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COMPULSORY LICENSE OF PATENTS
AS A WAY OF CONSTITUTIONAL BALANCE BETWEEN
PUBLIC AND PRIVATE INTERESTS
Prof. Milton Lucídio Leão
Barcellos
E-mail: milton@trademarks.com.br
Site: www.trademarks.com.br
Lawyer
and Licensed Patent and Trademark Attorney partner of Leão Intellectual
Property Office. Specialist in International Law at the UFRGS – Federal
University of Rio Grande do Sul. Masters in Law at the PUCRS – Catholic
University of Rio Grande do Sul (2006). PH.D in Course at the PUCRS –
Catholic University of Rio Grande do Sul and Member/Researcher of the Intellectual
Property Research Group of the Pos-Graduation Program in Law at PUCRS. Author
of the books “O sistema Internacional de patentes” (The
international patent system) and “Propriedade Industrial e
Constituição” (Industrial Property and Constitution). IP Courses
Professor in Brazil.
Summary: I – Introduction; II – Again
the Brazilian case of compulsory license (art. 71 of the Brazilian Industrial
Property Law); III –Demystifying the compulsory licensee
application – brief analysis of comparative law; IV – Motivation as an essential element
of public interest compulsory license; V – The control of the administrative
acts and the compulsory license of patents; VI – Conclusions; VII –
Bibliography.
P.S.: This article it was published in 2006 in Portuguese in two
Brazilian Specialized Magazines (ABPI Magazine and Revista Jurídica Magazine)
before the compulsory license of the Efavirenz (Merck) been issued by the
Brazilian President Luiz Inácio Lula da Silva, but the authors opinion still
the same as expressed on this article.
I - INTRODUCTION
Back to Sumary
The present work aims to investigate the
compulsory license institute, according to the article 71 of the Law
9.279/96, analyzing the procedures adopted in the Brazilian case and their
adaptation to the constitutional principles and the national and
international norms prescribed in the Brazilian Industrial Property Law
– BIPL (Law 9.279/96), Paris Convention (Decree n.º 75.572 from 1975
and Decree n.º 635 from 1992 referring to the Revision of Stockholm in 1967)
and the Agreement on Trade-Related Aspects of Intellectual Property Rights
– TRIPS (Decree n.º 1.355, from December 30th 1994) and the Law n.º
9.784/99.
More specifically, the study aims to analyze the Brazilian case involving the
“threat” of compulsory license of drug patents to AIDS treatment,
the conflict/harmony between public and private interests involved, the
procedure used and the duty of justification (material and not just formal)
of the related administrative acts .
Therefore, in this brief work, it is investigated the subject that came back
to the national scene in the first semester of 2005, creating international
repercussion and questions about the rights of intellectual property imposed
by TRIPS, and, by the other hand, the fundamental right of health.
II – ONCE AGAIN THE BRAZILIAN CASE OF
COMPULSORY LICENSE (ART. 71 OF THE BRAZILIAN INDUSTRIAL PROPERTY LAW)
Back to Sumary
The denominated “broken patents”, in
its general context, it is nothing else more than the legal possibility, in
specific cases prescribed by the Paris Convention, Agreement on Trade Related
Aspects of Intellectual Property Rights – TRIPS (in force in Brazil
through the Decree n.º 1.355 from December 30th 1994) and the Brazilian
Industrial Property Law (Law n.º 9.279/96), of establishing a flexibility of
property rights over specific patent, having in mind the reality in which it
is inserted the patent exploration context, imposing the compulsory license
to the patent holder, through the accomplishment of some requirements for
each adopted reason.
The compulsory license system was implanted in Paris Convention through the
Revision of Hague in 1925, substituting the original Paris Convention
projection of the called “obligatory work”, where the inventor
was obliged to work his/her invention in all countries where he obtained the
patent. This substitution, according to Di Blasi, Garcia e Mendes , was the result
of a search of
a more flexible disposal that would attend the national necessities of the
economy, but that would not cause lack of interest to the owner of the
patent.
