“Penciclovir”: Decision of the Superior Court of Justice of Brazil (Superior Tribunal de Justiça) 5 August 2021 – Case No. 1.543.826 – RJ (2015/0173736-6)

1. Under the terms of Art. 229-C of Law 9279/1996, the granting of patents for pharmaceutical products and processes depends on the prior consent of the Brazilian Health Regulatory Agency (ANVISA). 2. This favorable opinion constitutes a prerequisite for the granting of pharmaceutical patents by the Brazilian National Institute of Industrial Property (INPI). This is an inference that arises from the combination of this rule with the provisions of subsec. I of Art. 18 of the same law, which prioritizes the economic and social function of industrial property by considering inventions or utility models contrary to public health, whose protection falls within the regulatory agency’s powers, not to be patentable. 3. The expression “public health” has a broader meaning than “individual health”. It is not limited to treatment or recovery from disease, but comprises a set of preventive measures and control of diseases intended to ensure the physical, mental and social well-being of the community as a whole and each member of it, which includes full therapeutic assistance actions such as pharmaceutical assistance and the formulation of drug policies. 4. The amplification of the concept of health – beyond individual health – derives from its consecration as a right for all to be guaranteed by the State. It has the duty of formulating and executing economic and social policies aimed at reducing the risks of diseases and other illnesses and that ensure universal and equal access to “public health services” and the so-called “health actions” for the promotion, protection, and recovery of physical and mental well-being, so as to guarantee human dignity, an imperative of the Magna Carta of 1988. 5. To enable the implementation of this state duty, the Constitution created the Unified Health System (SUS), a world reference in the sector, which covers the aforementioned public actions and services (that are only complemented by private services) organized in regionalized networks and hierarchized in order to guarantee comprehensive care for the population, with priority given to preventive and curative care, without prejudice to care services (Art. 198). 6. When defining the field of action of SUS, Art. 6 of Law 8.080/1990 (Organic Health Law) reveals that such actions and services of public relevance are not limited to medical consultations, examinations and hospitalizations but also include full therapeutic assistance actions, including pharmaceutical assistance (item I, line “d”) and the formulation of drug policy (item VI). 7. The so-called full therapeutic assistance consists of the distribution of drugs – the prescription of which is in accordance with the therapeutic guidelines defined in a clinical protocol for the disease or illness to be treated – and the provision of therapeutic procedures on a home, outpatient, and inpatient basis, listed in tables prepared by the SUS federal manager (Art. 19-M of Law 8,080/1990, included by Law 12.401/2011). 8. In this scenario, the relevant role played by ANVISA in the sphere of economic-social regulation of the drug sector is extracted from the competence provided in item XXV of Art. 7 of Law 9.782/1999 – aimed at correcting market failures, by monitoring the evolution of drug prices – and from the fact that the regulatory agency performs the Executive Secretariat of the Drug Market Regulation Chamber (SCMED). This is an interministerial body created by Law 10. 742/2003, which has as objectives the adoption, implementation and coordination of activities intended to promote pharmaceutical assistance to the population by means of mechanisms that stimulate the supply of products and competitiveness among suppliers. 9. ANVISA’s institutional role in the process of granting pharmaceutical patents is not to be confused with the sanitary control of medicines, drugs and pharmaceutical inputs, performed within the scope of the registration procedure. “Patent granting” and “sanitary authorization” are distinct things. Interpreting them as synonyms means emptying the legislative option contained in Art. 229-C of the Industrial Property Law. 10. The difference in ANVISA’s and INPI’s perspectives of analysis of the pharmaceutical patent application eliminates any conflict of attributions. The INPI – currently linked to the Ministry of Economy – has the objective of ensuring the efficient protection of industrial property and, for this purpose, it uses fundamentally technical criteria, supported by all its expertise in the area, to evaluate patent applications. The granting of these is an administrative act of discretion linked to abstract and technological parameters set forth in the governing law and its internal regulations. ANVISA, the holder of specialized knowledge in the health sector in the exercise of the “prior consent” procedure, should enter into any aspects of the pharmaceutical products or processes that allow it to infer whether the granting of the exclusivity right will represent potential harm to SUS public policies aimed at guaranteeing pharmaceutical assistance to the population (even if they are extracted from the patentability requirements i.e. novelty, inventive step and industrial application). 11. Furthermore, there is no conflict between the interpretation herein conferred on Art. 229-C of the Industrial Property Law, and the rules provided for in the TRIPS Agreement, notably due to the mitigations introduced in 2001 with the Doha Declaration, providing that its implementation is consistent with each nation’s right to protect public health and, in particular, to promote access to medicines for all. 12. Recognizing ANVISA’s prior consent as a prerequisite of validity for the grant of a patent for a pharmaceutical product or process, it is therefore certain that in cases in which the contravention of public health policies is demonstrated the respective unfavorable opinion cannot be adopted only as a subsidy for INPI’s decision making. The binding nature of the refusal to consent is, therefore, unquestionable. […]