TRIPS Flexibilities for Public Health

TRIPS flexibilities are legal options that allow countries to protect public health while meeting international intellectual-property obligations. The TRIPS Agreement requires patent protection but permits safeguards that can improve access to medicines; the Doha Declaration on TRIPS and Public Health affirms members' right to use these safeguards.

Compulsory licensing and medicine exports

A compulsory licence allows use of a patented invention without the patent holder's consent, subject to legal conditions.

• Under Article 31, prior efforts to obtain a voluntary licence are generally required, but may be waived in a national emergency, other circumstances of extreme urgency, or public non-commercial use.
• An emergency is not a prerequisite for every compulsory licence; members may determine the grounds for granting licences.
• The patent holder must generally receive adequate remuneration, and the authorization is non-exclusive.
• Article 31bis enables production and export under compulsory licensing to eligible importing members with insufficient or no pharmaceutical manufacturing capacity, subject to safeguards.

Parallel imports and regulatory exceptions

• Article 6 leaves members room to determine their intellectual-property exhaustion regime. International exhaustion can permit parallel imports of genuine medicines lawfully marketed abroad, potentially allowing purchases from lower-priced markets.
• Article 30 permits limited exceptions to patent rights, subject to specified conditions.
• A Bolar-type exception allows use of a patented invention for obtaining regulatory approval before patent expiry, enabling faster generic entry after expiry; India's Patents Act provides a regulatory-use exception in Section 107A.

Patentability standards

Members can apply patentability criteria consistently with TRIPS, including novelty, inventive step and industrial applicability. Rigorous examination can prevent patents on inventions that do not meet these standards.

• India's Section 3(d) restricts patenting of new forms of known substances unless they demonstrate enhanced known efficacy, helping limit unjustified extensions of exclusivity.