The utilization of the compulsory license institute, in its different
modalities, it is prescribed in the arts. 68 to 74 of the Law n.º 9.279/96,
and Denis Borges Barbosa , based
on the in
force legal system, divides the compulsory license in the
following modalities:
- License for abuse of rights
- License
for abuse of economic power
- License of dependence
- License based on public interest
- Legal
license that the employee, co-titular of a patent, concedes ex legis
to his/her employer, according to the art. 91 § 2º of the BIPL/96
It is evident that each of the modalities of compulsory
license deserves a deep and detailed analysis, which is not the objective of
the present work, highlighting only the existence of different modalities of
compulsory license application resulting in the restriction of the particular
exercise of the right of property of patents, always searching for the
balance between the public and private interests which are involved. The
present article is focused on the modality of compulsory license based on
public interest, prescribed in the art. 71 of the BIPL.
In this context focused on the compulsory license institute based on public
interest, it is important to highlight the teaching of Denis Borges Barbosa :
“Such principles, which also devire from the clause of the due legal
process included in the Brazilian Constitution, in the balance between two
constitutional requirements – protection of property and social
interest – induce us to,apply the principle of proportionality.
In other words, the public interest must only prevail until the exact
proportion, and not beyond, which is needed to satisfy such interest. It
means that the compulsory license, according to the constitutional models,
cannot exceed the extension, the time limit and the indispensable form to
supply the relevant public interest, or to repress the abuse of patent or
economic power”.
In Brazil, after the Decree n.º 3201 from October 6th,1999 have been used as
an element of constant pressure by the Government, whose pressure was more
intense in 2001, through the Minister for Health in that moment, José Serra , we are living
now, in 2005, by the force of the Decree n.º3201 with the alterations made by
the Decree n.º 4830 from September 4th 2003, a new stage of
negotiating between Brazilian Government and the international laboratories
holders of the drugs patents related AIDS treatment, which resulted in the
recent administrative rule n.º 985 from June 24th 2005, from the Minister for
Health Humberto Costa .
Once more, Brazil
targeted the cannon, but did not shoot against the ships, the threats
resulting in a successful (or not) way of negotiating the reduction of
prices of the drugs that are part of the treatment cocktail for
HIV-infected-patients .
We can say that in the current case, the fuse had been lighted with the
declaration of public interest of the drugs derived from the association of
the active principles Lopinavir and Ritonavir, but, once more, it was not
shot the cannon.
We emphasize that the option of the Brazilian Government in adopting the
compulsory license based on the public interest (art. 71 of the Law 9.279/96)
was clearly done, among other aspects, by the facilitation of the
administrative procedure that such institute have if applied according to the
said norm.
However, by analyzing the mentioned art. 71 , we
can see the competence to grant the compulsory license, after being declared the
public interest by an Act of the Federal Executive Power, would be to the
Federal Executive Power and not to the Brazilian Patent and Trademark Office
– BPTO, since it is an exceptional situation, in which there is the
possibility of granting ex officio, different from the other cases prescribed in
the BIPL where it is stated that is needed a specific administrative process
which will happen along the Federal Bureau .
It is a logical-systematic conclusion analyzing the caput of the
art. 73 where it is stated “an application of a compulsory
license”, in order to become incompatible to the art. 71 where it is
stated “ex
office concession”.
Nevertheless, after the concession of the compulsory license as it is
prescribed in the art. 71, it is possible for the titular of the patent to
discuss administrative or judicially all aspects of this drastic form of
intervention in the private domain, such as the real public interest, time of
license, royalties, and other aspects.
It is important to have in mind that if the ex office license is based on public
interest, this license must be limited to the accomplishment of the public
interest, otherwise it would exceed the fundament of the license.
We cannot forget that, in the Brazilian case, we are talking about the drugs
for the AIDS treatment and it involves the fundamental right of health.
It is clear that we are talking about the fundamental right of health and it
would be, in this case and if it is confirmed what is said by the Government,
an emergency, because, according to the Government allegations, the
assistance program developed to support the patients with HIV with drugs
cocktail would be in danger if it was not renegotiated the price and the
access to the medicines mentioned.
