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Pharmaceutical patent term extension and patent prosecution in Brazil (1997-2018)

Mercadante, Eduardo ORCID: 0000-0001-5597-4863 and Paranhos, Julia (2022) Pharmaceutical patent term extension and patent prosecution in Brazil (1997-2018). Cadernos de saude publica, 38 (1). ISSN 1678-4464

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Identification Number: 10.1590/0102-311X00043021


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.

Item Type: Article
Official URL:
Additional Information: © 2021 The Authors
Divisions: International Development
Subjects: R Medicine > RS Pharmacy and materia medica
R Medicine > RA Public aspects of medicine > RA1001 Forensic Medicine. Medical jurisprudence. Legal medicine
Date Deposited: 17 Feb 2022 11:57
Last Modified: 22 Feb 2022 10:00

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