Legislation on biodiversity, access to genetic heritage and associated traditional knowledge in Brazil: impacts on research and development activities, on patent applications and on the economic exploitation of products
1. Why this subject reaches companies with no presence in Brazil
Brazil holds approximately 20% of the world’s biodiversity and exercises sovereignty over its genetic heritage, under Article 225, § 1, II, of the Federal Constitution and the Convention on Biological Diversity (CBD), promulgated by Decree No. 2,519/1998.
The Brazilian access and benefit-sharing (ABS) regime reaches any foreign company that: (i) carries out research or technological development on genetic heritage of Brazilian origin or on associated traditional knowledge, even if entirely abroad and even if based on sequences obtained from public databases; (ii) intends to apply for intellectual property rights arising from those activities; or (iii) economically exploits a finished product or reproductive material resulting from them.
Two premises are frequently misunderstood by international groups and deserve emphasis:
- the obligation does not depend on the company having a head office, branch or subsidiary in Brazil; the statutory test is the Brazilian origin of the material or of the information of genetic origin, not the place where the research is conducted;
- the registration obligation arises before, not after, the filing of the patent application, the scientific disclosure and the commercialization. Once that moment has passed, regularization remains possible, but it then depends on specific instruments and exposes the company to administrative penalties.
2. Applicable regulatory framework
Two decades after the first Brazilian rules on the exploitation of national biodiversity — Provisional Measure No. 2,052/2000, succeeded by Provisional Measure No. 2,186-16/2001 — Law No. 13,123 of May 20, 2015 was enacted and has been in force since November 17, 2015. The regulatory framework applicable today comprises, in summary:
- Law No. 13,123/2015 (Biodiversity Legal Framework), which revoked Provisional Measure No. 2,186-16/2001;
Decree No. 8,772/2016, its implementing regulation, amended, among others, by Decree No. 13,014 of June 10, 2026 (published on June 11, 2026), which introduced Articles 22-B to 22-E and created a dedicated registration mechanism for legal entities headquartered abroad;
- the Nagoya Protocol, approved by Legislative Decree No. 136/2020, with the instrument of ratification deposited on March 4, 2021, in force for Brazil at the international level since June 2, 2021 and promulgated domestically by Decree No. 11,865 of December 27, 2023, which expressly ruled out any retroactive effect of its provisions;
- Law No. 9,279/1996 (Industrial Property Law) and the Budapest Treaty on the International Recognition of the Deposit of Microorganisms, promulgated by Decree No. 13,011 of June 9, 2026;
- the National Bioeconomy Strategy (Decree No. 12,044/2024) and the National Bioeconomy Development Plan (PNDBio), launched in 2026, which signal governmental priority for the economic valuation of biodiversity and for effectively broadening benefit sharing.
CGen (Council for the Management of Genetic Heritage), created by Law No. 13,123/2015, is a collegiate body with deliberative, normative, advisory and appellate functions, chaired by the Ministry of the Environment and Climate Change (MMA).
SisGen the (National System for the Management of Genetic Heritage and Associated Traditional Knowledge), created by Decree No. 8,772/2016, is the electronic platform through which the obligations are discharged, in operation since November 6, 2017.
3. The triggering event: the concept of “access”
Since 2000, the axis of the Brazilian regime has been the concept of “access”. Under the previous rules, any use of samples of components of the genetic heritage or associated traditional knowledge depended on prior governmental authorization, without any clear definition of what would constitute an “access”. In practice, penalties were even imposed on companies that merely purchased ingredients on the market and used them in the manufacture of ordinary products.
Under Law No. 13,123/2015, access subject to governmental control only occurs where there is research or technological development (R&D). Article 2, XI, defines technological development as “systematic work on genetic heritage or on associated traditional knowledge, based on existing procedures obtained through research or practical experience, carried out with the purpose of developing new materials, products or devices, improving or developing new processes for economic exploitation”. The definition brought relevant certainty: the mere use of biodiversity inputs, without any R&D activity, does not constitute access.
It should also be noted that research and technological development activities concluded before June 30, 2000 — the date on which the first control regime came into force — and the economic exploitation of any product or process arising from them are not subject to the requirements of Law No. 13,123/2015.
3.1. Genetic heritage
Genetic heritage is defined as “information of genetic origin of plant, animal, microbial or other species, including substances derived from the metabolism of these living beings”. Three practical consequences follow from that definition:
- metabolic substances — and not only nucleic acids — are covered, which reaches extracts, isolated molecules and natural products;
- microorganisms are expressly included within the scope of governmental control;
- human genetic heritage is excluded from the Law, although pathogens isolated from human beings remain covered.
