Indian Patents Act promotes inventions

Concerns raised by US multinational corporations (MNCs) over the Indian Patents Act discouraging innovation have been refuted in a study released on Monday.

According to the study carried out by T.C. James, director, National Intellectual Property Organisation (NIPO), the number of patents issued for new pharma products in India have jumped more than three-fold from 765 in 2004-05 to 2,373 in 2008-09 after the patents act was introduced in the country. The total number of patents for companies across all segments have leaped from 1,911 to a whopping 18,230 during the period.

The study titled 'Patent Protection and Innovation' also points out that in 2004-05, as many as 40 per cent of the patents issued went to Indian companies and 60 per cent were given to foreign companies. In 2007-08, the number of patents issued to Indian companies fell to 21 per cent while those given to foreign companies went up to 79 per cent. James said this clearly shows that the Indian Patents Act is not discouraging innovation.

The study looks at the concerns expressed in a paper prepared by the US-India Business Council.

At the heart of the matter is Section 3 (d) of the Indian Patents Act, which has been put in place to prevent pharma companies from extending or "ever- greening" their patents by merely introducing some minor changes in a product to block Indian companies from launching cheaper generic versions of the drug.

US trade representative Ron Kirk had also expressed reservations over the Indian patent regime during his recent visit to New Delhi. Section 3(d) of the Act states that “the mere discovery of a new form of a known substance, which does not result in the enhancement of the known efficacy of that substance" shall not be treated as an invention within the meaning of the Act.

Companies are known to undertake a mere "tweaking" of the product to get an extension of the patent by claiming that the drug in question is a new product.

Pharma giant Novartis had first challenged the constitutional validity of this section in the high court but had lost the case.

It has now challenged the decision on its anti-cancer drug Gleevec, which was denied a patent on the ground that the company was resorting to ever- greening the patent without making any significant changes in the efficacy of the product. The case is now pending in the Supreme Court.

James pointed out that when India moved to the product patent regime in pharmaceuticals in 2005, it introduced modifications in Section 3( d) to guard against ' ever- greening' of patents.

This, he said, was done while withstanding pressure from many to restrict patenting of drugs to new chemical entities, since the government felt that it would not be TRIPS compatible. The section only sets a standard for inventiveness and does not debar incremental innovations which meet the criteria for patentability.