Patenting Biological Research in Brazil Marília Coutinho, Diogo da Costa Patrão, Ricardo Nicoliello Zorzetto Vêncio, Rodrigo Luiz Medeiro da Silva, Márcio Lucatelli, DOCUMENTO DE TRABALHO Lucimara Flávio dos Reis, Maria Angélica 7/ 03 Marin Núcleo de Pesquisas sobre Ensino Superior da Universidade de São Paulo NUPES Núcleo de Pesquisas sobre Ensino Superior Universidade de São Paulo Patenting Biological Research in Brazil Marilia Coutinho Diogo da Costa Patrão, Ricardo Nicoliello Zorzetto Vêncio, Rodrigo Luiz Medeiros da Silva, Márcio Lucatelli, Lucimara Flávio dos Reis, Maria Angélica Marin Núcleo de Pesquisas sobre Ensino Superior da Universidade de São Paulo Patenting Biological Research in Brazil Marilia Coutinho Diogo da Costa Patrão, Ricardo Nicoliello Zorzetto Vêncio, Rodrigo Luiz Medeiros da Silva, Márcio Lucatelli, Lucimara Flávio dos Reis, Maria Angélica Marin Equipe do NUPES Carolina M. Bori Diretora Científica Eunice R. Durham Coordenadora de Conselho Pesquisadores Ana Lucia Lopes Elisabeth Balbachevsky Omar Ribeiro Thomaz Auxiliares de Pesquisa Elisabete dos Santos Costa Alves Luciane da Silva Sebastião Alexandre Marquito do Nascimento Auxiliares Técnicos Juliana de Miranda Coelho Carneiro Regina dos Santos Auxiliares Administrativos Josino Ribeiro Neto Paulo Henrique Marques da Silva Vera Cecília da Silva Patenting Biological Research in Brazil Marilia Coutinho Diogo da Costa Patrão, Ricardo Nicoliello Zorzetto Vêncio, Rodrigo Luiz Medeiros da Silva, Márcio Lucatelli, Lucimara Flávio dos Reis, Maria Angélica Marin Abstract: New Intellectual Property guidelines were recently adopted in Brazil (new 1996 Law). Until this moment, the scientific community showed no interest in patenting research results nor approved of a more organized patenting system. A population of Biological Research scientists that identified themselves as patenters in the National Research Group System of the National Council of Scientific Development (CNPq) was studied. This pioneer population’s productivity was examined and some members were interviewed. The contents of these interviews were analyzed. The patents distribution by research area and institution was investigated. The main conclusions are that this population is different from their peers in their respective areas, showing greater productivity in many fields. Besides that, the study showed that patenting is not restricted to the applied areas of knowledge. This differentiated population may develop a leading role during the next period when industrial innovation policies will be implanted in the country.  This research was funded by FAPESP, project number 2000/11364-3.  Pesquisadora do Núcleo de Pesquisas sobre Ensino Superior – Universidade de São Paulo  Assistentes de Pesquisa 1 PATENTING BIOLOGICAL RESEARCH IN BRAZIL Introduction Among the great public policy issues in Brazil, perhaps few are as controvertible and mobilize such wide range of political actors as industrial innovation. There is a struggle to approve a new innovation law - with harsh arguments as to its contents -, incentives were created to foster technology transfer and the subject was never as discussed as now. All this effort, however, unfortunately does not change the much ingrained condition of innovative immaturity in the country. Considering National Innovation Systems (Nelson 1993, Patel & Pavitt 1994), institutional structures and incentive policies in the country, Brazil is, together with Mexico and India, among the immature countries. The cycle that leads from Research & Development (R&D) to industrial innovation and development has never been completed in Brazil and other Latin-American countries. Many offer explanations as to the origins of this condition. Previous studies have shown that scientists have been secondary victims of the import substitution policy adopted in Brazil for decades. They would never have found a “space” for themselves and their science in society, insulating themselves in their relative irrelevance and ivory tower (Schwartzman 1991). Relative here refers to the proportion of significant contributions, since there were always those among Brazilian scientists who were bright and relevant, making important technical and theoretical contributions. Nevertheless, institutionally, Brazilian science has had its transfer arm of knowledge to society amputated. This is true both to the private sector and to public demands. It has become insulated. The opening of Brazilian economy in the eighties, however, followed the many rounds of negotiations that resulted in the TRIPS. The country has changed, trade is opened and now Brazilians try to participate with the smallest possible shortfall in a globalized world and an increasingly technological economy. The question now is how these previously amputated scientist have reacted to the new context. Since 1996, Brazil has a new patent law that regulates pharmaceutical and 2 biotechnological inventions. Do scientists now regard their research results as inventions? If so, can they see them as goods to be protected and therefore patented? To answer these questions there is no other means as studying patents declared by scientists to the National Council for Scientific Development (CNPq) as innovativeness proxy. We understand this is not a good indicator, since there may and probably are a number of patents by Brazilian researchers that have not been declared to the CNPq, in what is called the Lattes system (which integrates information about productivity, institutional variables and much more). Since this system is becoming the main gatekeeper