A simple reading in the art. 1.º, III and the art. 4.º, II from the Brazilian
Constitution/1988 is enough to make us understand which rights must prevail
in a eventual conflict of principles in a case hereunder. However, an
isolated interpretation and without symmetry of the art. 5.º, XXIX, 170, 196,
197, 218 and 219 of the Federal Constitution from 1988 could result in the
huge mistake proposed by the Deputy Roberto Gouveia through the Project of
Law n.º 22/03 which includes the invention of medicines to prevent and treat
AIDS and its obtaining process as a non-patentable subject.
The PL n.º 22/03 represents an retrocession relating to the conciliatory
evolutions expressed by TRIPS (although the commercial intends, it adopted
the compulsory license as a counterbalance in order to balance the public and
private interests), where it exists a disposal fully accepted that Brazil would
consider to be patent every intellectual inventions with the three basic
requirements . If such Project
of Law is approved and effectively realized by law, besides the conflict of
this alteration of the Brazilian Industrial Property Law with the TRIPS, we
will be seen abroad as a country that do not respect international
agreements, causing serious damages to futures investments and international
relations.
On the other hand, the use of correct procedure for the compulsory license
will surely increase Brazil
qualities as a country that respect international agreements, but it is not
submissive to the commercial pressures imposed by developed countries and
their nationals . The little used
institute of compulsory license represents a legal disposal for Brazil to
make use what is stated in the art. 196 of the Federal Constitution/1988
without violating the national and international legislation.
Therefore, understanding that the Brazilian constitutional system applicable
to the specific of patents, especially what is stated in the art. 5.º, XXIX
of the Constitution/1988, adopted a mix of preponderance and combination of
the called utility and social plan theories , in
relation to a minor influence of the work and personality theories, it
remains clear that the institute of compulsory license is very welcome to
Brazilian legal system.
The big problem to be solved in each case hereunder is up to which point
could the momentary preponderance of the social plan theory be effective
without injuring the benefits of the utility theory as an incentive for new
medical solutions?
In other words, in which way, how long and by means of paying for which price
could we consider already accomplished the indirect public interest (and not
just the immediate public interest in the access to the drugs), consistent of
efficient stimulation for the development of new drugs?
We must always be careful and treat every people as citizens, and also
observe what Marc Nerfin says: Neither prince nor
merchant: citizen.
III – DEMYSTIFYING THE COMPULSORY
LICENSE APPLICATION – BRIEF ANALYSIS OF COMPARATIVE LAW
Back to Sumary
Different from what a great number of people
think, the compulsory license institute is not an intention projected only by
the developing countries, being far away from being considered an institute
that goes against the technological and economical development when applied
according to the legal system.
According to the Consumer Project of Technology (http://www.cptech.org/), we
have learned that several countries make usage or intend to make usage of the
compulsory license in their national context .
In addition to the mentioned cases, the USA Government, through its Justice
Department, have already used managing and legal demands to impose to big
companies the compulsory license of some technologies protected by patents to
others competitors.
In one of the mentioned examples, the General Lawyer Assistant of the
Antitrust Division of the Justice Department Anne K. Bingaman, said in her
lecture at the Law School of Kansas University in 1996 , the case of United States vs. S.C.
Johnson & Son, Inc. & Bayer A.G, in which it is
determined a compulsory license for the others competitors to use the
technology comprised in a new ingredient of insecticides .
There are other specific cases in United States of America, such as
the case Crater Corporation v. Lucent Technologies from June
6th 2001 (Decision by the US Court of Appeals for the Federal Circuit, in the
Crater Corporation V. Lucent Technologies. Docket No. 00-1125), in which the
company Lucent Technologies alleged that their production, which would be
violating the Crater Corporation patent, was ordered and authorized by the US
Government and it was made based on the § 1498(a). The Appealing Court of the
USA Federal Circuit accepted Lucent theory recognizing that it did not exist
the violation of the Crater Corporation patent, based on the § 1498(a) which
allows the use of the patent by the Government or for the Government (it
allows that third parties produce products object of patents for the
Government) without negotiating or obtaining a license from the owner of the patents
rights .
