The Relevance of Regional Specificities of Intellectual Property Regulations for Pharmaceutical Industries: Brazilian Law Changes That Immediately Affected Crucial US-Pharmaceutical Patents with Correspondents in Brazil

Abstract

In May, 2021, the single section of title 40 of the Brazilian industrial property act (LPI 9.279/1996), which guaranteed a minimum term of 10 years to a granted patent was found unconstitutional by a decision on the Direct Act of Unconstitutionality #5529/DF (ADI5529/DF). It resulted in crucial and immediate effects, especially in Brazilian pharmaceutical market, affecting the and the international interests of pharmaceutical companies in the Brazilian market. Such law changes, although being a national matter, but having international consequences must be under watch worldwide, since they are not arbitrary, but the result of the power that each country has to exert their legal freedom. Therefore, considering the information available on patent databases, this work evidences such effects, evaluating American pharmaceutical patents with correspondents in Brazil that had been benefiting from a particular provision of the Brazilian intellectual property law, the single section of title 40, which provide a minimum term to granted patents that took too long to be evaluated and should be an exception provision. From those data, we have found that 75% of those patents were affected in expressive ways, for instance, 38% of them immediately expired, and 33% had their terms drastically shortened. This work also shows that only 32% of those patents were not affected by the decision of unconstitutionality of single section of title 40 of the Brazilian law. This evidences a severe impact on the ways the national pharmaceutical companies will work, especially because this change immediately open to them several opportunities to explore drugs that, until the day before the decision, were in force and now are at public domain. However, they are not prepared to innovate and it may not be able to supply the market. On the other hand, multinational companies may withdraw from the market, since that are no longer working under a monopoly. The information disclosed in this work show that it will severely affect the Brazilian pharmaceutical market from now on and draws the attention to the need of companies to be aware of all national laws regarding to the market of interest.