Limiting the Patentability of Pharmaceutical Inventions and Micro-Organisms: A Trips Compatibility Review

Abstract:     
The Patents (Amendment) Act 2005 (hereafter ‘2005 Act’) was India’s last step towards achieving complete TRIPS compliance. This Act has had a long fairly long innings and generated considerable debate, both domestically and internationally. Despite the passing of this Act, which contained a number of safeguards against non meritorious pharmaceutical patents, the Left Parties wanted more and in particular wanted to introduce a provision that would have limited patent grants to only New Chemical Entities (NCEs).

Sensing that this could violate TRIPS, the government referred this issue to an expert committee headed by noted technocrat, Dr RA Mashelkar. In particular, it requested the Committee (or Technical Expert Group or TEG) on April 5, 2005 to study:

"a) whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps; and

b) whether it would be TRIPS compatible to exclude micro-organisms from patenting."

The Technical Expert Group (TEG) solicited the opinions of IP stakeholders and others interested in the issues that it was meant to resolve. In this regard, I was requested by the Intellectual Property Institute (IPI), London to provide a comprehensive and independent opinion on the foregoing issues.

My report finds as follows:

1. Limiting the grant of patents to new chemical entities and thereby excluding other categories of pharmaceutical inventions (the ‘proposed exclusion’) is likely to contravene the mandate under Article 27 of TRIPS to grant of patents to all ‘inventions’. Neither Articles 7 and 8 nor the Doha Declaration can be used to derogate from this specific mandate under Article 27.
2. The proposed exclusion amounts to an ‘unjustified differentially disadvantageous treatment’ of pharmaceutical inventions and is therefore likely to violate the ‘non discrimination’ mandate under Article 27.
3. If the aim of the proposed exclusion is to prevent a phenomenon loosely referred to as ‘ever-greening’, this can be done by a proper application of patentability criteria, as present in the current patent regime.
4. Lastly, it is important to distinguish the phenomenon of ‘ever-greening’ from what is commonly referred to as ‘incremental innovation’. While ‘ever-greening’ refers to an undue extension of a patent monopoly, achieved by executing trivial and insignificant changes to an already existing patented product, ‘incremental innovations’ are sequential developments that build on the original patented product and may be of tremendous value in a country like India.

Keywords: India, TRIPS, Patents, Pharmaceuticals, Drugs, Mashelkar Committee, Developing Countries

JEL Classifications: O34, K10, K33

Working Paper Series