Whether an organism qualifies as Brazilian genetic heritage turns on different tests depending on the taxonomic group, and the asymmetry frequently takes foreign companies by surprise.
For microorganisms the test is geographical rather than biological: under Article 2, sole paragraph, of Law No. 13,123/2015, a microorganism isolated from substrates of the national territory, the territorial sea, the exclusive economic zone or the continental shelf is deemed part of the genetic heritage existing in the national territory, irrespective of whether the species is native, cosmopolitan or exotic. Exclusion depends on cumulative proof, borne by the user, that the strain was isolated from a foreign substrate and that its importation was regular (Article 1, §§ 1 and 2, of Decree No. 8,772/2016); a strain that was lawfully imported but originally isolated from Brazilian soil remains national genetic heritage. For plant and animal species the test runs the other way: species introduced into the country are only treated as genetic heritage in in situ conditions where they form spontaneous populations that have acquired distinctive characteristics of their own within the national territory (Article 1, § 3), or where the material is a variety derived from an introduced species whose genetic diversity was developed or adapted by indigenous peoples, traditional communities or traditional farmers and which is not substantially similar to commercial cultivars (Article 1, § 4).
To provide legal certainty to agribusiness, the Decree charged the Ministry of Agriculture and Livestock with publishing reference lists of domesticated or cultivated species introduced into the country and used in agricultural activities, currently organised into five lists — plants, animals, aquatic species, ornamentals and plant pests. Species on those lists are not considered genetic heritage found in in situ conditions, so research involving them requires no SisGen registration and the economic exploitation of the resulting products triggers no benefit sharing. Because the lists are periodically revised through public consultation, the check must be performed and documented as at the date of each access activity, rather than once and for all.
3.2. In silico use and digital sequence information (DSI)
Since the Law defines genetic heritage as “information of genetic origin”, the understanding of the Brazilian authorities is that the use of nucleotide or protein sequences originating from Brazilian biodiversity constitutes access, even where those sequences were obtained from open-access public databases such as GenBank, and even where the company has never handled physical biological material. In such cases, registration must be made in SisGen indicating “in silico” as the source.
Likewise, the deposit of sequences of Brazilian origin in public databases is treated as disclosure of results and must therefore be preceded by registration of the access activity.
3.3. Associated traditional knowledge
Access to associated traditional knowledge of identifiable origin requires prior informed consent from the provider, in addition to registration. Where the origin is not identifiable, registration is equally due and any monetary benefit sharing is directed to the National Benefit-Sharing Fund (FNRB). The Law characterizes as incurable irregularities, among others, the declaration of access to genetic heritage alone where CGen identifies indications of access to associated traditional knowledge, and the obtaining of prior informed consent in breach of the statutory requirements.
3.4. Exclusions and relevant time limits
Activities that do not constitute access include, among others, mere commercialization, quality control testing and any activity that does not involve R&D on genetic heritage. In addition, under Article 46 of Law No. 13,123/2015 and Decree No. 11,865/2023, the economic exploitation of reproductive material of species introduced into the national territory by human action up to June 2, 2021 is not subject to benefit sharing in the context of agricultural activities — a carve-out of particular relevance to agribusiness and to plant and animal breeding companies.
4. SisGen registration obligations
Article 12 of Law No. 13,123/2015 lists the activities subject to registration:
Art. 12. The following activities must be registered:
I – access to genetic heritage or associated traditional knowledge within the country carried out by a national, public or private natural or legal person;
II – access to genetic heritage or associated traditional knowledge by a legal entity based abroad associated with a national public or private scientific and technological research institution;
III – access to genetic heritage or associated traditional knowledge carried out abroad by a national, public or private natural or legal person;
IV – shipment of a sample of genetic heritage abroad for the purpose of access, in the cases of items II and III of this heading; and
V – sending a sample containing genetic heritage by a national legal entity, public or private, to provide services abroad as part of research or technological development.
- 1º The registry referred to in this article will be defined by regulation.
- 2º Registration must be carried out prior to the shipment, or to the application for any intellectual property rights, or to the commercialization of the intermediate product, or to the disclosure of the results, final or partial, in scientific or communication media, or to the notification of the finished product or reproductive material developed as a result of the access.
