Intellectual Property System
Appropriate intellectual property protection in each country enables research and development to bring new medicines to patients.
(1) Intellectual Property System and New Drug Development
Aiming to contribute to global health, the member companies of the Pharmaceutical Manufacturers Association of Japan (PMAJ) are engaged in research and development of pharmaceutical products on a daily basis. In order to continue research and development, and to build and maintain a society and system that allows patients to access medicines in each country, it is necessary to have a system in which intellectual property, such as patents, trademarks, and R&D data, which are the results of research and development, are appropriately protected. Appropriate protection of intellectual property in each country will enable research and development to deliver the next new drug to patients, and will also help to strengthen the economy and other social infrastructure of each country.
(2) Access to medicines in developing countries and the contribution of intellectual property systems
We recognize the importance of bringing medicines for NTDs and infectious diseases such as HIV, TB, and malaria to patients in developing countries. We will cooperate to improve access to medicines by developing medicines for these diseases and improving the healthcare environment and health systems through public-private partnerships, etc., on the premise that the research results are protected by intellectual property rights. We also contribute to global health by promoting research and development and appropriate procurement of medicines through the flexible use of patent rights, including the right to exercise rights and relaxed licensing conditions, when it is deemed necessary to use intellectual property rights for the improvement of access to medicines.
3) Compulsory licensing
The Trade-Related Intellectual Property (TRIPS) Agreement issued by the World Trade Organization (WTO) in 1995 allows member governments to invoke the right to license technology protected by patent rights under certain conditions and without the prior consent of the patent holder. It is reasonable to invoke a compulsory license for the supply of medicines as an emergency evacuation measure to protect the safety of people's lives due to events specific to each country, and we recognize that this is an effective measure not limited to developing countries. On the other hand, access to medicines cannot be solved only by invoking compulsory licenses. There are still concerns that the implementation of compulsory licenses, which lack rationality and transparency, will make it difficult for appropriate R&D investment to take place. We will continue to engage in dialogue with governments to improve sustainable access to medicines.
Examples of member companies' efforts
| Participation in the WIPO Research Consortium (WIPO Re:Search) | Eisai and Takeda have joined the WIPO Research Consortium, an international joint project organized by the World Intellectual Property Organization (WIPO) for the development of drugs for NTDs. Each member organization will provide intellectual property and R&D know-how on drugs and candidates for NTDs, malaria, and tuberculosis free of charge to be shared with researchers and institutions for therapeutic drug development. |
|---|---|
| Participation in Pat-Informed (Patent Information Initiative for Medicines) | Astellas, Daiichi Sankyo, Eisai, Shionogi, and Takeda participate in Pat-Informed, a patent database jointly developed by WIPO and IFPMA, and provide information on registered patents for drugs in the prescribed disease areas and the WHO Essential Medicines List. The database is available in the following languages |