The controversial third amendment to the Indian Patents Act, 1970, -- providing protection for product patents as per the WTO obligations is being introduced at the cost of human health and domestic industry. The amendment, which the government is likely to bring in through an ordinance instead of a democratic process beginning with a debate in Parliament, spells a death knell for the domestic pharmaceutical industry.
The Indian Pharmaceutical Alliance has already warned that the domestic production capacity worth Rs 3,000-crore (1 crore = 10 million) will come to a standstill following the patent amendment. The prices of medicines will go up, with some of the drugs for life-threatening and chronic diseases hitting the roof. This is because a majority of the popular, cheaper and locally manufactured medicines that have been produced in the country from 1970 onwards will need to be withdrawn.
At the same time, the provisions to allow micro-organisms and microbial processes to be patented [as per the provisions of the Art 27.3 (b) of the TRIPs Agreement] will strengthen monopoly through a patent control over genes and cell lines, plant and animal varieties and will also shift medical research into the hands of those companies that have technical sophistication.
The third patent amendment therefore has the ability to stall future agricultural and biological research in India and for that matter in other developing countries.
Since the definition of micro-organisms has been extended to include genes, what is worrisome is the speed at which life science firms (read biotechnology companies) are drawing patents over genes, gene sequences and cell lines. For instance, Monsanto owns US patent (No: 5,159,135), which covers all GM cotton and in addition 228 other cotton gene sequences have also been patented. There are 25 patents on different characters of pineapple, 25 on raspberries, 21 on grapes, six on kiwi fruit, 11 on oranges, nine on apples, eight on pawpaw, four on strawberries and cherries, two on grapefruit, one each on tamarind and peach. There are also 43 patents on silk genes, including several on the golden orb-weaving spider, which makes the strongest and finest thread.
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Although wheat is the greatest hope for mankind, gene companies have already drawn patent on 228 gene sequences. Meanwhile, 152 patents have been applied for on rice. Those patents cover 584 genes or partial gene sequences. US Multinational Dow has applied for patents on 655 maize gene sequences, which is 30.3 per cent of the total number of applications. Du Pont has applied for another 587, Affymetrix (US) for 418, Monsanto for 102, AstraZeneca for 83. The top five maize companies have nearly 85 per cent of the total 2,181 applications between them.
Rice, for instance, is a crop known to originate from the Indo and the Japanese regions. It is primarily for this reason that rice is broadly classified into two categories: indica and japonica. The name is itself indicative of the regions from where that particular kind of rice originates. But unfortunately, the origin of rice provides no special provision for agricultural scientists. The Indian Council for Agricultural Research (ICAR), worlds second biggest farm research infrastructure in the public sector, had sometimes back bought a cloned gene for rice from Japan at a cost of Rs 30,00,000. The gene was inserted in the rice varieties but failed to show positive results. It was then inserted in eggplant knowing well that it would not work properly.
If in future ICAR is to purchase genes for rice from foreign biotechnology giants and institutes, the future of agriculture research is surely at stake. For the public sector, which is finding it difficult to provide salaries to its scientific personnel, buying genes at a prohibitive cost for biotechnology research will only block future research. With product and process patents in agriculture coming into vogue, the world is fast heading towards a scientific apartheid in the Third World.
This will also impact medical, human health and the pharmaceutical sectors.
Although the Federation of Indian Chambers of Commerce and Industry (FICCI) has said that the industry is prepared to accept all provisions that the government may decide to bring in through the patent amendment, the fact remains that the federation is only speaking on behalf of the bigger pharma companies and the MNCs that have set up production capacities in India.
What FICCI refuses to comment on is as to how the patent amendment would affect the future of medical research in India, whether or not most of the well-known medical research institutes will turn into mere outsourcing centres for western institutes.
The large-scale closure of the domestic generic drug manufacturing capacity will render the otherwise protective provision of compulsory licensing infructuous. Although Art 31 (b) of TRIPs Agreement permits grant of compulsory licence if the effort of obtaining production licence from a patent holder on reasonable commercial terms does not fructify, in reality, the provision does not mean much once the domestic generic manufacturers pull down the shutters.
And still worse, the prohibitive cost of drugs will make most of the essential drugs go out of the reach of the masses. The Madras High Court on a case filed by the MNC Novartis had recently ordered Indian companies to stop manufacturing an anti-cancer drug as it violated the provisions of the exclusive marketing rights. The Indian companies were marketing the drug for a months treatment at Rs 10,000 compared to a price of Rs 1.20 lakh (10 lakh = 1 million) that the MNC was charging.
Deviating from its constitutional obligations of ensuring health for all, the government is busy helping these companies to extract their pound of flesh.
