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

Bibliographic Data

ID5166084
AuthorsEduardo Mercadante (0000-0001-5597-4863, London School of Economics and Political Sciences, United Kingdom), Julia Paranhos (0000-0003-4425-7484, Universidade Federal do Rio de Janeiro)
Year2022
Volume38
Issue1
Pagese00043021-e00043021
Publication date2022-01-01
Open AccessYes
TypeARTICLE
VenueCadernos de Saude Publica (JOURNAL)
Journal identifiersISSN: 0102-311X • E-ISSN: 1678-4464
PublisherFapUNIFESP (SciELO) (PUBLISHER)
DOI10.1590/0102-311x00043021
PMID35107507
OpenAlexW4210737733
SciELOS0102-311X2022000105017
LanguageEN
Citations received2
References cited6

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

Agency (philosophy) · Extension (predicate logic) · Intellectual property · Patent application · Patent troll · Pharmaceutical industry · Term (time) · Intellectual Property and Patents · Pharmaceutical Economics and Policy · Public Health in Brazil

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Citations per year1
Citation span2024 - 2025 (2)
Highly citedNo

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