The Brazilian government filed a request to break the patent of the drug, Kaletra, used in the treatment of AIDS and currently imported from the American pharmaceutical company, Abbott Laboratories.
The drug, which is composed of the active ingredients, “Ritonavir” and “Lopinavir,” is used in all phases of AIDS treatment.
With this decision, the Brazilian government laboratory, Farmanguinhos, part of the Oswaldo Cruz Foundation, will produce the generic equivalent composed of the two active ingredients.
The decree in which the government declares the anti-retroviral substance a medication in the public interest and announces its mandatory licensing was published Saturday (25) in a special edition of the Federal Government Register (Diário Oficial da União).
Abbott Laboratories has ten days to challenge the Brazilian government’s decision. The Minister of Health, Humberto Costa, said that Brazil’s decision to adopt mandatory licensing, breaking the Kaletra patent, will save the country US$ 54.4 million (R$ 130 million) each year. The Farmanguinhos laboratory will only make the generic drug available commercially after a year of testing.
Kaletra will only enter the international public domain in 2012. Costa emphasized that Brazil has the backing of international law to break the patent (which represents a company’s property rights to scientific discoveries).
According to the Minister, the World Trade Organization’s (WTO) intellectual property agreement permits any country to make use of a drug patent without the owner’s consent under circumstances that are urgent and in the public interest.
Moreover, the 2001 Doha Declaration recognizes that the international patent agreement cannot supersede public health interests. Costa emphasized that patent-breaking can always be resorted to when the drug will be distributed for free, and Brazil will not export the generic form of Kaletra, nor will what Farmanguinhos produces be sold.
“This is the first time a drug patent is broken in Brazil. We are not committing a breach of contract in an international agreement,” Costa affirmed.
The Minister added that the contract with Abbott to buy Kaletra runs through May, 2006.
“We did not violate the contract, we shall continue making payments, and the laboratory is not prohibited from selling Kaletra in Brazil. Abbott can even participate in government bidding processes, and it will win, if the price is suitable,” the Minister said.
Kaletra currently costs US$ 1.17 a dose. Farmanguinhos will produce the generic form of Kaletra for US$ 0.68.
23,400 of the 170 thousand Brazilians who receive free medications from the National Sexually Transmitted Diseases and AIDS Program use Kaletra, which accounts for 30% of the budget allocated for the acquisition of AIDS treatment drugs.
Brazil will spend US$ 396 million (945 million reais) to purchase anti-retrovirals in 2005, and Kaletra represents US$ 107 million (257 million reais) of this total.
The drug has proved to be effective in blocking the reproduction of the HIV virus in patients who do not respond as well to other anti-retrovirals.
ABr – www.radiobras.gov.br