Paragraph 2 is the provision with the greatest operational impact. R&D activity may begin before registration, but registration must necessarily precede the first of the following milestones: the shipment of a sample abroad; the application for any intellectual property right; the commercialization of an intermediate product; the disclosure of results, whether final or partial, in scientific or communication media; and the notification of a finished product or reproductive material.
For companies with an international pipeline, the practical consequence is that the Brazilian compliance calendar must be synchronized with the intellectual property calendar and with the scientific publication calendar — including conference abstracts and preprints.
5. Companies headquartered abroad: the structural change of 2026
5.1. The rule of Article 12, II, and the historical bottleneck
Article 12, II, of the Law requires a legal entity headquartered abroad to be associated with a national scientific and technological research institution, whether public or private, in order to register its activities. In practice, that requirement created a significant bottleneck: foreign companies without prior scientific collaboration with Brazilian institutions were required to find a local partner willing to carry out the registration. SisGen, moreover, did not allow direct registration by foreign legal entities.
5.2. Decree No. 13,014/2026 and the association agreement for registration purposes
Decree No. 13,014 of June 10, 2026, published on June 11, 2026 and in force since publication, amended Decree No. 8,772/2016 to create the “association agreement for registration purposes”. The new route allows an access activity carried out by a legal entity headquartered abroad to be registered in SisGen by a national scientific and technological research institution, whether public or private, even where there is no scientific collaboration between the parties (Article 22-B).
The essential features of the new mechanism are:
- An exclusively instrumental and regulatory nature, intended to enable compliance with the registration requirements, traceability of the access, institutional liaison and regulatory monitoring of the information declared.
- The absence of any technical, scientific or operational liability on the part of the national institution for activities carried out outside its scope of action or control — which removes the main obstacle to Brazilian institutions signing up.
- Duties of the national institution: to register the activity in accordance with the data provided; to keep a record of the agreement and of the information used; to report to the competent authorities any indications of irregularity of which it becomes aware; and to cooperate with monitoring activities.
- Duties of the foreign company: to provide complete, up-to-date and adequate data; to ensure the accuracy and integrity of the information; to comply with the obligations of Law No. 13,123/2015 and other applicable rules; and to state the SisGen registration number in the intellectual property application or in the registration of any product or process arising from the access.
- Situations in which the mechanism does not apply (Article 22-C): where there is genuine scientific collaboration between the parties — in which case the ordinary rule of Article 12, II, applies — or where the national institution is an importer, subsidiary, controlled, affiliated, related company or commercial representative of the foreign company. Multinational structures therefore require a case-by-case corporate analysis.
It should be noted that the new route broadens the alternatives for regularization but neither transfers nor mitigates the substantive obligations of Law No. 13,123/2015, which remain entirely with the foreign company. It is advisable to define precisely, in the agreement, the scope of the national institution’s role and the counterparty’s duties of information and accuracy.
5.3. APBio and the Biodiversity Partners Network
The same Decree established the Alliance of National Public Scientific and Technological Research Institutions for Biodiversity (APBio), intended to promote institutional coordination, guidance, transparency and the dissemination of good practice in relation to association for registration purposes (Articles 22-D and 22-E). Membership of APBio is optional and is not a requirement for entering into the agreement: the foreign company may sign it with an institution of its choice, whether or not a member of the Alliance. Coordination lies with the Ministry of Science, Technology and Innovation and with MMA.
APBio complements the Brazilian Biodiversity Partners Network (RPBio), launched by MMA during COP-16 in October 2024 and comprising institutions such as the Rio de Janeiro Botanical Garden, the Museu Paraense Emílio Goeldi, the Federal University of Paraná and the University of Campinas.
5.4. SisGen 3.0 and the module for foreign users: current status
The functionality that will allow registration by foreign users forms part of version 3.0 of SisGen, which will include a module in English. At the 45th Ordinary Meeting of CGen, held on June 10 and 11, 2026, approval of the functionality was postponed pending the completion of additional technical testing. According to MMA, the official launch is expected in September 2026, a timeline that remains subject to change.
The launch is expected to be accompanied by a CGen resolution ratifying or amending Ministerial Ordinance MMA No. 199/2020 as regards compliance deadlines and the time frame applicable to foreign users — a sensitive issue, because Law No. 13,123/2015 and Decree No. 8,772/2016 reach activities carried out since June 30, 2000, whereas the Nagoya Protocol, in force for Brazil since June 2, 2021, produces no retroactive effect.
