Quantity vs. quality: an assessment of the current pipeline for rabies.

Abstract

To gain insight in the potential of the current pipeline for rabies to decrease the burden of disease by evaluating its relevance to high-risk countries. Rabies-related patent documents and clinical trials were retrieved from Espacenet and the WHO ICTRP, respectively. Data were cleaned, modulated and categorised into a pre-defined set of indicators those were used for (statistical) analyses on the number of patent applications, patent quality and type of stakeholders involved for different geographical areas. Analysis of 583 unique patent families applied for in the period 1954-2017 showed a steep growth in the yearly number of patent applications. A significant portion of new patent applications concern Chinese patents with relatively low quality that are filed by a dispersed group of applicants. Excluding these patents, the number of patent applications has been virtually stable over the years. A shift is seen in public stakeholders becoming more prolific as patent applicants. This shift is also reflected in clinical trials; key sponsors of clinical trials include public and private stakeholders originating from high-risk rabies countries. The majority of clinical trials investigate adjustments to existing vaccines that may improve accessibility. The results show a discrepancy between the quantity and quality of rabies patent applications that reflects national patent regulations rather than real progress in decreasing the burden of disease. This is in contrast to clinical trials, which focus on incremental innovations that are tested in clinical trials but may nevertheless have a potentially strong impact in high-risk countries.