for grant requests, research visibility and other institutional activities, this is the best indicator we have for the moment. We have used the Lattes system and observed that an increasing number of researchers declare their patent applications and granted patents, both in the country and abroad. Today, the number of patent offices in universities is increasing. There is still, however, a great institutional insufficiency. How did the pioneer patenters manage to patent their inventions? Is there something that distinguishes this population from their peers in their respective areas? Are their institutions different, favoring patenting activity? These are the questions we wish to approach in this study. We adopt the hypothesis that we are dealing with a differentiated population, which may play a leading role in the next period of industrial innovation policy implantation in the country. Patenting and Innovation in Brazil Is the future globalized world one of corporative innovation with no space for other actors? In spite of the minimum State prophets which see the end of universities’ role in the innovative process, there are reasons for a certain optimism: universities may be, if not THE locus, one of the privileged loci for industrial innovation (Etzkowitz & Leydesdorff 2000). Beis & Stahl (1999), for example, believe a considerable part of German industrial innovations are originated in public research institutions (PRI), which is in accord with Mansfield’s (1998) data for the United States. Besides that, Daniels (1997) believes, in 3 contrast to the great majority of scholars, that globalization will contribute to reduce, and not increase the technological abyss between mature and immature countries. Others, such as Bozeman, who has reviewed all the literature in technology transfer from Public Research Institutions (PRIs) to industry, believe that “the process of commercializing intellectual property is very complex, highly risky, takes a long time, cost much more than you think it will, and usually fails” (Bozeman 2000). Even maintaining a respectful distance from Bozeman’s pessimism and Daniels’ optimism, Brazil’s problems and its immaturity remain and are many (Albuquerque 2000, 2001). Brazil is not different from many other Latin-American countries where the distance between PRIs and industry is disconcerting. Public policies to overcome this condition look futile in face of the problem’s dimensions (Alcorta & Peres 1998). The issue becomes really visible when one considers technology transfer from PRIs to industry in micro-scale. The question we ask here is one that all countries have asked: to whom do the public interest research results, funded by public money and carried out in public institutions belong and what does it take to transfer it to industry (Ledermann 1994, Fujisue 1998; Licht and Nerlinger 1998)? In the United States, since the 1980’s, the Congress has approved eight technology transfer incentive programs. Until then, there was little interest from researchers in developing “useful” research. Scholars have attributed such disinterest to what, until the eighties, was the compulsory licensing of publicly funded research. All such research results would necessarily be of public domain, therefore not patentable, and therefore of no commercial interest. In 1980 the Bayh-Dole Patent and Trademark Amendments Act, amended by Public Law 98-620 in 1984, was approved. This new legal system eliminated the compulsory licensing commitment. According to Sandelin (1994), at least 60% of all university inventions were supported by federal funds. Research Institutions’ inventive activity is concentrated since then in biotechnology. Technology transfer has been intensified and technology management offices have sprouted in every university. The financial gains secured by these agencies has increased substantially in the nineties (Mowery, Nelson, Sampat & Ziedonis 2001). Today, at least 70,0% of the resource generating licenses in American universities originate in the life sciences (Association for University Technology Managers 1998). Specialized organisms to handle industrial property have increased in this period and the “technology transfer” professional has now a well defined role and position in most 4 American universities. There is even a journal devoted to the subject, the Journal of Technology Transfer (Bozeman 2000). Professional societies have appeared, the Association for University Technology Managers is one of them. It was created in 1994, has more than 2,700 members today and grows at a 10,0% rate/year. The Association for University Technology Managers (AUTM) members include university representatives, non-profit research institutions, government and industry. In spite of the growing efforts in Brazil to network technology transfer offices, there is no such society and professionals feel isolated and frequently at a loss over their tasks. Brazil has a long history of medication and foodstuff patenting rejection. The first industrial property law in Brazil was approved as early as 1809. Nevertheless, in 1945 - when industry was in fact growing - medicines and foodstuff obtained by chemical means were excluded from patentability. In 1969, changes in legislation completely eliminated pharmaceutical patenting (Bermudez, Epsztejn, Oliveira and Hasenclever, pp 13-14). Therefore, a domestic industry specialized in the production of “similar” medicines flourished. Added to that, national research was unfamiliar with technology transfer - institutional immaturity had to be the rule. A rather extensive