Brazil Declared AIDS Drug drug Tenofovir Of Public Interest

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Brazil Declares Patented AIDS Drug Of Public Interest, Could Expand

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By Jurberg for Intellectual Property Watch

22 April 2008.

The Brazilian government recently declared the drug Tenofovir, used

against HIV/AIDS, to be of public interest. The announcement signals

the country's interest in using an option to avoid the patent on the

drug and beginning the process of issuing a compulsory license for

the antiretroviral which is produced by the Gilead Science

biopharmaceutical company.

The Brazilian patent office, the National Institute of Industrial

Property (INPI), released a technical opinion in the Revista de

Propriedade Industrial (Industrial Property Magazine) on 8 April, on

patent application number PI 9811045-4, the patent for Tenofovir. The

technical opinion explains that Tenofovir is inconsistent with

Articles 8, 10 (VIII), 13, 24 e 25 of the Law nº 9279/96, the

Brazilian patent law. The decision was published in the Official

Daily.

Gilead was notified about the decision on 8 April and has 90 days to

express its opinion. At the end of this time, the INPI will publish

the final decision in accordance with the Brazilian law.

With the declaration of public interest by the Health Ministry, INPI

could give priority to the examination of an appeal by Gilead.

Tenofovir is one of the most expensive antiretrovirals in Brazilian

national AIDS programme. According Health Ministry, the drug is used

by 30,000 patients. The annual cost of this antiretroviral is U$1,387

per patient per year. The overall annual cost is approximately US$40

million, or 10 percent of the total cost of drugs in the Brazilian

programme. In Brazil, patients with AIDS receive free treatments.

India produces a generic version of Tenofovir and this treatment cost

US$170 per patient per year. If Brazil imported from India, the

yearly savings could be more than US$30 million.

According to official data from the Health Ministry, 474,273 people

were infected with HIV-1 in the country from 1980 until 2007. Of

these individuals, 67 percent are male and 33 percent are female, and

around 190,000 people had died as of 2006.

Data from Health Ministry and others sources reveals a reduction of

the mortality rate by around 50 percent with the use of

antiretrovirals.

Researcher Jane Galvão, senior program officer for HIV/AIDS/STI and

International Planned Parenthood Federation/Western Hemisphere Region

(IPPF/WHR) in New York, said that since the present policy of

coordinated distribution of antiretrovirals began, the number of

people living with HIV/AIDS receiving treatment has steadily

increased. An estimated 35,900 individuals received these drugs in

1997 and the number jumped to 175,000 in 2005.

Government spending on antiretrovirals has also followed an upward

trend: US$34 million in 1996 compared with US$438 million ten years

later. Although the Brazilian policy of antiretroviral distribution

has had notable success, it remains threatened by the high cost of

acquiring the drugs, which has led to disputes with international

pharmaceutical companies over prices and patents.

Since 1996, the Brazilian Health Ministry has created an anti-AIDS

programme that is recognised all over the world. Implementation of

this policy has had political, financial, and logistical challenges.

The country has received much acclaim for its multifaceted national

HIV/AIDS program, with strong leadership from the government and

civil society, the program includes care, education, prevention, and

epidemiological monitoring. But the most distinctive element of

Brazil's program is free and widespread distribution of

antiretroviral drugs to all HIV-infected people.

When Brazil announced for the first time its intention to break

patents on drugs for AIDS, in 2001, much progress was made in the

negotiations with the pharmaceutical companies, said Galvão. She was

general coordinator of the ABIA, a nongovernmental and non-profit

organisation founded in 1986 to take action against AIDS. After that,

she worked at the Brazilian AIDS Programme of the Health Ministry.

For her, there was a change in the way negotiations were conducted

between the National AIDS Programme, of the Health Ministry, and

pharmaceutical companies. " Nowadays, we have more strategies, " she

said.

Galvão said Brazil is acting within its rights with its latest

action. " This is a right to the country in using this measure to

declare the Tenofovir in the `public interest,' she said. Therefore,

there is no risk. "

According to Lucia Motta, an INPI press advisor, the patent

application of Tenofovir was requested through the Patent ation

Treaty, in 2000. This reduced the process to eight years. Motta said

that the time to analyse an application for a pharmaceutical is long

and complex and the time to finalise the process in Brazil is on

average equal with the rest of the world.

" Up this moment, INPI and the Brazilian government acted strictly

within the rules established by Law no. 9279/96, Therefore, there are

no grounds for international sanctions, " said Motta.

From the perspective of the Brazilian government, there are at least

two arguments for continuing the distribution programme. First, the

clear effect of antiretroviral treatment in reduction of deaths, and

second, the substantial reduction in hospital admissions and

treatment costs. The reduction of costs of hospital admissions and of

treatment of opportunistic infections was also great. For 1996-2002,

cost savings throughout Brazil have been estimated by the Health

Ministry to be close to $1.23 billion, said Galvão.

Despite the fact that the United States already suspended the patent

on Tenofovir substance, Gilead said that the Brazilian decision was

equivocal because the United States has not banned the patent and the

Brazilian decision could be appealed.

Jurberg may be reached at info@...

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