Civil society files patent opposition to increase access to HIV/AIDS medicines
Rio de Janeiro, 10 November 2011 – Brazilian civil society will oppose a patent application today for the key HIV drug lopinavir/ritonavir (LPV/r), in an effort to allow access to more affordable generic versions of the medicine. The move is part of efforts to use all available public health provisions within international trade rules to increase access to the drug for people living with HIV/AIDS. The international medical humanitarian organisation Médecins Sans Frontières (MSF) welcomes this action.
“The patent opposition being filed today has major implications for the future of the Brazilian response to HIV/AIDS, with the number of people who need this drug rising”, said Gabriela Costa Chaves, of MSF’s Access Campaign in Brazil.
The ‘pre-grant opposition’ is being submitted by the NGO Rebrip’s Working Group on Intellectual Property against a patent application filed by US pharmaceutical company Abbott for the heat-stable versions of LPV/r and ritonavir. The opposition is based on the fact that the applications lack novelty and an inventive step, being merely a combination of existing drugs, and known technologies for producing heat-stable formulations, respectively.
A similar opposition led to the patent for LPV/r being rejected in India in 2010.
With this patent opposition, civil society groups in Brazil are adding their voices to a collective action launched today by civil society groups in a number of developing countries to reduce the price and expand access to LPV/r. This involves different strategies in countries, including requests for compulsory licences to override patents and filing patent oppositions to prevent the granting of patents. Both measures are public health safeguards enshrined in international trade rules.
LPV/r is recommended by the World Health Organization and used primarily in ‘second-line’ HIV therapy for people who have become resistant to their first set of medicines. More than 40,000 people in Brazil today take LPV/r – and since people living with HIV in Brazil are among those who have been on treatment the longest in the developing world, this number is expected to increase steadily as people become resistant to their medicines over time.
In Brazil, the drug alone accounts for 16% of the government’s expenditure on antiretroviral medicines. High prices have led to consistent calls from civil society for the government to issue a compulsory licence to override the patent and allow cheaper versions of the drug to be produced or imported – which nearly happened in 2005. Should the patent on LPV/r be granted, it would extend the patent monopoly from 2017 until 2024, threatening expanded access to second-line therapy for people living with HIV in Brazil, and could establish a precedent for other countries.
"MSF started HIV treatment programmes in Latin America around ten years ago; in the last few years, as we’ve handed those programmes over to local authorities, it was with the confidence that they would be able to provide people with the treatment they needed to stay alive”, said Michelle Childs, Director of Policy Advocacy of MSF Access Campaign.
“Access to the drug lopinavir/ritonavir is critical for people living with HIV who have become resistant to their first medicine combination. Today we are concerned that access to this drug has shrunk with lopinavir/ritonavir now priced out of reach, which is quite worrying given the increasing number of people that need to switch to this drug”, Ms Childs said.
“We are seeing a growing trend that so-called ‘middle-income’ countries are being shut out of across-the-board drug company price discounts and are being forced to individually negotiate prices with companies – we have seen that such case-by-case negotiations often lead to higher overall prices. It is crucial that other means be pursued to ensure access to this drug, by making full use of flexibilities in global trade rules, such as compulsory licensing or opposing the granting of patents. This is part of an important collective action by civil society groups in a number of countries is to increase access to lopinavir/ritonavir", she says.