Brazil HIV Drug Patent Ruling Allows Generics, Sends Pipeline Process Into Doubt

Word is spreading of a recent decision by a Brazilian judge to annul a patent on a key AIDS drug, effectively allowing less expensive generic versions into the country, and calling into question other such patents. [Update: decision added.]

The decision is available here [pdf, in Portuguese]

According to a statement by the Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI/Rebrip), a coalition of non-governmental organisations, the judge granted a request by Cristália, a Brazilian generic producer, to annul a patent held by Abbott Laboratories.

The patent was on the drug ritonavir and lopinavir (lop/r), which is marketed under the brand name Kaletra and used to treat HIV infection. [Clarification: the patent was on lopinavir, so the decision allows the Brazilian company to make a generic lop/r combination, according to a source.]

The decision was issued on 23 February in the Federal Court of Rio de Janeiro, GTPI said. The decision was first reported in Brazilian newspaper Folha de São Paulo. An English language version of the decision is not yet available.

Sources said it is likely that Abbott will appeal the decision. An Abbott spokesperson was not reached for this story. No press release appeared to be issued on the Abbott website. [Update: a source said it has been reported that Abbott asked that the nullification order be made pending a decision on the appeal but that the appeal has been denied.]

A leading feature of the case is that the patent was granted under the “pipeline” process, which allowed “revalidation” of patents granted in other countries while Brazil was modifying its patent law for certain new areas including pharmaceuticals.

The judge in this case ruled that the pipeline process was unconstitutional, according to sources.

The pipeline process in Brazil had already come into question in recent years (IPW, Public Health, 13 May 2010; IPW, Public Health, 22 January 2008) and this decision furthers that movement.

But according to sources, the judge ruled that there was not a question in this case of the absence of review of the drug by the health ministry’s Health Surveillance Agency (ANVISA). This has been a sensitive issue in recent years in Brazil as it has given a say in drug patent decisions to the health authorities.

The judge found that the patent was granted (“revalidated”) by the Brazilian IP office (INPI) before the prior consent rule entered into effect in Brazil, a source said.

A global campaign by NGOs was launched last autumn to open rinotavir/lopinavir to generic competition (IPW, Public Health, 16 November 2011).

A patent on the same drug was rejected in India last year (IPW, Public Health, 4 January 2011).

GTPI said the Rio decision could save Brazil millions of dollars through its national anti-HIV programme as the patent meant it could not allow sale of generics despite their availability on the international market.

“The price paid by Brazil is US$763 per patient/year, but there are generic versions of approved quality by the World Health Organization (WHO) sold for US$402 per patient/year, a price 47% lower,” the group said.

Abbott and the Brazilian government had reached an agreement in 2005 for the company to lower its prices on the drug, after the Brazilian government issued a decree declaring it to be of public interest, the first step to a compulsory licence.

At that time, the drug consumed some 30 per cent of Brazil’s national budget on antiretroviral treatment, GTPI said. Now it represents some 16 per cent of such spending.