Medicine patents in Brazil – legislative changes and their impacts.
Text taken from the interview with Katia Jane Ferreira available on our YouTube channel.
Katia Jane Ferreira, graduated in chemical engineering and law, master's degree in civil law, specialist in patents and competitive intelligence, has been working in the intellectual property area for 25 years. Partner at Aoki, Ferreira, Mattioli & Yamashita.
It was only in 1996 that the technological area, including pharmaceuticals, was covered by the patent protection law: I think we must go back a little in time to understand how we got here, because this subject has been much debated lately and object of an STF (Federal Court of Justice) discussion.
Our current legislation, the legislation that covers not only pharmaceuticals, but all areas of technology, is a 1996 legislation. It is law 9279 of ‘96, which is the result of a need to change our intellectual property legislation at that time. Until then, the old industrial property code did not provide for protection for the chemical, pharmaceutical and food areas. This area of technology became subjected to patent protection in 1996/1997, when the legislation came into force. We have very interesting historical moments, because by then the issue patent was not present in our scenario, in our market. Everyone could do whatever they wanted, since there was no provision for protection.
Bringing a little of this historical overview, we have a very important pillar of patents, which is the time of validity, the time of protection. This is the discussion we are facing now, which is no longer so much of a discussion because there is already a decision that revolves around this time of validity.
In the old legislation of our industrial property code prior to 1996, protection was guaranteed for 15 years. But by the forces of international treaties, including a very important treaty called TRIPs , a treaty related to trade versus intellectual property, this period of validity was guaranteed as the minimum 20 years that is adopted today in large jurisdictions. And we are talking about 20 years uniformly for all countries. What happens is that Brazil, due to a local issue, this deadline ended up being modified.
The INPI (National Institute of Industrial Property) bottleneck: Here, the prompt of patents was directly conditioned by the processing capacity of our National Institute of Industrial Property (INPI), which is the body responsible for analyzing the patents filed, and deciding for their protection - or not.
The resources that Brazil has available at the INPI are insufficient compared to the number of processes to be analyzed and that is why there was an accumulation that we call the “back lock”. In general, no cases in the drug area were analyzed before the age of 10 years.
In this scenario, Brazil, aiming to provide some kind of minimum protection, established that in our local legislation patents would be valid for 20 years from the filing date, that is, from that initial application to the National Institute of Industrial Property, or 10 years from the grant, applying greater term.
So, we had a situation in which the INPI started to do the exam after 10 years of age, and with that we reached patents of 21, 22, 23, 24 years, and we know cases of up to 32 years of validity.
This was the situation we were living in and in my view, it was not a good situation for neither sides: neither for the generics and similar industry, nor for the innovative industry, as it was an environment of great uncertainty for both sides.
The change in legislation : The impacts generated by this chronic situation throughout this 20-year experience that we have lived here in Brazil were submitted to the STF through a direct constitutionality action, which is action 5529, the object of discussion in many STF sessions.
The STF saw fit to consider the sole paragraph of article 40 unconstitutional, which is precisely this apparatus that says that patents will not be valid for less than 10 years in the granting. From the moment it ceases to exist, there are impacts.
these impacts were modulated by the Supreme Court itself. What does the STF tell us? For the pharmaceutical area, no patent that won the 10-year concession will continue with it.
From now on, as of the publication of this decision, all patents retrogress to what they should have earned, which is 20 years from the concession. The effects of modulation for the area of drugs were significant. For other technological areas, patents persisted with this extended period of validity, of 10 years from the concession, but from now on, patents that are granted will only gain 20 years.
And there is still a third aspect of modulation that cases that were judicialized, because many companies questioned this issue of the sole paragraph of article 40 being applied to patents in the pharmaceutical and agribusiness area. Judicial cases will also be modulated. But for the pharmaceutical area, the great result is that all patents that were entitled to the 10-year concession now have 20 years from the filing date. This is a significant impact for all actuators in this scenario.