“Since pharmaceutical patent applications must be submitted for prior approval by the Brazilian National Agency for Sanitary Surveillance before being prosecuted at the BPTO, this adds to the already high average grant time.”
A key issue of discussion with respect to the Brazilian patent system has to do with patents granted by the Brazilian Patent and Trademark Office (BPTO) under the following sole paragraph of Article 40 of the Brazilian IP Law:
Article 40 – The term of a patent for an invention shall be 20 (twenty) years and for a utility model 15 (fifteen) years as from the filing date.
Sole Paragraph – The term shall not be less than 10 (ten) years for inventions and 7 (seven) years for utility models, as from the date of grant, except where INPI is prevented from carrying out the substantive examination of the application due to pending litigation or for reasons beyond its control.
This provision guarantees that patentees enjoy a 20-year term from filing and is particularly relevant due to the considerable examination backlog at the BPTO.
The 10-year minimum validity term from the date of grant is especially significant in the pharmaceutical field. Since Article 229-C of the Brazilian IP Law determines that any pharmaceutical patent application must be submitted for prior approval by the Brazilian National Agency for Sanitary Surveillance (ANVISA) before being prosecuted at the BPTO, this adds to the already high average grant time for pharmaceutical patents.
Patent Backlog Background
Historically, there has always been an overload of work at the BPTO. One major reason for that is the reduced number of examiners in the most diverse technical areas compared to that of other patent offices around the world. Besides the standard delay in starting examination, there is also a significant delay involved with having a technical examination completed in the administrative phase.
The BPTO has acted on several fronts to reduce the examination backlog, as well as to achieve speedier examination timings in the future. The BPTO’s review of internal procedures was a starting point for these improvements. While the backlog has already been reduced by around 44% as result of this process, there are still more than 82,000 patent applications pending.
The years 2019 and 2020 were marked in Brazil by a range of BPTO initiatives to reduce the number of pending patent applications. The goal is to complete examination of patent applications within an average time of two years, thus almost eliminating the backlog.
Despite these efforts, prolonged examination times remain a problem, and pharmaceutical patents are perhaps most affected.
Examination Workflow of Pharmaceutical Applications
In practice, all patent applications from the pharmaceutical area (those having International Patent Classification (IPC) A61K, for instance, referring to preparations for medical, dental, or toilet purposes), are sent to ANVISA to obtain prior approval from the agency as an initial step in the examination phase. Once the prior approval is published, the BPTO can proceed with its technical examination.
Although the process seems simple, since ANVISA does not have the ability to assess patentability, many patent applications are held up awaiting review, further exacerbating the backlog.
Pharmaceutical Patent Applications Granted in 2020
A deeper analysis of pharmaceutical cases confirms that about 60% of all pharmaceutical patent applications granted in 2020 fell within the relevant paragraph of Article 40 and had a term of 10 years of validity from grant.
For all technical areas, around 30% received 10 years of validity from grant in 2020, but, according to the BPTO’s data, the average length of protection beyond the regular term (20 years counted from filing) is traditionally less than two years. Among patents that were granted based on the 10-year term that are still in force, there are only nine patents for which the term of protection extends 10-13 years (see Figure 1):
(Source: Figure 1 prepared by the author)
The current estimate from the BPTO is that almost 8,000 pending patent applications from various technological fields will be subject to the 10-year minimum term of protection if granted as of 2021, of which more than 2,700 patent applications are classified as belonging to the pharmaceutical field (see Figure 2). This is because the BPTO is waiting on ANVISA’s analysis of about 745 patent applications in order to proceed with the technical examination. If prior approval is not granted by ANVISA, the application is dismissed, and it will no longer appear in the examination queue.
(Source: Figure 2 prepared by the author)
Article 40 is currently being challenged in Brazil’s Supreme Court. The main argument is that it creates uncertainty around the term of validity at the time of filing – since it could be 20 years from filing or 10 years from grant, whichever is longer – and results in harm to society by blocking competing products in the market, as well as to competitors interested in reproducing the claimed technology, which impedes investment in the economy. According to the plaintiff in the case, the term of protection of a patent should be clear as of the time of filing.
The BPTO should be commended for its efforts to speed up examination timings, but considering the number of patent applications in the pharmaceutical area still awaiting conclusion of examination, the Office must work closely with ANVISA to ensure that prior approval is granted more efficiently for those cases that do not deal with substances of prohibited use in Brazil.