[Ip-health] Brazil Declares Patented AIDS Drug Of Public Interest, Could Expand Access

[Sarah Rimmington]

Intellectual Property Watch
http://www.ip-watch.org/weblog/index.php?p=3D1015

22 April 2008
Brazil Declares Patented AIDS Drug Of Public Interest, Could Expand Access

By Claudia Jurberg for Intellectual Property Watch
The Brazilian government recently declared the drug Tenofovir, used
against HIV/AIDS, to be of public interest. The announcement signals the
country=92s 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 n=BA 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 Galv=E3o, 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=92s 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 Galv=E3o. 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. =93Nowadays, we have more strategies,=94 she said=
.

Galv=E3o said Brazil is acting within its rights with its latest action.
=93This is a right to the country in using this measure to declare the
Tenofovir in the =91public interest,=92 she said. Therefore, there is no ri=
sk.=94

According to Lucia Motta, an INPI press advisor, the patent application
of Tenofovir was requested through the Patent Cooperation 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.

=93Up 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,=94 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 Galv=E3o.

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.

Claudia Jurberg may be reached at info@ip-watch.ch.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/