Novartis exposes India's weak patent laws. Will generics be kicked out?

An ongoing case in Madras High Court has brought forth a damning revelation: the Indian government remains confused about its patent laws and the latter are now under threat. A May 2006 petition filed by Novartis, the pharmaceutical multinational, has sought changes in India's patent laws. Potent enough to restrict access to affordable medicines in developing countries, the case is pointer to the messy cluster of laws in the country's pharmaceutical sector.

In January 2006, India's patent office rejected a patent request for its cancer drug Gleevec. The Swiss firm had applied for patent sanction for a crystalline version of Gleevec, claiming the drug was an innovation. In existing Indian patent law, patents can be granted only to substantial innovations or completely new products. Gleevec is used to treat blood cancer patients.

While government slumbers While government slumbers, another front has opened up in the battle between civil society organisations and pharmaceutical mncs over access to generics. For instance, Cancer Patient Aid Association of India, a Mumbai-based non-governmental organisation, had filed a pre-grant opposition with the patent office in Chennai to ensure access to the generic version of Gleevec. Similarly, in March 2006, the Indian Network for People Living with hiv/aids (inp+) filed a pre-grant opposition against a patent claim for a fixed-dose combination of zidovudine and lamivudine by GlaxoSmithKline. The patent was for a simple combination of two existing drugs, which the company claimed was an innovation. Thus, the verdict in the Novartis case will crucially affect a decision on this patent.

The challenge What in the Indian patent law has Novartis challenged? In May 2006, Novartis said parts of the Indian Patents Act, which restricted patents on old medicines, were not compliant with World Trade Organisation (wto) rules, which India is party to.

The company singled out section 3d, by which already known drugs are not given patents. This provision enables Indian generic manufacturers produce copies of drugs and sell them at affordable prices; today, India is a major player in the generic medicines scenario in the world. In contrast, in countries Novartis has obtained a patent on Gleevec, the drug is sold at us$ 2,600 per patient per month. Many Indian companies produce a generic form of the Gleevec and sell it for a tenth of the price it is sold in the us.

"Gleevec has been awarded a patent for the beta crystal form in 36 other countries, including China. That Gleevec failed the Indian test for patentability indicates the problems in India's patent system,' says the company's website in its comments on the Gleevec case.

Civil society counters this argument. "The case is just a ploy to create confusion on patent systems in developing countries,' says Leena Menghaney of the Delhi office of M