Pharmaceutical Companies claim extension of approximately 63 patents in Brazil

After 3 years of the action for the declaration of unconstitutionality (ADI 5529) judgment that prevented the validity of medicine patents for more than 20 years, several foreign and Brazilian pharmaceutical companies are seeking through the courts the extension of approximately 63 medicine patents in Brazil.

 

One of the pharmaceutical companies’ defense arguments is that, in other countries the event of proven slowness on the part of the public authorities in analyzing patent applications, an extra period of validity is granted through Patent Term Adjustment. 

 

On the other hand, representatives of generics and national industries claim that this extra period requested by pharmaceutical companies harms competitiveness in the Brazilian market.

 

 

It is worth noting that in recent disputes related to this topic, the Brazilian court denied a request to extend the term of the medicine patent, even after the INPI took 15 years to analyze the case. In view of the above, it is expected that Brazilian justice will maintain its understanding in these new cases pending decision.

 

It is important to mention that INPI has dedicated itself in recent months to reducing the backlog for analyzing patent applications.

 

 

Autores: Tatiane Robles Martins, Advogada Pleno e Cesar Peduti Filho, Peduti Advogados 

Fontes: https://www.jota.info/tributos-e-empresas/saude/farmaceuticas-brasileiras-e-estrangeiras-disputam-prazo-de-63-patentes

 

 

If you want to learn more about this topic, contact the author or the managing partner, Dr. Cesar Peduti Filho or Daniel Eustáquio Ramos Marinho.

Se quiser saber mais sobre este tema, contate o autor ou o Dr. Cesar Peduti Filho.

The current status of Bill 2,338/2023: regulating artificial intelligence in Brazil

The regulation of Artificial Intelligence (AI) is a global concern, and Brazil is making significant progress in this area through Bill 2.338/2023. This proposed legislation seeks to establish a comprehensive framework to govern the use and development of AI technologies, ensuring ethical standards, user protection, and promoting innovation. We aim to provide an overview of the bill’s current status and key provisions as Brazil works towards AI regulation.

 

Background of the Bill

 

Bill 2.338/2023, introduced in the Brazilian Congress, is a landmark initiative to regulate AI, aligning with international trends for responsible AI governance. The proposal responds to rapid advancements in AI and addresses concerns such as privacy, discrimination, accountability, and transparency. By establishing a legal framework, Brazil aims to balance the benefits of AI innovation with the need to protect individual rights and public safety.

 

Key Provisions of the Bill

 

The bill covers various aspects of AI use, with a focus on:

 

– Ethical Principles and Human Oversight: Ensuring AI systems are used in ways that respect human rights, non-discrimination, and transparency. There is an emphasis on human oversight over AI decision-making processes; 

 

– Risk-Based Approach: Classifying AI systems according to their potential risk to society, with higher-risk applications subject to stricter requirements. This approach echoes the European Union’s AI Act and aims to minimize harm from high-stakes AI systems in areas like healthcare, finance, and law enforcement; 

 

– Data Privacy and Protection: Reinforcing the principles established by Brazil’s General Data Protection Law (LGPD), the bill mandates that AI developers and users adopt measures to protect personal data used in AI training and operation; 

 

– Accountability Mechanisms: Introducing requirements for developers and deployers to ensure AI systems are safe and reliable, along with liability rules for damages caused by AI.

 

 

Legislative Progress: 

 

The bill is currently under review in the National Congress, where discussions and amendments are ongoing. As of now, the House of Representatives has held several public hearings to gather input from experts, industry representatives, and civil society. While there is broad support for regulating AI, stakeholders have raised concerns about the need for flexibility to foster innovation and avoid overly restrictive rules.

 

Amendments to the initial draft have been proposed to address these concerns, such as clarifying the scope of the regulation, refining risk classification criteria, and ensuring that small and medium-sized enterprises (SMEs) are not disproportionately burdened by compliance requirements. The timeline for the bill’s passage remains uncertain, but there is optimism that it will progress swiftly, given the global momentum towards AI regulation.

 

Implications for Businesses

 

Businesses operating in Brazil, particularly those in sectors heavily reliant on AI, should prepare for the changes that this legislation will bring. Companies may need to:

 

– Review and Update AI Practices: Conduct internal audits to ensure that their AI applications comply with the ethical and risk-based requirements proposed in the bill; 

 

– Enhance Data Protection Measures: Strengthen data governance practices to align with both the LGPD and forthcoming AI regulations.

 

– Engage in Policy Discussions: Stay informed about the bill’s progress and participate in public consultations to voice concerns or support for specific provisions.

 

Looking Ahead

 

Bill 2.338/2023 represents a significant step towards establishing a responsible AI regulatory framework in Brazil. While the legislation is still being shaped, its eventual passage will mark a crucial milestone in Brazil’s digital transformation journey. Businesses should closely monitor developments, assess the potential impact on their operations, and prepare to adapt to the new legal landscape.

 

The regulation of AI is particularly important in Brazil due to the country’s historical context of social inequality and entrenched prejudices. Without adequate safeguards, AI systems risk perpetuating or even exacerbating biases present in society, leading to unfair outcomes in critical areas such as hiring, law enforcement, and access to financial services. Bill 2.338/2023 aims to ensure that AI development and deployment prioritize fairness and inclusivity, taking into account Brazil’s diverse population and addressing the risk of discriminatory practices. Proper regulation can help harness the potential of AI to reduce inequality while protecting vulnerable groups from technological harms.

 

As discussions continue, the bill will likely evolve to better reflect the needs of the market while upholding the ethical use of AI. The challenge will be to craft a regulatory framework that promotes innovation without compromising public interest and individual rights.

 

 

If you want to learn more about this topic, contact the author or the managing partner, Dr. Cesar Peduti Filho or Daniel Eustáquio Ramos Marinho.

Se quiser saber mais sobre este tema, contate o autor ou o Dr. Cesar Peduti Filho ou Daniel Eustáquio Ramos Marinho.