Tavares

BPTO releases three additional Intellectual Property Guides for Businesses

Tavares Office — Mon, 14 Sep 2026 19:15:31 +0000

The Brazilian Patent and Trademark Office released three additional editions of its Intellectual Property Guide for Businesses on August 26, 2026. With the new publications, the collection now includes nine practical guides designed to support businesses in the strategic use and management of intellectual property. The series was developed in partnership with the Intellectual Property Office of Singapore (IPOS). The original publications were adapted by BPTO for the Brazilian context, providing businesses with guidance on how to understand and manage their intellectual property assets. The three new guides focus on international operations, the integration of intellectual property into corporate strategy, and the identification and management of IP-related risks. Guide 7: Managing intellectual property in international operations Guide 7: How to Manage Your Intellectual Property When Operating Internationally addresses issues related to the protection and management of intellectual property assets outside Brazil. The publication covers topics such as: How intellectual property laws operate in foreign jurisdictions; Expanding IP protection to international markets; Enforcing rights outside Brazil; Available support channels for companies operating internationally. These issues become increasingly relevant as companies expand into new markets and need to consider the specific characteristics of intellectual property systems in different jurisdictions. Guide 8: Integrating intellectual property into business strategy Guide 8: Enabling Commercial Success Through Your Intellectual Property Strategy focuses on incorporating intellectual property into corporate planning and business strategy. The guide addresses: The role of intellectual property in corporate strategy; The stages involved in planning an IP strategy; Developing and structuring that strategy; Practical implementation; Sources of support available to businesses. The publication highlights how intellectual property can be incorporated into decision-making processes related to business development and management. Guide 9: managing and reducing intellectual property risks Guide 9: How to Manage and Reduce Intellectual Property Risks in Your Business focuses on managing and reducing intellectual property risks in your business. The publication addresses: Risks associated with intellectual property assets; Ways to reduce exposure to third-party rights; Procedures to consider when facing allegations of infringement; Available guidance and support channels. Preventive risk management can be particularly relevant for companies that develop, use or commercialize technologies, trademarks, and other intangible assets. The collection now includes nine practical guides With the release of the three new publications, the Intellectual Property Guide for Businesses series now comprises nine practical guides. The expanded collection covers different aspects of intellectual property management, including protection, strategy, internationalization and risk management. Together, the guides provide resources for businesses seeking to incorporate intellectual property considerations into broader management and strategic planning processes, particularly in areas involving international expansion, technology development and intangible assets.

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Artificial intelligence accounts for a growing share of software registrations at BPTO

