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Vaccine R&D in Brazil: The effectiveness of push and pull regulations

C�assia Rita Pereira da Veiga a, Claudimar Pereira da Veiga a, b, *, Jansen Maia Del Corso a,Wesley Vieira da Silva a

a Business School Graduate Program (PPAD), Pontifical Catholic University of Parana (PUCPR), Imaculada Conceiç~ao, 1155, 80215-901, Curitiba, PR, Brazilb Business Management Graduate Program (DAGA), Department of General Administration and Applied, Federal University of Parana (UFPR), 632 Loth�arioMeissner Ave, Jardim Botanico, 80210-170, Curitiba, PR, Brazil

a r t i c l e i n f o

Article history:Received 1 May 2015Received in revised form4 April 2016Accepted 13 May 2016

Keywords:InnovationImmunobiologicalsIndustrial property lawTechnological innovation lawGood lawPatent

Abbreviations: R&D, Research and Development;(‘Lei de Propriedade Industrial’); LIT, Technological InnTecnol�ogica’); LDB, Good Law (‘Lei do Bem’); IP, IntelleIntellectual Property Organization; WTO, World TradRelated Aspects of Intellectual Property Rights; IPC,cation; PNI, National Immunization Program (‘ProgramINPI, Brazilian National Institute of Industrial Propertpriedade Industrial’).* Corresponding author. Business School Graduate

Catholic University of Parana (PUCPR), ImaculadaCuritiba, PR, Brazil.

E-mail address: claudimar.veiga@gmail.com (C.P. d

http://dx.doi.org/10.1016/j.wpi.2016.05.0060172-2190/© 2016 Elsevier Ltd. All rights reserved.

a b s t r a c t

Government regulations can guide the technological progress, investment in research and development(R&D), and institutional organization of a specific sector. In this context, using patent data, this studyaimed to analyze the effectiveness of three laws that pertain to R&D in Brazilian pharmaceutical marketfor vaccines. The results reveal an increasing international interest in the Brazilian market since thepromulgation of the Industrial Property Law. Despite its limitations, this study reveals significant effortsand promising results in Brazil with respect to ensuring that technological and industrial policies andstrategies incorporate innovation in vaccine R&D and change the economy's competitive circumstances.

© 2016 Elsevier Ltd. All rights reserved.

1. Introduction

Government regulations can guide the technological progress,investment in research and development (R&D), and institutionalorganization of a specific sector [1]. In Brazil and worldwide, thereis strong government intervention in the pharmaceutical sectorthat aims at balancing public-health spending and the sector'stechnological and industrial goals [2,3]. To analyze R&D in theBrazilian pharmaceutical market for vaccines, this study sought toevaluate by patent data the impact of three specific laws: the In-dustrial Property Law (‘Lei de Propriedade Industrial’ - LPI) No.9279/1996 [4], the Technological Innovation Law (‘Lei da Inovaç~ao

LPI, Industrial Property Lawovation Law (‘Lei da Inovaç~aoctual Property; WIPO, Worlde Organization; TRIPS, Trade-International Patent Classifi-a Nacional de Imunizaç~oes’);y (‘Instituto Nacional de Pro-

Program (PPAD), PontificalConceiç~ao, 1155, 80215-901,

a Veiga).

Tecnol�ogica’ - LIT) No. 10,973/2004 [5], and the Good Law (‘Lei doBem’ - LDB) No.11,196/2005 [6], which operate at different stages ofthe innovation chain. The LPI can be considered to be a pullmechanism that operates downstream and that aims to increasethe attractiveness of the market for new companies through themanagement of intellectual property (IP) rights [7e9]. In contrast,the LIT and LDB are push mechanisms that operate upstream andattempt to decrease the cost of R&D through direct public funding,tax credits for R&D, and investment in research infrastructure[7e9].

Innovations in vaccines have not always been the target of the IPrights [10,11]. The negative outcomes caused by the inadequatecontrol of production and processes have made these laws morestringent and significantly increased R&D costs. Therefore, toguarantee a return on the large investments, the granting of IPrights has been required [10]. Previously, in Brazil, many privatelaboratories ceased the production of serums and vaccines [12]. Tosolve the shortage crisis [11], the government encouraged domesticproduction by public institutions [12]. However, these institutionslacked sufficient technological expertise to produce compleximmunobiologicals.

