Brazil: the second medical use in patent law

The development of a new use of an existing compound may be granted patent protection. This means that a second medical use can be claimed in an application even though the compound is known.



does a second use classify as a second chance?

This announcement comes from a recent decision brought by a tribunal in Rio de Janeiro, Brazil (Primeira Seção Especializada do Tribunal Regional Federal da 2ª Região). The tribunal went to establish that in principle everything that is not listed as ‘excluded’ or ‘non-patentable’ in the Law 9.279/96 is entitled to protection and so, it may allow the registration of the so-called second use patents.

This type of patent is also known in Europe as the ‘second medical use’ and granted following the practice of the Swiss Federal Intellectual Property Office (known as the Swiss type claims) and now very much in use by the European Patent Office (without the need to use Swiss type claims).

The declaration by the regional court came as an appeal case. The Brazilian Instituto Nacional da Propriedade Industrial (INPI) had denied a patent for a second medical use to combat Déficit de Atenção / Hiperatividade (TDAH).

It is understood that a second use application must also meet the criteria of patentability and of course, one may ask: is the invention new? Actually is not BUT even though the conventional notion of novelty is not satisfied, it may be still protected if the use is not comprised in the state of the art.

This decision reminds me the situation in India. Both Brazil and India are leaders in the pharmaceutical industry and actually before being part of the TRIPS Agreement none of them recognised or granted patent in the pharmaceutical sector. After both countries became parties of the TRIPS we have seen how their respective national legislations and case law have transformed. Yet, India does not recognise and does not grant patent for second medical use e.g. Merrell Dow v Norton and Penn (known as the 'Terfenadine' decision). Moreover, the Indian Patent Act 2005 bans Evergreening. Will this mean that India will be far ahead than Brazil in the pharmaceutical market? We now need to wait and see if another Brazilian decision relating to second medical use overturns this one.

Source ABIFINA.