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About

Editor-in-Chief,   Anatole Krattiger

Editorial Board

Concept Foundation

PIPRA

Fiocruz, Brazil

bioDevelopments-   Institute

CHAPTER NO. 17.1   Current Issues of IP Management in Health and Agriculture in Brazil
Editor's Summary, Implications and Best Practices

Krattiger A, RT Mahoney, L Nelsen, JA Thomson, AB Bennett, K Satyanarayana, GD Graff, C Fernandez and SP Kowalski. 2007. Editor’s Summary, Implications and Best Practices (Chapter 17.1). From the online version of Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices. MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.

© 2007. A Krattiger et al. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.

Editor's Summary

For innovative developing countries, such as Brazil, an uneven mix of capabilities, such as increasingly developed productive and research capacity, emerging capacity for innovation, yet low integration between scientific and industrial policies and a general lack of innovation in health policies, creates both challenges and opportunities. Brazil is facing these challenges, and in so doing provides other innovative, and near-innovative, developing countries with an example of how to proceed in building capacity, seizing opportunities and realizing success.

Brazil’s National System for Innovation in Health is composed of a complex network that includes universities, research institutes, pharmaceutical companies, medical and hospital equipment manufacturers and suppliers, hospitals and government agencies and control institutions. The system, as compared to the equivalent systems found in developed and developing countries, embodies similarities but also peculiarities. To summarize, the most distinctive aspect of the Brazilian system is, possibly, the scientific infrastructure focused in biomedical research with government investment.

A crucial early step is the establishment of sound and workable policy. As an example, in March 2004, the Brazilian government initiated the PITCE—Política Industrial, Tecnológica e de Comércio Exterior [Industrial, Technological and Foreign Trade Policy]. The pharmaceutical sector was selected as being one of the four strategic areas for the policy. The main targets are:

  1. to increase the national production of vaccines and medicines determined as priorities by the National Health Policy, with emphasis on generic medicines and those intended for the treatment of Sexually Transmitted Diseases, including AIDS;
  2. to increase the access to medicines by the population; and
  3. to avoid the continuous increase in the trade deficit.

Investments will be made to modernize public laboratories and the purchasing power of the State will be harnessed. One of the funding strategies for the sector will be the PROFARMA - Programa de Apoio ao Desenvolvimento da Cadeia Produtiva Farmacêutica [Program for the Support to the Development of the Pharmaceutics Productive Chain], backed by the BNDES. This program has three main courses of action:

  1. investment in production;
  2. investment in R&D; and
  3. the consolidation of locally controlled companies.

From an institutional policy-driven perspective, Brazil presents two outstanding examples of IP policy applied to specific sectors: the role of EMBRAPA (Institute of Agricultural Research of the Ministry of Agriculture) in the Brazilian seeds market and the role of FIOCRUZ (an institute of the Ministry of Health that works in the research, education, technological development and production in the field of the human health). In the controversy over the “drug cocktail” for the AIDS Program of the Brazilian government, FIOCRUZ, through Far Manguinhos (its drugs production unit) provided the Ministry of Health with the cost structure of the drugs that constitute the “drug cocktail” used in the AIDS Program, identifying the necessary technology for its production. EMBRAPA, supported by an IP policy in the area of plant varieties, was able to assemble partners, both public and private, to work on the development of new plant varieties, allowing the country to keep the majority of national plant varieties after the promulgation of the Plant Variety Protection Law in 1997, pursuant to the agreement on Trade-Related Aspects of Intellectual Property (TRIPS) requirements.

Both FIOCRUZ and EMBRAPA represent a new standard of research organization, wherein the search for partnerships and the sharing of proprietary results are efficiently implemented. The search for complementing capabilities, which would be impossible to find in a single research institution or national economic agent, is what drives this standard. This standard, therefore, provides for public sector R&D to be targeted at the relevant markets, without losing focus on the mandate and rationale for the generation of technical and scientific knowledge for the greater public good of the nation.

From the perspective of IP laws and their effective implementation, Brazil has taken its TRIPs obligations seriously, enacting legislation towards compliance. For example, pursuant to the TRIPS Agreement, Brazil introduced a new legislation for Authorship Rights (Law no. 9610/98), Computer Programs (Law no. 9609/98), and the Plant Variety Protection Law (Law no. 9456/97). The latter, aims to facilitate the IP protection of innovations in plants. In this regard, a radical change in the Brazilian institutional outlook relating to the protection of intellectual property is transpiring, strongly reflected in the dynamics for the IP protection of biotechnological innovation in Brazil.

Brazilian domestic legislation, which is implemented via the enacting of new laws, is also catalyzing rapid change. For example, in the field of health and agriculture research, there is the promulgation of the Innovation Law (Law no. 10973, of December 2nd, 2004). An increase in partnerships between companies, universities and scientific and technological institutes is expected to be one outcome. Another outcome would be the possibility of attracting university researchers to start companies, stimulating the creation of technology-based companies, that would then be capable of marketing the results of research undertaken in universities and research institutes. Since participation of researchers in the management of private companies is now allowed, the entrepreneurial potential of these professionals can be realized. It also allows for the efficient sharing of public research space and infrastructure with private companies. The law cuts off several bureaucratic hindrances, such as a mandatory bidding process for the licensing of patents belonging to a public agency.