In addition, the 1990s were marked by increased efforts in theR&D sector to produce novel vaccines through the application ofnovel technologies so that foreign pharmaceutical companies could

C.R.P. da Veiga et al. / World Patent Information 46 (2016) 11e1812

identify an entry point for promising new markets in this sector.Consequently, an activity that for many years relied on public, ac-ademic, and private institutions, which perform activities of a socialnature, became the subject of large private investments [13]. Dur-ing the same period, important regulatory changes in IP rights inthe pharmaceutical area occurred in Brazil.

The transfer of the debates from the World Intellectual PropertyOrganization (WIPO) to the World Trade Organization (WTO)stimulated the standardization and strengthening of IP rights [14].The regulatory framework that was responsible for this change wasthe promulgation of Trade-related Aspects of Intellectual PropertyRights (TRIPS) in 1995 [11], which a short time later culminated inthe approval of the LPI in Brazil. This new legal framework in thepharmaceutical area aimed to promote technological developmentand capacity in Brazil to stimulate economic and social develop-ment. However, approximately 20 years after the LPI's promulga-tion, it is unclear whether this pull mechanism promotes nationalinnovation and is indirectly responsible for Brazil's economic andtechnological growth [14e18] or whether IP policies are simply anattraction for the increase in the consumer market of foreigncompanies [19e22].

More recently, again with the aim of encouraging investment inR&D, the Brazilian government has provided legal instruments thatencourage innovation activities that can generate solutions for thecountry's public health system [23,24]. The LIT was launched in2004, followed by LDB in 2005. The LIT is a push mechanismorganized around three axes [5]: (i) the creation of an environmentthat is conducive to the formation of strategic partnerships be-tween universities, technological institutes, and private companieswith the potential to share infrastructure, equipment, and humanresources, (ii) the stimulation of the participation of science andtechnology institutes in the innovation process, and (iii) theencouragement of innovation in the private sector. The LDB grantstax incentives to companies that conduct R&D on technologicalinnovation and uses this push mechanism to encourage privateinvestment in innovation and to connect private companies withuniversities and research institutes [6]. There have been no studieson the impact of the LIT and LDB in promoting vaccine R&D.

In the global context of economic crisis, there is an increasingawareness among policy makers of the crucial role that vaccinescan play in preventive medicine and their potential to obtain eco-nomic and public health benefits [25,26], particularly in developingcountries inwhichmany vaccine-preventable diseases are endemic[27,28]. In addition, the worldwide demand for vaccines hasemphasized the need to increase the local capacity for vaccine R&Din emerging economies, such as Brazil [24], which is considered tobe an innovative developing country [29].

Thus, using patent data, this study aimed to evaluate the impactof three Brazilian laws on vaccines innovation chain, i.e. the inno-vative strength of Brazil and the degree of autonomy in innovationproduction as well as the attractiveness of the Brazilian market forforeign companies active in the pharmaceutical market for vac-cines. To the best of our knowledge, few empirical studies haverecently evaluated the Brazilian pharmaceutical market from the IPperspective. Such studies primarily investigate Brazilian biodiver-sity [1,30,31] or focus on biotechnology patents [32,33] but do notspecifically analyze vaccines. In addition, industrial incentive pol-icies in Brazil achieve different results for similar industrial seg-ments [1], which indicate the need for studies that consider thedevelopment of a specific industrial sector through changes in theprocess of renewal of national innovation policies [23,24] and in theprocess of adaptation to international harmonization agreements[11].

This paper is structured as follows. After this introduction, inSection 2, we examine the literature on three Brazilian innovation

policies. Section 3 describes our research method. In Section 4, weexamine the results and discuss the relevant insights. Finally, inSection 5, our concluding remarks are put forward.

2. Literature review

This section presents a literature review on three Brazilianinnovation policies and their objectives and limitations. This isaccomplished in order to better interpret patent data.

