Brazil: Life Sciences, Biotechnology & Nanotechnology

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Brazil's patent office has revised its examination guidelines for new use inventions in chemistry, particularly medical uses, following extensive stakeholder consultation. The updated rules now permit post-filing data under certain conditions while maintaining restrictions on dosage regimen and patient group claims, creating a mixed landscape for pharmaceutical patent protection in Latin America's largest market.

Brazil's Life Sciences legal landscape is undergoing significant transformation through regulatory consolidation, pricing reforms, and evolving IP frameworks. Recent Supreme Court decisions on patent extensions and healthcare judicialization, combined with stricter CMED pricing controls, are reshaping market access strategies and creating both challenges and opportunities for pharmaceutical and biotech companies operating in this complex regulatory environment.

New regulation establishes guidelines for the research, development, governance, and use of artificial intelligence in medical practice, with a focus on safety, transparency, and accountability...

O "Brasília em Pauta" é um boletim semanal preparado pela equipe de Contencioso de Brasília...

Confira os principais movimentos regulatórios que impactam setores como saúde suplementar, farmacêutico, cosméticos, alimentos, biotecnologia e produtos sujeitos à regulação do MAPA...

Instrução Normativa, que passa a vigorar em Junho, traz lista de autoridades estrangeiras aprovadas pela Anvisa para registro otimizado de dispositivos médicos e dispositivos médicos IVD;

New Normative Instruction (IN), which comes into force in June, brings a list of equivalent foreign regulatory authorities approved by ANVISA and the requirements for optimized registration of medical devices...

Petições que já tenham sido alvo de avaliação por autoridades passam a tramitar com mais agilidade perante a Anvisa, facilitando a regularização desses produtos...