What does Brazil’s accession to the Budapest Treaty mean for innovative companies and the biotechnology sector

Innovation, biotechnology and the business environment

Brazil’s recent adherence to the Budapest Treaty marks a significant step in the national and international intellectual property landscape. On 20 October 2025, the National Institute of Industrial Property (INPI) submitted the letter of accession to the World Intellectual Property Organization (WIPO), with Brazil becoming the 92nd signatory country. For entrepreneurs and managers, this is not merely a diplomatic formality: it opens new opportunities and requires strategic attention — especially in sectors such as biotechnology, pharmaceuticals, agribusiness, health, and other industries in which deposition of microorganisms, genetic inputs or development of inventions involving biological material is relevant. From now on, companies in these fields should revisit their protection systems, innovation structure and IP compliance — particularly with regard to biological material deposit for patent purposes domestically and abroad. In this article we explore the legal and practical aspects of this accession, its implications for corporate innovation management and the precautions that managers should adopt to integrate this development in the corporate environment, always with an educational focus and without making promises of results.

Legal aspects of the accession and its impact on the patent system

The Budapest Treaty essentially regulates the international recognition of the deposit of microorganisms (or other biological materials) for patent purposes. The logic is that when an invention involves biological material that cannot be fully described in writing — for example strains of microorganisms, cell lines, viruses, bacteria or fungi — such material may be deposited with a recognized International Depositary Authority (IDA). By doing so, the applicant meets the sufficiency requirement (or “adequate written description” or “enablement”) required for a patent application. Under Brazilian law, Law No. 9.279/96 (Industrial Property Law – LPI) already provides in art. 24, sole paragraph, that “in the case of biological material essential to the practical realization of the subject-matter of the application and which cannot be described in the form of this article … the report must be supplemented by deposit of the material in an institution authorised or in an international agreement indicated by the INPI”. Thus, accession to the treaty connects directly with the national patent system and reduces an asymmetry that existed — namely: the national applicant needed to rely on deposit abroad or face uncertainty whether the country was treaty-member. With accession, Brazil can nominate national institutions as IDA, enabling companies, researchers or labs to deposit biological material in Brazilian territory, which may reduce logistics, time and cost — and favour greater strategic control of these deposits.

Implications for companies and patent protection

For managers of companies engaged in R&D, biotech innovation or intending to globalize their patents, the accession contains several practical impacts:

1. Reduction of logistical barriers and deposit costs: Previously, deposit of microorganisms often required sending abroad and costs associated with transport, storage and compliance with another country’s norms. Now, with possible national IDA, costs may drop and internationalisation may become more agile.

2. Greater legal certainty for domestic inventors: The company or lab will now rely upon an internationally recognised framework, reducing risk of invalidation or challenge later due to non-compliance with the deposit requirement. In particular, the sufficiency requirement (art. 24 LPI) no longer rests solely on foreign deposit.

3. Greater international competitiveness: Participation in a globally recognised regime allows Brazilian companies to gain market credibility and easier access to the global innovation and commercialisation chain — a key point in biotech, agritech, health and tech-licensing sectors.

4. Requirement of governance and innovation compliance: With accession, companies must review internal policies of R&D, technology transfer, confidentiality, management of biological material and IP, to ensure deposits are duly made, monitored and patent rights protected in Brazil and abroad.

5. Integration with biodiversity and genetic resource policies: Being a megadiverse country, Brazil has specific obligations relating to conservation, sustainable use of genetic resources and benefit-sharing. Accession to the treaty shows an articulation between innovation policy and biodiversity policy — something companies must take into account especially when biological material involves national genetic resources.

   
   
   
   

   Practical implications for the business manager

   
   

   Strategy of intellectual property in the biotechnology context

   
   

   For companies operating, or planning to operate, with innovation involving biological material — be they labs, start-ups, universities or industrial firms — it is essential to revise their innovation pipeline in light of the following practical points: first, map internally which inventions involve microorganisms or biological material which cannot be fully described in writing, to know whether deposit under the Budapest Treaty regime will be required or whether the domestic regime is sufficient. Second, plan the timing of the deposit: the patent filing must contemplate the deposit and obligations of art. 24 LPI. Third, align R&D contracts, technology transfer agreements and international partnerships with clauses providing for deposit, ownership, responsibility for costs and destination of biological samples.

   
   

   Costs, schedule and compliance

   
   

   From a business viewpoint, accession to the treaty may reduce cost of foreign or multiple deposits, but one must consider: who will bear the deposit cost? Which domestic laboratory will be authorised as IDA? What is the timeline until it is fully operational and reliable? The manager must budget for the transition phase and create internal schedule for adaptation. It is also recommended to implement documentary control: records of deposit, custody contracts, backups, monitoring of deadlines and confidentiality obligations, besides policies for sample storage and backup regimes in case of IDA failure.

   
   

   Risk mitigation and asset valuation

   
   

   A formalised patent protecting an invention with deposit under an international regime strengthens the company’s intangible asset — which may contribute to investment capture, licensing or international partnership. On the other hand, lack of compliance may result in patent invalidation, loss of exclusivity or litigation. Accordingly, the company’s compliance area, together with its legal department, must monitor the accession to the Budapest Treaty and guarantee internal procedures are adequate. Also, it is advisable to insert this variable in due diligence in M&A operations or licensing contracts, since investors and partners value the robustness of the IP protection chain.

   
   

   Sectoral overview and market opportunities

   
   

   For sectors such as agribusiness, health, cosmetics, functional foods and industrial biotechnology, Brazil’s accession to the treaty presents a competitive advantage. Domestic companies can more easily develop and protect inventions with biological basis, use national infrastructure for deposit and attract international partnerships with greater credibility. From the public regulation side, the measure aligns with innovation-stimulus policies, biodiversity protection and sustainable use of genetic resources — a fact managers should leverage to realign their innovation strategy with public objectives, opening space for incentives, financing and technical-scientific cooperation. Yet it is important that this opportunity be managed strategically, not just reactively — in other words, it is not enough merely to “know that Brazil joined” the treaty, but rather to prepare the company to operate effectively in this context.

   
   

   Guidance on preventive legal advisory

   
   

   Brazil’s accession to the Budapest Treaty is unquestionably a significant evolution for the business environment of innovation and intellectual property. However, for this evolution to yield concrete results for the company, it is essential that managers, together with their legal team or specialised counsel, undertake a systematic review of innovation, R&D, patents and contracts that involve biological material or microorganisms. Adopting a preventive stance means anticipating impacts: from contractual adaptation, to laboratory selection, budgeting, documentary control and strategic alignment. It is recommended that the company seek specialised legal counsel in intellectual property — especially to evaluate the patent pipeline, review technology transfer contracts, define who is responsible for deposit, and ensure compliance with art. 24 LPI and the requirements of the international treaty. Such support is relevant not only for compliance but to transform the normative option into competitive advantage. In summary: the modernisation of Brazil’s industrial property regime through this accession reveals a window of opportunity for companies innovating with biological basis. However, to exploit it effectively, planning, governance, investment and suitable legal support will be necessary. Putting into motion this set of actions now will certainly increase the chances of the company consolidating its position in both domestic and international markets under the aegis of patent protection and sustainable innovation.