2.1. Industrial property law (LPI)

None industrial sector excite stronger feelings than the phar-maceutical industry in regard to balance in the protection of in-tellectual property between the short-term interests in maximizingaccess and the long-term interests in promoting creativity andinnovation [34]. Pharmaceutical patents have always been objectsof divergence, but the discussions have significantly increased inlast two decades. The displacement of the discussions in the field ofIP of the World Intellectual Property Organization (WIPO) to theWorld Trade Organization (WTO) has pressed countries to stan-dardize and strengthen IP rights [35] in order to remove obstaclesto international trade. The TRIPS agreement established the mini-mum parameters for intellectual property protection of pharma-ceutical products and processes to member states of the WTO [36].

According to the TRIPS agreement, the purpose of a patentsystem is to promote appropriate balance contributing to the pro-motion of technological innovation and to the transfer anddissemination of technology, to the mutual advantage of users andproducers of technological knowledge and in a manner conduciveto social and economic welfare and to a balance of rights and ob-ligations [34]. Studies evaluating the effectiveness of the patentsystem in meeting these goals show contradictory results [37],especially when it refers to developing countries. Some studiessuggest that the patent system feeds innovation and, indirectly, it isresponsible for the economic growth of developing countries[18,35,38,39]. Others studies argue that IP policies only increase theattractiveness of specific market in developing countries and theincome transfer for multinational companies [40e42] installed inthese countries.

It was only in 1996 that Brazilian Congress approved the patentlaw, assuring patent protection of pharmaceutical products andprocesses (LPI, Law 9279/1996) [4]. Patent law reform fundamen-tally changed the knowledge appropriability regime since localpharmaceutical firms could replicate medicines until 1996 throughreverse engineering process. Contested is whether patent lawshave promoted indigenous technology innovation in developingcountries as the Brazil. On the other hand, new regulatory ar-rangements can increase the attractiveness of the Brazilian marketfor foreign companies and thus LPI can be considered to be a pullmechanism to encourage innovation [7e9].

2.2. Technological innovation law (LTI)

In order to achieve technological autonomy and industrialdevelopment, the Brazilian congress has enacted an intellectualproperty-oriented technology law, Law 10,973, in 2004 [5]. Thisnew policy framework named technology innovation law intro-duced provisions on incentives for innovation and scientific andtechnological research in the production environment. Amongother things, this piece of legislation attempts to facilitate thepublic-private R&D cooperation, with engagement of Brazilianpublic research institutes and private-sector enterprises.

Aside from tax incentives to provide public-private cooperation,important aspects of this law are the creation of science and

C.R.P. da Veiga et al. / World Patent Information 46 (2016) 11e18 13

technology institutes and their technological innovation centers(TICs) [6]. Most TICs are part of public universities and control thedisclosure of developed technological or scientific creations, eval-uate innovations and technologies, seek the best protection for thedeveloped technologies, negotiate, draft, manage and enforcetechnology transfer agreements, as well as licence agreements inconnection with intellectual property or know-how developed bythe institute. Although university patenting is not a novel phe-nomenon in Brazil [43], research in the last decade has noticed apositive impact of this legal change on Brazilian universities' pat-enting activity [44].

However, the innovation should not happen only in universities,investment in R&D must occur in both the public as well as privaterealms for the system to optimally function [45]. Firms often cannotinnovate alone and universities do not often possess the expertise,resources or incentives to convert technological innovations tomarket-ready products [23]. Crucial for innovation is the interac-tion among various organizations and firms, often sharing knowl-edge, technology, facilities, and even researchers. Encouragingpublic-private technology transfer is an important component ofall innovation policies [10,46].

LTI, a push mechanism that operate upstream in the innovationchain [7e9], share some key features with the US Bayle-Dole andCRADA laws of the 1980s, but Brazil has different institutionalproblems regarding technology innovation incentives and tech-nology markets [18]. In developing countries, such as Brazil, tech-nology innovation promotion policy can be trumped by health costcontainment policy [18] and by unattractive support innovation toprivate companies with regard to tax regimes [48].