Under the regulations currently in force, legal entities headquartered abroad will have one year from the date the functionality becomes available to regularize activities carried out without prior registration. This deadline is the most relevant compliance window of the period and should be planned for in advance.
5.5. Regularization of past activities
For pre-existing exposure, Ministerial Ordinance MMA No. 199/2020 set out the conditions for signing a Term of Commitment between foreign institutions and the Federal Government for the purpose of regularizing access to genetic heritage and associated traditional knowledge. The central assessment is always the same: to verify, activity by activity, whether what was carried out from June 2000 onwards qualifies as “access” in the statutory sense and, if so, to determine whether regularization will take place through registration, product notification or the execution of a Term of Commitment, with the corresponding benefit sharing.
5.6. Immediate practical recommendation
Regardless of the time frame ultimately adopted, foreign companies are advised to begin without delay a survey and diagnosis of assets involving Brazilian biodiversity, gathering, for each research line and each product: the scientific and common name of the species, the source of the sample (including any in silico use and the database of origin), the date of access, the supply chain, the intermediate and finished products developed, the countries of commercialization and the corresponding patent applications. That inventory is the indispensable input for registration as soon as the system becomes available.
6. Shipment of samples abroad
The shipment of a sample of genetic heritage abroad for the purpose of access requires a specific SisGen registration and the execution of a Material Transfer Agreement (TTM) in the form approved by CGen. Each shipment must be registered individually, even where covered by a single TTM, and samples must be accompanied by the shipment guide, the TTM and the registration receipts. Shipment in breach of the statutory requirements is one of the most frequently penalized infractions.
7. Benefit sharing
Benefit sharing is due upon the economic exploitation of a finished product or reproductive material arising from access, and not upon the research activity itself. The essential points are:
- Liable party: the obligation falls on the last link in the production chain that manufactures the finished product or the reproductive material. Intermediate products are exempt, which avoids cascading charges along the chain.
- Monetary modality: 1% of the annual net revenue obtained from the economic exploitation, a percentage that may be reduced to as little as 0.1% under a sectoral agreement. A frequent inaccuracy should be corrected here: the calculation basis is the annual net revenue determined under Brazilian law, and not the worldwide sales price of the product.
- Non-monetary modality: equivalent to 75% of the amount due under the monetary modality (that is, 0.75% of annual net revenue), implemented through projects, technology transfer, capacity building, product distribution and other forms provided for in the regulations, by means of a non-monetary Benefit-Sharing Agreement submitted for review by the Federal Government.
- Allocation: in the case of genetic heritage and of associated traditional knowledge of non-identifiable origin, funds are allocated to the FNRB, whose collection is operated through payment slips issued with the support of BNDES. In the case of associated traditional knowledge of identifiable origin, benefit sharing is agreed with the provider.
- Exemptions: micro-enterprises, small businesses, individual micro-entrepreneurs and traditional farmers and their cooperatives, within the statutory limits, in addition to the agricultural carve-out already mentioned regarding species introduced up to June 2, 2021.
Once the finished product or reproductive material has been created, the user must notify it in SisGen and submit the benefit-sharing agreement within one year from the notification.
8. Patent applications and other intellectual property rights
8.1. Registration prior to filing and conditional grant
Two provisions operate together. The first is the aforementioned Article 12, § 2, which requires registration prior to the application for any intellectual property right. The second is Article 47 of Law No. 13,123/2015, which conditions the grant of an intellectual property right over a finished product or reproductive material obtained from access upon registration or authorization under the Law. In other words, non-compliance not only exposes the company to administrative penalties but may also prevent the grant of the patent.
The Regulation provides to the same effect:
Art. 109. In order to comply with the provisions of §2 of art. 12 of Law no. 13.123, of 2015, the user, when applying for an intellectual property right, must inform whether there has been access to genetic heritage or associated traditional knowledge, as well as whether there is a registration of access carried out under the terms of this Decree.
Art. 118. The user who applied for any intellectual property right, economically exploited a finished product or reproductive material, or disclosed results, final or partial, in scientific or communication media, between November 17, 2015 and the date on which the registration is made available, must register the activities referred to in art. 12 of Law No. 13,123, of 2015 and notify the finished product or reproductive material developed as a result of the access.
- 1 – The deadline for the registration or notification referred to in the caput shall be one (1) year from the date on which the CGen makes the registration available.
