Análise do setor de P&D farmacêutico no Brasil com base em depósitos de patentes e acordos de parceria em empresas públicas e privadas voltados à inovação de medicamentos

Abstract

Pharmaceutical inputs form the foundation of the drug production chain, including active ingredients, biological substances, excipients, and reagents. The 2022 supply shortage crisis highlighted Brazil’s dependence on imported active pharmaceutical ingredients, stimulating debates on strengthening research, development, and innovation. Universities plays a key role in addressing infrastructure and technical capacity limitations. This study analyzed the national R&D landscape for APIs through patent filings and strategic partnerships. A total of 859 patent applications were analyzed, correlating applicants’ countries of origin with national participation. The highest concentrations were found on groups A61K 47 (211 records), A61K 31 (142), C07K (131), and A61K 9 (129), all related to pharmaceutical or medical preparations. Continuous participation of foreign companies, particularly from China, was observed in the Brazilian pharmaceutical innovation landscape. Between 1997 and 2023, national inventive activity increased, with 47 patent filings in the A61K, C07, and C12 domains, involving 37 applicants, predominantly higher education institutions. National filings were mainly concentrated in subclasses A61K 31, A61K 9, and C12P. A Patentscope search identified 106 pharmaceutical patents classified under subclass A61P, primarily related to antineoplastic and anti-infective agents and treatments for nervous system disorders. Patent WO2022061431, filed by UFRJ in co-ownership with UFJF and INMETRO, stands out. Of the 112 filings analyzed, 65 involved universities, 24 pharmaceutical companies, 15 independent researchers, and 8 public companies. In the second stage of the study, interviewees held managerial or technical analysis positions, mostly with degrees in Pharmacy. Private companies were predominantly large-sized, whereas public companies showed greater diversity. Regarding API procurement, private companies prioritized direct purchasing, while public companies mainly relied on public bidding processes. Half of the companies reported having a dedicated R&D department. Public companies showed greater progress in research on synthesis, semisynthesis, natural sources, and biomolecules compared to private firms. One public and one private company did not believe that partnerships with universities reduce labor and equipment costs. Except for funding allocated to equipment acquisition reported by one public company, most firms were unaware of government programs supporting technological development and innovation. Overall, Brazil shows still incipient yet relevant progress in API research, development, and innovation, largely driven by universities. Nevertheless, dependence on foreign companies and limited national industrial participation persist, reinforcing the need for integrated public policies to strengthen technological autonomy in APIs.