German Pharmaceutical Company Chooses NOT to Register Drug in Brazil Due to Risk of Patent Expropriation

Boehringer Refuses to Register Tipranavir in Brazil Because of Patent Law


By Michel Lotrowska


Sem Fronteiras Campanha Acesso a Medicamentos Essenciais / Access Campaign for Essential Medicines


January 21, 2008


Company refrain from launching and anti-aids drug because it disagrees with the patent law of the country ESTADO DE S PAULO -19TH FEBRUARY FABIANA LEITE


Although [l]egal, the decision not to register a drug is harmful for patients that need it to go on with their treatment.


The pharmaceutical laboratory Boehringer Ingelheim decided not to launch a medicine against aids in Brazil. The medicine called tipranavir is used in patients that are resistant to most other drugs against the disease. By not registering the medicine in the country, the company makes it difficult for patients who need it to have access as a last treatment alternative no medicine can be sold, offered by the Public Health System - SUS, without registration.


Recently, the Public Prosecutor of the State of SE Sao Paulo went to court to get this medicine as well as another one, recommended for a patient that has the immune system extremely weak and that already doesn’t respond to other medicines. The man has no money to import the drug. The court was favourable to the request, but the order has not arrived yet to the State Authorities of SE Sao Paulo, that will be obliged to import the medicine. The patient is only using some antibiotics says the public prosecutor Felipe Pereira.


The laboratory BI renounced to register the drug and the decision was unilateral. It conditioned the registration to the guarantee that the patent would be honored. As the government has a process for this, the president of the laboratory decided not to register, although the local office was trying to. The laboratory really decided not to register because of lack of guarantee of the patent. It was an extremely wrong decision, affirms the infectologist Adauto Castelo Filho, [who] was involved in the group of specialists that was analyzing studies with the medicine in Brazil.


According to Castelo, the decision was taken already in the middle of 2006, before the compulsory license of other medicine against aids, efavirenz, that took place in May last year. Nevertheless, this decision was never turned public. Partners of the company, nevertheless, affirmed to the newspaper that the compulsory licensing buried the possibility of the medicine be made available in Brazil. But also the fact that the Brazilian market for the medicine is not a priority for the company weighted in the decision of denying access to Brazilian patients of the drug being sold in Europe and the US.


BI pointed out they respect the Brazilian legislation and promised to bring the product in the country. The substance tipranavir, being an important medicine to control the infection (...) is in the relation of launching of the company that is programmed for the next years, in Brazil, informed the company (one of the 20 big one in the world) in a release. Nevertheless, every launching of BI is part of a chronogram guided by global strategies of the company, and, therefore, that can possibly be altered. According to the company, 92 patients that were part of a study with the drug in Brazil keep receiving the drug, paid by the lab.


The decision not to register a drug is a right of the patent holder. Nevertheless, currently, even without the guarantee of the exclusivity of production of a medicine in the country, other pharmaceutical companies don’t stop offering their products. The launching is usually done before the end of the analysis done through a long process implemented but the Patent Office (INPI) and the Local Drug Regulatory Authority (ANVISA) through the prior consent.


The decision of the company is not new in the pharmaceutical world. Others already denied to launch medicines in countries where the patent legislation is considered bad for its business, like Thailand, that already issued compulsory licenses.


NEGOTIATION IS LACKING


Castelo Filho calculates that between 2 and 3 thousand patients could benefit from tipranavir. For him, there was a lack of negotiation between the Brazilian Government and the Ministry, that would not have worked hard enough to bring the drug, that is very expensive. The Aids program is bringing very soon another drug for cases of resistance, Darunavir.