2.3. Good law (LDB)

The LDB (Law No. 11.196/05) was established in 2005 and pro-vides fiscal incentives to companies that invest in R&D (100% ofdeduction on expenses classified as operational expenses andexclusion from 50% to 250% of the expenses in projects with uni-versities) as well as incentives to partnering with medium andsmall sized firms [6]. LDB represents a new institutional resource, apush mechanism that operates upstream and contributes for na-tional companies become efficient and competitive to face thefierce international competition due to market globalization.However, previous studies indicate the need for a review on currentmechanisms and certain suggestions for improving this instrumentbecause the percentage of companies that benefit from these in-centives is still very small [49] since it depends on certain expertiseto take advantage of the law and the tax option of Braziliancompanies.

3. Research method

This study used data from patent families published between1990 and 2014 that were retrieved from Espacenet® (which is a freeand public technological database) to evaluate the impact of threeBrazilian laws on vaccines innovation chain. These data wereanalyzed as a whole in an effort to establish associations with theLPI, LIT, and LDB laws and provide insights that are cannot becaptured using other sources. Data were selected using the Inter-national Patent Classification (IPC) Code A61K39, which refers tomedicinal preparations that contain antigens or antibodies. Thesearch was refined using the symbol BR in the publication number,which denotes the patents that were granted in Brazil. These pri-mary data were analyzed by date of publication and classified aspatents filed by both Brazilian residents and non-residents to assess(i) the innovative strength of Brazil and the degree of autonomy ininnovation production and (ii) the interest of the national market

for foreign individuals or institutions that produce innovations invaccines. The distribution of patent families was also analyzed byapplicant nationality and applicant type, as described in thefollowing and illustrated in Fig. 1.

4. Results

4.1. Distribution of patent families by publication date

Fig. 1 presents the evolution of the number of patent familiesclassified as A61K39 that were published annually in Brazil be-tween 1990 and 2014. In total, the search performed in Espacenet®

retrieved 3663 patents that were published during this period. Thesearch for patents that were classified as IPC A61K39 during thesame period of publication in any country yielded 292,787 patents,which indicates that only 1.25% of all of the patents grantedworldwide were published in Brazil. The search using BR in thepriority number yielded 308 patents. Considering that the appli-cants in most cases request priority from their home countries,these data suggest that few documents were published by Brazilianinstitutions. This supposition was confirmed by the results of thestudy, which indicate that only 212 of the documents (5.79%) thatwere granted in Brazil were from Brazilian applicants. In addition,1.80% of the analyzed documents contained no record of theapplicant.

Fig. 2 shows that the distribution of patents classified as IPCA61K39 published in Brazil has increased since the late 1990s andreached significant peaks in the 21st century. Generally, until the1970s, the use of vaccines as a public-health strategy was largelyconfined to the industrialized Western nations and only becameavailable in the developing world after considerable delay [7]. Atfirst, as shown in Fig. 2, there was no significant vaccine R&D atBrazilian companies and institutions, and the Brazilian market wasnot attractive for the registration of foreign patents. In 1973, theNational Immunization Program (‘Programa Nacional deImunizaç~oes’ - PNI) was created in Brazil. However, it was only inthe 1990s that several vaccines were offered free of charge tospecific population groups [50]. The availability of free vaccinationswas a result of the Brazilian Constitution of 1988, which introducedfree and universal access to health care as a civil right [51].Thereafter, the government's purchasing power was strengthened,and a continually increasing public budget for vaccine production[24,46] was allocated. This change in the size of the domesticmarket aroused the interest of innovative foreign companies, whichwere also attracted by the promulgation of the LPI in 1996. The newlegislation granted the multinational pharmaceutical companiesthe financial ownership of the industrial property rights to theirhigh-tech products, which were previously copied in developingcountries [18].