Tavares Office — Thu, 10 Sep 2026 19:43:54 +0000

Software registrations in Brazil are accelerating in 2026, reflecting the growing role of digital technologies and artificial intelligence in business activities. By August, Brazilian Patent and Trademark Office (BPTO) had recorded 6,017 software registration filings, approaching the 7,232 registrations recorded during the whole of 2025. During the first half of 2026 alone, filings increased by 75% compared with the same period of the previous year. BPTO projects that software registrations will continue to grow at an average annual rate of 15.6% between 2026 and 2030. Artificial intelligence is already becoming a significant component of this growth. AI-related software gains relevance Data from BPTO show the increasing presence of artificial intelligence among software registration filings. In 2025: 1,372 filings, representing 19% of the total, were related to artificial intelligence. Based on data collected through May 2026: 639 registrations were related to AI; Out of 3,040 filings analyzed during the period. The figures illustrate the growing role of artificial intelligence in software development and reflect the expanding strategic importance of digital technologies across different business activities. Software becomes a strategic business asset According to Érica Guimarães Correia, Head of BPTO’s Division of Computer Programs and Integrated Circuit Topographies, software is no longer limited to an administrative support function. It now plays a direct role in areas such as: Process automation; Operational efficiency; Customer experience; Cost reduction; Data analysis; Decision-making; Business scalability. In some business models, the software itself is the product or service offered by the company. This shift increases the importance of identifying, managing, and protecting technology assets developed by businesses. How software protection works in Brazil In Brazil, computer programs are protected under copyright law rather than patent law. The registration system administered by BPTO concerns the program’s source code. Registration is not required for copyright protection, but a registration certificate may serve as evidence of authorship in the event of a dispute. It may also be relevant in business and legal contexts involving: Public procurement processes; Financing; Licensing; Technology transfer; Negotiations and agreements involving the exploitation of software. Software registration can therefore form part of a broader strategy for managing intangible assets and documenting rights related to technologies developed by companies and professionals. AI cannot be recognized as an author of software The growing use of artificial intelligence also raises questions about authorship. According to the BPTO specialist, under the rules currently applicable in Brazil, authorship remains linked to a natural person, since artificial intelligence is considered a tool and cannot claim authorship. Brazilian copyright legislation establishes that the author is the natural person responsible for the creation. The distinction between author and right holder is also particularly relevant in a corporate environment: The author is the natural person responsible for creating the software; The right holder may be either a natural person or a legal entity and holds the economic rights associated with the use and commercial exploitation of the program. Where a developer is hired to conduct software research and development as part of their employment duties, the developer remains the author. At the same time, the company may hold the corresponding economic rights. Code reproduction and the challenges of AI-generated content Another issue concerns situations in which artificial intelligence tools generate code based on existing content. According to the BPTO representative, a potential dispute may involve comparing source codes to determine whether protected content has been reproduced, particularly when the reproduced portion represents a significant or distinctive element of the software. BPTO does not assess the merits of potential plagiarism or code reproduction. In the event of a legal dispute, the matter may be examined by the Brazilian courts, potentially with technical analysis carried out by a court-appointed expert. As AI becomes increasingly integrated into software development, questions surrounding authorship, ownership, and the use of protected content are becoming increasingly relevant to technology and intellectual property strategies. Software protection in an increasingly technology-driven economy The growth in software registration filings and the expanding presence of artificial intelligence-related technologies reflect a broader shift in the role of digital assets within companies. As software becomes more directly connected to value creation, automation, and the delivery of products and services, issues such as authorship, ownership, and source code protection become increasingly relevant to the management of intangible assets. These issues were discussed during a webinar held by Assespro-PR on August 11, focusing on intellectual property applied to software and the implications of artificial intelligence for technologies developed by companies.

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Businesses have until December to request priority examination for trademark applications in Brazil

Tavares Office — Tue, 08 Sep 2026 17:52:47 +0000

Businesses and entrepreneurs who rely on trademark registration for their commercial activities have a new opportunity to request priority examination from the Brazilian Patent and Trademark Office (BPTO). Since September 1, 2026, BPTO has resumed issuing the payment guide required for priority examination requests in categories that had been temporarily unavailable. The current application window will remain open until December 31, 2026, as part of the second four-month period of Phase II of the pilot project established under BPTO/PR Normative Ordinance No. 67/2026. 1,500 slots available in the second period Normative Ordinance No. 67/2026 divided 3,000 requests under Phase II of the pilot project into two four-month periods, with 1,500 slots allocated to each period. The first period ran from May 1 to August 31 and reached its available capacity, resulting in the temporary suspension of the relevant payment guide. The second period began on September 1 and will remain open until December 31, 2026. The current allocation includes: 1,500 available slots; A shared quota covering 13 priority examination categories established under BPTO/PR Normative Ordinance No. 66/2026; A minimum reservation of 100 slots for each category; A limit of ten requests per applicant. The current period therefore represents the remaining opportunity for applicants seeking to use one of these priority examination mechanisms in 2026. Priority examination does not eliminate the opposition period Priority examination may accelerate the examination stage of a trademark application, but it does not remove other procedural steps required under Brazil’s trademark system. Under Article 84-L of BPTO/PR Ordinance No. 27/2025, priority processing takes place after the formal examination stage and the expiration of the opposition period. Under Law No. 9,279/96, third parties have 60 days from the publication of the trademark application to file an opposition. As a result, priority treatment may accelerate the examination itself, but it does not eliminate the period during which third parties may challenge the registration. Incomplete documentation may result in the loss of a priority slot The documentation submitted with the priority examination request is another relevant factor. According to attorney Vinicius Augusto Del Rio, slots are allocated in the order in which requests are filed, and applications are assessed based on the evidence submitted with the request. If the documentation does not fully demonstrate compliance with the requirements of the applicable priority category, the request may be denied after the slot has already been used. Article 84-N of INPI/PR Ordinance No. 27/2025 provides that decisions concerning priority examination requests are not subject to appeal. In such cases, a new request may be submitted with the appropriate documentation, subject to the availability of slots at that time. Deadline requires attention to procedural requirements The resumption of the payment guide provides a new window for applicants seeking to accelerate the examination of trademark applications in Brazil during 2026. However, access to the available quota does not remove the need to comply with the specific procedural and documentary requirements applicable to each priority examination category. With the second four-month period running until December 31, 2026, preparing the required documentation before filing remains an important step for applicants seeking to make use of the priority examination system.

