The law of Generics allowed the growth of national industries, But investment in Research, Development and Innovation (P, D & I) remained practically null. Based on this scenario of fragility of the Brazilian industry, a research in database of patent documents, using as methodology, a search strategy, according to the International Patent Classification (IPC) was done. This survey, based on the analysis of the patent documents obtained, allowed us to reach the objective of the study, which is to introduce the situation of the national pharmaceutical industries in relation to investment in innovation. The results indicate the lack of investments in innovation in Brazil, allowing the conclusion that the country is totally dependent on the imports of medicines. This fact positions the multinational industries in a situation of superiority, facilitating the practice of abusive prices, since these take advantage of the patent protection.
Objectives The aim of the present study was to present the market scenario of biotechnological drugs, especially insulin. In addition to Brazil, a study was conducted that considered the United States market, which has the largest market of biotechnological products in the world and in China, for presenting an increase in investments in the biotechnology area and is a BRICS member. Methods A market survey of biotechnological drugs and insulin was carried out. The information that was used is provided through the IMS Health Customer Portal from 2010 to 2014, and was searched in the AliceWeb database between 2011 and 2016, and we consulted Insights magazine (published by IMS Health). Information was also obtained from the Brazilian Association of the Pharmaceutical and Pharmaceutical Industries (Abiquif) (2012–2016) and from the International Diabetes Federation (IDF), available on its websites, to identify sales of biotech drugs and, more specifically, insulin. Key findings The deficit in the Brazilian trade balance between 2012 and 2016, related to medicines, remains high, mainly driven by the acquisition of high value‐added drugs, mainly biotechnological drugs, such as insulin. In 5 years (2010–2014), the value of the commercialization of insulin increased by an average of 100%. In 2010, the total marketing value of insulin was approximately US $16 billion, and in 2014, it was approximately US $29 billion. The three laboratories that stand out in the world, namely, Sanofi, Lilly and Novo Nordisk, are the main laboratories that market insulin in Brazil. Conclusions The observed results make evident the import dependence for the acquisition of insulin, which can lead to a national shortage and possible cases of death and sequelae from diabetes in patients who did not receive adequate treatment, besides contributing to the trade deficit.
RESUMODesde a promulgação da lei que regula direitos e obrigações relativos à Propriedade Industrial, Lei n. 9.279/96, baseada nos preceitos ditados pelo TRIPS -Trade-Related Aspects of Intellectual Property Right, a retomada da proteção dos produtos e processos farmacêuticos, inicialmente, através dos arts. 230-232 que possibilitaram a revalidação, no Brasil, de patentes concedidas no exterior, sem análise de mérito, vem sendo debatida em diversos foros. Embora não seja de opinião unívoca, é constante e acirrada a discução sobre a constitucionalidade do ato de se conceder o privilégio à uma suposta invenção sem análise dos requisitos básicos de patenteabilidade exigidos
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