This is one of the recognized flexibilities available under Article 8 of the TRIPS Agreement that countries are free to adopt in their legislation as per Doha Declaration.
The Declaration states that TRIPS Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all.
As such the said provisions of section 3(d) of the Patents Act, 1970 are fully compliant with Article 27(1) of the TRIPS Agreement read with Article 8 of the said Agreement.
U.S. Follow-Up Question: We understand from India's response that an invention that meets the three criteria of patentability could not separately be denied a patent on the grounds specified in Section 3(d). Is this correct? If not, please explain the interaction between the patentability criteria and Section 3(d).
Reply: Patents are available to an invention that meets the three criteria of patentability. However, the provisions for requirement of enhancement of the known efficacy under section 3(d) of the Patents Act, 1970 are only for the mere discovery of a new form of a known substance, as like salts, esters, ethers, polymorphs, isomers, etc. which may be obtained by minor modifications, particularly in the pharmaceutical sector. This provision has been made only to prevent the ever greening of product patents.
