Position on Intellectual Property in Developing Countries

Astellas believes that intellectual property protection of research and development is essential to the creation of innovative new drugs and technologies. At the same time, we acknowledge that a variety of inter-related factors in select developing countries may inhibit access to care, although we do not believe that intellectual property protection is a factor in limiting Access to Health.

Intellectual property protections increase access to medicines by incentivizing research and development that creates new drugs and technologies.

Astellas commits to not filing or enforcing patents in Least Developed Countries (LDCs)^*1 defined by the United Nations or Low Income Countries (LICs)^*2 defined by the World Bank. We recognize that these countries can be the subject of flexibilities allowed in Declaration on the TRIPS agreement and public health (Doha Declaration)^*3, in order to address social and economic concerns. Of note, LDCs have secured an exemption from the TRIPS agreement until 2033, which Astellas supports. Astellas also commits to considering flexibilities in licensing patents in other developing countries on a case-by-case basis, in order to address pressing health challenges, while recognizing these challenges are the shared responsibility of multiple actors, including the pharmaceutical industry.

Astellas believes in improving patient health through creating innovative new drugs and technologies. We believe compulsory licenses are appropriate only in the case of a national emergency or other circumstances of extreme urgency, in accordance with international rules, and only when all other alternatives have been exhausted. The Doha Declaration reflected in Article 31bis of the TRIPS agreement articulates the foundation for support for intellectual property rights and the need for delivery of life saving medicines to LDCs and LICs.