Addressing the Gene Therapy Bottleneck in the EU: Patent vs. Regulatory Incentives

Abstract Today, the US leads the field of personalised medicine gene therapies, while the EU lags behind. The implementation phase of gene therapy technologies remains a significant bottleneck in Europe, with limited data on their availability, quality, safety, and efficacy. The legal framework for gene therapies differs significantly between the US and the EU as methods for the treatment of the human body by therapy are excluded from patent protection in Europe. Taking the creation of R&D incentives and information disclosure as core objectives of modern patent systems, this article analyses the potential to repeal the existing patentability exception to allow for patent protection for gene therapies as such. We demonstrate the contentious rationale of the exception and its inhomogeneous application, and express doubt over patent protection as a solution to the existing problems. In doing so, we explore a realm that has become a neighbouring field of intellectual property law in the domain of healthcare innovation: the regulatory framework of medicinal products and regulatory exclusivities. We propose a second-tier regulatory protection mechanism, which we argue offers greater potential to address the challenges of gene therapy development in the EU healthcare market than amendments to European patent law. Specifically, we argue that granting remuneration rights for extended reporting on the administration of advanced therapy medicinal products (ATMPs) prepared under the hospital exemption might establish steering effects in the right direction.