Patent characteristics for leishmaniasis treatment as a basis for freedom-to-operate analysis

Among the main zoonoses with the highest morbidity burden is leishmaniasis. The parasite of the genus Leishmania is its etiological agent. There are three forms of the disease: cutaneous, mucocutaneous and visceral. Pentavalent antimonial drugs are used for leishmaniasis treatment, however toxic side effects and parasite resistance have been detected. Intellectual Property Rights (IPRs) protect inventions that promote benefits to society, and patents are particularly notable for preserving advancements in biotechnology. To introduce innovative technologies, it is necessary to analyze the elements and processes involved in the development of products that may be protected by IPRs. This process consists of product deconstruction into its elements for an intellectual property analysis to contemplate commercial viability, and to determine strategies to avoid infringing third party rights (Freedom-to-Operate approach). In this project, a sample of patents protecting treatments directed against leishmaniasis were evaluated in order to know their characteristics, and to establish useful elements for Freedom-to-operate strategies. Open access patent databases were used (The Lens, Google patents, Patentscope, among others), and relevant characteristics such as claims, owners, technology protection region, or year of application for protection were determined. The sample obtained includes patents from 1967 to 2023. The majority of patents were found to be located in countries such as Brazil or the United States, and described developments focused on compounds derived from chemical synthesis, polypeptides, extracts, antigens, or structural components of the parasite. There are several patents that have already expired and whose information can be freely used. The Bolar exemption would allow the use of information from these patents for regulatory compliance purposes. This study provides an overview of what has been patented for leishmaniasis treatment, and information on Freedom-to-operate focus.