Newsletter Edition 25 - May 2021


Respect for patents is the best way

In charge of ABPI, lawyer Luiz Edgard Montaury Pimenta has faced turbulent days due to the recent fissures in the intellectual property legal system. After successive trial sessions, the STF (Supreme Federal Court), by majority vote, declared the Sole Paragraph of Article 40 of the Brazilian Industrial Property Law – which grants a compensatory term of ten years for BPTO delays – unconstitutional and invalidated the pharmaceutical patents in force that benefited from this term. For ABPI’s president, the overthrow of this device is a bad marker of Brazil for investors in innovation. In this interview, like others he has given to the press, ABPI’s president analyzes the effects of this historic trial.

What is the consequence for Brazil of the recent decisions of the STF on the validity of patents?

Luiz Edgard Montaury Pimenta: The direct consequence is the extinction, already, of more than three thousand patents in the pharmaceutical area that were in force. And, for patents granted from now on, none will have the minimum ten-year term provided for in the Sole Paragraph of Article 40 of the Brazilian Industrial Property Law. They only start to benefit from, after being granted, the 20-year term from the application. This without considering that there is always the possibility that the exam will take a long time – even because, in the case of those in the pharmaceutical area, there is still the obligation of prior consent by Anvisa (National Health Surveillance Agency), before patents are granted by the BPTO, as provided for in this same law. Concerning the indirect consequences, we could say that the greatest concern would fall on the issue of legal uncertainty, besides representing a clear sign of discouragement to innovation, research, and development.

Can the decision that overturned pharmaceutical patents and healthcare equipment that had already been extended make drug prices cheaper?

LEMP: In theory, the decision may bring prices down, but it is an apparent advantage, which is valid for the short term. The problem is that overturning a patent is a bad signal for industry, research centers, Brazilian companies, and even universities. If, in the future, new variants of the coronavirus or any new virus appear, without the guarantee that their patents will be respected, what is the incentive of these companies and institutions to invest in new drugs?

Can the invalidation of the sole paragraph of Article 40 facilitate Brazil’s access to vaccines against Covid-19?

LEMP: The answer is no. On the contrary, it may even hinder Brazil’s access to vaccines. The foreign pharmaceutical industry can assess that Brazil is disrespecting Intellectual Property based on a unilateral change in the rules that the country has adopted for decades. It must be remembered that Brazil depends on importing inputs, on technology that comes from abroad, and this decision can create embarrassment for vaccine import. In public health matters, respect for patents is always the best way.

How do you evaluate Bills 12/2021 and 1,171/2021, which proposes that the government decree the temporary compulsory license of vaccines patents, diagnostic tests, and medications to face Covid-19 as a way to accelerate the population’s immunization process?

LEMP: If approved, these bills that are being processed in Congress will have little or no effect and will not speed up immunization at all. In fact, in our Industrial Property Law, there is already a provision for compulsory licensing in these cases. It is like going over old ground. We do not need other laws on this topic. If the government wishes, based on this law, it decrees the compulsory license of certain medications.