produce a medicine to treat or prevent a different disease and with a mechanism of action different from the use already revealed.

It is important to highlight that evidence of the new use must be present at the time of filing, and proof of the claimed use will not be accepted during the technical examination.

Furthermore, proof must occur through in vivo tests, because in vitro tests do not always confirm in vivo results.

New use claims for preparing a medicine must specify the disease to be treated

Claims for new use that refer to disorders, syndromes, symptoms or any other generic terms, such as “gastro-intestinal disorders”, “respiratory syndromes”, will not be accepted, as they cause uncertainty regarding the matter to be protected.

The novelty is evaluated depending on the disease to be treated

However, the most challenging requirement to have a patent for a second medical use granted in Brazil is not novelty, but inventive step.

To this end, the BPTO analyzes five specific topics to check the inventiveness of a second medical use, namely:

  • The mechanism of action.
  • The aetiology of the disease.
  • The structure-activity relationship.
  • The side effects.
  • The symptoms of the disease to be treated.

In addition to the novelty and inventive step requirements, as with any patent application, the specification of an application related to a second medical use must clearly and sufficiently describe the new use.

It is also important to highlight that in accordance with the Examination Guidelines for the application of Article 32 (Resolution No. 93/2013) regarding the modification of therapeutic method claims to “Swiss formula” type claims.

It is understood that the scope of a therapeutic method claim is quite distinct from the scope of a “use of a compound X to prepare a medicine to treat a disease”, since the first provides a method of treatment to the individual, while the second refers to the application of an active substance in the preparation of a medicine to treat a specific disease.

Therefore, in light of the provisions of article 32 of the Brazilian Industrial Protection Law, it will not be admitted, after the date of request for examination, changes from therapeutic method claims to claims written along the lines of “use of a compound X to prepare a medicine to treat a disease” (Swiss formula), as such a change clearly alters the object contained in the valid set of claims.

It is worth noting that these details of the Brazilian Law have differences in relation to other jurisdictions, where other claim formats are accepted for the protection of second medical use, requires adaptations to the application for correct filing in Brazil.

Taking into account patent legislation in Brazil, it is essential that the applicant is properly guided by agents with knowledge and experience in these particularities.

 

Sources:

5/5 - (2 votes)

Rogerio Rovetta

Patent Engineer. Brazilian office

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