The increase in the number of patents granted in Brazil to non-resident applicants after 1996 indicates the increasing internationalinterest in the Brazilian market. However, the innovative activitiesconducted at the national level exhibited no signs of substantiveprogress after the LPI's promulgation. However, Fig. 2 shows amajor improvement in the national scenario during the last decade,with 75% of the patents from Brazilian residents being granted after2004, which coincides with the promulgation of the LIT and LDB.Clearly, these laws cannot be considered to be unique conditions forthe occurrence of higher rates of innovation. However, the dataenable us to confirm the direct relationship between the regulatoryenvironment and the stimulus for R&D in critical areas of Brazil[24].

Additionally, it is important to note that the increase in thenumber of patents (from residents and non-residents) submitted tothe Brazilian authority that is responsible for the LPI's

Fig. 1. Research model studying the impact of three Brazilian laws on vaccines innovation chain.

0

50

100

150

200

250

300

350

Num

ber

of p

aten

ts

Publication dateTotal Resident Non-resident

Fig. 2. Patent families classified as IPC A61K39 and granted in Brazil classified by date of publication and by applicant type (residents and non-residents).

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implementation, the National Institute of Industrial Property(‘Instituto Nacional de Propriedade Industrial’ - INPI), is one of thefactors that is responsible for the delayed registration of patents. Arecent study has indicated that the current average waiting periodfor a patent to be granted by the INPI is 11 years, irrespective of thetechnological field [52]. The data obtained from the Espacenet®

database using the IPC code A61K39 indicate an average of 2.90

years between the applicant's submission date and the publicationdate. However, an analysis by decade suggests an increase in theperiod required for the registration of innovations from 2.18 yearsbetween 1990 and 1999 to 2.39 years between 2000 and 2009 andto 4.89 years for documents granted between 2010 and 2014, asstatistically detailed in Table 1. The long lead time required bypatent examination may discourage submissions to the INPI by

Table 1Analysis time for publication of patent families classified as IPC A61K39 and retrieved from the Espacenet® database.

Application date (interval in years) Publication date (interval in years) Analysis time for publication (Years)

n SD CL ME ILD Mean SLD

1988e1998 1990e1999 571 0.93 0.95 0.08 2.11 2.18 2.261994e2008 2000e2009 2346 1.08 0.95 0.04 2.35 2.4 2.441996e2013 2010e2014 746 1.74 0.95 0.12 4.78 4.9 5.03

n ¼ Number of patents; SD ¼ Standard deviation; CL ¼ Confidence level; ME ¼ Margin of error; ILD ¼ Inferior limit data; Mean ¼ average; SLD ¼ Superior limit date.

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residents and non-residents.

4.2. Distribution of patent families by nationality

Fig. 3 presents the distribution of patent families by the na-tionality of the first applicant. All countries listed in Fig. 3 had oneor more patents with mixed nationality, i.e., applicants fromdifferent nationalities, including Brazil, who had a joint patent withthe United States. The results using the IPC code A61K39 indicatethat the US holds 43.30% of all patents published in Brazil in thestudy area and is thus the country with the most interest in theBrazilian vaccine market. European countries hold approximately33.28% of the patents, and Japan and Australia hold 3.16% and 1.69%of these patents, respectively. Brazil, where patents were published,holds 5.79% of the documents and is the main representative inLatin America, which is also represented by Cuba (1.67%). In 2.16% ofthe documents, it was not possible to determine the nationality ofthe applicant. Overall, previous studies emphasize the substantialinternational interest in the Brazilian market [49], which isconfirmed with patents granted to 45 different countries.

4.3. Distribution of patent families by applicant

As reported in section 4.1, an increase in the number of patentsgranted to Brazilian residents was observed after 2004, which co-incides with the promulgation of the LIT and LDB. These pushmechanisms aimed to promote the relationships between univer-sities and private companies and encouraged the latter to invest ininnovation. Additionally, the mechanisms envisioned a develop-ment process that facilitated the unification of scientific productionand industrial activity. To assess the effectiveness of this new legalframework, the patent families from Brazilian applicants and USapplicants (i.e., the most frequent applicant) were classified into

0 500Others (31 countries)

Denmark

Cuba

Italy

Japan

Belgium

Switzerland

Germany

United States of America

Number

Fig. 3. Distribution by nationality of patent famil

public institutions (PI), private companies (PC), or mixed patentsthat contain public and private applicants (PI þ PC). The classifi-cation was performed based on a search of the applicant websites.Organizations such as hospitals, universities, and non-profit orga-nizations were considered to be public institutions. To assess thechange of the results over time, the documents were grouped ac-cording to distinct time periods. The results of this analysis aresummarized in Table 2.