- 2 – Once registration or notification has been carried out in good time, the user will not be subject to administrative sanctions.
8.2. INPI practice
In the electronic filing form, the applicant must declare whether the claimed invention arises from access to Brazilian genetic heritage and/or associated traditional knowledge and, if so, state the CGen registration or authorization number. Where that statement is missing or inconsistent, INPI issues a specific office action, suspending prosecution of the application for the period allowed for compliance.
Three practical points deserve emphasis in international portfolios:
- the declaration is made at filing, which requires the compliance check to take place before entry into the PCT national phase or direct filing in Brazil, rather than during technical examination;
- divisional and continuation applications inherit the subject matter of the parent application, so the access analysis must be repeated for each new filing;
- the presence of Brazilian-origin subject matter in applications drafted abroad is not always apparent to the applicant — sequences, strains, extracts and molecules obtained from collections or databases frequently have a Brazilian provenance that is not flagged in the technical documentation.
8. Penalties and enforcement
The most recurrent infractions are access to genetic heritage or associated traditional knowledge without registration, the economic exploitation of a finished product without prior notification, the commercialization of an intermediate product without access registration, failure to regularize within the statutory deadline, and shipment in breach of the statutory requirements.
The administrative penalties set out in Law No. 13,123/2015 and Decree No. 8,772/2016 include warnings, fines, seizure of samples and products, suspension of sales, embargo and interdiction of the activity, cancellation of registrations and authorizations, and loss or suspension of tax benefits and official financing lines. Fines applicable to legal entities may reach BRL 10 million per infraction, with provision for doubling or tripling in aggravated circumstances — for example, where the sample comes from a species on official lists of endangered species.
Law No. 13,123/2015 does not create criminal offences of its own. That does not, however, exclude the possible application of other statutes to related conduct, notably Law No. 9,605/1998 (environmental crimes), depending on the circumstances of the case.
Enforcement is carried out by IBAMA — and, in the case of access for agricultural activities, by the Ministry of Agriculture and Livestock — and has been intensifying. Following Operation Terra Brasilis, Operation Guardians of Biodiversity, launched in March 2026, inspected 47 cosmetics and pharmaceutical companies across twelve states and resulted, up to April 2026, in 51 infraction notices and approximately BRL 2.2 million in fines, focusing on the misappropriation of traditional knowledge associated with species such as annatto (Bixa orellana), Brazilian pepper (Schinus terebinthifolia) and jagube (Banisteriopsis caapi). The pattern of enforcement shows that it is not confined to large companies or to field activities: cross-referencing regulatory filings, labels, publications and patent applications is now an ordinary means of identifying irregularities.
9. The international layer
9.1. WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge
Adopted by consensus on May 24, 2024 at the close of the Diplomatic Conference held at the headquarters of the World Intellectual Property Organization (WIPO) in Geneva and chaired by Brazilian Ambassador Guilherme de Aguiar Patriota, the Treaty aims to enhance the effectiveness, transparency and quality of the patent system and to prevent patents from being erroneously granted for inventions that are not new or inventive in relation to genetic resources and associated traditional knowledge.
The Treaty establishes a mandatory disclosure requirement: where the claimed invention is “based on” genetic resources and/or associated traditional knowledge, the applicant must disclose the country of origin or the source of the genetic resources and, where applicable, the indigenous peoples or local community providing the traditional knowledge. Article 5.3 deserves emphasis:
Article 5.3. Subject to Article 5.4, no Contracting Party shall revoke, invalidate or render unenforceable the patent rights conferred solely on the basis of an applicant’s failure to disclose the information specified in Article 3 of this Treaty.
The Treaty will enter into force three months after the deposit of fifteen instruments of ratification or accession and imposes no obligations on applications filed before its entry into force. Status as of July 8, 2026: 44 signatories and four ratifications or accessions — Albania, Malawi, Peru and Uganda. Eleven further deposits are therefore required to trigger entry into force.
Brazil signed the Treaty and, on June 8, 2026, the Executive Branch submitted it to the National Congress for approval, a step required for ratification.
9.2. Digital sequence information (DSI) and the Cali Fund
At the 16th Conference of the Parties to the CBD (COP-16, Cali, Colombia, 2024), Decision 16/2 established the modalities of a multilateral mechanism for sharing benefits arising from the use of digital sequence information on genetic resources, together with the creation of a global fund — the Cali Fund, launched in February 2025.