We should add the comments of the Prof. Benjamin Coriat, Professor of
Economics of the University of Paris, referring to the case of the use of
compulsory license by USA, just after September 11, 2001, in the case of the
threat anthrax attack :
“(...) The situation seems to be all the more untenable seeing as
during the post-September 2001 anthrax attacks, the United States did not
hesitate to trigger compulsory licensing clauses and pass orders to their
pharmaceutical firms for tens of millions of units of a medicine that was
covered by a patent belonging to the Bayer Company, which was forced to agree
to drastic cuts in its sales price. In these sorts of conditions and still
within the framework of the same type of problem, how long can we keep the
countries of the Third World from using
competitive mechanisms to ensure their procurement in ARVs?”
We conclude that the compulsory license is not a Brazilian or a developing country
solution, but it is an instrument to keep the balance between the rights of
property of patents and the others public interests involved , where all
managing or legal acts/decision must be linked to a duty of motivation.
IV –
MOTIVATION AS AN ESSENTIAL ELEMENT OF PUBLIC INTEREST COMPULSORY LICENSE
Back to Sumary
The art. 50 of the Law 9.784/99 is clear in
requiring motivation for the administrative acts as an essential element for
its validity , highlighting
that in its first paragraph, that “motivation must be explicit, clear
and congruent”.
Such observation related to the application of the art. 50 of the Law
9.784/99 in the case of compulsory license based on public interest was done
by Prof. Dr. Juarez Freitas in a meeting of PUCRS’ Group of Research in
Intellectual Property when it was discussed the subject “Compulsory
License and the fundamental right of health” on 07/07/2005.
Prof. Dr. Juarez Freitas says that “When said in another way, it is
important to understand that motivating, in our context, has become, since
the advent of the Fundamental Text, a duty of radial reach, requiring an
explicit reasonability of the administrative acts lato sensu, acquainted with
other requirements linked to the fundamental guarantees of the due process of
law” .
Such considerations lead us to analyze the motivation exposed in the
Administrative Rule n.º 982 by the Ministry for Health on 06/24/2005, in
order to analyze if it has enough material establishment to attend the duty
imposed by the art. 50 of the Law 9.784/99.
We verify the referred Administrative Rule in some points of its
establishment, has important arguments, but with no reference to the
scientific basis that sustain them.
The Administrative Rule mentions, for instance, “the historical of the
prices charged in the referred medicine and the expressive increase of the
amount acquired, without a correspondent price reduction” as one of the
establishments of the declaration of public interest. However, it does not
give us clear subsidies for an interpretation/verification about what is
said, that means, this Administrative Rule should be supplemented with concrete
data of paid values and acquired quantity year by year to correctly fulfill
the requirements of the art. 50 § 1º of the Law 9.784/99 regarding to its
statement.
It is important to emphasize that, once more, in the recent case involving
the active principles Lopinavir and Ritonavir from Abbott Laboratory, it was
not declared the application of the compulsory license, so as to the arsenal
prepared by the Government (negotiations, threats, publication of the
Administrative Rule) had been good and valid (or not, according to the
interpretation of the “advantage” obtained) to the negotiations
of the medicines composed by the active principles mentioned.
According to Bruce A. Lehman ,
quoting a research Sarah Boseley, in 2002, malaria and tuberculosis kill,
respectively, 1,5 million and 2 million of people every year, while AIDS is
killing 3 million every year, and mostly of these deaths are concentrated in
Africa (2,3 million of death/year of HIV/AIDS just in Africa).
Such statistics, probably also available in Brazilian context, must be part
of the motivation, whether it is to fundament the recognition of public
interest of some medicine, or it is to justify the importance of a system of
patents that intends to reduce death related to some disease whose research
have been developed because the financial returns assured by patents.
In recent studies developed in Modern Legal Hermeneutics class of
PUCRS’ Master Degree, it is important to remind the observations of
Prof. Juarez Freitas referring to Chaïm Perlemnan’s text, that is to
say, according to him, a rule is not arbitrary in itself, becoming arbitrary
only if it remains unjustified .
If it is not provided the preventive and obligatory material motivation (and
not just formal), it is clear that the act practiced will be reviewed,
according to Prof. Juarez Freitas, in their demerit.