literature discusses the technological immaturity problems in Brazil. Schwartzman (1991, Schwartzman, ed. 1995), for example, explores the issue of the Brazilian science and technology system evolution with chronic difficulties. Such difficulties made it more attractive and cheaper for industry to import technology. The absence of Intellectual Property Rights (IPR) made it more expensive and risky to get involved in the development of domestic technology (Vessuri 1990, 1997). This has resulted in the universities absorbing all the research functions, since the high costs and low reliability of developed technology turned industry’s interest away from R&D. Albuquerque (2000) has stated that Brazilian specificities (high proportion of individual patents, foreign firms with important activities, low involvement with R&D activities and lack of continuity of patenting activities) identify the country as an immature innovation system. His further studies reinforce such findings (Albuquerque 2001). The idea of a National Innovation System, which is a more or less diffuse network of technological innovation development fomenting public and private institutions, is not new. It has been gaining, however, additions and criticism. One of them comes from Arocena and Sutz’s group (2000, 2001) from Uruguay. These authors claim that the mere application of neo-shumpeterian concepts to Latin America, with no regard for the region’s peculiarities, do not help to solve local technological development problems. As an alternative, they propose 5 eight general modules about each region’s economic dynamics. These, in turn, allow for the evaluation and comparability of local innovation systems. One of the outstanding characteristics of Latin-American innovation systems is, for example, its more frequent contribution to the public sphere. For some scholars, this would be an immaturity trace. Again, the issue of the State’s involvement in patenting and innovation suggests that it will remain an important player. Even in developed countries the State is the chief investor in areas of great public importance. PRIs relationship with industry are presently different and universities are more “porous” to private sector interactions. As a result, innovation remains and increases in PRIs everywhere. Studies from Europe, United States and Australia corroborate this claim (Godin B. & Gingras, Y., 2000; McMillan G.S., Narin F. & Deeds D.L., 2000). In the study conducted in the United States, for example, the authors claim that “...our results indicate that the biotechnology industry depends on public science much more heavily than other industries” (McMillan G.S., Narin F. & Deeds D.L., 2000). The fact that relationships are more flexible, frontiers less clear, imply that universities and PRIs in general must have even stronger technology transfer organisms to handle them. Material and Methods The material for the researchers’ study was the on-line information provided by the Lattes system from the CNPq. We recovered socio-academic and technical productivity data for the selected individuals. Sixty-seven patents and 48 pioneer patenters were identified. From this pool, 19 individuals answered a questionnaire about difficulties and other issues involved in patenting. Research support agencies were studied through direct contact and interview with those that held leading positions or through information from the agency’s publications. 6 Results 1. Research support agencies Brazil has no institutionally structured system to support possible inventors. When researchers succeed in patenting their inventions, difficuties abound (financial, lack of information, etc.). The two most significant agencies were approached: the federal CNPq and the São Paulo agency FAPESP. The information about CNPq was provided by the department head, Eury P. Luna Filho, who kindly described how patenting activities developed in the CNPq. According to him, patenting activities, which integrate CNPq’s legal department, started some twenty years ago. Then, it was unsystematic and inventors were assisted in a haphazard way. Since the late 70’s and early 80’s, internal guidelines were established. In this period, it was widely held among researchers that patents would not benefit the country’s scientific progress and that the free communication of research knowledge should not be restricted. With the new patent law from 1996, which included pharmaceutical patenting, the department had to commit more constant and permanent assistance. The Intellectual Property Support Service, in the legal department, was founded in the year 2000. Nevertheless, since 1998 the CNPq already provided assistance of this kind: information to the researcher, orientation as to the patenting activities and patent application and software registration writing. The Service is composed of two full time staff members and one trainee. One of the staff members holds a law degree with specialization in Intellectual Property Rights. Still according to Mr. Luna Filho, the Service attends about eight requests each month. The Center for Technology Patent and Licensing (NUPLITEC) was established by FAPESP with the intention of protecting the intellectual property of research results supported by the agency and to license the resulting products. Scientific Director J.F. Perez explained that patents are costly and what is really important is licensing. NUPLITEC intends to do business with the patenting activity and for this reason they are pro-active in seeking commercial partners. The idea is immediately mobilizing the Center 7