By Karina Daiha 

(This article was first published on Mondaq on 4 June, and transcribes the interview conducted with Dr. Átila Duque Rossi, PhD, from the Molecular Virology Laboratory of the Federal University of Rio de Janeiro (UFRJ) on May 17, 2020)

On March 11, 2020, the World Health Organization characterized COVID-19, a disease caused by the new coronavirus (scientifically called SARS-CoV-2), as a pandemic. Two months later, Brazil is the country with the third highest number of confirmed cases, according to data released by Johns Hopkins Hospital.

Brazil, an emerging country of continental proportions, faces several obstacles to fighting the disease, including, for example, the difficulty of mass testing the population. On the other hand, the Brazilian scientific community is seriously committed to contributing to global efforts in combatting COVID-19.

On the scientific front, Dr. Átila Duque Rossi PhD, from the Molecular Virology Laboratory of the Federal University of Rio de Janeiro (UFRJ), has been playing a key role in monitoring infections in public health professionals in the city of Rio de Janeiro.

The interview transcribed below, was conducted with Dr. Rossi by Karina de Godoy Daiha M.Sc., partner at Venturini IP, and addresses the panorama of Brazil’s position regarding innovation in the fight against COVID-19.

Question: What is it like to be working on the scientific frontline to combat COVID-19 in Brazil, a country so affected by the pandemic?

 Dr. Rossi: It is very gratifying to be able to contribute as a scientist to the situation that we are experiencing in our country. Science is often neglected, especially in Brazil, but at a time as critical as this, we can truly show its value. Undoubtedly, being part of this process brings great satisfaction and compensates for the associated risks.

Question: What is the participation of Brazilian science in the innovative effort to combat COVID-19?

Dr. Rossi: Brazil has made great efforts to add to the international scientific efforts of combating COVID-19, especially with regard to diagnosis. In the times we are living in, where policies of social isolation are necessary, diagnosis works as a thermometer to support decision-making by health authorities. Currently, we do not have any national tests and we depend on imported products that make our testing capacity much lower than necessary.

Other research efforts in Brazil include vaccine treatment and production strategies, but there are many obstacles for our country on this path. One of the main obstacles is the fact that most of the supplies used in such research here require import processes for their acquisition. This is due to the lack of national companies focused on the production of these materials and the low attractiveness for international companies to produce locally in Brazil. Thus, research laboratories find themselves hostage to the world economic scenario, to the related price fluctuation, and the slow and complicated import-related bureaucracy, which ends up resulting in long delivery times. This, unfortunately, directly impacts Brazil’s ability to monitor the “state of the art” for the production of innovation in any research topic, and this is no different for studies on SARS-CoV-2.

Karina Daiha: Dr. Rossi pointed out very well the problem of technological dependence historically faced by Brazil, mainly in the biotechnology sector. In a recent survey published by the Brazilian Patent Office in relation to patent applications filed in Brazil involving methods of diagnosing respiratory viruses, no national company or research institution stood out. Historically, the number of patent application filings in Brazil has always been much higher for non-resident applicants than for Brazilian residents.

Data on patent filings is an indicator of a country’s innovative efforts. In view of what we observe in Brazil, it is very clear that, although the efforts of our scientific community are praised, the national biotechnology market and its supplies is still dominated by foreign technology. To look at it from another angle, we see that less than 1% of patent applications filed under the PCT enter the Brazilian national phase. Since the protection afforded by the patent is regional, companies and research institutions in Brazil have broad knowledge available and exploitable that could be applied precisely to reduce our technological dependence.

Question: Could you point out, among the global initiatives in progress, which ones seem most promising?

 Dr. Rossi: In terms of better understanding our relationship with SARS-CoV-2, I would say that the most promising initiatives are those related to vaccine production. Vaccines work prophylactically (before the disease phase) and protect not only the individual but also the community, since the subject is no longer a possible transmitter of the infection. This has gigantic relevance in a pandemic context, where the main challenge is precisely to “stop” the infectious agent and, with that, stop the emergence of cases.

In addition, this virus, so far, does not pose as many challenges for the development of an immunization strategy. However, the production of a vaccine is a long process and, given the urgencies of this pandemic, we need a faster strategy to fight infections, especially for the most serious cases. In this sense, I believe that the search for drugs already approved for human treatment by health regulatory agencies is also a very promising path.

Karina Daiha: The development of new uses for known drugs, as mentioned by Dr. Rossi, is a strategy widely used by pharmaceutical companies, whether in a pandemic season or not. The protection for this type of invention is the so-called “second medical use”.

In Brazil, treatment methods are not considered as inventions by the Industrial Property Law, in force since 1997. However, the second medical use is subject to protection if claimed in the format known as the “Swiss-style claim”. However, the BRPTO (the Brazilian Patent and Trademark Office) analyzes this type of invention in a very restrictive way. According to current guidelines, the invention will only be sufficiently described if it presents in vivo tests proving the new use. If these tests have been carried out on animals, they must demonstrate the possibility of being applied to the humans or animals to be treated. In addition, it is necessary to clearly specify the disease to be treated and references to disorders, syndromes or symptoms in general are considered generic and undefined.

Question: In a pandemic era, when the development of treatments and vaccines is a matter of emergency, what are the starting points of scientific research? Is the research process different in a situation like the one we are currently facing?

Dr. Rossi: In these times, in order to speed up the process of regulating the use of a medicine, science usually invests in the search for a new effect of an already known product. An example is the anti-SARS-CoV-2 effect drugs used to treat HIV (as was done in studies of Ritonavir and Lopinavir). As for vaccines, because these are based on the induction of very specific antibodies, it is unfortunately not possible to adopt the same approach. Here, the times for production and licensing end up being maintained in order to prove their safety of use. The same is true for prospecting of drugs that are not yet recognized as medicines.

What is different [in a pandemic] in relation to the formalities in the research is the fact that combined, often multicentric, efforts can count on support from both the government and the regulatory bodies to accelerate the progress of bureaucratic and production processes. In addition, making funds available through public notices and private donations also greatly accelerates the emergence of promising results due to the high costs of research. However, with regard to the stages of scientific investigation, it is important to maintain all quality screens to avoid introducing a new factor that further aggravates the situation.

Karina Daiha: although the Brazilian government has made use of compulsory licenses only once in the past, it is also important to point out that patents can be compulsorily licensed in Brazil in cases of national emergency, such as the one we are currently experiencing. Thus, if any of the already known drugs demonstrates effectiveness in the treatment of COVID-19, and if that drug is under the protection of one or more patents, compulsory licenses may be enacted by the executive branch in respect of such drugs.

Originally published on Mondaq, 4 June 2020