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HEALTH-INDIA: Anger Grows at Novartis’ Bid to Hog Cancer Drug

Keya Acharya

BANGALORE, Jan 30 2007 (IPS) - A public outcry has followed the challenge offered by Novartis AG in the Madras High Court to the Indian Patents Act as violating international trade laws and restricting the Swiss pharmaceutical giant’s trade.

A public outcry has followed the challenge offered by Novartis AG in the Madras High Court to the Indian Patents Act as violating international trade laws and restricting the Swiss pharmaceutical giant’s trade.

In April 2005, the Indian government as a member of the World Trade Organisation (WTO) and signatory to its trade-related intellectual property (TRIPS) provisions amended domestic law to recognise 20-year patents on products, annulling the country’s 7-year patents on processes.

A slew of important generic-drugs or those being produced after patent expiry have since been forced off the market, unless, as per clauses in the amended Indian Patents Act, the patent applications can be proved to be not ‘new’ or involving innovative molecular research.

In the first test of the amended Indian law, Novartis applied for a patent on its leukaemia-treatment drug ‘Gleevec’, but was rejected by the Patents Office in southern Chennai city as not being innovative enough. The company thereafter filed a writ in the Madras High Court, located in Chennai, challenging the rejection.

The court hearing was adjourned to Feb. 15 due to Novartis wishing to include a recent report commissioned by Indian Parliament and headed by R.A. Mashelkar, former head of the Council of Scientific and Industrial Research, to look into the question of patentability.


The Mashelkar report asks for inclusion of patents on medical entities with ‘one or more’ inventive steps, in the ‘national interest’, thereby allowing patents on products that do not involve new molecules.

Several legal and civic groups are outraged at the report as having ‘sold out’ to corporate interests, and have been slamming Novartis ever since it exerted exclusive marketing rights in 2004 for Gleevec, pushing prices up from 175 US dollars to 2,000 dollars per month of treatment, affecting immediately India’s 25 million leukaemia patients.

“I think what happened in court yesterday (Monday) is an example of ‘double-speak’ in India,” says Dr. Thelma Narayan, joint convenor of ‘Jan Swasthya Abhiyan’, the national face of the global People’s Health Movement (PHM).

” Novartis was recently given a global award with United Nations recognition for ‘corporate social responsibility’, yet millions in India and poor countries are either dying or not being able to afford treatment due to the company’s bid at market monopoly of a generic drug. I think such giant MNCs need to be exposed,” Bangalore-based Narayan told IPS.

“If the Mashelkar report had defined inventions properly, we could have saved the situation,” B.K Keayla, a former patent commissioner of India and part of the ‘People’s Commission’ headed by former prime minister Inder Kumar Gujral, told IPS. Keayla says he has organised four commissions on patents awareness with influential individuals participating but, ‘’no one has cared enough.”

At least seven civic, legal and health groups together with the PHF and the Medecins Sans Frontieres (MSF) have been campaigning actively in the last year against Novartis filing for patent claim on Gleevec.

Lawyers’ Collective, the legal advisers to the Cancer Patients Aid Association opposing Novartis in court, have broadened the issue in public to include essential drugs since the Novartis judgement will indirectly impact the manufacture and affordability of generic drugs for not only leukaemia but also for treatment of other significant cancers, HIV/AIDS and several other diseases in developing countries.

Anand Grover of the Lawyers’ Collective blames the Indian government’s seemingly pro-corporate stance and says it is being influenced by western trade agendas, especially that of the United States. “Government policies are only thinking about the hype of India being poised as an economic powerhouse, without addressing the needs of its poor. ”

Keayla too agrees that corporate agendas, especially of multinational drug giants, have influenced government, but believes that civic groups could have strategised differently for better effect.

“They need to campaign for including HIV as a national emergency and then get generic drugs out of the patents’ circle,” Keayla said. According to Grover there are several equally essential drugs that cannot be termed as treatments for national emergencies.

Under Indian law, and allowed by WTO under the Doha Declaration, generic drugs used for public health emergencies can be manufactured under licence.

“Winning from the patent office itself, due to our pre-grant opposition, was a big thing, ” says Naveen Thomas of the All India Drug Action Network, based in Bangalore.

“We can still fight with ‘them’, everything is not lost,” said Dr. Prakash Rao of the state-level Drug Action Forum in Bangalore.

Yet the Indian medical fraternity has been visibly silent in this civic discontent against what Novartis’ patent claim stands for. Dr. Ananth Phadke of the Centre for Enquiry into Health and Allied Themes at Pune in south-western India, feels that Indian doctors are not sensitised enough to drug histories and patents in their medical curricula, besides being ‘wooed’ by drug manufacturers.

But Dr. Ajay Kumar, president of the Indian Medical Association (IMA) with over 178,000 doctor-members countrywide, says he feels ‘very strongly’ about the whole issue of generic drugs and price rise through patenting.

“Corporatisation of medicine serves only one percent of India’s population. I will be taking up the issue of pricing and allowing Indian pharmaceuticals to manufacture generics with the government,” Kumar told IPS, over telephone from the eastern Indian city of Patna.

The next legal challenge taking shape in India is the multinational drug lobbies’ pressure on the government to insert ‘data exclusivity’ or the prevention of use of data from clinical trials by the Drug Controller’s Office, through amendments in the Drugs and Cosmetics Act that controls drug marketing.

“By implication, as long as the exclusivity lasts, generic producers would have to submit their own data to prove safety and efficacy, which would oblige them to repeat the clinical trials. This is something that would cause significant delay that many generic manufacturers cannot afford,” says a WHO bulletin released in March 2006.

The Affordable Medicines and Treatment Campaign, spearheaded by the Delhi-based Lawyers’ Collective has conveyed its concern to Indian Prime Minister, Manmohan Singh, highlighting how data exclusivity impedes the use of compulsory licences in public health emergencies and prevents drug regulatory authorities themselves from relying on test data already in their possession for subsequent approval of generic versions of the medicine.

 
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HEALTH-INDIA: Anger Grows at Novartis’ Bid to Hog Cancer Drug

Keya Acharya

BANGALORE, Jan 30 2007 (IPS) - A public outcry has followed the challenge offered by Novartis AG in the Madras High Court to the Indian Patents Act as violating international trade laws and restricting the Swiss pharmaceutical giant’s trade.
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