Source: http://iptango.blogspot.com/2015/10/brazilian-politicians-will-vote-for-new.html
Timestamp: 2017-01-24 11:16:34
Document Index: 289428647

Matched Legal Cases: ['art. 40', 'art. 4', 'art. 5', 'art. 13', 'art. 14', 'art.\n43', 'Art. 42']

IP tango: Brazilian Politicians will vote for new Pharma Laws
Brazilian Politicians will vote for new Pharma Laws
Last month IP Tango was delighted to host a guest post from our Brazilian friend Magda Voltolini, on the topic of sham litigation. Now we are pleased to welcome her back with her perspective on the chances of Brazil applying the flexibilities of the Doha Declaration. This is what she writes:
Are Brazilian politicians applying the
flexibilities on the basis of the Doha Declaration? The Brazilian National Congress is apparently
ready to reform Law N. 9279 of 14 May 1996 (Law 9279/96) regulating rights and
obligations relating to industrial property. In fact, the Committee on Constitution,
Justice and Citizenship (CCJC) will soon vote Bill N. 139 of 2 February 1999 (Bill139/99) and its annexes, which aim at modifying the provisions concerning rights
awarded by the patent and conditions that grant compulsory licenses including
those relating to pharmaceutical products and processes.
On 17 September Deputy Andre
Moura, Rapporteur of the Bill 139/99 voted to amend Law 9279/96
repealing the sole paragraph of art. 40, altering arts. 10, 13, 14, 31, 43, 68,
195 and 229-C and adding arts. 31-A and 43-A to art. 4 of the Law 9279/96. However, the Brazilian Fine Chemicals,
Biotechnology and Specialty Industries Association (Abifina) and the
Pharmaceutical Research Industry Association (Interfarma) support opposite
views. If the proposed Bill passes, Abifina ideas will prevail and the
Brazilian generic industry will certainly benefit from the new law.
For instance, the proposed Bill is also expanding
the grounds of Government non-commercial use of patents and patent applications
on the basis of public interest. In its article 43.A(6), it forbids the
Judiciary Branch to decide on matters concerning whether the objectives of
public interest were established to justify the Government authorization of the
non-commercial use of the object of a pharmaceutical patent or patent
application. However, as a fundamental right and guarantee, the Brazilian Constitution stipulates that “the law shall not exclude any injury or
threat to a right from the consideration of the Judicial Power”. (art. 5, XXXV)
The table below illustrates a snapshot of
the changes proposed by Bill 139/99 amending Law 9279/96.
Law 9279/96
Bill 139/99
40. An invention patent shall remain in
force for a period of 20 (twenty) years, and a utility model patent for a
period of 15 (fifteen) years from the date of filing. Sole Paragraph. The term shall not be
less than 10 (ten) years for an invention patent and 7 (seven) years for a
utility model patent, beginning on the date of granting, unless the INPI has
been prevented from examining the merits of the application by a proven
pending judicial dispute or for reasons of force fmajeure. 10. The following are not considered to
be inventions or utility models: I. discoveries, scientific theories, and
X. any new property or new use of a known
substance or mere use of a known process, unless such known process results
in a new product;
XI. new forms of known substances, which
do not result in the enhancement of the known efficacy of the substance.
Single paragraph. For the purposes of
this article, salts, esters, ethers, polymorphs, metabolites, pure form,
particle size, isomers, mixtures of isomers, complexes, combinations, and
other known substance derivatives should be regarded as the same substance,
unless they differ significantly in properties as regards efficacy. (NR)
13. An invention is endowed with
inventive step provided that, to a technician versed in the subject, it is
not derived in an evident or obvious way from the state of the art. 13. An invention is endowed with inventive step
provided that, to a person skilled in the art, it is not derived in an evident
or obvious way from the state of the art, and since it represents a
significant technical improvement over the state of the art. (NR) 14. A utility model is endowed with
inventive act provided that, to a technician versed in the subject, it is not
derived in a common or ordinary way from the state of the art. 14. A utility model is endowed with
inventive act provided that, to a person skilled in the art, it is not
derived in a common or usual manner from the state of the art, and since it
represents a technical improvement over the state of the art. (NR) 31. After publication of the application
and up to the end of the examination, interested parties may submit documents
and data to assist the examination. Sole Paragraph. The examination shall not
begin before 60 (sixty) days from the publication of the application. 31. After publication of the patent
application and up to the end of the examination, any person may submit an
opposition. (1) The applicant will be notified of the
opposition, through publication in the official gazette, and may respond
within sixty (60) days from the publication date of the opposition.
(2) In cases where an opposition to a
patent application has been submitted, INPI is allowed to request technical
opinions from the Public Administration, organizations recognized by the
Government as consultation bodies and members of the faculty and students of
higher education universities. (3) After a complaint is filed, the
examiner may, on the basis of a grounded requirement, request any further
clarification as it deems necessary, as well as the submission of additional
(4) The examiner must necessarily give an
opinion on every filed opposition, indicating the reasons why it accepts or
rejects the information there presented ...................................
