Protecting biotechnology inventions

The biotechnology industry covers genetic research, animal and human healthcare issues and the development of innovative biomedicines and foods, as well as environmental issues. The many uses and benefits of biotechnology inventions are increasingly attracting investors. As such investments are high risk and much time must be spent to improve products and processes, biotechnology companies often rely on IP rights – particularly patents – to protect their assets.

Why choose Brazil when protecting a biotechnology invention?
As well as being the fifth-largest country in the world, Brazil is rich in terms of natural resources and biological diversity. As a result, it leads the way in agricultural technology. In addition, a significant number of companies are involved in:

• healthcare, including the development of biomedicines, vaccines and related processes;
• bioenergy and biofuel technology; and
• environmental issues relating to bio-prospecting the country's biodiversity and genetic heritage.

A major incentive for biotech innovation in Brazil, particularly in the healthcare field, is the high degree of cooperation between public institutions and private companies. This is highlighted by the government's focus on innovation under the public-private partnership programme.

Biotechnology plays an important role in the Brazilian economy and for this reason Brazil is a high priority for companies when crafting IP strategies.

How does BRPTO handle biotechnology patent applications?
The patentability criteria for biotechnology patent applications are based on the Industrial Property Law (9,279/96). The main provisions excluding subject matter from patent protection in the biotechnology area are as follows:

• Therapeutic, surgical and diagnostic methods applied to humans or animals are not considered to be inventions (Article 10(VIII) of the law). The acceptable claim format is “use of a compound in the manufacture of a medicine 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 law). 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 law). Biological materials produced by synthetic means but identical to those occurring in nature in terms of their composition are not patentable. 
• Natural biological processes or methods are not considered to be inventions (Article 10(IX) of the law). Human intervention in the process or method conferring a permanent feature is enough to show that it is not natural.

In 2015 the Brazilian Patent and Trademark Office (BRPTO) published guidelines on the examination of biotechnology patent applications (Resolution 144), which established the examiners' understanding of patentability. According to existing BRPTO practice, the following subject matter is patentable:

• recombinant, modified or synthetic biological materials such as genes, proteins or sequences, if they can be clearly distinguished from their natural counterparts;
• monoclonal, recombinant, humanised or chimeric antibodies;
• transgenic micro-organisms such as bacteria and yeasts;
• biological processes or methods, such as those for obtaining, modifying, manufacturing or using biological materials or living beings; and
• compositions or 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.

In order to be patentable, biotechnology inventions must meet the same essential requirements as those in any other field of technology (ie, novelty, inventive step and industrial application). Other requirements must also be complied with, such as clarity and sufficiency of disclosure (Articles 24 and 25 of the Industrial Property Law).

As different criteria apply in different jurisdictions, applicants must ensure that they mark out the scope of protection of the patent application carefully in order to match the subject matter to the patentability criteria and their interests in Brazil.