The studies that analyzed IP data in Brazil indicated that a largeshare of pharmaceutical R&D activities are conducted by univer-sities [53] and that there is substantial resistance to the intellectualappropriation of knowledge generated in these institutions [54].The study results indicate that most R&D in Brazil is conducted inuniversities (96 patents) and that the involvement of public in-stitutions in the granting of patents has increased over time.

Additionally, the results indicate a cultural change in the Bra-zilian academy, which is at present more responsive and preparedfor the conversion of scientific knowledge into commercial activity.The 212 patents considered in this analysis had 84 different Bra-zilian applicants (see Table 2), with the highest participation fromthe Oswaldo Cruz Foundation (26 patents), Butantan Institute (18patents), and several universities, particularly the Federal Univer-sity of Minas Gerais (‘Universidade Federal de Minas Gerais’ eUFMG; 33 patents) and the University of S~ao Paulo (‘Universidadede S~ao Paulo’ e USP; 16 patents). In addition, ownership of 39documents was shared between public universities/institutions.

Despite the stimulus provided by the LIT and the LDB andconsidering the limited data of this study, the participation ofBrazilian private companies or university-industry partnerships inthe granting of patents did not increase for the Brazilian applicants.However, it is important to consider that public-private partner-ships can result in patents not shared between the two sectors,depending on the agreements established [24], and that the IP

1000 1500 2000

of patents

ies retrieved from the Espacenet® database.

Table 2Classification of patent families retrieved from the Espacenet® database by type of applicant (public and/or private) and in three distinct time periods for Brazilian and USapplicants.

Country Brazil United States

Period Public (PI) Private (PC) PI þ PC Public (PI) Private (PC) PI þ PC

1990e2014 141 (66.5%) 58 (27.4%) 13 (6.1%) 342 (21.6%) 1138 (71.8%) 104 (6.6%)1990e1999 16 (48.5%) 15 (45.5%) 2 (6.0%) 69 (29.4%) 154 (65.5%) 12 (5.1%)2000e2009 67 (65.7%) 30 (29.4%) 5 (4.9%) 228 (21.6%) 751 (71.3%) 75 (7.1%)2010e2014 58 (75.3%) 13 (16.9%) 6 (7.8%) 46 (15.5%) 234 (78.8%) 17 (5.7%)

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rights should not prevent members from creating strategies toprotect the implementation of solutions in public health [53]. Un-like Brazil, the results from the US are more spreaded and indicatethat the percentage share of patents filed in Brazil that originated inprivate companies increased over time, particularly the companiesWyeth (93 patents), Pfizer (69 patents), Biogen (49 patents), andCorixa (44 patents). These multinational companies are notinvolved in R&D in Brazil and consequently have a limited impacton the development of innovative products and processes at thenational level [23]. Many studies emphasize the need to involve theprivate sector in pharmaceutical R&D activities [10,46] with the aimof transforming basic research into novel commercial products[23]. However, results from various studies indicate that this pro-cess does not occur in Brazil.

5. Concluding remarks

In Brazil, health care is under the tutelage of the government,which ensures interventionist and regulatory characteristics forR&D in science, technology, and pharmaceutical innovations [51].Considering that the market forces alone do not foster a productiveenvironment [10], the Brazilian government has implementedpolicies to support the development of national vaccines selectedbecause of market reasons, public-health strategies, or addedtechnological value [24,46]. Therefore, using patent data, this studyaimed to analyze the effectiveness of push and pull regulations invaccine R&D in Brazil.

