04.09.2008 Brasilien

Patentantrag auf AIDS-Medikament in Brasilien abgelehnt

Die Brasilianische medico-Partnerorganisation ABIA (Associação Brasileira Interdisciplinar de AIDS) hat einen bedeutenden Erfolg in der Auseinandersetzung um Pharma-Patente und den Zugang zu AIDS-Medikamenten zu vermelden. Das Brasilianische Patentamt (INPI) hat den Patentantrag des Konzerns Gilead auf den Wirkstoff Tenofovir abgelehnt. Für das staatliche Behandlungsprogramm ist Tenofovir eines der wichtigsten zugleich aber auch eines der teuersten Medikamente. Durch diese Entscheidung könnte der Preis nun deutlich fallen.

ABIA lieferte dem INPI Fakten die zeigten, dass die Wirksamkeit von Tenofovir und seine Struktur bereits seit den 1980gern bekannt sind. Damit konnte nachgewiesen werden, dass es sich nicht um eine Neuerfindung des Pharmakonzerns Gilead handelt und folglich ein Patent nicht rechtens wäre.

ABIA wurde 1987 gegründet und hat sich zu einer sehr anerkannten Nichtregierungsorganisation in Brasilien entwickelt. Sie ist insbesondere engagiert im Kampf gegen AIDS und der Verteidigung der Menschenrechte der HIV-Betroffenen.

ABIA Pressemitteilung vom 2.9.2008:

INPI denies patent for the anti-retroviral Tenofovir

Medicine is one of the most expensive of the anti-Aids cocktail; company has 60 days to appeal

The National Institute of Industrial Property (INPI) denied the patent granting for the anti-retroviral Tenofovir, one of the most expensive and important medicine used by the STD/Aids National Program. The producer company, Gilead, has 60 days to appeal, affirmed INPI's press office. However, for those monitoring the process, there are very little chances to revert the decision.

Tenofovir is currently used by 31,3 thousand patients, accounting for US$ 43,4 millions (around R$ 72 millions) for the government. It is estimated that by the end of this year, this number will go to 37 thousand people.

Even with the possibility of appeal, the INPI's decision brings a new perspective to price negotiation of Tenofovir in Brazil. The Secretary of Science, Technology and Strategic Products from the Ministry of Health, Reinaldo Guimarães, affirmed that the agreement with Gilead is ending very soon. "We will certainly ask for a lower price compared to what is charged today: US$ 3,25 the dose (R$ 5,40)", affirmed. The generic produced by the Indian company Ranbaxy costs US$ 0,4 (R$ 0,66) per dose. Meanwhile, Brazil cannot change supplier. Ranbaxy has signed an agreement with Gilead that prohibits the commercialization of the product in Brazil.

There is another producer, the Indian company Cipla. However, the generic produced by this company has not yet received the pre-qualification of the World Health Organization, essential requirement for the commercialization of the product in the Country. The conclusion of the prequalification might also take place before the end the year. "Any decision will have to be taken cautiously. The most important is that there will be no shortage of the medicine, with whatever decision that will be taken", said the Secretary.

The reportage could not contact Gilead yesterday. The analysis of Tenofovir's patent began in 1998, but only in April (of 2008) the process was speed-up. The Ministry of Health declared the medicine of public interest and, with that act, obtained the priority status (for analysis) at the INPI. Another reason for the Ministry of Health to ask for the speeding up of the analysis has been the intention of Gilead to restrict the use by the national aids programme of generic versions of Tenofovir. In 2006, the company granted a voluntary license to Indian producers, under the condition that the medicine could not be sold to Brazil.

"It is a victory. Now, producers will think twice before filing a patent application for a medicine that doesn´t bring innovation, for the sake of keeping their monopolies.", said the lawyer from the Rebrip's Working Group on Intellectual Property (GTPI) and member of the Brazilian Interdisciplinar Aids Association (ABIA), Renata Reis. In 2007, ABIA and the Oswaldo Cruz Foundation introduced technical arguments to INPI, showing that the formulation of Tenofovir did not bring any technological innovation, one of the requirements for the granting of a patent, according to the Industrial Property Act.

Health declared the public interest

The Ministry of Health published, in April 2008, a decree declaring Tenofovir as a medicine of public interest. The anti-retroviral is one of the most expensive and important for the National SDT/Aids Programme. Produced by the company Gilead, it is used by 30 thousand patients in Brazil and accounts, alone, for 10% of the expenses of medicines in the programme.

The drug patent was already denied in United States and the expectation is that the same happens in Brazil. The National Institute of Industrial Property (INPI) did, also in April, a report not favourable to the granting of this right.

In June, the Brazilian Interdisciplinary Aids Association (Abia) introduced in India an opposition against the granting of the patent, which is under analyses in that country. If the right is granted in India, Brazil will not be able to import generic versions of Tenofovir produced there.

Abia argues that the medicine does not bring innovation, essential requirement to have the patent granted. The active ingredient of Tenofovir is already known since the eighties.

(Lígia Formenti)