Provision that extends drug patents suspended by Toffoli
On April 7, 2021, Rapporteur Justice Dias Toffoli partially granted the request for provisional emergency relief requested by the Office of the General Counsel for the Federal Government – PGR in the Direct Action for the Declaration of Unconstitutionality (ADI) No. 5529, which deals with the request for preliminary suspension and declaration of unconstitutionality, by the Brazilian Supreme Court, of the sole paragraph of article 40 of the Intellectual Property Law (LPI).
Thus, the sole paragraph of article 40 of the LPI, which deals with patent validity terms, is suspended from that date only for patents on pharmaceutical products and processes and health equipment and/or materials.
UNDERSTAND THE DETAILS
What are the invention patents and utility model terms?
According to article 40 of the LPI:
• invention patents are valid for 20 years; and
• utility model patents, for 15 years.
The terms are counted from the date of the patent registration.
Are there any exceptions to these terms?
Yes, if the time for the analysis of the application for registration by the Brazilian Patent and Trademark Office – INPI is too long, the head of article 40 of the LPI must be construed in conjunction with its sole paragraph which provides:
• that invention patents are valid for at least 10 years; and
• utility model patents, for 7 years.
The periods are counted from the date of grant of the patents.
Therefore, the sole paragraph of article 40 of the LPI would apply if the INPI took more than 10 years in the analysis of the application for an invention patent or 8 years in the analysis of the application for a utility model patent, when, respecting the minimum concession periods, the protection periods would be longer than the 20 and 15 year maximum terms provided for in the head of the same article.
What does PGR claim in ADI 5529?
According to the PGR, the case of the sole paragraph allows the granted patent to remain valid for an indefinite period, against the principle of temporary patent protection (established in item XXIX of article 5 of the Federal Constitution).
• that the delay caused by the INPI would place an undue burden on the entire society, which goes against § 6 of article 37 of the Federal Constitution, according to which legal entities of public law must answer for any damages caused to third parties by their agents; and
• that the indefinite extension of the terms of invention patents and utility models would violate rights such as legal certainty, free competition and consumer protection.
Even though the delay caused by the INPI causes, in fact, a burden to society and legal uncertainty, the claim regarding the indefinite term of the patents would not land on its feet, since, even if the term is long, it is determined when the patent it is granted and, in most cases, it is very close to the maximum term provided by law.
The average patent term in Brazil is quite high compared to the other countries that are members of the BRICS (Russia, India, China and South Africa)¹. However, according to information from the 2019 Intellectual Industrial Property Indicators (Indicadores de Propriedade Industrial 2019) of the INPI, the technical decision of the invention patent process has taken an average of 11 years, which would increase the term of the patent by only 1 year. According to a report released in 2020 by the Law and Poverty Group of University of São Paulo’s Law School, Brazil has an average of 24.305 years for drug patent terms, which would increase the legal term by just 4 years.
¹ GRUPO DIREITO E POBREZA. The Unconstitutionality of Article 40, Sole Paragraph, of the Industrial Property Law from a Comparative Perspective. São Paulo, 2020. p. 36. Available at: http://abiaids.org.br/wp-content/uploads/2020/12/GDP-2020-A-inconstitucionalidade-do-artigo-40-parágrafo-único-da-LPI-sob-uma-perspectiva-comparada.pdf. Accessed on 04/09/2021.