Synthesis between clinical trials and patent families about leprosy

Abstract

The aim of this study is Perform a comparative analysis between clinical trials and patent families about leprosy worldwide in the last 20 years, using three technological aspects: diagnosis, drug/treatment and vaccine. A prospecting search in patent bank was conducted in the ORBIT Intelligence system, from Questel company. The search strategies utilized were based on ORBIT system, for each of the technological aspects established in the study (diagnosis, drug/treatment and vaccine). Clinical trials prospecting process was performed using simulations by WHO International Clinical Trials Registry Platform (ICTRP). Searching was carried out following a step-by step provided by the platform. A twenty-year time cut was adopted to harmonize the comparative analysis between patent and clinical trials recovered. Seventy-one clinical trials (11 for diagnosis, 54 for drug and 6 for vaccine) and 3323 patent families (790 for diagnosis, 1515 for drug and 1018 for vaccine) were identified, both distributed into 58 institutions and 21 countries. Through quantitative and qualitative analysis, a pattern of similarity was observed between institutions sponsoring clinical trials and holders of patent families, mainly related to years of registration and unionist priority filing, countries where clinical trials were performed and countries of unionist priority for patent families, phases of clinical trials and legal status of filed patent families. In summary, it is suggested that new public policies should be created to encourage synergy between clinical trials and patents, in order to induce a safe path to technological independence and, accordingly, a better performance in the struggle against leprosy in Brazil.