Biology, Biotechnology & Pharmaceutical

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Brazil as a global biotechnology hub

Brazil has become one of the most important biotechnology markets in Latin America, both for innovation and patent protection. Between 2019 and 2022, patent applications in this area exceeded 17% of the total applications in the country. With more than 58,700 applications registered since 2010, Brazil has consolidated its importance on the international stage.

Why does Brazil import for foreign applicants?

According to data from the 2025 Country Commercial Guide (U.S. Department of Commerce), Brazil is the largest healthcare market in Latin America, investing 9.7% of its GDP in healthcare, representing US$135 billion. Furthermore, according to the World Bioenergy Association (2025), Brazil is one of the largest global producers and consumers of biofuels.

The Brazilian market is heavily driven by global players:

Foreign dominance: Approximately 86% of all biotechnology patent applications are filed by applicants from outside Brazil.
Main origins: The USA leads with 37% of inventions, followed by Switzerland, Germany, and France.
Prominent companies: Leaders such as Roche (Genentech), BASF, Regeneron, and Novartis are among the top applicants.
Medical preparations account for 50% of biotechnology applications in the country.

What can (and cannot) be patented?

For foreign professionals, understanding the nuances of the Brazilian Industrial Property Law (BIPL 9.279/96) is crucial, as Brazil has specific restrictions that differ from other jurisdictions.

Patentability exclusions (articles 10 and 18 of the Brazilian industrial property law)

Living organisms and natural materials: Patenting all or part of natural living organisms and biological materials found in nature is prohibited. However, the use of natural materials (Swiss-type claims) or in processes is permitted.
Biological processes: Essentially biological processes are not patentable. Processes that mimic biological processes, where the distinction from the natural process is clear, are eligible for protection.
Medical treatments: Brazil does not allow patents for therapeutic or surgical methods, although it does allow patents for the use of products in the preparation of medicines (Swiss-type claims).

Protection opportunities

Transgenic microorganisms: These are the only category of living organisms that can be patented, provided they meet the requirements of novelty, inventive step, and industrial application.
Frontier technologies: There is a high concentration of foreign applicants in gene editing (CRISPR), viral vectors, antibodies, and liposome delivery systems.

Regulatory requirements and compliance

Compliance goes beyond the Brazilian PTO. Inventions that utilize Brazilian biodiversity require extra attention.

International agreements: Brazil is a signatory to the Nagoya Protocol and recently approved its accession to the Budapest Treaty (Legislative Decree No. 174/2025).
Biodiversity law (13.123/2015): Registration with CGEN is mandatory for access to Brazilian genetic resources, under penalty of impacting the administrative regularity of the patent.
Biosafety law (11.105/2005): Express prohibition of genetic technologies restricting use.
Sequence listing: Since July 2022, the use of the WIPO ST.26 (XML) standard has been mandatory for sequence listings.

Speeding up the exam: fast-track strategies

The patent backlog has been reduced by more than 80% since 2019. Currently, it takes 4 to 5 years for a patent to be analyzed in Brazil; however, more than 60% of Biotechnology patents have already received a final decision.

Brazil offers expedited examination procedures options that can drastically reduce the granting time to 9 to 16 months:

Green Patents: For sustainable technologies and sustainable agriculture.
Health Priority: For products and processes intended for the diagnosis or treatment of cancer, AIDS, rare and neglected diseases.
PPH (Patent Prosecution Highway): Use of examinations performed at partner offices abroad to expedite the Brazilian process.
Technology in the Brazilian Market: Trade, import or export in Brazil of the product that is the subject of the patent application.
Infringements: Patent application being counterfeited in Brazil.
Elderly Applicant: an individual aged 60 or older.

How can CN&V help?

CNV has extensive experience representing international applicants before the Brazilian Patent Office (INPI), particularly in biotechnology, pharmaceuticals and chemical innovations.

Strategic drafting and amendment of claims: Adjusting claims to avoid refusal due to “reach-through claims” or unpatentable subject matter.
Advisory services to avoid adding unnecessary material (Art. 32, BIPL): After payment for the technical examination, the law does not allow voluntary amendments, but there are practical approaches that may allow strategic claim adjustments.
Technology transfer: Registration of licensing agreements and consulting on Brazilian legislation (where improvements belong to those who developed them).
Contracts: Such as Confidentiality and Non-Competition Agreements (NDAs), Patent Commercial Representation and Distribution Agreement.
Strategies for accelerating patents: Document analysis for priority examination requests.
Collaborative training: Exchange of ideas on differences between the Brazilian patente landscape and that of other jurisdictions.
Monitoring of Third Parties/Competitors: Proprietary patent surveillance system for Research and Development or technology blocking.