V – THE CONTROL OF THE ADMINISTRATIVE ACTS AND THE
COMPULSORY LICENSE OF PATENTS
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Aulis Aarnio brings
to us excellent subsidies to understand, in the present case, where the focus
of the administrative acts control must be situated:
“Understanding as a dialog, the juridical justification that uses
public reasons cannot be based on manipulations. The principles of juridical
certainty does not allow that the final choice among the alternative
interpretations be only the result of the persuasive use of the power. A good
justified dialog always follows a rational argumentation. The point is to
convince the other and not to manipulate. Why? Because all idea of what is
Law is deeply linked to our expectative related to the conduct prescribed by
the authorities. The arbitrariness and the blind decisions are alien to the
European conception about Law and justice.
It does not mean that each particular case has just one right answer. On the
contrary, the idea of the rational juridical argumentation just supposes that
the decisions are well motivated. Our expectative is just for << the
best justification >>, not for correct solutions”.
There is no doubt that the compulsory license based on public interest is
granted by an act from the Federal Executive Power (art. 71 – Law
9.279/96), so that such acts are subjected to administrative and judicial
control regarding to their syntony before the principles and the fundamental
rights.
In what concerns to the judicial control of the administrative acts it is
important to say that the application of the law in the case hereunder
concerns to the “Judges” (although Hart mention
“Courts”), being important to reproduce what H. L. A Hart says: “On
the other hand, predictions of judicial decisions have undeniably an
important place in the law. When the of open texture is reached, very often
all we can profitably offer in answer to the question ‘What is the law
on this matter?’ is a guarded prediction of what the courts will do.
More over, even where what the rules require is clear to all, the statement
of it may often be made in the form of a prediction of the courts’
decision”.
Therefore, any act of the Federal Executive Power that recognizes or declares
ex officio
the compulsory license of specific patent(s) can be re-analyzed by the
Judiciary, according to the exposed in art. 5, XXXV of the Brazilian
Constitution from 1988, what it is not news for any researcher of Legal and
Social Sciences.
However, it remains the questions about the capacity of interference of the
legal decisions in the administrative acts, in our opinion being perfectly
possible for Judiciary to analyze questions referring to the motivation of
the administrative acts.
In order to understand the application of the administrative acts in the case
of compulsory license we must primarily understand what has been elaborated
in the item II herein, concerning to the constitutional perspective of the
patents rights, and then, analyze the case hereunder and its adaptation, in
other aspects, to the principle of proportionality.
Furthermore, according to Prof. Juarez Freitas, when it comes to the Principle of
proportionality and the stopping of unfair sacrifices, if for excess
(abuses), if for inoperative in the accomplishment of the claimed state duty, the public administrator “is obliged to
sacrifice the minimum to preserve the maximum rights”, in order that
“the violation of proportionality happens when, having two legitimate
values to balance, the administrator gives priority to one instead of another
or even to an exaggerated sacrifice of this one ”.
Bringing such lessons to the case of compulsory license based on public interest,
as an example, we have that the stipulation through an Administrative Act of
a too long period or a price too low as royalties not based on an enough
material motivation would produce “unfair sacrifices” for excess
or abuse relating the rights of property of determined patent.
Yet, it is also possible the existence of “unfair sacrifices” for
“inoperative execution of the liabilities State
duty” , so that an eventual passivity of the State before specific cases
that demand and effective actuation can cause a violation of the
proportionality principle (adjustment, necessity and proportionality in
strict sense) as well.
In fact, even the exceed and the inoperative are injuring to the public
interest, so that the state entity must be alert to their obligations and
limits of intervention in the rights of property of patents.
Back to Sumary
We have at disposal a legal instrument of balance
between the rights of patent’s property and public interest and it
should be used in our national context. However, this statement does not mean
that the compulsory license must become banal, because such generalization
would go against the own public interest, compromising all system of patents
that needs the balance between public and private interests.
In sum, we can say that, in the recent case involving Abbott Laboratories,
presuming (it did not happened) the inexistence of the agreement, the threat
of compulsory license based on public interest would be legitimate if it
observes, among other aspects, the duty of material motivation and if the
period, conditions and price to be paid for the license were respecting the
material motivation adopted, in order to repair the conflict of rights.
