The Brazilian Patent Office (BPO) has historically experienced some of the longest pendency times in the world, in some cases patent applications taking more than 15 years to grant. As compensation to patentees for delays by the BPO, if prosecution lasted more than 10 years, a minimum patent term of 10 years from date of grant was automatically applied. This effectively extended the term of the patent beyond the usual term of 20 years from the filing date.
The Brazilian Supreme Court has now determined that, even in view of the significant backlog of patent applications at the BPO, this extension is unconstitutional. One of the underlying reasons for the decision is the fact that the extension was applied automatically at grant, regardless of whether the patentee contributed to any delay in prosecution.
How does the decision affect pending applications?
The decision means that all patents granted in Brazil from 12 May 2021 onwards will now have a 20 year term calculated from the filing date, regardless of any excessive delay in prosecution by the BPO.
Given the BPO’s backlog, this decision affects thousands of patent applications in all areas of technology that have been pending for over than 10 years.
Consideration should be made by any applicant in these circumstances as to whether examination can be expedited. For example, the Patent Prosecution Highway may be an option for some applicants.
What does the decision mean for patents that have already been granted with an extended term?
The decision does not affect the term of patents that have already been granted with the benefit of the minimum 10 year term from grant, except for patents that:
- relate to pharmaceutical products and processes, as well as equipment and materials for use in healthcare, and/or
- patents that were subject to invalidity lawsuits filed before 7 April 2021.
These patents will have their term reduced retroactively, so they have a term 20 years from date of filing.
The BPO has already indicated that it is reviewing these patents and that any patents relating to the exclusion will be republished with a 20 year term from filing. The BPO has indicated that patents with the following International Patent Classifications will undergo review:
- Medical technologies (A61B, A61C, A61D, A61F, A61G, A61H, A61J, A61L, A61M, A61N, H05G, G16H)
- Preparations for dentistry (A61K/6)
- Diagnosis involving enzymes (C12Q/1)
- Relating to diagnosis (G01N/33)
This is likely to affect more than 3,000 granted patens in the pharmaceutical and health sector, granted with the 10 year provision. There may be instances where the decision to adjust the term of a patent will be challenged, creating uncertainty around its expiry date.
Impact
This decision will have an immediate impact on the pharmaceutical field in Brazil, in some instances allowing generic and biosimilar companies to launch earlier than previously anticipated.
In addition, it is likely that we will see patentees in this field push back and seek legislative change to deal with the fundamental issue of delay in obtaining granted pharmaceutical patents. An alternative framework may be considered, possibly in line with the patent term extension granted in the USA or the Supplementary Protection Certificate regime in Europe. However, there is a more fundamental issue that need needs to be addressed to deal with the significant backlog at the BPO in order to minimise these delays.
This article was written by Sarah Couper.
1 June 2021
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