AIPPI Resolution Q280 on Diagnostic Methods

AIPPI Resolution Q280 on Diagnostic Methods

The AIPPI issued a resolution on question 280, concerning the possibility of patent protection of inventions relating to medical diagnostic methods. The AIPPI resolutions address this entity’s understanding on Intellectual Property issues with worldwide relevance.

The AIPPI understands that patent protection must be granted, without discrimination, for any inventions in all technological fields, including those related to diagnostic methods in the health area.

This association states that it is desirable for countries to harmonize their laws and regulations to allow the patentability of inventions related to medical diagnostic methods. For the entity, a clear and consistent position on this issue, in all jurisdictions, would simplify the search for patent protection for this type of invention, as well as increase legal certainty regarding the protection of this type of technology.

The AIPPI also considers that: (i) products and kits should not be excluded from the eligibility of patent protection merely because they are intended for using in diagnostic methods; (ii) methods and uses involving diagnostic issues and based on one or more biological parameters should not be excluded from patent protection.

Finally, the AIPPI understands that countries may not consider acts performed by doctors and/or veterinarians in the course of their professional duties an infringement of patent rights.

It should be noted that Article 10, item VIII, of IP Law no. 9,279/1996, provides that diagnostic methods, specifically aimed at application to the human or animal body, are not considered to be inventions or utility models. On the other hand, diagnostic methods performed on samples outside the human or animal body find patent protection in the country. Thus, if Brazil wishes to comply with the AIPPI guidelines and to adopt full protection in this area, a legislative change would be necessary.

This is a controversial issue, since the understandings about what should or should not be subject to patent protection in the country do not find a unified position.