A judge in Brazil has annulled Abbott Laboratories’ patent there on its HIV/AIDS drug Kaletra (ritonavir and lopinavir), say local reports.
In the Federal Court of Rio de Janeiro, Judge Daniela Pereira Madeira granted a request by Brazilian generics producer Critalia to annul the patent, ruling that its grant under the country’s pipeline process – which allowed patents granted in other countries to be revalidated while Brazil’s patient legislation was undergoing changes – was unconstitutional.
The Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI/Rebrip), has welcomed the decision. It points out that the patent’s existence has meant the Brazilian government has only been able to purchase the drug from Abbott for use in the nation’s HIV/AIDS treatment programme, at a price of US$763 per patient per year, despite the fact that generic versions, whose quality is approved by the World Health Organisation (WHO), are available on the international market for 47% less, at $402 per patient per year.
More than 40,000 people in Brazil are being treated with Kaletra, and it accounts for about 16% of spending by the National Department of STD/AIDS and Viral hepatitis on antiretroviral drugs, says the group, which also notes that a decision on a class action filed by GTPI together with the Federal Prosecutors Office on December 1, 2005, requesting the issue of a compulsory license for the drug, is still awaited.
Also pending is a Direct Action of Unconstitutionality (ADI), filed at the Brazilian Supreme Court on May 2009, triggered by a petition filed by GTPI in November 2007 challenging the constitutionality of the pipeline mechanism. From the filing of the ADI until December 2010, Brazil could have saved more than $3.8 billion if it had purchased generic versions of the drug available in the international market, says the group.
Meantime, on March 31 the prices of around 20,000 drugs in Brazil are to rise by as much as 5.85%, based on three levels of generic competition. Level one consists of products for which generics account for at least 20% of sales – these will receive the full 5.85% price rise. Level two represents products where the market share of generics is 15%-20%, which will be permitted a price increase of up to 2.80%. For level three, where generics’ market share is under 15%, the price rise can be no more than 0/25%.
Commenting on the move, analysts at IHS Global Insight say they expect the price increases to reach consumers around June-July. Although the 5.85% price rise is “scaring consumers and consumer associations across Brazil,” this price increase is lower than the 6.01% rise granted in 2011, they add.
