[Ip-health] Boehringer refuses to register tipranavir

[Sean Flynn]

The article implies that the drug is patented in Brazil.  Assuming that is =
true, there are clear grounds for a compulsory license for " failure to wor=
k the subject matter of a patent on the territory of Brazil."

Brazil's Patent law states:

Chapter VIII
Licenses
Section III
Compulsory Licenses
Art. 68. A patent shall be subject to compulsory licensing if the owner exe=
rcises his rights therein in an abusive
manner or if he uses it to abuse economic power under the terms of an admin=
istrative or judicial decision.
(1) The following may also be grounds for compulsory licensing:
I. failure to work the subject matter of a patent on the territory of Brazi=
l, failure to manufacture or
incomplete manufacture of the product or failure to completely use a patent=
ed process, except for failure to
work due to lack of economic viability, in which case importing shall be ad=
mitted; or
II. marketing that does not satisfy the needs of the market.
(2) A license may be requested only by a party having a legitimate interest=
 and having the technical and
economic capacity to effectively work the subject matter of the patent for =
the purposes predominantly of
the internal market, not subject in such case to the exception contained in=
 item I of the preceding
paragraph.
(3) If a compulsory license is granted on the grounds of abuse of economic =
power, a period of time,
limited to that laid down in Article 74, shall be secured to a licensee who=
 proposes to manufacture locally,
to import the subject matter of the license, provided it has been placed on=
 the market directly by the patent
owner or with his consent.
(4) In the event of importation in order to exploit a patent or importation=
 as provided in the preceding
paragraph, third parties shall also be allowed to import a product manufact=
ured according to a process
patent or a product patent, provided it has been placed on the market direc=
tly by the patent owner or with
his consent.
(5) A compulsory license under paragraph (1) may only be requested on expir=
y of three years after grant of
the patent.

-----Original Message-----
From: ip-health-admin@lists.essential.org [mailto:ip-health-admin@lists.ess=
ential.org] On Behalf Of michel lotrowska
Sent: Monday, January 21, 2008 7:47 AM
To: ip-health@lists.essential.org
Subject: [Ip-health] Boehringer refuses to register tipranavir in Brazil be=
cause of patent law


Company refrain from launching and anti-aids drug because it disagrees with=
 the patent law of the country
ESTADO DE S=C3O PAULO -19TH FEBRUARY - FABIANA LEITE

Although Legal, the decidion 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 resistent to most other drugs against the disease. By not=
 registring the medicine in the country, the company makes it difficult for=
 patients who need it to have access as a last treatment alternative - no m=
edicine can be sold, offered by the Public Health System - SUS -, without r=
egistration.

Recently, the Public Prosecutor of the State of S=E3o 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=B4t respond to=
 other medicines. The man has no money to import the drug. The court was fa=
vourable to the request, but the order has not arrived yet to the State Aut=
horities of S=E3o 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 unil=
ateral. It conditioned the registration to the guarantee that the patent wo=
uld be honored. As the government has a process for this, the president of =
the laboratory decided not to register, althought the local BI office was t=
rying 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, that was involved in the group of spec=
ialists 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, t=
hat took place in may last year. Nevertheless, this decision was never turn=
ed public. Partners of the company, nevertheless, affirmed to the newspaper=
 that the compulsory licensing burried the possibility of the medicine be m=
ade available in Brazil. But also the fact that the brazilian market for th=
e medicine is not a priority for the company weighted in the decision of de=
nying access to brazilian patients of the drug - the drug being sold in Eur=
ope and the US.

BI pointed out they respect the Brazilian legislation and promissed  to bri=
ng the product in the country. "The substance tipranavir, being an importan=
t medicine to controle the infection (...) is in the relation of launching =
of the company that is programed for the next years, in Brazil", informed t=
he 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, therefor, 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. Nevert=
heless, currently, even without the guarantee of the exclusivity of product=
ion of a medicine in the country, other pharmaceutical companies don=B4t st=
op 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 legislati=
on is considered bad for its business, like Thailand, that already issued c=
ompulsory licenses.

NEGOTIATION IS LACKING

Castelo Filho calculates that between 2 and 3 thousand patients could benef=
it from tipranavir. For hime, there was a lack of negotiation between the B=
razilian Government and the Ministry, that would not have worked hard enoug=
h to bring the drug, that is very expensive. The Aids program is bringing v=
ery soon another drug for cases of resistence, Darunavir.


michel lotrowska
 M=E9dicos Sem Fronteiras
Campanha Acesso a Medicamentos Essenciais
Access Campaign for Essential Medicines