Biotech Patents in Brazil
The Potential of Brazil
Brazil is extremely rich in natural resources and biological variety. The production of ethanol fuel from sugarcane – Brazil is the world’s second largest producer – is just an example: the potential is even greater, as a very advanced agri-industrial technology pairs with an abundance of arable And biofuels are not the only application of biotechnology: biological drugs constitute another rising sector that attracts enormous investments in R&D.
Patentability of biotech inventions in Brazil is based on two major normative acts: the Industrial Property Law (IPL) n. 9.279/96 and the Guidelines for the examination of biotech patent applications (resolution n.144) published by the Brazilian Patent Office in 2015.
The two acts are to be considered together when examining patentability of biotech inventions: the “old” IP law, indeed, provides a series of exclusions, whereas the Guidelines specify the patentability of biotech inventions in a very detailed way, keeping up with the most recent technological advancements.
According to the IPL, the following can’t be patented: therapeutic, surgical and diagnostic methods, natural living beings, biological materials found in nature or isolated from it and natural biological processes/methods.
However, the Guidelines establish that the following inventions are patentable, as long as they possess the traditional elements for patentability, that is, being novel and involving an inventive step: transgenic microorganisms; recombinant, modified and synthetic biological materials such as genes, proteins, sequences if they can be clearly distinguished from their natural counterparts; monoclonal, recombinant, modified and chimeric antibodies; biological processes and methods, like those for obtaining, modifying, manufacturing and using biological materials and living beings; compositions and formulations comprising biological materials or strains as found in nature and at least one additional component that does not represent a mere dissolution of a non-patentable subject matter.
Moreover, the Innovation Law n. 10.973/2004 aims at nurturing collaboration between the academia and the enterprises, and the Biosecurity Law n. 11.105/ 2005 governs safety, monitoring, and cultivation of biotech crops: although they are not directly related to patents, they help enhance the legal framework that surrounds biotechnology and create the ideal environment for the investments and research to strive.
Notwithstanding the legal framework tries to cope with technological progress, the path to obtain a biotech patent is not exactly smooth. Backlog is one of the main issues that plague the patent process in Brazil: according to data from the INPI, the average time for granting a biotech patent is around 12 years.
There are several reasons for the backlog: first the insufficient infrastructure of the INPI; second the lengthy procedure that provides a double examination performed by the Brazilian Health Surveillance Agency (ANVISA) for all biotech patents.
For this reason, since 2012 Brazil, has introduced a fast route for green patents in the field of alternative energy, transportation, energy conservation, waste management and agriculture. The Green Patent program, born as a pilot program, seems to have achieved excellent results, with an average waiting time of two years and has become permanent on the 6th of December 2016.