Brasil se encuentra cerca a aprobar varias reformas a su ley de patentes, ajustadas al ADPIC, con el fin de asegurar la competencia y garantizar el acceso a medicamentos.
La Ley que propone Brasil se ajusta a los tratados multilaterales y permitirá el uso pleno de las salvaguardas del ADPIC, por ejemplo:
- Limita la vigencia de la patente a 20 años
- Aclara que no se otorgarán patentes de segundos usos o nuevas formas de sustancias conocidas
- Incrementa el estándar de altura inventiva para evitar las patentes incrementales, que no significan avances mas allá del estado del arte
- Crea un sistema efectivo y amplio para las oposiciones de patentes
- Aclara que la protección de datos de prueba no impide su uso para el registro de productos de competencias
- Actualiza el sistema de anuencia previa de la autoridad de medicamentos cuando se trata de solicitudes de patentes de medicamentos
- Incorpora el uso de una patente para fines públicos no comerciales.
Firmar la carta: escribir a
Professor Brook K. Baker: b.baker@neu.edu
incluyendo la siguiente información:
Nombre
Afiliación institucional
País
aclarar si se firma solo la carta, solo el informe técnico o se firma la carta y el informe técnico.
Pueden hacerlo cargando los datos en la web
http://infojustice.org/support-brazilfirmar preferentemente antes del 10 de julio
Carta de académicos
Open Letter from Global Academics in Support of Proposal to Amend
Brazil’s Patent Law to Take Advantage of TRIPS-compliant Flexibilities
July
10, 2013
We are legal, intellectual property, trade, development, human rights,
and other academics and legal experts who are writing in support of the
proposed changes to Brazil’s patent law recently released by the Brazilian
government and recommended in a report by the Brazilian House of
Representative, Center for Strategic Studies and Debates, titled Brazil’s Patent Reform: Innovation Towards National Competitiveness.[1]
The draft law and report propose amending Brazil’s existing patent law to take
greater advantage of policy options (aka “flexibilities”) that are permitted by
the World Trade Organization’s agreement on Trade Related Aspects of
Intellectual Property Rights and that would promote access to affordable
medicine in Brazil as well as adherence to Brazil’s national and international
human rights obligations. As documented the attached Technical Review, in our
judgment each of the described reforms is both TRIPS compliant and desirable in
light of Brazil’s human rights obligations and public health goals and in light
of its goal of increasing its technological and innovation capacity and
self-reliance with respect to knowledge goods.
Bill no. H.R. 5402/2013[2] proposes the
following substantive amendments to the Brazil Patent Act, Law no. 9279, of May
14, 1996:
a) limits the
patent term at 20 years maximum, as authorized by Article 33 of the TRIPS
Agreement (see Article 2, revoking Patent Act Art. 40, sole §);
b) clarifies
subject matter that is not considered inventive particularly new use patents
and patents on new forms of known substances, as allowed by TRIPS Articles 1.1,
7, 8, 27.1 and 27.3(a) and along the lines of Section 3(d) of the India Amended
Patents Act 2005 (see Article 3, amending Patent Act Art. 10);
c) increases the
standard of inventive step, as allowed by TRIPS Articles 1.1, 7, 8, and 27.1
and along the lines of the India Amended Patents 2005, to require a
“significant technical advance in regards to the state of the art” in order to
heighten the standard for incremental innovation and to discourage
ever-greening (see Article 3, adding Patent Act Art. 13 [with respect to
patents] and 14 [with respect to utility models]);
d) creates a
full-fledged pre-grant opposition mechanism, including provision for electronic
submission of evidence of related inventions and prior art and for commission
of technical opinions from academic and other experts, as allowed by TRIPS
Articles 1.1, 7, 8, and 62.4 (see Articles 3 and 4, amending Patent Act
Art. 31 and adding Art. 31-A);
e) clarifies that
the protection of undisclosed pharmaceutical test data in Brazil prevents
unfair commercial use and unauthorized disclosure, but permits “use, by
government bodies of test results or other undisclosed data, for market
approval of products equivalent to the product for which they were initially
presented,” as allowed by TRIPS Article 39.3 (see Article 3, amending
Patent Act Art. 195),
f) updates the
Sanitary Agency's (ANVISA) prior consent mechanism for pharmaceutical patents,
in accordance with the recently adopted ANVISA Resolution 21/2013 and as
allowed by TRIPS Article 1.1, 7, and 8, granting ANVISA the duty to analyze,
prior to the Patent Office, patent applications involving
pharmaceutical/chemical (i) products that have previously been rejected by the
Agency, and thus present health risks, and (ii) compounds that are of interest
to support Brazil's National Health System’s access to medicines policy or a
pharmaceutical care program, and that may not meet the patentability
requirements set forth by the Patent Act (see Article 3, amending Patent
Act Art. 229-C, and Article 5, amending Article 7 of Law no. 9782 of 26 January
1999);
g) incorporates
within the Patent Act the public non-commercial use mechanism as set forth by
the WTO TRIPS Agreement Article 31 (see Article 4, adding Patent Act
Art. 43-A).