43. The provisions of the previous
Article do not apply:
IV. to a product manufactured in
accordance with a process or product patent that has been introduced onto the
domestic market directly by the patentholder or with his consent; 43. .................................................................................
...................................................................... IV. to a product manufactured in accordance with
a process or product patent that has been introduced to the domestic or international
market directly by the patent holder or with his consent;
68. The titleholder shall be subject to
having the patent licensed on a compulsory basis if he exercises his rights
derived therefrom in an abusive manner, or by means thereof engages in abuse
of economic power, proven pursuant to law in an administrative or judicial
decision. (1) The following also occasion a
compulsory license: I. non-exploitation of the object of the
patent within the Brazilian territory for failure to manufacture or
incomplete manufacture of the product, or also failure to make full use of
the patented process, except cases where this is not economically feasible, when
importation shall be permitted; or II. commercialization that does not
satisfy the needs of the market (2) A license may be requested only by a
person having a legitimate interest and having technical and economic
capacity to effectively exploit the object of the patent, that shall be
destined predominantly for the domestic market, in which case the exception
contained in Item I of the previous Paragraph shall be extinguished. 68.
............................. (1) ......................... I. non-exploitation of the object of the
incomplete manufacture of the product, or also failure to make full use of a patented process; or
(2) A license may be requested only by a
destined predominantly for the domestic market. 195. A crime of unfair competition is
perpetrated by anyone who: .............................................................................
XIV. divulges, exploits, or utilizes,
without authorization, results of tests or other undisclosed data whose
preparation involves considerable effort and that were submitted to
government agencies as a condition for obtaining approval to commercialize
products. Penalty—imprisonment, for 3 (three)
months to 1 (one) year, or a fine. 195. ...........................................................................
(3) The provisions of item XIV do not
apply to the use of results of tests or other undisclosed data, by government
agencies, for marketing approval of equivalent products to the product for
which they were originally presented.
229. The provisions of this Law shall
apply to pending applications, except as regards patentability of substances,
materials or products obtained by chemical means or processes, and alimentary
or chemical-pharmaceutical substances, materials, mixtures or products, and
medications of any kind, as well as the respective processes for obtaining or
modifying them, which shall only be privileged under the conditions
established in Articles 230 and 231. 229-C. The granting of patents for pharmaceutical
products and processes shall depend on the prior consent of the National
Health Surveillance Agency - ANVISA, which shall examine the object of the
patent application in the light of public health.
(1) It is considered that the patent is
contrary to public health, according to regulation, when:
I. a product or pharmaceutical process
contained in the patent application presents a risk to health; or
II. an application for a product patent
or pharmaceutical process is of interest to medicines or pharmaceutical care
policies within the Unified Health System - SUS
and does not meet the patentability
requirements and other criteria established by this law
(2) Following the examination of prior
consent and published the result, Anvisa shall return the request to the INPI, which shall carry out the
technical examination of the approved application and shall shelve
permanently the non-approved applications.
4. The provisions of treaties in force in
Brazil are equally applicable to natural and legal persons who are nationals
of or domiciled in this country. 31-A. The INPI must offer intuitive
electronic channel, easily accessible, interconnected to the global computer
network, wherewith anyone can, free of charge, present evidence or proof of
previous existence, in Brazil or abroad, of the claimed invention or state of
Single paragraph. Even after the possible
grant of the patent, and especially during the process of opposition and
administrative nullity proceedings, it is authorized the submission of
evidence or proof of previous existence, in Brazil or abroad, of the claimed
invention or state of art.
43-A. The Government, through an Ordinance
of the Ministry of State concerned, may make non-commercial use of the object
of patents or patent applications without the consent or authorization of the
patent holder or the patent applicant, directly or by hiring or by
authorization to third parties for the purposes of public interest, including
those of national defense and social interest. (1) If the invention is a process, the
public non-commercial use of the patent or patent application will cover the
use in connection with any product that can be obtained by the process that
is protected object by the patent or
(2) The Government shall notify the
holder of the patent or patent application when making non-commercial use;
(3) The non-commercial public use will
I. it will not prevent the full exercise
of other rights of the holder of the patent or patent application;
II. it will not be exclusive,
sublicensing not being permitted; III. it will be made exclusively to meet
the objectives of the Ordinance that authorized the use, being forbidden any
other use, not related to the non-commercial public use,
matter contrary to Art. 42 of this Law;
(4) The remuneration for non-commercial
public use, which will be fixed by the Government according to the circumstances
of each case, take into account the percentage that could be routinely
determined in a voluntary license between independent parties, applied to the
cost for the Government resulting from the use of the object of the patent or
patent application and weighted by the contribution made by the holder in the
transfer of technology of manufacturing or employment;
(5) In the case of patent applications,
the amount of compensation will be deposited in escrow until the grant of the
(6) The Judicial Branch is forbidden in
the case of public non-commercial use to decide whether the purposes related
to the general interest are established;
(7) Non-commercial public use will not be
suspended, limited or interrupted by a judicial dispute concerning the fixed remuneration.