Biotechnology is a fascinating industry involving genetic research, animal and human health care issues, the development of innovative bio medicaments and food with desirable characteristics, as well as the use of the environment. The wide range of uses and benefits brought about by the Biotechnology industry are increasingly attracting investors. Due to high-risk investments and time spent on obtaining improved products and processes, biotech companies looking for security often rely on the Intellectual Property system, especially patents, as essential parts of their assets.
Why choose Brazil to get protection for your biotechnology invention?
Brazil is the fifth largest country in the world. Besides its huge land area, it is rich in terms of natural resources and biological diversity and, as a result, is in a leading position in agricultural technology.
Although agriculture is one of the most important industries, there are a significant number of large and small companies involved in: (i) human health care, including the development of bio medicaments, vaccines and related processes; (ii) bioenergy and biofuels technology; and (iii) environmental issues related to bio-prospecting the biodiversity and genetic heritage. Among the incentives for biotech innovations seen in Brazil, particularly in the field of human health, there is cooperation between public institutions and private companies. This is highlighted in the Brazilian government´s focus on innovation under the Public Private Partnership (PPP) program.
Biotechnology plays an important role in the economy of Brazil and this is the reason why it has become a target country for Intellectual Property strategies.
How does the Brazilian Patent Office handle patent applications in the biotech area?
The analysis of the patentability criteria of biotech patent applications is based on the provisions of the Brazilian Industrial Property Law (IPL) # 9,279/96. The main aspects that exclude subject matter from patent protection in the biotech area are the following:
Therapeutic, surgical and diagnostic methods applied to humans or animals are not considered to be inventions (Article 10 (VIII) of the IPL). The claim format currently accepted is the following:
- “use of a compound in the manufacture of a medicament for specific treatments”;
- Natural living beings, in whole or in part, are not considered to be inventions (Articles 10 (IX) and 18 (III) of the IPL). Animals and plants, even if transgenic, are not liable to protection. The term “in part” is usually interpreted as including cells and tissues;
- Biological materials found in nature or isolated from it are not considered to be inventions (Article 10 (IX) of the IPL);
- Biological materials produced by synthetic means but identical to those occurring in nature in terms of their composition are not patentable; and
- Natural biological processes/methods are not considered to be inventions (Article 10 (IX) of the IPL);
- Human intervention in the process/method conferring a permanent feature is enough to show that it is not natural.
The Brazilian Patent Office published Guidelines in 2015 for the examination of biotech patent applications (Resolution # 144) establishing the examiners’ usual understanding regarding patentability. According to the Brazilian Patent Office’s current practice, the following subject matter would be patentable:
- Recombinant/modified/synthetic biological materials such as genes, proteins, sequences if they can be clearly distinguished from their natural counterparts;
- Monoclonal/recombinant/modified/chimeric antibodies;
- Transgenic microorganisms, such as bacteria and yeasts;
- Biological processes/methods, such as those for obtaining, modifying, manufacturing and using biological materials and living beings; and
- Compositions/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.
To be patentable, biotech inventions have to meet the same essential requirements as those in any other field of technology, i.e. be innovative and have an inventive activity and industrial application. Other requirements must also be complied with, i.e. clarity and sufficiency of disclosure (Articles 24 and 25 of the IPL).
As there are specific areas in each jurisdiction, it is essential to mark out the scope of protection of your patent application carefully in order to correlate the subject matter with the patentability criteria and your interests in Brazil.