In pursuing
the patent law reforms outlined above, Brazil is exercising its lawful
sovereign right to make use of TRIPS-compliant flexibilities so as to meet its
aspirations and needs with respect to self-reliant and sustainable development,
participation in the global knowledge economy, and fulfillment of its human
right obligations to its people. Brazil
is also joining countries like India, the Philippines, Argentina, and Zanzibar,
which have already incorporated legal rules that prevent excessive granting of
patents and promote patent quality, particularly on global public goods such as
medicines, and with progressive civil society movements in other countries like
Uganda and South Africa where campaigns to amend TRIPS-plus patent legislation
have recently been launched. Brazil is
also relying on, and has closely documented, a broad array of scholarly
research and expert analysis that supports each of the patent reform
initiatives that it is proposing.
Indeed, many of the steps that Brazil is taking to help ensure patent
quality and eliminate abusive patents practices can be understood as locally
tailored versions of steps recently taken in high-protection jurisdictions such
as the U.S. and E.U., where increasing concern has been expressed about the
anticompetitive effects of overgrown patent laws. In the US, for example, both Congress and the
Supreme Court have recently imposed new restrictions on patent law and
introduced new measures to improve patent quality.[3]
If history
serves as a guide, we can expect that the United States, Europe, and
patent-intensive industries, especially the patent-based multinational pharmaceutical
industry, will oppose the proposed reforms both internally in Brazil and
internationally in various forums. We
fully expect that there will be vigorous, even angry protest; claims that
Brazil is undermining pharmaceutical innovation locally and globally; and
threats of retaliatory action. But in
our collective and considered view, Brazil’s patent reforms are both modest and
prudent, as well as fully compliant with international norms. Armed with these reforms, Brazil should be
able to reduce the number of weak pharmaceutical (and other) patents that are
filed; weed out poor-quality patents through informed opposition procedures and
the involvement of experts in its drug regulatory authority in the review
process; prevent evergreening of patent monopolies by restricting secondary
patents on new forms and new uses of known substances and by limiting patents
to 20 years only; preclude the creation of a new form of monopoly on data
submitted to drug regulators; and allow Brazil to have ready access to government-use
licenses upon notice and payment of adequate remuneration so as to meet the
needs of its patients for affordable medicines.
If adopted and
implemented, the proposed reforms will help Brazil to protect, respect and
promote human rights, and also help incentivize local production, generic
entry, and competition, and lead to greater technological capacity and
employment in patent-based industries.
We applaud the Brazilian patent reform initiative and hope for its
speedy adoption and implementation.
Very truly yours,
Professor Brook K. Baker, Northeastern U. School of Law, Program on
Human Rights and the Global Economy, Honorary Research Fellow, University of
KwaZulu Natal, Durban, S. Africa
Professor Amy Kapczynski, Yale Law School
[1] This comprehensive
Report, which has previously been made available on a limited basis in draft
form and will be released in final form on 10 July 2013, is nearly 300 pages
long and documents a long process of consultation on patent reform in Brazil
and some of the challenges Brazil faces, particularly in terms of access to
medicines, because of TRIPS-plus patent rules it prematurely adopted in 1996 in
response to trade pressure from the United States. The Report also documents policy incoherence
and inconsistencies between different levels and branches of government as well
as persistent problems in the administration of the Brazil Patent Office, which
is experiencing a growing backlog of unexamined patent applications. Although the Report touches on other
important policy issues that will be further explored in Brazil, such as
increasing its research and development expenditures, exploring alternative
innovation-incentive systems, reforming its governance architecture for
intellectual property policy, and increasing the capacity and performance of
its Patent Office, we focus our attention solely on proposed revisions to
Brazil’s Patent Law.
[2] We are relying on an informal English
translation of the proposed bill annexed to the Report. Accordingly, the precise language in official
English versions may be slightly different.
[3] See,
for example, http://www.peertopatent.org/ and the new provisions for post-grant
patent opposition created by Congress in the US, as well as the U.S. Supreme
Court’s recent restrictions on patentable subject matter, in Bilski v. Kappos (2010), Mayo v. Prometheus (2012), and Association for Molecular Pathology v.
Myriad Genetics (2013). Concern
about anticompetitive behavior surrounding pharmaceutical patents is
demonstrated by FTC v. Actavis
(2013). It is perhaps worth noting, in
addition, that many secondary patents of the type that would be covered by
proposed Article 3 in the Brazilian reforms appear to be invalidated in
litigation in the U.S., in a process that is much more expensive, but may
achieve similar results. See C. Scott Hemphill & Bhaven N.
Sampat, ‘Evergreening, Patent Challenges, and Effective Market Life in
Pharmaceuticals,’ Journal of Health
Economics 31, (2012) 327-339.
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