AIDS drug provokes patent battle in India

By Amelia Gentleman and Hari Kumar
Copyright by The International Herald Tribune

THURSDAY, MAY 11, 2006

NEW DELHI A legal challenge to a patent application in India on a crucial AIDS drug was filed this week in Delhi by two patients' rights groups, who claim that thousands of lives could be put at risk if the patent is approved.
If the drug, tenofovir, is granted a patent, the manufacture of cheaper versions in India will become illegal, making the drug too expensive for patients in developing countries.

The suit is one of the first major challenges to an Indian patent legislation introduced last year that was designed to control the country's large pharmaceutical industry, which for decades has specialized in making cheaper copies of Western manufactured medicines.

The Indian patent office is processing about 9,000 patent applications, most of them filed by international pharmaceutical companies. Patient advocates warn that the supply of a wide range of vital drugs to people in the developing world may be jeopardized. Hundreds of thousands of AIDS patients in developing countries are treated with generic Indian drugs.

Those backing the legal challenge are hopeful that this case, if successful, could help set a legal precedent, thereby making it easier to block other pending patent applications. They say the recent rejection of a patent application by Novartis for a cancer drug, on the grounds of similar legal arguments, gives some cause for optimism.

The Delhi Network of Positive People and the Indian Network for People Living with HIV/AIDS registered a formal opposition Tuesday to a patent application by the U.S.-based Gilead Sciences for the drug tenofovir disoproxil fumarate, commonly known just as tenofovir.

Their lawyers make the case on a scientific technicality, arguing that tenofovir is not a new drug, but just a modified version of an earlier drug, and therefore not eligible for a new patent under India's act.

The successful challenge to a patent for the cancer drug, Gleevac, was also made on this basis - that the application claims "a new form of a known substance."

The World Health Organization recently recommended the drug for patients who are just starting treatment for AIDS and for those who have been receiving anti-retroviral treatment therapy for some time, but who have become resistant to other treatments. The drug has relatively few known side effects and is in wide use in the United States and Europe, although less so in the rest of the world.

"These generic drugs are not only consumed in India," said Leena Menghaney of Médecins Sans Frontières, or Doctors Without Borders, in 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. These drugs are very important, which is why we are opposing this patent application.

"People who suffer extreme side effects from other drugs, and people who have developed resistance to other drugs, have been waiting for an effective substitute such as tenofovir. If they don't get it, then probably their lives will be at risk, and certainly their quality of life will be worse."

Eric Goermaere, of Médecins Sans Frontières in South Africa, said in a written statement: "We have all been waiting impatiently to get tenofovir as a generic from India. It's clear that the world desperately needs more sources of tenofovir. If Gilead is granted the patent, our patients will face a potentially deadly delay."

In developed countries, Gilead's tenofovir costs $5,718 per patient per year. According to company's Web site, it has been offering the drug at cost to treatment programs in eligible developing countries. But officials with Médecins Sans Frontières said the company has not yet made the drug available in many low-income regions. A spokeswoman for Gilead, Erin Edgley, said in an e-mail message that the company declined to comment.

Cipla, one of the largest generics companies in India, is already marketing a generic version of tenofovir, called tenvir, at a cost of $700 per person per year in India.

Yusuf Hamied, chairman of Cipla, said the drug would in time be made available in Africa for about half the price in India. Tenvir will have to be withdrawn if the Gilead patent, which would last for 12 years, were granted.

About 150 protesters, many of them HIV-positive, demonstrated outside the Indian Parliament on Wednesday in support of the legal action, carrying banners declaring "Patients before patents" and "Lives before profit." A number of campaigners were detained when they crossed the police barriers.

Among the protesters was Loon Gangte, president of the Delhi Network of Positive People, who like more than 5.1 million people in India is HIV-positive.

"If this patent is granted, it will chop off a lifeline for me," he said, adding that he has been taking anti-retroviral treatment for the past 3½ years. "Any time now I am going to become resistant to the first line treatment and I will need new drugs. For many of us living with HIV/AIDS, newer drugs like tenofovir offer new hope of continuing treatment.

"If the government grants the patent the price of these drugs will go up, and I won't be able to afford them. It is a life- and-death issue for me and many more people like me around the world. We do not want to die when our lives can be easily saved."

The Indian patent law, introduced last March, was designed to regulate the copying of Western medicines by the Indian pharmaceutical industry and to bring the country into line with World Trade Organization rules.

International aid organizations warned that the legislation could mark the beginning of the end of affordable generic drugs.
Supporters of the legislation counter that patents ensures that pharmaceutical companies have the security to invest in further research allowing them to develop vital drugs. They argue the patent law also creates benefits for the Indian pharmaceutical industry as it begins to develop world-class drugs. Those innovators will want protection from generic copies.

The AIDS patients rights' groups issued the formal opposition to the patent on a scientific technicality, arguing that tenofovir is not a new drug, but just a modified version of an earlier drug.

Cipla plans to start a parallel legal opposition to the patent application.

"We have never been against intellectual property and patents," Hamied said by telephone from Mumbai. "We are against monopoly. I believe that life- saving, essential drugs should be freely available and the innovator should be paid a suitable royalty payment for his invention."

He said he believed that a large number of the 9,000 patents currently pending will ultimately prove to have no basis in law and will be rejected. Most of them were filed speculatively before the Indian legislation was passed in 2005 and before the precise details of the new legislation were announced.

Hamied called on those multinational corporations with patents are pending which do not comply with the current Indian law, "to withdraw them voluntarily, instead of entering into litigation after litigation after litigation."