On December 26, 2004, the Union government of India issued the Patents (Amendments) Ordinance, which will change the way the country does business on protecting the intellectual property rights of pharma companies, amongst others. Now, the ordinance is before the parliament, which has to do one of three things: amend it, pass it or reject it.
So, will the ordinance become law? At risk is the armtwisting deadline set up by the World Trade Organization (wto), egged on by us corporate interests. They want the intellectual property of the large companies to be protected so that they can invest more in research and development and find more cures for new and life-threatening diseases.
At risk also is the issue of the health of millions of Indians, who many believe may be at the losing end if the amendment allows for monopolies in the critical business of medicine to thrive.
But what are product patents and how do they differ from the process patents that were followed earlier? Which life saving drugs could be on the list? How will the Indian pharmaceutical industry cope, as a major quantum of drugs they manufacture goes out of their hands? Will patients now have to pay twice, thrice or ten times of what they pay now for a drug? What about the poor who cannot pay? Will access to drugs be affected once generic equivalents of patented drugs stop being made locally?
Are there any ways India could protect its citizens through the bewildering maze of patentspeak? The very way healthcare operates in this country is about to change. We need some answers, quickly.
clifford polycarp investigates the imlpications of entering a new patent regime.
Patents get a makeover
Santosh Rana has a type of blood cancer -- chronic myeloid leukaemia -- that was detected in early 2003. His doctors prescibed him an anti-cancer drug, Glivec. He could afford it, they said; the cost of treatment would come to between Rs 9,000 to Rs 12,000 per month. But then things changed. Out of the blue, in November 2003, Rana suddenly found he could not afford his cancer treatment anymore. The same drug now cost him Rs 1,20,000 per month.
His doctors explained that what had changed was that Novartis India had been granted exclusive marketing rights by the government. The company had also filed, and won, an injunction against all other Indian companies manufacturing a 'copycat' version of the drug. The very sort of drug that Rana was buying each month.
This was 2003. In 2005, the situation will change even further, as the government gets ready to pass the Patents (Amendment) Ordinance 2004. The Indian Patents Act 1970, was amended in 1999 and 2002, so that India could comply with the provisions set out by the Trade Related Aspects of Intellectual Property Rights (trips) agreement of the wto.
This agreement is meant to protect the rights of the inventors -- from drugs to seeds -- and builds in provisions that do not allow companies to sell what is known in the pharma parlance as 'copycat drugs'. The 1999 amendment provided for exclusive marketing rights, which gave the inventor company 5 years of protection. Now, with the proposed third amendment, this provision will be further tightened.
The ordinance of the government of India provides for product patents, instead of process patents. India's 1970 patent protection act, protected only the process involved in developing drugs and not the end product itself. Several Indian companies had innovated, by producing the same drug through a different process. These drugs, called generic versions, came at much lower costs. But while end users benefitted, the inventor companies cried foul, arguing that the costs of their invention were not paid. This loss, they said, would mean that they would not be able to invest further in drug research, and that would end up endangering even more lives.
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