Therefore, analyzing cases like this, which involves compulsory license based
on public interest, we must pay attention to the observations of Marcelo Alves that “the
most important weapons to prevent and combat epidemics are, those always
claimed by Greeks to consolidate the politic life: knowledge and cooperation
(or complicity) among men. And the cooperation, or complicity, request
reciprocal trustful, and in order the trustful between men grows it is
requested that the justice reigns”.
Back to Sumary
_________. Acordo mantém patente de droga anti-Aids, Folha de São Paulo de
09/07/2005.
AARNIO,
Aulis. Tradução de Josep Aguiló Regla. Sobre la justificación de las
decisiones jurídicas - La tesis de la única respuesta correcta y el principio
regulativo del razonamiento jurídico.
ALVES,
Marcelo. O lugar do Direito na Política in Direito e Política. Rogério Dultra
dos Santos (Org.), Editora Síntese, Porto Alegre, 2004
BARBOSA,
Denis Borges. Uma Introdução à Propriedade Intelectual, 2a. Edição,
Ed. Lumen Juris, 2003.
CORIAT, Benjamin. The New Global Intellectual
Property Rights Regime and Its Imperial Dimension – Implications for
“North-South” Relations. Artigo preparado para o Seminário de 50 anos de aniversário do BNDS,
Rio de Janeiro, Brasil, setembro de 2002.
DI
BLASI, Clésio Gabriel. GARCIA, Mario Augusto Soerensen. MENDES, Paulo Parente
Marques. A propriedade industrial. Ed. Forense, Rio de Janeiro, 1997.
FISHER, William. Theories of Intellectual
Property in Stephen Munzer, ed., New Essays in the Legal and Political Theory
of Property. Cambridge
University Press, 2001.
FREITAS,
Juarez. O controle dos atos administrativos e os princípios fundamentais. Ed.
Malheiros, 3.ª edição, São Paulo:
2004.
HART, H.L.A The Concept of Law, 2.ª Edição, Oxford University Press, 1994.
LEHMAN, Bruce A. Intellectual Property and
Compulsory Licensing: Pharmaceuticals and the Developing World. Artigo apresentado na 12.ª Conferência
Anual sobre Direito e Política da Propriedade Intelectual Internacional,
Abril de 2004, Nova Iorque, Estados Unidos da América.
NERFIN, Marc. Neither Prince nor Merchant:
Citizen – An Introduction to the Third System (IFDA Dossier nº 56 p.
3-29 reproduzido em
Development Dialogue, 1987, nº 1).
PERELMAN,
Chaïm. Ética e Direito. São Paulo: Martins Fontes, 1996.
DI BLASI,
Clésio Gabriel. GARCIA, Mario Augusto Soerensen. MENDES, Paulo Parente
Marques. A propriedade industrial. Ed. Forense, Rio de Janeiro, 1997, p. 42.
Free translation of the author.
BARBOSA, Denis Borges. Uma Introdução à
Propriedade Intelectual, 2a. Edição, Ed. Lumen Juris, 2003, p. 501
BARBOSA, Denis Borges. Uma Introdução à
Propriedade Intelectual, 2a. Edição, Ed. Lumen Juris, 2003, p. 501. Free
translation of the author.
He was
responsible by the “intention” because the institute was not
effectively used; it was used just like a “threat” that resulted
in a decrease of the prices charged as royalties of the drugs protected by
patents.
The
administrative rule n.º 985 from June 24th 2005: “Declares for the
reason of social sustainability of the Brazilian program to combat AIDS,
public interest related to the medicines that comes from the association of
the active principles Lopinavir and Ritonavir, to compound the list of
inhibitors of protease that must compound the therapeutically arsenal to the
treatment of the infection of HIV/AIDS in Brazil”.
According
to the news from Folha de São Paulo Newspaper from September 7th, 2005
entitled “Agreement maintains patent of anti-aids drug”, there
was an agreement between the Abbott Company and the Brazilian Government to
reduce the price of the medicine, in order to promote an increase number of the
patients being treated, and it was arranged the transfer of the future
technology to produce the drugs when the duration of the patent is closed.
Law
9.279/96 – Art. 71.
