Patent Strategies for Attenuated Pathogen Vaccines

David Dolberg, Senior Director of Intellectual Property, Sanaria Inc.

Malaria is a major health concern for people traveling to and living in malaria-endemic areas, causing 249 million clinical cases and 608,000 deaths in 2022, numbers essentially unchanged over the past decade. Plasmodium falciparum (Pf) is the eukaryotic parasite that is responsible for the vast majority of these deaths. To date, there is no licensed vaccine available in the United States or European Union that prevents malaria, although two partially effective vaccines, indicated for use in infants and small children, are licensed in some African countries. The World Health Organization has recently called for improved vaccines that at once prevent Pf infection in > 90% of recipients while also blocking transmission from mosquitoes to humans, enabling these vaccines to be used in malaria-elimination campaigns. Sanaria Inc. is developing highly effective, aseptic, live, attenuated Pf vaccines designed to address this need and which also can be used to protect travellers to malaria endemic areas. As Senior Director of Intellectual Property, my job has been to develop strategies for patent protection of these vaccines.