Commenting on this, IPA president and Wockhardt chairman, Habil Khorakiwala said that the IPA's concern about the current draft of the patent bill was on two core points. First, exclude patentability of new forms of previously patented compounds. Second, allow a provision for pre-grant opposition to patent application. If the definition of what is patentable matter is not further clarified, it may lead to evergreening of patents, which is against the interest of both, the consumer and the industry. If this has to be taken care of, then changes have to be made in Section 3 of the Indian Patents Act accordingly.
Khorakiwala added that IPA had cautioned the government on attempts to extend the patent life beyond the stipulated period. If allowed, it would delay the process of reaching patented products to patients at affordable prices. As far as the matter of pre grant opposition is concerned, IPA is of the view that before deleting this (section 25), the government should wait for at least three years, experience it and then decide whether it needs to be done away with.

Presently, most of the countries that honour product patents have provision for post-grant opposition, which is a part of the draft bill, but countries like Australia and New Zealand provide for pre grant opposition. IPA's concern was that if post-grant opposition is brought in, it would only lead to high number of litigation cases and clog up the courts, while in the pre-grant, it becomes the responsibility of the patent office to look into the matter.

Stressing on this point, D G Shah, secretary general of IPA said that Indian courts grant injunctions easily and it is the consumer who is injured. If pre grant opposition continues, it would be better as it can be decided earlier whether a product is eligible or not.

Khorakiwala said that the government is supportive of the changes suggested by them. When asked which would be the drugs that would come under the product patent, Shah said that the government had identified 11 molecules but has kept the list under wraps.

Khorakiwala led an IPA delegation to Ram Vilas Paswan, union minister for chemicals, fertilisers and steel and appraised him of the concerns of the industry in this regard. The delegation included Satish Reddy of Dr Reddy's Laboratories, Malvinder Singh of Ranbaxy Laboratories and Sudhir Mehta of Torrent.

''India is in a strong position vis-a-vis international business international business is concerned,'' IPA president and Wockhardt chairman Habil Khorakiwala said. He further said that as per reports, India's pharmaceutical exports are about Rs15, 000 crores and looking at the present situation, it is estimated to rise to Rs 19,000 crores by 2010. IPA also highlighted the need for steps to support pharmaceutical research in India.

The government has in principle agreed to the suggestion and has asked IPA to come up with detailed proposals. Responding to inflationary pressures on the economy and as goodwill gesture, IPA member companies, at their meeting with the minister agreed to freeze the current prices of medicines until 31 March 2005.

''We took this decision, despite the all round escalation in input prices on account of the oil price hike, with a view to alleviating the hardship to consumers and assisting government's efforts to contain inflationary pressures,'' Khorakiwala said.

In a detailed presentation to the minister, IPA highlighted the enormous strides taken by the Indian pharmaceutical industry in recent years and the huge potential ahead. India has over 60 plants approved by the USFDA, which is the largest number anywhere outside the US. India also accounted for the largest number of drug master files (DMFs) approved by the USFDA.

IPA sought the government's support in achieving the lofty export ambitions of this knowledge-based industry. IPA is the association of 11 leading research-based national pharmaceutical companies. They collectively contribute 90 per cent of the R&D spend in pharmaceuticals, account for 50 per cent of total exports and share about 30 per cent of the domestic market. They have been pioneers in providing the medical fraternity with the latest medicines at the lowest prices in the world.