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Irisin and the patentability of new methods for treating diseases in Brazil

By Karina Daiha

New research led by Brazilian scientists has indicated a relationship between levels of the hormone – irisin – produced by muscles in response to exercise and Alzheimer’s disease (AD). The study was published earlier this month in one of the most renowned international scientific journals, Nature Medicine.

The study has found that irisin plays an important role in the memory function. The first part of the research verified that the human AD brain and AD mouse models have low levels of irisin. Perhaps more interestingly, the scientists also discovered that boosting brain levels of irisin either pharmacologically or through exercise in mice with Alzheimer’s could rescue their memory.

The results of these tests in mice suggest the importance of physical exercise in fighting against such neurodegenerative disease. The development of a treatment in human patients using irisin, however, requires further investigation.

Hopefully, if these results can be confirmed in human testing, the scientific and medical communities will be a step closer to finding a cure to Alzheimer’s. The manufacture of an effective drug together with a therapeutic method could lead to an important discussion regarding the patentability of new methods for treating diseases around the world.

In Brazil, such a new method for treating Alzheimer’s disease can currently not be patented. According to the Brazilian patent statute, therapeutic methods for use in the human or animal body are not considered inventions. Both the molecule itself and the biological material found in nature are barred from patent protection.

On the other hand, a pharmaceutical composition comprising irisin is patentable in Brazil. Moreover, the use of irisin in the manufacture of a medicament to treat Alzheimer’s disease (the so called “Swiss-type use claim”) may also be permissible under the patentability rules. The latter, although potentially acceptable, comes up against a very restrictive interpretation by the Brazilian Patent Office (INPI).

The INPI’s current position is that the specification must include in vivo tests to assure that the use claim in the Swiss-type style is sufficiently disclosed. In vitro tests give an indication of the claimed therapeutic use, but only in vivo tests prove the therapeutic activity.

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