WTO Agreement on TRIPS

The TRIPS Agreement gives WTO members policy space to protect public health while maintaining minimum standards for intellectual-property protection. These public-health flexibilities allow governments to limit patent rights, facilitate access to medicines and design patent rules suited to national needs, subject to TRIPS conditions.

Legal foundation

Articles 7 and 8 connect intellectual-property protection with social welfare and permit TRIPS-consistent measures necessary to protect public health. The Doha Declaration on TRIPS and Public Health, 2001 confirms that TRIPS should be interpreted and implemented to support access to medicines for all.

Principal public-health flexibilities

• Under Article 31, a member may authorize compulsory licensing or government use without the patent holder's consent. Prior negotiation may be waived during emergencies, extreme urgency or public non-commercial use, but safeguards such as adequate remuneration and review remain applicable.
• Members may determine the grounds for compulsory licences and decide what constitutes a national emergency or extreme urgency.
• The Article 31bis system permits medicines made under compulsory licence to be exported to eligible members with insufficient pharmaceutical manufacturing capacity.
• Under Article 6, members may choose their exhaustion regime, thereby permitting parallel importation of a patented product lawfully marketed elsewhere.
• Article 30 permits limited exceptions to patent rights if they satisfy its three-part test; this can support regulatory approval of generic medicines before patent expiry.
• Members retain room to apply patentability standards and specified exclusions under Article 27, while least-developed countries receive special transition arrangements for pharmaceutical patents and related protections.

Use in Indian patent law

India employs these flexibilities through the Patents Act, 1970. Section 3(d) restricts patents for new forms of known substances unless they show enhanced efficacy; Sections 84 and 92 provide for compulsory licensing, while Section 107A protects regulatory-use activities and specified parallel imports.