In cases of national emergency or public interest,
declared in an act of the Federal Executive Authorities, insofar as the
patentee or his licensee does not meet such necessity, a temporary ex officio
non-exclusive compulsory license for the exploitation of the patent may be
granted, without prejudice to the rights of the respective patentee.
Sole Paragraph. The act of grant of the license will establish its term of
validity and the possibility of extension.
Law
9.279/96 - Art. 73. An application for a compulsory license must be
formulated by indicating the conditions offered to the patentee.
§ 1o Once the application for a license has been presented, the
patentee will be notified to respond within a period of 60 (sixty) days, at
the end of which, in the absence of a response from the patentee, the
proposal will be considered as accepted under the conditions offered.
§ 2oAn applicant for a license who alleges abuse of patent rights or
abuse of economic power must file documentary proof.
§ 3o If a compulsory license is requested on the basis of lack of
exploitation, it will rest with the patentee to prove exploitation.
§ 4o If there is a contestation, INPI may take the necessary steps,
including the establishment of a committee that may include specialists that
are not part of INPI, with a view to arbitrating the remuneration that will
be paid to the patentee.
§ 5o The organs and entities of the direct or indirect, federal, state
and municipal public administration will provide INPI with such information
as it is requested with a view to assisting the arbitration of remuneration.
§ 6o In arbitrating remuneration, the circumstances of each case will
be considered, taking into account obligatorily the economic value of the
license granted.
§ 7o Once the process is duly filed, INPI will come to a decision
regarding the grant and the conditions of the compulsory license within a
period of 60 (sixty) days.
§ 8o Appeals against decisions granting a compulsory license will not
have suspensive effects.
Art.
27.1 TRIPS - Without injury of the disposed in the paragraphs 2 and 3 below,
any invention, product or process, in every field of technology, can be
object of patent, since it is new, involves a inventive degree and can be
applied in the industry. Without injury of the disposal in the paragraph 4 of
the Article 65, paragraph 8 of the Article 70 and paragraph 3 of this
Article, patents will be available and the rights of patents will be used
without discrimination of local of the invention, field of technology and the
facts of the products be imported or produced in the local.
I mean commercial pressures because effectively TRIPS represents a
international legislative point of the direct relation between intellectual
property and commerce.
This observation is done specifically to the system of patents,
according to the interpretation realized by Prof. William Fisher analyzing
the four theories of intellectual property: Work Theory, Utility Theory,
Personality Theory and Social Plan Theory, which can be studied in FISHER,
William. Theories
of Intellectual Property in Stephen Munzer, ed., New Essays in the Legal
and Political Theory of Property. Cambridge University
Press, 2001. Accessed in April 20th, 2005 in http://www.law.harvard.edu/Academic_Affairs/coursepages/tfisher/.
NERFIN, Marc. Neither Prince nor Merchant: Citizen – An
Introduction to the Third System (IFDA Dossier nº 56 p. 3-29 reproduced in
Development Dialogue, 1987, nº 1).
In http://www.cptech.org/ip/health/cl/recent-examples.html that is
many examples of Countries such as USA, Germany, Korea, South África, Malasya
between other Countries that are using the compulsory license according to
the TRIPS and domestic rules.
Acessed in http://www.usdoj.gov/atr/public/speeches/960919ks.htm in
July 2nd, 2005.
"United
States v. S.C. Johnson & Son, Inc. & Bayer A.G. is a
case in which, we alleged that a patent license agreement between the
defendants violated Section 1 of the Sherman Act. Johnson dominated the
highly concentrated U.S.
household insecticide market. Bayer developed and patented a new active
ingredient for household insecticides and prepared to enter the U.S. market
with its own product. It then abandoned its plans and granted a license for
its active ingredient to Johnson. It did not license any other U.S.
manufacturer. The case was settled by consent decree, which in part requires
Bayer to license its ingredient to other interested parties for the United States."
