Innovations for microbiome targeting interventions - a patent landscape analysis indicating overall patenting...

The human microbiota have been implicated in the aetiology and remedy of a host of disorders. However, due to the pervasive uncertainty inherent in the field of microbiota-targeting interventions and associated issues with establishing rigorous safety and efficacy profiles, regulatory oversight is suboptimal. This can dissuade innovators from further exploring novel and much needed health interventions. Modification of regulatory protocols and practices requires focussed efforts and funding to build the evidence base around future regulatory needs. Such modification can be critically informed by identification of changes and trends in technology fields to facilitate identification of regulatory gaps. To this purpose, this study rigorously collected and analysed patent data from Espacenet - covering the years 2013-2018 - and created a patent landscape analysis of microbiome targeting interventions with a focus on medicinal products. Pertinent patenting activity has declined overall. While, in absolute terms, patents most frequently claimed inventions targeting disorders of the gut and alimentary tract, relative year-on-year interest increases have been substantial for cancer, and disorders of the (neuro-)muscular and respiratory systems - driven by the private sector. Academic stakeholders showed top interest in disorders of the metabolism, anti-infectives, and skeletal and dermatological diseases. Although medicinal preparation claims dominated our dataset, a third of patents claimed food preparations, while only 1% claimed application as a diagnostic. Finally, China is, by an inordinate margin, a market of particular interest for both domestic and foreign innovators, indicating that microbiome targeting intervention innovation for EU and US markets might be frustrated. This study is the first to empirically demonstrate that live biotherapeutic product innovation is decelerating and potentially frustrated, supporting the urgent need for improved regulatory standards. Our results indicate which disease areas deserve particular attention for research funding to facilitate proper regulatory appraisal in the near- to mid-term future.