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Brazil and South Korea expand cooperation in intellectual property and technology

Tavares Office — Thu, 03 Sep 2026 17:14:50 +0000

Brazil and South Korea are expanding cooperation across strategic areas, including trade, investment, technological development and intellectual property. The relationship gained further momentum following South Korean President Lee Jae-myung’s state visit to Brazil and renewed efforts to advance discussions on a potential trade agreement between Mercosur and South Korea. In the field of intellectual property, the bilateral relationship already includes institutional cooperation mechanisms between the countries’ industrial property authorities. At the same time, South Korean companies are increasing their presence in Brazil’s patent and trademark system. Trade negotiations and strategic cooperation Discussions surrounding a potential trade agreement between Mercosur and South Korea cover several areas relevant to economic integration, including: Trade in goods and services; Investment; E-commerce; Intellectual property. The growing relationship comes at a time of increasing global demand for advanced technologies and stronger supply chains connected to the digital economy and the energy transition. South Korea has a strong industrial presence in sectors such as: Semiconductors; Rechargeable batteries; Electric vehicles; Electronics. Brazil, meanwhile, holds significant reserves of rare earth elements used in a wide range of technologies, including information and communication technologies, 5G networks, the Internet of Things, semiconductors, biotechnology, nanotechnology and metrology. Institutional cooperation in intellectual property Brazil and South Korea already maintain specific cooperation mechanisms in the field of industrial property. In 2024, Brazilian Patent and Trademark Office (BPTO) and South Korea established a Memorandum of Understanding on Industrial Property, providing for training initiatives and exchanges of knowledge and experience between the institutions. BPTO also maintains a Patent Prosecution Highway (PPH) agreement with the Korean Intellectual Property Office (KIPO). The mechanism is intended to accelerate the examination of certain patent applications in both jurisdictions, strengthening cooperation between the two industrial property systems. Intellectual property and international business The relationship also involves initiatives designed to support companies operating in international markets. BPTO has developed an Intellectual Property Guide for Exporters, designed to help Brazilian companies identify and protect their intellectual property assets abroad. The guide includes information on South Korea’s intellectual property system, helping Brazilian exporters understand local requirements and develop appropriate protection strategies for their intangible assets. South Korean companies increase their presence in Brazil Data for 2025 point to growing interest from South Korean companies in the Brazilian market. According to INPI rankings, South Korea surpassed Japan to become the third-largest country of origin for patent applications filed by non-residents in Brazil, accounting for approximately 9% of the applications included in the ranking. South Korea also holds a prominent position in trademark activity. Among the countries of origin of non-resident applicants mentioned in the ranking, it ranks only behind the United States. These figures highlight the growing use of Brazil’s intellectual property system by South Korean companies and reinforce the country’s relevance as a market for international investment and expansion. Technology, intangible assets and future opportunities Closer ties between Brazil and South Korea create opportunities for cooperation between two economies with distinct industrial and technological capabilities. South Korea brings a well-established industrial base in technology-intensive sectors, while Brazil combines natural resources, a large consumer market and innovation capabilities across different industries. Within this context, intellectual property can support: Joint technological development; Investment initiatives; Technology transfer; The development of new value chains; The protection and commercialization of intangible assets. Further bilateral cooperation and progress in Mercosur–South Korea negotiations could therefore expand not only trade flows, but also the exchange of knowledge, technology and intellectual assets.

