NEW DELHI, May 11: A legal challenge has been launched in India against a patent application for a vital AIDS drug and the outcome could affect thousands of lives in the developing world, health groups said on Thursday.
The wrangle is one of the first big tests of last year’s patent law curbing the right of firms to make copycat versions of drugs that have slashed the prices of anti-retroviral AIDS treatment and other drugs in the Third World.
“This is about lives,” Loon Gante, head of the Delhi Network of Positive People, said. The network is party to the suit filed this week along with the Indian Network of People Living With Aids.
“We’re not against big pharmaceutical companies, we just want the drugs to be made and for them to be accessible and affordable to people everywhere,” said Mr Gante. He is among India’s 5.1 million people who are HIV-positive, the second highest number in the world after South Africa.
The suit against a patent application filed by California-based Gilead Sciences involves a drug called tenofovir disoproxil fumarate, which has fewer known side affects than others in the anti-retroviral arsenal. It is among around 7,000 to 9,000 applications in ‘the patent mailbox’ in India.
The World Health Organisation has just recommended the medicine for patients undergoing treatment for the first time. It says it is also good for those who have been on anti-retroviral therapy and who require newer drugs because they have become resistant to other first-line drugs.
“Granting the patent would set a dangerous precedent for access to important drugs,” said lawyer Amin Tahir of India’s non-profit Alternative Law Forum handling the case, adding he expected a ruling in four to six months.
If Gilead were granted the patent, generic production of tenofovir in India, where a generic version has been marketed since last year, could be prevented until 2018, said Doctors Without Borders.
In addition, future generic production of fixed-dose combination pills containing tenofovir would also be blocked. Such combination drugs have had a big impact in scaling up global AIDS treatment by simplifying it, it said.
“Limiting production of tenofovir and that of other newer essential drugs to a single company keeps prices high because generic competition is blocked,” said Ellen ‘t Hoen, policy director for the group’s campaign for access to essential medicine.
A generic version of the drug — tenvir — is being produced by one of India’s biggest generic players, Cipla, which says it plans to export it to Africa where millions of people live with HIV-AIDS.
Cipla, which has also filed a challenge to Gilead’s patent application, said it was confident of succeeding.
Gilead’s patent application did not conform to India’s new patent act as the drug was known before 1995 and did not have the ‘novelty’ required under the law to be granted a patent, Cipla chairman Yusuf Hamied said.
Gilead could not be reached for comment but says on its website it offers low-cost ‘global access’ in developing countries.
India’s new law recognising foreign patents was introduced to comply with world trade rules and ended a copycat trade that allowed pharmaceutical makers to duplicate drugs patented abroad as long as they used a different process.
The act has escape clauses allowing the government to force patent-holders to grant licences to local firms in the event of national health emergencies.—AFP
