Section 3(d) - Indian Patent Act

In the previous post, I mentioned about the court case Novartis has filed challenging the provision of the Indian Patent Act under which its patent application for Glivec was rejected. This provision is precisely Section 3(d) of the Indian Patent Act (2005). This provision is quite unique to Indian law - similar rules are absent in the laws of most countries. It was created primarily in the interest of public health, and refuses patent protection to new forms, uses or minor modifications of existing drugs unless they differ significantly with regard to efficacy.

The Economic Times has an interesting editorial comparing two opposing points of view on this issue - one by D.G. Shah, Secy-General of the Indian Pharmaceutical Assn., who supports Section 3(d) and the other by Prabuddha Ganguli, CEO, VISION-IPR, Mumbai who thinks that a change should be made. Both make good well-reasoned arguments, making the case a lot more grey than I initially reasoned. But given how the situation in India is, my socialist side seems to dictate policy in my head, and side with Shah intead of Ganguli! The Indian law disallows the following:

Changes in the physical properties (shape and size) of a drug substance, without any significant change in its efficacy; change of dosage form (tablet to syrup) for ease of administration among children; development of a tablet containing three drug substances (triple therapy) for better compliance among the AIDS patients.

Ganguli makes a strong stand against these being able to patent these incremental inventions:

1. Inability to meet the patentability requirement of newness - because the changes are obvious to any chemist. It is precisely this point that Shah challenges.
   
2. Confers monopoly for what cannot be considered an invention.
3. Allows patent protection beyond the stipulated 20-year period.
4. The incremental changes (he even refuses to recognize them as inventions!) present a very attractive proposition to pharmaceutical companies in terms of their risk-reward valuation - which will cause big pharma to turn to them instead of trying to focus research resources on real innovation and core drug discovery research. It seems like a stretch - but the point is very well taken.
5. Eliminating Section 3(d) would allow companies to patent molecules that were discovered before 1995. As per its TRIPS agreement, India has no obligation to provide patent protection to these molecules. A very compelling point - Novartis's fight to eliminate this provision seems more like a strategy to try and do an end run around this.
   
6. Deleterious impact on prices of drugs in India, their access to the population and the impact on healthcare costs and public health as a whole.
   

On the other hand, Shah clearly defines the requirements to be classified as a patentable invention: should be novel (new), the inventive step should be non-obvious to a person skilled in the art, and be useful (capable of industrial application). He argues that the so-called incremental changes are in fact not obvious even to the trained professional - such as the exploitation of the differing properties of derivatives (eg salts) or different crystalline structures of drug molecules for effective drug delivery, production of stable formulations, etc. As a result, the incremental looking inventions are far more than that. He says that such changes do make far-reaching impact and should be patentable so that companies are encouraged to pursue them. He makes the same argument as Novartis - that Section 3(d) stifles innovation, reduces competitiveness of industry and is a step in the wrong direction.

Section 3(d) has certainly become center stage - I for one am all or it - more so from the point of view of the needs of Indian society than for the protection for innovation. Lets see if the Chennai High Court feels the same way