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Brazil advances in innovation, R&D and startups, but structural challenges continue to affect competitiveness

Tavares Office — Tue, 01 Sep 2026 14:25:08 +0000

Brazil’s technology sector has recorded progress across innovation, research and development, talent formation and entrepreneurship. At the same time, data presented in the second edition of the TICs 2026 study, released by Softex Observatory, highlight structural challenges that continue to affect the country’s competitiveness. The publication examines Brazil’s Software and Information and Communication Technology Services Industry and analyzes talent development, the labor market, technology adoption, research and development, and startup activity. The findings point to an expanding business and technology base, alongside challenges related to professional qualifications, innovation costs, R&D investment, and the maturity of the entrepreneurial ecosystem. Technology education expands, but quality and retention remain challenges Training technology professionals remains a strategic factor for the development of Brazil’s digital economy. In 2024, Brazil recorded: 4,190 Information Technology programs, representing 9.2% of higher education programs; 50% of the available programs concentrated in the Southeast region; 30.57% located in the state of São Paulo; 87.3% of available places offered through distance learning; 109,875 professionals graduating through distance-learning programs, an increase of 30.6% compared with 2023. Despite this expansion, the study identifies challenges related to education quality and student retention. Around 71% of programs evaluated by ENADE received scores of 2 or 3, while dropout rates in private distance-learning programs exceed 50%. Strategic fields have also expanded rapidly. Enrollment in Artificial Intelligence programs increased from 396 to 3,250 between 2022 and 2024, while the number of available places in Cyber Defense grew from 4,785 to 113,080 between 2019 and 2024. Business base and technology adoption continue to expand Brazil’s technology business landscape has also grown significantly. In 2025, the country had 627,124 companies in the Software and ICT Services Industry, representing a 21% increase from 2023 to 2025. The adoption of Artificial Intelligence also increased: From 12.94% to 17.46% across companies on average; From 38.24% to 48.88% within the Information and Communication sector. Cloud computing had already been adopted by 55.64% of companies and by 74.71% of organizations in the ICT sector. The main barriers to innovation identified by the study include: Technology costs: 78.6%; Shortage of qualified professionals: 54.2%. These figures suggest that the expansion of technology adoption is occurring alongside the need to increase the availability of specialized talent and address barriers to innovation. Technology sector offers above-average remuneration In 2025, the sector accounted for 1.32 million formal employment relationships, equivalent to 2.20% of Brazil’s total. Average remuneration reached R$8,253.55, approximately 64.28% above the services sector average. The data underscore the economic relevance of technology-related activities and reflect growing demand for qualified professionals in areas that are increasingly strategic to the digital economy. R&D grows, but investment remains below leading global innovation hubs In research and development, the study points to growth in investment and scientific infrastructure, although Brazil remains behind the world’s leading innovation economies. Brazil invests between 1.3% and 1.7% of GDP in science and technology, compared with 6.35% in Israel and 5.32% in South Korea. Within the Software and ICT Services Industry, R&D expenditure increased from: R$1.9 billion in 2008 to R$3.6 billion in 2017. Spending on specialized scientific and technical activities exceeded R$10 billion. Brazil also has 583 Science and Technology Institutions (STIs), of which **57.1% operate in Technology and Communication-related fields. Software registrations increase while ICT patent filings decline The intellectual property indicators presented in the study reveal contrasting trends. Software registrations with the Brazilian Patent and Trademark Office (BPTO) increased from 2,099 in 2020 to 7,232 in 2025, indicating significant growth in the formal registration of software assets. At the same time, patent applications related to Information and Communication Technologies declined by 20.4%. The differences between these indicators highlight distinct dynamics within Brazil’s innovation system and underscore the importance of monitoring how companies, research institutions, and entrepreneurs use intellectual property protection mechanisms. Startup ecosystem grows, but maturity and access to capital remain challenges In 2025, Brazil had 3,923 technology-based startups, within a broader ecosystem of 22,869 startups. Most were still in the early stages of development: 67% were in the validation or traction stages; Only 3.3% had reached the scale stage; 50.1% reported no revenue. The B2B model accounted for 70% of companies, while SaaS solutions represented 64.4% of the ecosystem analyzed. Access to investment capital remains another key challenge. Venture capital funding declined from US$11.2 billion in 2021 to US$4.5 billion in 2025. For the first time in 15 years, Mexico surpassed Brazil in investment volume. Regional concentration also remains significant: the Southeast accounts for 40.2% of startups, São Paulo for 24.8%, and Santa Catarina for 13.3%. Brazil’s innovation ecosystem: growth alongside structural challenges The TICs 2026 findings point to consistent growth in Brazil’s technology sector, driven by business expansion, increased adoption of technologies such as artificial intelligence and cloud computing, and the development of strategic talent pipelines. At the same time, indicators related to R&D investment, talent availability, patent applications and access to capital demonstrate that further progress will depend on addressing structural challenges. In this context, Brazil’s future competitiveness will depend not only on the continued expansion of its technology sector, but also on its ability to transform knowledge, research, development and entrepreneurship into technologies, intellectual assets and scalable businesses.