Brazil must eliminate the stigma of being a peripheral economy,and IP management is essential for that purpose. This decision isnot only technical but also, above all, political. The main criticism ofthe LPI involves the disregard for the safeguards authorized by theWTO [11] that considered the country's level of development topromote national innovation before the introduction of a morerestrictive IP system [55]. In addition to the requirements of theTRIPS agreement, Brazil accepted bilateral agreements signedoutside of the WTO, which are designated TRIPS-plus [56,57]. Theimmediate effect of these agreements was the stringent system forthe protection of the rights to pharmaceutical patents, which madeBrazil a technology importer but without the technology transferand capacity-building that was necessary in the country [58].Despite their limitations, our results confirm this information bydemonstrating that the pull mechanism of incentives granted bythe LPI stimulated international interest in the Brazilian market.However, the innovations at the national level did not achievesignificant progress. Nevertheless, it is necessary to avoid a naiveapproach based solely on autochthonous and self-sufficientdevelopment. It is necessary to acknowledge and understand theimportance of international technology transfer, particularlythrough partnerships with multinational companies [46], for na-tional capacity-building [7,24]. Therefore, further research isrequired to understand how price controls in health policies affectR&D in Brazil [18] and to investigate improved IP management,which is only part of the process to improve Brazilian R&D [10,11].

After making innovation the focus of industrial policy [24],Brazil has made significant progress in the innovation agendaduring the last decade while becoming an international provider ofvaccines and moving, albeit slowly, from incremental innovation tothe development of novel products [7,11]. This study demonstratedthat the LIT and the LDB facilitated advances in vaccine R&D inBrazil. However, these push mechanisms must be improved for thecountry to become part of the global innovation scenario. In Brazil,most R&D on health remain government-sponsored and is con-ducted in public institutions, contrary to the practice of developedcountries [18,23]. Themain criticism of the LIT and the LDB refers tothe small number of companies that took advantage of governmentsupport for innovation [47]. This lack of interest occurred becausethe instruments to support innovation are unattractive with regardto tax regimes. These regimes are little known, complex, andbureaucratic, which creates legal uncertainty. In addition, mostBrazilian private firms are small and medium-sized and not theprimary target of the instruments for supporting innovation.Furthermore, large domestic companies lack the culture of inno-vation and traditionally only focus on the national market to thedetriment of international competition.

In addition to the stimulation of innovation in private com-panies, another challenge for the LIT and the LDB was to transformuniversity research into marketable inventions and support theuniversity-industry relationship. Our results indicate the promi-nent role of Brazilian universities in scientific research but alsoreveal the limited role of researchers in private companies in Brazil[18], which makes the country highly dependent on universities forthe generation of patents [59]. Although several universities aredistinguished with respect to patent filing, they do not alwaysattract or stimulate the interest of the industrial sector, which hasnot requested these patents and has late access to information. TheBrazilian government has provided financial and tax incentivesbefore promoting the implementation of successful technologycenters [60]. Thus, the lack of public-private partnerships confirmsthat the simple distribution of incentives is not an effective mea-sure if the parties involved are not prepared to cooperate in aninnovative environment [1,60e63]. Despite the promulgation ofthe LIT and the LDB, major challenges remain with respect to thecreation of a more legitimate environment for technological ex-change between the productive sector and the producers ofknowledge in Brazil.

The study results are promising and underscore the significantnational efforts that have been made in Brazil to ensure that na-tional policies and technological and industrial strategies incor-porate innovation in vaccines and change the competitivecircumstances of the economy. In this sense, one can think of theinnovation promotion system as a government public policy systemthat is able to serve social and economic interests and that pro-motes sustainable development. However, the provision of regu-latory and tax incentives does not necessarily imply higher rates ofinnovation. Cultural issues, competing political issues, and the needfor regulatory adjustments must also be considered. The present

C.R.P. da Veiga et al. / World Patent Information 46 (2016) 11e18 17

findings have limitations, including the exclusive use of patent dataas attractiveness measure without considering other social andeconomic performance indicators. Moreover, in the intellectualproperty context, the selection of a specific pharmaceuticalsegment using IPC, and temporal and regulatory limitationsrepresent important limitations to this study. However, these dataprovide insights that cannot be captured using other sources,particularly if analyzed as a whole with the aim of establishingcorrelations with other data. This subject is complex, and the pre-sent study did not intend to exhaust the topic.

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