New Delhi:AIDS patient Loon Gangte survives on a daily cocktail of generic pills, but fears that if Swiss pharmaceutical giant Novartis wins a challenge to India’s patent laws, his cheap drugs lifeline could dry up.
“Not only my life, but the lives of thousands of others are at stake, and they aren’t just in India, but around the world,” says Gante, 40, who has lived with the disease for the past decade and is head of a local HIV/AIDS action group.
Novartis has filed an appeal in Chennai, contesting a part of the country’s patent law. If it succeeds, activists say, it would allow far wider granting of patents—sharply reducing the availability of cheap generic medicines.
Critics also say that if Novartis wins its case, millions around the globe could be left without a supply of affordable generic cancer and other drugs from India, a main producer of such medicines.
Novartis’ challenge goes to the heart of India’s Patents Act, which says a new patent cannot be granted for an old drug unless changes make it significantly more effective.
The drug maker insists so-called “incremental innovations” should be patentable and says India’s refusal breaches its World Treaty Organization (WTO) obligations.
“Indian patent law creates new hurdles for pharmaceutical innovation, and narrows down what is patentable by making additional requirements for patentability inconsistent with international agreements,” Ranjit Shahani, vice-chairman of Novartis India Ltd, told AFP.
Novartis said its court action was not about HIV/AIDS, and it was specifically contesting the Indian patent office’s rejection in January 2006 of an application for a new, more easily absorbed version of its anti-leukaemia drug, Gleevec.
“It was patented in more than 40 countries, but it failed the India test for patentability. That indicates the deficiencies in the Indian patent system,” said Shahani, also head of the Organization of Pharmaceutical Producers of India.
India’s patent office turned down the application, saying the new drug’s efficacy did not differ significantly from the earlier version. Indian firms are producing knock-off versions of Gleevec, but selling them at a fraction of the price charged by Novartis for the original. Critics said a ruling in favour of the Swiss firm would be used as a precedent for Indian patent applications on other drugs.
“There will be other groups that will quote a decision in favour of Novartis and try to win on the same grounds,” said Hariharan Narayanan, a rights activist in Chennai. A hearing on Novartis’s patent appeal, which began earlier this week, is to resume on 15 February.
Medicins Sans Frontieres (MSF), or Doctors Without Borders, said a court ruling in favour of Novartis would have implications for the generics market worldwide.
“It will cut off the generic drugs lifeline,” said Leena Menghaney, access campaign officer at MSF in India. “It will be a disaster for the Third World. The impact of the case is going to be felt by patients in developing countries who are affected by all kinds of illnesses, not just HIV-AIDS,” she said.
The group’s AIDS programmes provide treatment to 80,000 people in 30 countries and source the bulk of their generic drugs from India. India has long been a key provider of cheap generic medicines as it did not issue drug patents until two years ago, when it was obliged to adhere to WTO intellectual property regulations.
Now, it allows patents for new inventions after 1995, or for an updated drug showing much greater efficacy. But it rejects applications for minor changes to existing drugs aimed at extending the life of original patent monopolies from their original 20 years—a practice critics dub “evergreening”.
Shahani argues that “if you take life in general over 40 to 50 years, there are no major breakthroughs (in drugs), most are incremental innovations.”
“You will demotivate scientists, and if there is no research on incremental innovation, there will be no research and no generics,” he said. “For medical research you need time, energy and money and if investors don’t get a return they will run away,” Shahani added.
However, MSF said drug companies were seeking “spurious” patents on “new” drugs offering little in the way of big advancements, such as for turning pills into capsules or making medicines heat-resistant.
“If we lose, the drug companies will regain their monopoly over drugs and prices will shoot up, and we won’t have these affordable drugs,” said Gante, who heads the Delhi Network of Positive People. “It is about the life and death of us.” AFP