India – TRIPS Compliance – the Unfinished Agenda

India’s Commerce & Industries Minister constituted a Technical Expert Committee to study two critical issues which were not considered by the Parliament when passing the Patents (Amendment) Act 2005. Issues concerning patentability of ‘new chemical entities’ and ‘micro-organisms’ were referred to the Expert Committee. If any amendments are suggested to safeguard the interests of these products, they will be incorporated in the new legislation.

The Expert Committee has the following Terms of Reference:

Whether it would be TRIPS compliant to limit the grant of patents for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps; and

Whether it would be TRIPS compatible to exclude micro-organisms from patenting.

The above Terms of Reference stem from the premise that India can comply with the obligations under the TRIPS Agreement without allowing patentability of micro-organisms and providing product patents only for ‘new chemical entities’. The provisions of the TRIPS Agreement that is directly relevant to these issues are Article 27(1) and Article 27(3)(b). Article 27(1) of the TRIPS Agreement mandate all Member States (WTO Member Countries) to provide patent protection for all inventions whether products or processes and in all fields of technology. Article 27(1) obliges Member States not to discriminate technological fields in granting patents for products or processes. The above being the case, it will become a contentious issue if the patentability is restricted only to ‘new chemical entities’.

TRIPS Agreement does not permit the Member States to exclude microorganisms from patentability. Article 27(3)(b) makes it clear that Member States are entitled to exclude plant and animals but not microorganisms from patentability. However, it is unsure if TRIPS permits Member States to exclude biological substances (like genes and cells) from patentability. The Expert Committee is likely to submit its recommendations in the next 2-3 months. Whether those recommendations will lead to yet another amendment in the Indian Patents law is something that one has to wait and watch.