[Ip-health] Ministerial Directive 681 - 8 April 2008 - Translation of tenofovir act that declares public interest for the analysis of tenofovir patent

[MSF Michel Lotrowska]

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Jos=E9 Gomes Tempor=E3o



Ministerial Directive 681 - 8 April 2008



Declares of public interest the antiretroviral medicine Tenofovir in order
to get a priority analysis of the patent application at the National
Institute of Intellectual Property (INPI).



THE STATE MINISTER FOR HEALTH, in the use of the attributions granted to hi=
m
by the article 87, sole paragraph, bullet IV, of the Federal Constitution,
and in view of Art. 3 of the decree number 3.201 of 6 October 1999, and



Considering that health is a fundamental human right, according to the term=
s
of the Article 25 of the Universal Declaration of Human Rights, of 10
December 1948, and of Article 12 of the International Covenant on Economic,
Social and Cultural Rights of 16 December 1966, incorporated in the nationa=
l
legal framework by the decree number 591 of 6 July 1992, that ensure the
right of every person to enjoy the highest level of mental and physical
health;



Considering that the right to prevention and treatment of endemic,
professional and other types of diseases is a human right provided by the
Article 10 of the San Salvador Protocol, dated 17 November 1988,
incorporated in the national legal framework by the decree number 3.321 of
30 December 1999;



Considering that the State must guarantee the free and universal access to
health actions and services, with the obligations determined in the law
9.313 of 13 November 1996 to ensure the continuity of the distribution of
medicines needed to treat people living with HIV/Aids;



Considering that Tenofovir is indispensable for the treatment of people
living with Aids and that in Brazil it is recommended as an initial therapy=
,
with a clear trend that its use will increase, with an estimated 31,300
people to use this drug in 2008;



Considering that technical comments were already submitted to the INPI, by
Farmanguinhos/Fiocruz/MoH related to the patent application PI 9811045, tha=
t
demonstrate a lack of inventive step, i.e. the absence of one of the
requirements of patentability needed to grant a patent, according to Articl=
e
8 of the Industrial Property Law;



Considering that for the same reason, the lack of inventive step, the
correspondent to the patent application being analysed by the INPI with the
number PI 9811045 was denied by the North American Patent Office (Patent US
5.935.946) in January 2008;



Considering that the application of a patent to the INPI generates
expectations of monopolistic rights, with impact on the price of the
product; and



Considering that in agreement with the content of the Resolution
132/2006/INPI, Art 3 =93will be analysed in priority, automatically, those
patent applications whose object are included in an act of the Federal
Executive Power that declares National Emergency or Public Interest, in the
hypothesis described in paragraph 1 and 2 of Article 2 of the decree number
3.201 of 6th October 1999=94;

decides:

 Art. 1 To declare of public Interest the antiretroviral medicine Tenofovir
in the view of requesting a priority examination of the patent application
number PI  9811045, filed at the patent office.

 Art 2 This Ministerial Directive is effective from the date of its
publication.

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PS - This is a non official translation of the Directive.

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