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Expiration of semaglutide patent accelerates race for new injection pens in Brazil

Tavares Office — Wed, 26 Aug 2026 17:53:34 +0000

The expiration of semaglutide patent protection in Brazil has triggered a new phase of competition in the market for medicines used to treat diabetes and manage weight. Following the end of the protection period, Brazil’s Health Regulator Agency, Anvisa, began approving a new generation of semaglutide-based products, including synthetic versions and the first generic in the category. According to VEJA, 12 semaglutide-based medicines have now been authorized by Brazil’s Health Regulator Agency (Anvisa), with some already available and others still awaiting pricing and commercial launch. Patent expiration opens the market to new competitors Semaglutide became globally known through Ozempic, developed by Danish pharmaceutical company Novo Nordisk. With patent protection ending in Brazil, local manufacturers began competing for a share of a rapidly expanding market. The first major development came in May 2026, when Anvisa approved Ozivy, manufactured by Brazilian pharmaceutical company EMS. The product contains synthetic semaglutide and reached Brazilian pharmacies in June, selling 200,000 units in July alone, according to the report. In July, Anvisa also authorized five other similar medicines: Owozy Seemasun Zempneo Semavy Orsema The agency subsequently approved two additional products, including the first generic version developed by EMS. Competition now involves different regulatory categories and development approaches. Competition and potential price impact The growing number of manufacturers is expected to increase competition and potentially put downward pressure on prices. Ozivy, the first domestically produced semaglutide injection pen, entered pharmacies at USD 64 (R$ 333) per unit under EMS’s Vida + Leve program. The company attributes its competitive pricing to internally developed technology and fully local production. Novo Nordisk, meanwhile, remains active in the Brazilian market. In late 2025, the company entered into an agreement with the Brazilian pharmaceutical company Eurofarma to produce and distribute semaglutide-based medicines. The development demonstrates that patent expiration does not necessarily remove the original innovator from the market. Instead, it can fundamentally reshape competitive dynamics once exclusivity ends. Innovation beyond replication The arrival of new products also highlights the distinction between biological and synthetic medicines. The semaglutide originally used in Ozempic and Wegovy is a biological medicine manufactured using cultured cells. Several of the products now authorized in Brazil, however, use semaglutide produced through chemical synthesis. This distinction is relevant to both intellectual property and regulatory strategies, as patent expiration does not simply mean reproducing the original technology developed by the innovator. In the case of Ozivy, for example, the use of a synthetic manufacturing route allowed the product to be classified as a new medicine, despite using the same underlying active substance. The generic version subsequently approved by Anvisa uses Ozivy as its reference product. Regulatory oversight keeps pace with market expansion The rapid increase in the number of available products has also prompted Anvisa to intensify its review of registration applications. According to the report, the agency reviewed 24 applications, of which 11 had been completed at the time of publication: six were approved and five rejected. The regulatory process includes assessment of technical dossiers and inspections of manufacturing facilities. The expansion is occurring alongside concerns over an illegal market for unregulated products. Between November 2025 and July 2026, 9.2 lb of semaglutide and 330 lb of tirzepatide in raw-material form were imported. During the same period, Anvisa conducted 33 inspections of compounding pharmacies, 14 of which were conducted jointly with the Federal Police. Intellectual property and pharmaceutical market transformation The semaglutide case illustrates how the expiration of patent exclusivity can rapidly reshape competition within a pharmaceutical market. The arrival of new market participants may contribute to: Greater availability of medicines; Development of alternative manufacturing technologies; Potential price reductions; Increased competition among manufacturers; Broader access to treatments. At the same time, the case demonstrates that patent expiration is only one step in the market-entry process. Regulatory approval, manufacturing capacity, pricing, and commercial strategies also determine how quickly competition reaches consumers.