Under the indicative parameters adopted, companies that use and benefit from DSI and that exceed at least two of three thresholds — total assets of USD 20 million, sales of USD 50 million and profit of USD 5 million, averaged over the preceding three financial years — should contribute annually 1% of profits or 0.1% of revenue. Sectors identified as highly dependent on DSI include, among others, pharmaceuticals, nutraceuticals, cosmetics, industrial biotechnology, plant and animal breeding, and artificial intelligence services associated with genetic resources. At least 50% of resources are earmarked for indigenous peoples and local communities. Academic institutions and non-commercial entities are excluded.
Three observations are relevant to corporate planning. First, contributions are indicative in nature and private-sector uptake has so far been very limited. Second, thresholds and rates are due to be reviewed at COP-17, scheduled for October 2026 in Yerevan, Armenia. Third, and most sensitive, there is as yet no definition of how a contribution to the Cali Fund interacts with the benefit sharing due under Law No. 13,123/2015, which creates a risk of double payment for companies using DSI of Brazilian origin. The issue remains open and should be monitored.
9.3. Due diligence in the European Union
Users established in the European Union are subject to Regulation (EU) No. 511/2014, which imposes due diligence obligations in respect of genetic resources and associated traditional knowledge from countries that are Parties to the Nagoya Protocol and have applicable access measures in place at the date of access. With the Protocol entering into force for Brazil on June 2, 2021, material of Brazilian origin accessed from that date onwards became subject to those obligations, including the retention of documentation for twenty years after the end of utilization and the submission of due diligence declarations at the prescribed checkpoints. Enforcement has been strengthened in several Member States.
In that context, discussions continue within CGen as to which Brazilian document will serve as the internationally recognized certificate of compliance (IRCC) for the purposes of the Nagoya Protocol, the Certificate of Regularity issued through SisGen being the leading candidate.
10. Practical compliance roadmap
For foreign companies carrying out R&D with biological material that may be of Brazilian origin, filing patent applications arising from those activities or commercializing the resulting products, the following sequence is suggested:
- Map the portfolio: identify species, strains, extracts, molecules and sequences of possible Brazilian origin across all R&D lines, including material obtained from collections, suppliers and public databases.
- Qualify each activity: determine whether there was research or technological development and therefore “access” in the statutory sense, distinguishing it from mere commercial use.
- Establish the time frame: separate activities carried out before and after June 30, 2000, November 17, 2015 and June 2, 2021, given the different treatment of each period.
- Select the registration route: scientific collaboration with a national institution (Article 12, II) or an association agreement for registration purposes (Article 22-B of Decree No. 8,772/2016), checking the exclusions of Article 22-C beforehand, particularly in groups with a subsidiary or importer in Brazil.
- Synchronize the calendars: align SisGen registration with patent filing, scientific publication, sample shipment and commercial launch milestones.
- Size the benefit-sharing exposure: identify who, in the chain, manufactures the finished product or reproductive material, and model the impact of 1% (or 0.75% under the non-monetary modality) of annual net revenue.
- Prepare the regularization of past exposure: assemble the documentation needed to use the one-year window from the date the foreign-user functionality becomes available in SisGen 3.0, or the Term of Commitment under Ministerial Ordinance MMA No. 199/2020.
- Monitor the regulatory agenda: the launch of SisGen 3.0 and the CGen resolution on deadlines and time frame; the passage of the WIPO Treaty through the National Congress; and COP-17 in October 2026.
11. Conclusion
The Brazilian access and benefit-sharing regime has ceased to be a peripheral environmental compliance topic and has become a structural element of intellectual property planning and product launch. Decree No. 13,014/2026 removed the main practical obstacle faced by foreign companies — the impossibility of registering their activities without a pre-existing scientific partnership — and, together with SisGen 3.0, should open a regularization window of defined duration. At the same time, enforcement has intensified and Brazil has consolidated its accession to relevant international instruments, from the Nagoya Protocol to the Budapest Treaty, with the WIPO Treaty currently before the legislature.
For the international company, the recommendation is a single one: treat the analysis of the origin of biological material as a mandatory step in the R&D and patenting workflow, rather than as a subsequent diligence exercise. The cost of timely compliance is significantly lower than that of regularizing under an infraction notice — which may involve, in addition to the fine, the suspension of sales and the impossibility of obtaining the corresponding patent.
Author: Pedro Henrique Figueiredo – [email protected]
Dannemann Siemsen
Av. Rodolfo Amoedo, 300 – Barra da Tijuca
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