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Plans to Patent AIDS Drug Provoke Legal Fight in India Over Higher Cost

By Amelia Gentleman
and Hari Kumar
THE NEW YORK TIMES


NEW DELHI

AIDS groups this week brought an important test of India’s new patent law, which restricts the ability of Indian companies to produce low-cost generic drugs.

Two patients-rights groups sued to stop Gilead Sciences, a California biopharmaceutical company, from patenting the anti-retroviral drug Viread — the company’s brand-name version of tenofovir, which is available here as a generic drug, from being granted a patent. If it is patented, the groups contend, making the cheaper versions will become illegal, and the drug will become too expensive for patients here and in other developing countries.

The patent law, enacted in March to bring India in line with World Trade Organization rules, frustrates some companies in the country’s large pharmaceutical industry, which makes copies of many Western medicines. International organizations providing medical aid and advocates for patients fear that the law could cut off their access to affordable generic drugs.

The Indian patent office is processing about 9,000 applications, most for drugs made by big international pharmaceutical companies.

“These generic drugs are not only consumed in India,” said Leena Menghaney of Doctors Without Borders in New Delhi, which is working with the Indian groups on the issue. “People in Africa and the Caribbean are relying on India to produce these drugs. The quality matches that of U.S.-manufactured drugs, but the prices are affordable.”

The immediate challenge came when the Delhi Network of Positive People and the Indian Network for People Living with HIV/AIDS formally registered opposition to a patent application by Gilead Sciences for tenofovir.

The lawyers for the groups made their case on Tuesday, contending that tenofovir is not a new drug, but a modified version of an earlier drug, and therefore not eligible for a new patent under India’s new law.

Those backing the legal challenge are hoping to gain a legal precedent for use in other patent applications. They say the recent rejection of a patent application by Novartis for a cancer drug, Gleevac, on the grounds of similar legal arguments gave some cause for optimism.

The World Health Organization recently recommended tenofovir for patients who are just starting treatment for AIDS and for those who have been receiving antiretroviral treatment therapy for some time but who have become resistant to other treatments.

In developed countries, Gilead’s tenofovir costs $5,718 per patient per year. Cipla, one of the largest generic companies in India, is marketing a version called Tenvir, at a cost of $700 per person per year in India. Yusuf Hamied, chairman of Cipla, said the drug would eventually be made available in Africa for about half that price.

But Tenvir would have to be withdrawn if Gilead were given a patent, which would be in effect for 12 years.