[india-drug] Re: Landmark revoking of US patents on Tenofovir (2)

["O'Brien Bone & Joint Centre" <obrienbjc@gmail.com>]

Landmark revoking of US patents on Tenofovir - more drugs to follow?(2)
******************* 

Further news from Brazil on this same subject, with a different method
of denying a patent on public interest grounds, read below

http://www.ip-watch.org/weblog/index.php?p=1015

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'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 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.

"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.

This work is licensed under a Creative Commons License. All of the
news articles and features on Intellectual Property Watch are also
subject to a Creative Commons License which makes them available for
widescale, free, non-commercial reproduction and translation.

-- 
with warm regards and wishes
girish

Rtn Dr NV Girish Kumar
MBBS Dortho FRCS(Ire) FRCS(Trauma & Ortho)
O'Brien Bone & Joint Clinic
Coimbatore - 641002
Pediatric Ortho, Joint Replacement, Arthroscopy, Advanced Trauma Care
Surgeon

Secretary, Indian Medical Association, Coimbatore branch, 2007-8
Trustee, IMA Masonic Mahaveers Rotary Midtown Blood Bank
District Chairman, Polio Corrective Surgery, RID 3200, 2005-6, 2007-8