As India’s intellectual property protection policy comes under intense criticism in the United States — a pro-health group, South Africa’s Treatment Action Campaign, has come out in support of the Indian generic drugs industry.

In an open letter to US Trade Representative Ambassador Michael Froman, TAC expressed its concern at the “mounting US pressure” on India’s generic medicines industry.

The letter comes at a time when US Vice-President Joe Biden is in India to improve trade ties between the two countries.

In its letter, the TAC said that it specifically objected “the placement of India on the US ‘Special 301 Watch List’ over objections to the country's intellectual property system, as well as subsequent condemnation from Members of Congress stemming from US pharmaceutical industry pressure, and attempts by a group of US commercial businesses (under the banner of ‘Alliance for Fair Trade with India’) to influence Vice-President Biden’s current meetings in India.”

India’s generic manufacturing industry has become as an essential source of affordable medicines, producing over 80 per cent of medicines, and as many as 90 per cent of paediatric medicines are used in the developing world, the letter said.

Landmark judgments

Following the landmark patent cases on cancer drugs Glivec and Nexavar, there has been pressure on India to increase its intellectual property protection despite the fact that in both instances India acted in compliance with the WTO’s agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), the letter said.

Through strict patentability criteria outlined in Section 3(d) of the Indian Patents Act which grants new patents only to medicines with enhanced efficacy, India has avoided granting excessive monopolies for secondary use, combinations or mere minor incremental changes.

It would be hypocritical of the US Government to condemn this legal action after the Bush Administration threatened to utilise similar flexibility to produce a stockpile of ciprofloxacin (Cipro) — enough to treat 10 million people in the face of an Anthrax scare in 2001[9], the letter said.

In South Africa, the combination of low patentability criteria and the lack of an effective patent examination system have lead to excessive patenting in the country, maintaining artificially high prices on newer, more effective medicines and blocking generic equivalents from entering the market. Restrictions on India would amplify such problems on a disastrous global scale, the latter pointed out.

“At a time of budget deficits and funding cuts, additional costs must not be incurred to restrict access to life-saving medicines that millions of people rely on around the world. We urge the US Government to stand strong against pressure from the pharmaceutical lobby and actively support and applaud enabling policies that ensure that India, the ‘pharmacy of the developing world’, can continue to produce affordable generic medicines that so many of us rely on to stay alive,” TAC Chairman Anele Yawa said in the open letter.