[Ip-health] Brazil introduced an opposition to a patent on an Aids medicine

[MSF Michel Lotrowska]

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Brazil introduced an opposition to a  patent on an Aids medicine




If the patent is granted, Country will not be able to import generic
versions of Tenofovir produced in India



L=EDgia Formenti, de O Estado de S. Paulo =96 Thrusday. June 26th 2008



BRAS=CDLIA =96 A new front of dispute against Tenofovir's patent, one of th=
e
most expensive medicine used by the National STD/Aids Programme, was
initiated on Thursday, 26th, by Brazilians. The Brazilian Interdisciplinary
Aids Association (Abia) entered with an opposition in India against the
granting of a patent for this medicine, which is under examination in that
country. The interest is justified: if the patent is granted in India,
Brazil will not be able to import generic versions of Tenofovir produced
there.

In the patent opposition, Abia argues that the medicine does not bring
innovation, an indispensable requirement to have the patent granted. "The
active ingredient of tenofovir is known since the 80=B4s", affirms Renata
Reis, Abia's lawyer and coordinator of the Working Group on Intellectual
Property (GTPI).

The opposition, proposed jointly with an Indian non-governmental
organization Sahara Centre for Residential Care & Rehabilitation (Sahara),
meets two basic objectives.  To guarantee that Brazil has access to generic
versions of the medicine and to the active ingredient =96 starting point fo=
r
the production of the anti-retroviral in Brazil.

Tenofovir's patent is considered fragile in several parts of the world. The
north-American patent office questioned the drug patent, produced by Gilead=
.
In Brazil, the patent application is under analysis at the National
Institute of Industrial Property (INPI). In the first step of this process,
the industry lost. In April, INPI wrote a report against the grant of this
patent. Now, Gilead has until 7th of July to contest. After that, INPI will
have to publish a decision. There is a great expectation that this patent
will be rejected.

"Although we are confident that tenofovir's patent will not be granted in
Brazil, we need to ensure that generic version produced in India are
available for our Aids programme," said Abia's general coordinator, in a
note. =93This will contribute to the sustainability of our national AIDS
program=92s universal access policy, upon which 180,000 Brazilians depend o=
n
for their lives.=94

The interest for the generic medicine is explained by Renata. If the patent
is not granted in Brazil, a good alternative for the market will be generic
sources of medicines. Most of them, produced in India.

In this manner, for example, Brazil obtained the anti-retroviral efavirenz,
for which a compulsory license was issued by the government last year. As
Brazil did not have immediate capacity to produce the drug, they (the
government) procured from the international market.

"Access to generic versions and to the raw material is essential. The first
one allows an immediate solution for the supply, when is necessary to escap=
e
from high prices set by the manufacturer. ", affirmed M=E1rio Scheffer, of =
the
(NGO) Grupo pela Vidda. "And the raw material is essential for the next
step: when the Country starts to produce the drug", complemented.

The threat in the procurement of the raw material started with an
opposition, proposed in 2006 by NGOs also for the medicine's patent in
India. In a reaction to this opposition, Gilead offered voluntary licenses
to several generic Indian companies. However, these agreements include
provisions which prohibit the commercialization of both raw material and
final product to some developing countries, including Brazil.

"And the consequences are clear. In Brazil, the company is selling tenofovi=
r
for US$1.387 per patient (per year). In India, the cheapest generic version
is US$158 per patient per year.



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