28 USC 1498 - (a) Whenever an
invention described in and covered by a patent of the United States is used
or manufactured by or for the United States without license of the owner
thereof or lawful right to use or manufacture the same, the owner’s
remedy shall be by action against the United States in the United States
Court of Federal Claims for the recovery of his reasonable and entire
compensation for such use and manufacture. Reasonable and entire compensation
shall include the owner’s reasonable costs, including reasonable fees
for expert witnesses and attorneys, in pursuing the action if the owner is an
independent inventor, a nonprofit organization, or an entity that had no more
than 500 employees at any time during the 5-year period preceding the use or
manufacture of the patented invention by or for the United States.
Nothwithstanding [1] the
preceding sentences, unless the action has been pending for more than 10
years from the time of filing to the time that the owner applies for such
costs and fees, reasonable and entire compensation shall not include such
costs and fees if the court finds that the position of the United States was
substantially justified or that special circumstances make an award unjust.
For the purposes of this section, the use or manufacture of an invention
described in and covered by a patent of the United
States by a contractor, a subcontractor, or any person,
firm, or corporation for the Government and with the authorization or consent
of the Government, shall be construed as use or manufacture for the United States.
CORIAT, Benjamin. The New Global Intellectual Property Rights Regime
and Its Imperial Dimension – Implications for “North-South”
Relations. Article prepared for the Seminar of 50 years of the BNDS, Rio de Janeiro, Brazil, September 2002.
In this affirmation, we understand the ample concept of “public
interests”, such as for abuse of rights, abuse of economic power,
dependence and public interest in the strict sense.
Art. 50. The administrative acts must be motivated, indicating the
facts and juridical fundaments, when:
I – deny, limit or affect rights or interests; II – impose or
intensify duties, responsibilities or sanctions; (…); VI – comes
from reexamine ex
office; VII – stop applying jurisprudence about this
question or do not agree with opinion, expert report, official report; VIII
– convert in annulations, revocations, suspensions or ratifications of
administrative acts.
§ 1º The motivation must be explicit, clear and congruent, it can consist in
declarations of agreement with fundaments of anterior reports, information,
decisions or propositions, which, in this case, will be part of the
act.
§ 2º In the solution of different cases related to the same subject, it can
be use a mechanic way that reproduce the fundaments of the decisions, since
it does not injure right or guaranty of the interested.
§ 3º The motivation of the decisions of the commissions or oral decisions
will have the respective minute or written report.
FREITAS, Juarez. O
controle dos atos administrativos e os princípios fundamentais. Ed.
Malheiros, 3.ª edição, São Paulo:
2004, p. 261. Free translation of the author.
LEHMAN, Bruce A. Intellectual Property and Compulsory Licensing:
Pharmaceuticals and the Developing World. Article presented in the 12.ª
Annual Conference about Politics and Rights of International Intellectual
Property, April 2004, New York,
United States of America,
http://www.consor.com/editor/docs.
PERELMAN, Chaïm. Ética
e Direito. São Paulo: Martins Fontes, 1996, p. 60.
AARNIO, Aulis.
Translation of Josep Aguiló Regla. Sobre la justificación de las decisiones
jurídicas - La tesis de la única respuesta correcta y el principio regulativo
del razonamiento jurídico. P. 30 e 31. Free translation of the author.
HART, H.L.A The Concept of Law, 2.ª Edição, Oxford University
Press, 1994, p. 147.
FREITAS, Juarez. O
controle dos atos administrativos e os princípios fundamentais. Ed.
Malheiros, 3.ª Edição, São Paulo,
2004, p. 38. Free translation of the author.
Bringing the question to the compulsory license based on public
interest in stric
sense (art. 71 of the Law 9.279/96), we have that, if it was
proved the missing budget to acquire medicines, the perspective of the
increasing number of people portable of the HIV/AIDS in Brazil, the real
increase of medicines that will be necessary to acquire in the future and not
foreseeing the reduction of the prices of the medicines, and other facts, the
State could be responsible for not provide its duty of act (inoperative) if
it does not try all ways, in the legality, to accomplish what is stated in
the art. 196 of the Federal Constitution from 1988 and the Law 9.313/96.
ALVES, Marcelo. O lugar
do Direito na Política in Direito e Política. Rogério Dultra dos Santos (Org.),
Editora Síntese, Porto Alegre, 2004, p. 34/35. Free translation of the
author.
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