[Ip-health] Brazilian AIDS programme may replace Viread with generic

[Ellen T HOEN]

>From Scrip today.

Brazilian AIDS programme may replace Viread with generic

The Brazilian health ministry has declared Gilead Sciences's antiretroviral
Viread (tenofovir disoproxil fumarate) to be of public interest, a move
that could prompt Brazil's patent office (the INPI) to reject the company's
patent application for the product and allow the government to buy a
generic version of the drug for its HIV/AIDS programme.

Before the ministry's declaration, the INPI examined patent application PI
9811045-4, which covers tenofovir, and found it to be inconsistent with
article eight of Brazil's patent law, because it said it lacked novelty and
an -inventive step", and therefore did not meet the necessary requirements
for patentability.

The INPI's findings also took into account the US Patent and Trademark
Office's decision to issue a non-final rejection of Gilead's patents
covering tenofovir disoproxil fumarate in January (Scrip No 333, p 18).

An invention that does not comply with the legal requirements is not
patentable and the application for that patent should not be granted by the
INPI," said Reinaldo Guimaraes, secretary of science technology and input
strategy at the ministry of health.

Although it is not patented in Brazil, tenofovir has been available through
the country's National STD/AIDS Programme since 2003. It is one of the most
expensive treatments that the programme offers and is used by around 31,000
patients, costing the government $1,387 per patient per year, according to
the health ministry.

However, through purchasing a generic version from India - where the Indian
generics company Cipla is opposing Gilead's patent application on similar
grounds - the government could provide treatment at the much lower cost of
$170 per patient per year, the ministry claims. Cipla has been marketing a
generic version of tenofovir in India since 2005 (Scrip No 3332, p 21).

-If the patent is rejected in Brazil, as it was in the US, Brazil would be
able to buy the medicine from whichever supplier offers the best price,"
the National STD/AIDS Programme told Scrip. But until the INPI reaches a
final decision, the Brazilian government will continue to buy the drug from
Gilead.

The INPI's opinion was published in the Official Journal of the Union on
April 10th, from which point the body has 90 days to reach a decision. It
notified Gilead of its decision on April 8th, giving the company 90 days to
respond. The firm told Scrip: Gilead has and continues to work with the
Brazilian government to ensure the supply of access to its leading
antiretroviral, Viread."

Last year President Luiz Inacio Lula da Silva issued a compulsory licence
for Merck & Co's antiretroviral Stocrin (efavirenz; Scrip No 3257, p 22).
Shortly afterwards Abbott agreed to reduce the cost of its second-line
antiretroviral Kaletra (lopinavir plus ritonavir tablets) from $1,500 per
patient per year to $1,000 per patient per year.

Brazil's AIDS/STD Programme aims to provide everyone in the country living
with HIV/AIDS with the appropriate treatment free of charge and has been
lauded as a great success. However, some critics claim that such focus on
HIV/AIDS detracts from providing treatment for other conditions.
francesca.bruce@informa.com