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BPTO releases 2027–2036 Strategic Plan focused on long-term institutional development

Tavares Office — Tue, 25 Aug 2026 18:38:34 +0000

Brazilian Patent and Trademark Office (BPTO) published its Strategic Plan for 2027–2036 on August 14, 2026. The document establishes the Institute’s long-term strategic direction and reflects the results of a collective, participatory strategy-building process. The new framework sets out seven Strategic Objectives, aligned with BPTO’s mission, vision and values. The strategy will subsequently be translated into action plans for the Institute’s different areas, with medium-term targets and projects. A decade-long strategic framework The ten-year planning horizon establishes a long-term framework to guide BPTO’s institutional initiatives and priorities. Key elements include: Planning period: 2027–2036 Seven Strategic Objectives Collective and participatory development process Alignment with the Institute’s Mission, Vision and Values Implementation through Action Plans Definition of medium-term targets and projects Connecting strategy and implementation According to BPTO, the new framework adopts an integrated model, under which the strategic guidelines will be implemented through Action Plans developed by the Institute’s different areas. This approach connects long-term strategic planning with medium-term implementation, translating institutional objectives into specific projects and targets. The framework also fits within BPTO’s broader governance structure, which includes instruments such as the Action Plan, Monitoring Center, Multi-Year Plan and the National Intellectual Property Strategy. Implications for Brazil’s intellectual property system BPTO’s Strategic Plan provides a long-term framework for an institution that plays a central role in Brazil’s intellectual property system. The Institute is responsible for granting and registering several forms of industrial property rights, including patents, trademarks, industrial designs and geographical indications. Against this backdrop, long-term institutional planning can provide direction for the development of processes, projects and targets related to the agency’s activities. The document is also expected to serve as a reference for planning across BPTO’s different areas, connecting institutional objectives with implementation initiatives. Next steps The publication of the Strategic Plan marks the beginning of a new 2027–2036 planning cycle. Implementation will take place through the Action Plans developed by BPTO’s different areas, which will establish medium-term projects and targets. The full Strategic Plan is available through BPTO’s official portal.

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Tropical wines and exports: Brazil’s São Francisco Valley as a global benchmark

Tavares Office — Mon, 17 Aug 2026 11:00:56 +0000

Brazil’s São Francisco Valley, located in the country’s semi-arid Northeast, has emerged as a global benchmark in fruit production and an innovative wine-producing region. The area accounts for around 90% of Brazil’s grape exports, underscoring its importance in international agricultural trade. A high-tech agricultural hub The region’s success is driven by irrigation, research, and advanced agricultural practices: Year-round production cycles Strong integration between research institutions and producers High export orientation Global grape export leader The São Francisco Valley dominates Brazil’s grape exports: Up to 95% of exported table grapes originate from the region Key markets include Europe and North America Strong logistics and infrastructure support global distribution Unique tropical wines The region is also known for producing tropical wines, a rare phenomenon globally: Two harvests per year due to climate conditions Distinct aromatic and fresh profiles Recognized through Geographical Indication (GI) Intellectual property and GI relevance Geographical Indications play a key role in positioning the region internationally: Protect origin and reputation Enhance product value Support regional economic development

