Abstract
In Brazil, if patent prosecution takes more than 10 years, this extra period is added to the regular 20-year term. This paper analyses all pharmaceutical patents granted by the Brazilian National Institute of Industrial Property (INPI) with term extension and later discusses some intellectual property and health policy implications. On average, pharmaceutical patent applications wait seven years after substantive examination is requested before being examined, which takes only three and a half years. Furthermore, the role of the Brazilian Health Regulatory Agency (Anvisa) in providing prior consent has a marginal effect in prolonging the prosecution. Therefore, the extension of pharmaceutical patents' term is caused by the number of pending applications per examiner, which halts the prosecution for double the time it takes to examine the applications. Thus, proper solutions should focus on reducing the backlog per examiner at the INPI, which has caused the extension of 92% of the pharmaceutical patents in three and a half years, on average. We concluded that the Brazilian pharmaceutical patenting policy is biased towards the patentee. This imbalance will only be effectively corrected when the INPI is financially and administratively autonomous to reduce the ratio between the pharmaceutical patent application backlog and the number of examiners.
Highlights
Signed in 1994, the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement changed the intellectual property paradigm
The ex-post statistical analysis of the term extension of pharmaceutical patents granted by the INPI, after Brazil became harmonized with the TRIPS Agreement, was done in two stages
This section presents the analysis of the pharmaceutical patents granted with term extension in Brazil between 1997 and 2018: 630 or 92.2% of the extendable patents
Summary
Signed in 1994, the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement changed the intellectual property paradigm. The three major changes imposed by TRIPS on every World Trade Organization (WTO) member were: (a) the prohibition to exclude any technological field from patenting; (b) the obligation to reform national legislations to guarantee the mandatory minimum requirements – preserving some flexibilities –; and (c) the deadline for the harmonization process, depending on the income level 1. This was especially to the detriment of developing countries, most of which enjoyed their discretionary powers under previous agreements, for example, excluding pharmaceuticals from patenting. This study investigates how the Brazilian harmonization to TRIPS affected the patent office concerning pharmaceutical patent prosecution
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
