India Decision on Tenofovir Patent Could Prove Vital to Patients in Brazil

by Gopalan on  June 28, 2008 at 11:19 AM Drug News   - G J E 4
 India Decision on Tenofovir Patent Could Prove Vital to Patients in Brazil
The world is indeed becoming a globalized village. Action in one corner seems to impact life thousands of miles away, even if separated by oceans!

Brazil HIV/AIDS activists are appealing to India not to grant patent to tenofovir. For if the Californian firm Gilead Sciences are to be given the patent, it would come in the way of import of the generic version from Indian firms. The application filed by Gilead has been pending in India since 2005.

Tenofovir is recommended by the World Health Organisation as a treatment for those who suffer side-effects from other HIV drugs or those who develop drug resistance.

Tenofovir disoproxil fumarate, commonly known just as tenofovir, is in a class of antiviral medications called reverse transcriptase inhibitors. When HIV infects a cell, reverse transcriptase copies the viral single stranded RNA genome into a double-stranded viral DNA. The viral DNA is then integrated into the host chromosomal DNA which then allows host cellular processes, such as transcription and translation to reproduce the virus. RTIs block reverse transcriptase's enzymatic function and prevent completion of synthesis of the double-stranded viral DNA thus preventing HIV from multiplying.

Brazilian AIDS advocacy group ABIA (Brazilian Interdisciplinary AIDS Association) and the Indian NGO SAHARA (Centre for Residential Care & Rehabilitation) have submitted an opposition against the grant of a patent in India to Gilead Sciences for the key AIDS drug tenofovir.

The opposition has been filed on the ground that the drug consists of a previously known compound, and should not be considered an invention according to India's Patents Act. India's patent law is pro-public health, with strict patentability criteria. A major public-health safeguard in the law is the provision against patenting of minor improvements of known medicines (section 3(d)). The law also allows any party to oppose patent applications that do not deserve patents under Indian law.

Civil society groups have also filed an opposition to Gilead's patent application on tenofovir in Brazil. The patent offices in both India and Brazil will be reviewing the case in July.

"Although we are confident the tenofovir patent will not be granted in Brazil, we must ensure that the option of importing affordable generic versions from India remains open to our AIDS programme," said Veriano Terto, ABIA's general coordinator.

An estimated 31,000 people living with HIV are expected to receive tenofovir through Brazil's national AIDS programme by the end of 2008.

As a result of patent oppositions filed in India previously in 2006, Gilead offered voluntary licenses to several Indian generic manufacturers, even though no patent on the drug had been granted.

These agreements are restrictive and do not permit export of the drug or raw material (active pharmaceutical ingredient) to certain middle-income countries, including Brazil. This allows Gilead to continue to charge high prices in these countries. In Brazil, Gilead sells tenofovir for US $1,387 (Rs 59,571) per patient per year, and in comparison, the cheapest available generic version manufactured in India costs only US $158 (Rs 6770) per patient per year.

Generic drugs are less expensive because generic manufacturers don't have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment—including research, development, marketing, and promotion—by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don't have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs.

Manufacturers seek to extend their hold on their drugs even after the expiry of the patent by coming up with slightly different versions.

Brazil would not be able to procure generic versions from India if the patent is granted to tenofovir. But if the application is rejected, Indian generic companies that did not sign the voluntary license agreement with Gilead would be able to supply the drug to Brazil and other middle-income countries. This would mean Brazil could purchase affordable generic versions of tenofovir from multiple producers competing against each other, helping bring prices down.

"We want more options to promote competition in the market and bring down drug prices," Gabriela Chavez, a pharmacist with ABIA told The Hindu. "If the patent is granted in Brazil but not in India, Brazil has the option to apply for a compulsory licence [a provision for public health emergencies sanctioned by the World Trade Organisation] to buy the drug at lower cost from Indian companies. If the patent is not granted in Brazil or India, Brazil has the option to import either the key ingredients or the finished medicines from Indian companies," she said.

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."

"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."

"There's a global momentum building against the granting of a patent in India on tenofovir," said Loon Gangte, president of the Delhi Network of Positive People (DNP).

Source: Medindia

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