The Hindu Business Line : The patent divide

THE GOVERNMENT'S OVER-ARCHING theme of `reforms with a human face' will be on test when resolving the contentious issues in the Third Amendment to the Patents Act 1970. With the January 2005 deadline to bring in product patents looming, the pharmaceutical industry, among other sectors, would feel the impact. Quite predictably, domestic and multinational pharma players are standing on either side of the patent divide. The bones of contention are mainly two: The definition of what is patentable, and the proposal to scrap the pre-grant opposition, which allows interested parties to oppose the grant of a patent.

The Patents (Third Amendment) Bill is with a Group of Ministers for ironing out these issues before being brought before Parliament in its winter session. For domestic players, the need for clarity in the definition of patentability cannot be over-emphasised as they fear that innovator companies will adopt the expedient of `ever-greening' to retain their exclusivity. The fear is that after commercially exploiting the patent-life of a medicine, drug majors would make marginal changes to the molecule and claim another 20 years of exclusivity. A medicine in a solid form, for example, could be re-introduced in a crystalline form, on the expiry of the patent on the original. But pharma MNCs turn the same argument back, contending that domestic companies adopt similar methods, such as changing the delivery system of a medicine, to claim exclusivity in global regulated markets. The MNCs argue that any innovation from an originator company should be given a full patent life, to keep me-too drugs at bay. The amendment must look at protecting original research and innovation, even as it seeks to make drugs more affordable. It could work out a middle-path of granting limited period exclusivity instead of a full 20-year patent-life. So, any technical innovation, be it an alternative indication for a medicine or a different delivery system, could be rewarded just enough to keep research alive. That way, generic players making chemically-equivalent versions of the same drug can come into the picture soon enough, so that competition can keep a check on prices and the consumer has a choice.

As for pre-grant opposition that is part of the current patent regime, domestic companies feel the provision should not be scrapped. It would weed out frivolous applications and help the Patent Controller's Office make an informed decision before granting a patent. Else, patent issues could clog the courts, they contend. The view from the other side is that any `vested' interest can use the provision to frustrate the originator company's efforts and the ensuing delay would erode the drug's patent-life. Given that pre-grant opposition is based on publicised data, the Government could look at retaining the provision. However, in the interest of original research, all opposing applications should be dealt with in a set time-frame. The Indian consumer and his right to affordable medicine being at the heart of the patent debate, the amendment should ensure that regulatory systems are foolproof to prevent the stifling of original research.