Domestic drug cos, MNCs spar over Patent Act

Written by H.F. Khorakiwala, Wockhardt Chairman and IPA President, it says big pharma players misuse ‘evergreening’ to keep modified versions of their patented drugs in the market, even after the original drug goes off-patent.

IPA says, domestic industry can capture one-third of the global generics trade — or exports worth Rs 90,000 crore by 2010 — if only India’s new TRIPS-compliant Patents Act keeps ‘evergreening’ at bay.

‘‘We’re saying, we don’t need to introduce those drug patents in India as it could harm consumers and domestic players,’’ says D.G. Shah, IPA Director-General.

But pharma MNCs have reacted angrily to IPA’s assertions. “Yes, generics are a key strength of home-grown pharmas; but no, exports will not suffer if new forms of already patented drugs are patentable,” is their refrain.

‘‘Intellectual Property Rights will not have a major impact on overall revenues in India,’’ says S. Ramakrishna, Senior Director, Corporate Affairs, Pfizer Ltd, citing an Indian Drug Manufacturers’ Association report on which CMIE, FDA and BCG collaborated.

‘‘Exports are 40 per cent of India’s total pharma revenues, but generics were 90 per cent of total exports in 2000-01. And 25 of India’s top 30 export destinations are WTO member countries, leaving no more than 10 per cent of overall export revenues likely to be affected by product patents,’’ says the report.

Ramakrishna says 3 per cent of India’s drug market comprises drugs under patent. So domestic growth is being driven by patented and older molecules as well as their extensions — the same growth IPA opposes in its letter, he adds.

‘‘We understand the capabilities of Indian industry in incremental improvement to drugs. But we’re saying, why introduce these drugs in India. Take them to the US and EU so that Indian consumers don’t suffer,’’ says Shah.

But Ramakrishna voices a common apprehension of MNCs: That a future Patents Act may not incentivise improvements on existing and known innovations. ‘‘The Act should not limit patent protection solely to New Chemical Entities. India has skills and inventiveness for research that is fundamentally incremental,’’ he says.

The clincher, however, is the 4,200 new patent applications for modified patented drugs filed by Indian companies like Ranbaxy, Cipla and Wockhardt, according to the PCT database. Of these, 55 per cent are for incremental innovations. Ranbaxy’s 239 applications alone have 122 for incremental improvements.