Patent Legislation and Drug Repositioning: A Comparative Study from the Perspective of Acceleration of Drug Development

Due to the demand for cost-effective drug development, the medicinal sector has introduced drug repositioning (DR) that relies upon identification of a new efficacy for a targeted disease, for a known substance in an existing drug. The DR strategy shortens the drug development process because the DR and the original drug have the same ingredient, eliminating clinical trials and reducing overall costs. This strategy is promoted by the academia-industry collaboration. In this new paradigm, technology transfer via patent licensing is an effective way to accelerate DR development. Though patents play a vital role, a patentable invention is not internationally defined due to the territoriality of the patent laws. This issue is exacerbated for inventions of DR drugs.

As the DR strategy is rather novel, it has not been validated whether the current patent laws are suitable to promote DR technology transfer. This monogram-based thesis therefore aims to analyse patent laws from the perspective of promoting DR technology transfer. Due to increasing importance of the economic partnership between Europe and Japan, this thesis focuses on the comparative analysis between Europe and Japan on the legal problems pertaining to the DR development on the basis of the legal reasoning in laws, cases and current practical issues.

The subject matter of the invention of DR drugs is categorised into second medical use invention under the European Patent Office practice and medical use invention under the Japan Patent Office practice. The DR invention has been justified as a valuable invention, and the necessary protection of DR inventions that truly contribute to society has been clarified.

The goal of this thesis was to identify a suitable model of patent legislation to accelerate an international DR drug development through technology transfer. The results indicate that patent law can fulfil its function and promote the much-needed innovation in the medical field.

Patents also play a vital role as technical documents. Patent offices and the World Intellectual Property Organisation have databases of all patent documents. With the databases, patent offices offer a licensing system, the License of Right, an excellent tool for facilitating the matching process linking patent owners with licensees. This thesis has justified the License of Right as a suitable model for accelerating technology transfer in DR drug development and validated the framework of the model. The DR development with technology transfer would be enhanced by the DR License of Right.