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Patent challenges become central in global HIV/AIDS response strategies

Tavares Office — Thu, 13 Aug 2026 11:00:06 +0000

Pharmaceutical patent frameworks have once again become a focal point in the global response to HIV/AIDS, with experts advocating for mechanisms that expand access to essential medicines, particularly in the Global South. The discussion centers on the use of intellectual property flexibilities — such as compulsory licensing — to balance innovation incentives with public health needs. Patents and access to treatment Patent systems grant temporary exclusivity over drug commercialization, which can directly influence pricing and availability. In the HIV/AIDS context: Patent protection may limit generic competition High costs can restrict access in low- and middle-income countries Local manufacturing capacity is seen as a strategic priority Addressing these barriers has historically played a key role in expanding access to antiretroviral therapies worldwide. Flexibility mechanisms Key policy tools under discussion include: Compulsory licensing: allows production without patent holder consent under specific conditions Technology transfer: supports local pharmaceutical manufacturing International cooperation: promotes broader access to health technologies These mechanisms are considered essential to improving global preparedness and response to health crises. International perspectives The debate includes perspectives from regions facing structural healthcare challenges, where stigmatized diseases can intensify broader social and economic crises. Brazilian initiatives have also been highlighted as examples of efforts to expand manufacturing capacity and improve access to treatment. Policy implications The issue underscores a fundamental policy challenge: balancing innovation incentives with equitable access to healthcare. Key considerations include: Sustainability of public health systems Incentives for pharmaceutical R&D Reduction of inequalities in access to medicines The topic remains under active discussion among governments, industry stakeholders, multilateral organizations, and civil society.

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Patent term adjustment debate resurfaces, raising questions on predictability and innovation in healthcare

Tavares Office — Tue, 11 Aug 2026 11:00:12 +0000

The discussion on reintroducing a patent term adjustment (PTA) mechanism has resurfaced in Brazil’s healthcare sector, bringing renewed attention to regulatory predictability and innovation incentives. While part of the industry views the mechanism as a way to strengthen legal certainty and attract investment, stakeholders linked to generics, biosimilars, and public health argue that the current framework already provides sufficient protection without extending patent terms. Regulatory background Since 2021, Brazil has not maintained a mechanism to compensate for delays in patent examination. This followed a Supreme Court ruling that invalidated provisions guaranteeing a minimum patent term in such cases. Legislative proposals are now under discussion to reintroduce a structured adjustment model, including: Proportional extensions based on administrative delays A maximum adjustment period of up to five years Defined deadlines for requesting adjustments after grant These proposals aim to align Brazil with international practices. Predictability and innovation impact Predictability in patent systems is a key factor influencing R&D investment decisions. Extended examination timelines can: Reduce legal certainty over intellectual property rights Increase transaction and licensing costs Delay market entry of new technologies Compared to leading economies such as China, Brazil’s patent activity remains significantly lower, reinforcing the debate on how to strengthen its innovation ecosystem. Patent Term Adjustment (PTA) PTA is a mechanism designed to compensate patent holders for undue administrative delays in the examination process. Its main features include: Case-specific application rather than automatic extension Eligibility tied to unjustified delays by the patent office Objective of restoring effective exclusivity time The mechanism is widely used internationally to balance protection and regulatory efficiency. Trade-offs: access vs. innovation Reintroducing PTA involves a strategic policy choice: Access-oriented approach: prioritizing affordability through generics and biosimilars Innovation-driven approach: encouraging investment and technology inflow Balancing these priorities is critical in a sector characterized by high development costs and strong reliance on intellectual property protection. Next steps The debate continues across legislative and industry forums. Any future adoption of a PTA mechanism is expected to influence: Investment strategies in Brazil Competitive dynamics in the pharmaceutical sector Access to new treatments and technologies

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