From the standpoint of IP capacity building, the Innovation Law demands the establishment of technological innovation offices at universities and research centers. Indeed, it is hoped that this powerful innovative incentive will encourage the protection and commercialization of academic inventions, fostering economic dynamism and new job opportunities, and creating an environment for maximizing utilization of intellectual property for the benefit of the nation, its institutions, and its people. However, as the authors note, serious challenges remain. Countries that present rich biodiversity, such as Brazil, still need to acquire the ability to act more dynamically in the challenging environment of protection and exploitation of intellectual property, whether to protect local inventions or to gain the knowledge to acquire technology developed by third parties. The demand for highly qualified professionals in this field of work is most urgent, as is the strengthening of the National Institute of Industrial Property. More energetic and integrated actions on the part of Brazil’s public administration would contribute to a more mature policy in the area of industrial property and to the development of a configuration for a more competent system for innovation and IP management.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policy-makers

  • IP policy should be linked to scientific, technological and innovative development, and it should also be an integral component of the agricultural, health, industrial and foreign trade policies.
  • It is not sufficient to only pass laws that require public sector institutions to build IP and technology transfer offices. Public sector R&D institutions need support, encouragement and incentives. This will spur and accelerate the full utilization of public sector generated intellectual property.
  • IP laws and their enforcement is a challenge in Brazil, as it is in other innovative developing countries. When properly implemented, IP regimes can play major roles as critical drivers in the global economy, fostering an IP environment favorable for technology transfer, domestic innovation and foreign direct investment.
  • To implement policy, IP capacity building is essential. This will require investment at the national level, to fund ongoing capacity building, at both the human and institutional levels, in IP awareness and management.
  • Strengthening the institutions that manage intellectual property ought to be an ongoing process, with IP policies linked to innovation agendas, such that investments in R&D can realize their maximum potential.
  • Misunderstanding, misapplication and misinterpretation of the law is, in many instances, a result of the poor expertise in the field of intellectual property. Therefore, investing in solid IP capacity building can have far-reaching, sustainable and positive impact.

For Senior Management (university president, R&D manager, etc)

  • Coordinating R&D networks with university policies/guidelines will be essential for establishing and implementing an institutional system of best practices in IP management.
  • Investments in technology transfer offices (TTOs) will facilitate the diffusion of innovations. This can occur via management of intellectual property and the creation of links to the private sector. However, from the very start, the foundation of successful relationships between the public and private R&D sectors is training in IP management.
  • The qualification and training of personnel in IP management practices, including negotiating techniques, licensing and technology transfer contracting, becomes essential to advance the mission of the university, especially as greater investments are made in biotechnology R&D.

For Scientists

  • To maintain scientist’s effective work, it is fundamental that she/he knows the IP policies of the institution as well as policies relating to the commercial exploitation of the intellectual property. This then permits the scientist to interact with colleagues with full understanding of what constitutes IP best practices, for example, when it is prudent to contact the technology transfer office with questions concerning possible IP issues.
  • Scientists must be aware of, understand, and adhere to university IP policies and guidelines. This will create confidence, both internally and externally, that intellectual property is taken seriously, fostering greater opportunities for technology transfer and various research collaborative arrangements. For an innovative developing country, such as Brazil, these sorts of activities will catalyze R&D progress, for the good of the university and your research program and the nation.
  • Be aware of the ownership policies concerning inventions and other intangible assets, and be committed to following them. Report new intellectual assets to the TTO, pursuant to university policy as articulated by the technology transfer office.

For Technology Transfer Officers

  • Remain aware of recent changes and developments in IP law.
  • Establish and maintain IP capacity awareness and training, not only for personnel from the TTO itself, but also for university administrative and R&D personnel. IP awareness is everyone’s business.
  • Technology transfer officers oversee and ensure implementation of university IP policies via, for example, negotiation and technology contracting and also implement market-monitoring protocols.
  • Smooth interactions with scientists is the foundation for a successful TTO operation. Since scientists often are the best “salesmen” of the protected technology, understanding the rationale embedded in the technology, and the type of technical solution it offers, can synergize maximal utilization of R&D investment.
  • Institutional IP policies should embody, articulate and memorialize the guiding principles for the activities of the TTO, consistent, of course, with the mission of the university and the greater public good of the nation.

Krattiger A, RT Mahoney, L Nelsen, JA Thomson, AB Bennett, K Satyanarayana, GD Graff, C Fernandez and SP Kowalski. 2007. Editor’s Summary, Implications and Best Practices (Chapter 17.1). From the online version of Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices. MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.

© 2007. A Krattiger et al. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.