lunes, 8 de julio de 2013

Apoye a la reforma de Ley de Patentes de Brasil, carta de académicos

 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.


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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

Professor Sean Flynn, American University Washington College of Law, Program on Information Justice and Intellectual Property


[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, 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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