Data Protection and Patents for Bio-Inputs and Agrochemicals in Brazil

Dr. Lidia Cristina Jorge dos Santos

Figueiredo e Santos Sociedade de Advogados

In an era where sustainable agriculture is becoming increasingly crucial, Brazil stands at the forefront of the bio-input revolution. This exclusive interview with Dr. Lidia Cristina Jorge dos Santos, a distinguished legal expert from Figueiredo e Santos Sociedade de Advogados, delves into the intricate world of data protection and patent processes for bio-inputs and agrochemicals in Brazil. Dr. Santos provides valuable insights into the regulatory landscape, discussing approval timelines, legal hurdles, and the ongoing modernization of Brazilian legislation in these pivotal sectors.

How does the patent application and data protection process for bio-inputs work?

In recent years, there has been a notable promotion of the bio-inputs market in Brazil, especially in light of the global trend towards sustainability and environmental protection. This promotion undoubtedly reflects the implementation of the National Bio-inputs Program, created by Decree 10.375/2020.

The National Bio-inputs Program defines bio-inputs as ″the product, process, or technology of plant, animal, or microbial origin, intended for use in the production, storage, and processing of agricultural products, in aquatic production systems or planted forests, which positively reflect in the growth, development, and response mechanisms of animals, plants, microorganisms, and derived substances that interact with physical-chemical and biological products and processes.″

The innovations generated in recent years for bio-inputs have raised queries about the mechanisms that should be developed for their protection (patent and protection of data submitted for registration).

Patent

A patent is a legal title that documents (INPI) and legitimizes the right of the author of a protected invention. It prevents third parties, without consent, from producing, using, putting on sale, selling, or importing for up to 20 years.

In Brazil, the rights and obligations related to patents are regulated by Law 9.279/96 (LPI). The granting of patents is the responsibility of the INPI. The subject of the patent can be a device, a tool, a new product, a composition, a new manufacturing method, or technical advancement. However, those seeking a patent involving bio-inputs must prove novelty, inventive activity, and industrial application (Articles 8, 11, 13, and 15 of the LPI) and go through the entire necessary administrative process with the National Institute of Industrial Property (INPI) to obtain it.

The LPI, in its Article 10, item IX, clearly delineates what does not qualify as an invention or utility model and consequently establishes what cannot be patented:

″Art. 10. The following are not considered inventions or utility models:

(...)

IX - whole or parts of natural living beings and biological materials found in nature, or even isolated from it, including the genome or germplasm of any natural living being and natural biological processes.″

Another necessary prohibition is in Article 18, item III of the LPI, which states that whole or parts of living beings, except transgenic microorganisms, cannot be patented:

″Art. 18. The following are not patentable:

(...)

III - whole or parts of living beings, except transgenic microorganisms that meet the three patentability requirements - novelty, inventive activity, and industrial application - provided in Article 8 and are not mere discoveries.

Paragraph single. For the purposes of this Law, transgenic microorganisms are organisms, except whole or parts of plants or animals, that express, through direct human intervention in their genetic composition, a characteristic not normally attainable by the species under natural conditions.″

Therefore, in Brazil, there is no protection for inventions having as their object: 

1. plants and animals (as well as their parts, such as cells) even if genetically modified; 

   
   

2. biological materials found in nature, isolated or synthetically produced, with natural counterparts; and 

   
   

3. essentially natural biological processes. The exception for living beings is attributed to genetically modified microorganisms (i.e., bacteria, archaea, fungi, unicellular algae not classified as plants and protozoa), provided they meet the patentability requirements.

Despite prohibiting the patentability of living beings and essentially biological processes, Brazil does not exclude protection for obtaining non-patentable matter, such as processes for obtaining transgenic plants. In Brazil, biotechnology companies, especially in the agricultural sector, hold numerous patents seeking protection for the process, not the product itself, to obtain protection, even indirectly, for matters not eligible under the LPI.

Data Protection

Law 10.603/2002 regulates the protection against unfair commercial use of information related to test results or other undisclosed data submitted to competent authorities as a condition for approving or maintaining registration for the commercialization of veterinary pharmaceuticals, fertilizers, pesticides, their components, and related products.

The protected information is that which involves considerable effort to develop and has commercial value while undisclosed.

The protection of information occurs for varying periods (1, 5, and 10 years) and implies a) non-use by the competent authorities of the test results or other data submitted to them in favor of third parties and b) non-disclosure of the test results or other data submitted to the competent authorities, except when necessary to protect the public.

What have been the approval times?

The approval times for bio-inputs vary and depend on their classification and legal framework. Bio-inputs classified as pesticides are being approved in approximately 12 months.

Have there been any changes in agrochemical regulations due to recent legislation?

Bio-inputs that fall into the pesticide category are now subject to Law 14.785/23, which has brought several changes involving the competencies of evaluation bodies, labeling, inspection, and approval times, among others.

What are the recent legal actions involving the protection of chemical pesticide data?

The judiciary has addressed some issues regarding data protection. Among them are the applicable period for protecting data presented for post-registration changes (inclusion of crops, application methods). There is also the discussion on the possibility of submitting a request for evaluation of an equivalent technical product while the protection period is still in effect, as in the case of the active ingredient chlorantraniliprole.

How do you assess the current bio-inputs legislation, and what changes do you see as necessary?

A specific legislation for bio-inputs is a necessity. Today, products are regulated as fertilizers, inoculants, and pesticides. There is no precise regulation for the registration of products with multiple functions. Clear regulations are required to enable the development of bio-inputs activities to allow the market to grow without entrepreneurs fearing they are not complying with all legal requirements.

The Congress is aware of these needs. Currently, the two bills being processed are PL 658 and PL 3668. They both seek to bring specific and unified regulations for all bio-inputs. Additionally, various sector entities have come together to seek a common understanding of the regulation of the topic due to its importance and relevance. The consensual proposal will be presented as a substitute to PL 658 and will continue through Congress.

This story was initially published in the 2024 Latin America Focus. Download the magazine to read more stories.

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