Brazil: New Guidelines for the Examination of New Uses of Known Products

This new Chapter 9 does not introduce substantial changes to the content of the previous chapter, but it clarifies some points, includes examples, and thus aims to better ensure uniformity in the results of the examinations.

According to the new Chapter 9, patent applications for this type of medical invention are those that disclose the use of a known chemical-pharmaceutical product to produce a medicament intended to treat, prevent, or diagnose a disease or pathological condition different from that for which said product was already used in the prior art. With this new wording, pathological conditions are now also included, that is, any abnormal physiological or anatomical condition, as well as subjective and objective manifestations of the disease, that are not classified as a disease or syndrome.

On the other hand, the new Chapter 9 states that the application must clearly and sufficiently describe the intended use, presenting unequivocal and sufficient evidence, preferably in vivo trials, demonstrating said use at the time of filing the patent application and allowing its reproduction by a person skilled in the art. The results of in vitro, ex vivo, or in silico trials may provide evidence of the new therapeutic use; however, they are often not confirmed in vivo due to pharmacokinetic aspects, among others, related to the drug's behavior in the body. If there are doubts as to whether the results of the submitted in vitro, ex vivo, or in silico trials reflect the alleged therapeutic activity, supplementary information may be submitted to confirm what was already described in the original application, provided there is sufficient evidence to conclude that the therapeutic activity is real and not speculative.

In the case of a patent application seeking protection for a group of products described using a Markush formula, the application must enable a person skilled in the art to realize the invention, based on examples of demonstrated activity for at least one representative compound from each chemical class of the different substituents.

These new Chapter 9 Guidelines do not change the format that must continue to be used, known as the "Swiss type format," nor do they change the non-patentableability of claims directed to the use of a known product for a known purpose and that include other essential technical characteristics such as a patient group, dosage, therapeutic regimen, route of administration, etc. Claims of novel use that refer to disorders, syndromes, symptoms, or any other generic term, or claims of novel medical use that refer to the condition treated, prevented, or diagnosed in terms of its mechanism of action, will continue to be inadmissible.