The Declaration relates to how sovereign states can formulate domestic policy to protect their interests and remain within International law. The subtitle of the Declaration is ‘Regulatory Sovereignty under TRIPS’.
1. Sovereign states should retain the discretion to adopt a patent system which is best suited to their technological capacities as well as their social, cultural and economic needs within International law.
2. Four key points are relevant at this time: states are faced with an unprecedented number of patent filings which can create impediments to research and commerce, new technologies and business practices are affecting the regulatory function of the patent system (e.g. business methods, biotechnology, computer inventions and NPE’s), patents are increasingly used as strategic assets, and patent rights have gradually been strengthened without corresponding protection of public interests.
3. There is a friction between the patent system and public policy goals such as protecting the environment and access to affordable medicines.
4. Sovereign autonomy has been eroded by international law and agreements. The purpose of the present Declaration is to set out the options that states retain under international law, particularly under TRIPS.
5. The impact of patents on innovation depends strongly on the level of technological and economic development of the relevant country. Patents must not interfere with dynamic competition and there must be a balance with public policies and interests.
6. The Declaration notes that states have often not taken full advantage of the regulatory discretion available under TRIPS.
7. States have latitude in defining what is patentable and how patentability requirements are applied, and so patent protection can be denied for new uses of known substances, for example.
8. States can determine whether patent rights are exhausted and have latitude over the grounds for which compulsory licences are granted.
9. TRIPS does not limit the grounds for government use.
10. TRIPS does not require an authority finding infringement to grant injunctive relief.
The Declaration can be found here.