by Pedro Moreira
May 14, 2020
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* Sorry, this entry is only available in Brazilian Portuguese.
Worldwide, pharmaceutical and biotechnology companies and universities are undergoing an intense process of research and development (R&D) of treatments, equipment and vaccines to prevent and/or treat coronavirus, whether they are totally new or already existing but now directed to a new use, a new application, against COVID-19.
R&D phases are the most varied:
Some treatments, equipment and vaccines are still under theoretical and bench research, such as for example evaluation of a hyperimmune therapy TAK-888 by company Takeda, partnerships between companies Johnson & Johnson and Sanofi with the Biomedical Advanced Research and Development Authority (BARDA) to identify molecules, and a new use of combined drug therapy lopinavir/ritonavir from company AbbVie.
Others are more advanced, in initial clinical phases, such as for instance new uses of medicines Remestemcel-L (human mesenchymal stem cells) and Actemra (tocilizumab) from companies Mesoblast and Roche, respectively.
There are also those in more advanced clinical phases, implementing human trials on a small scale, such as for example immunotherapeutic treatment APN01 of a recombinant protein form from company Apeiron Biologics, and human trials on a large scale, such as for instance a new use of drug remdesivir by company Gilead Sciences, and development of a potential mRNA vaccine and vaccine INO-4800 by companies Moderna and Inovio Pharmaceuticals, respectively.
In Brazil, the Ministry of Health has monitored R&D of at least nine clinical trials on the use of already existing alternatives, but now aimed at treatment against COVID-19, with the participation of research centers, universities and hospitals, such as for example the “Coalizão Covid-19 Brasil” (Covid-19 Coalition Brazil) formed by hospitals Albert Einstein, HCor, Sírio Libanês, Moinhos de Vento and Alemão Oswaldo Cruz, and by the Brazilian Partnership for Research in Intensive Care (BRICNet Partnership) and Beneficência Portuguesa de São Paulo.
Expectations of success by the end of 2020 are very optimistic and close to reality.
The race for life is clear, essential and major, but the commercial and financial side effect that a new pharmaceutical technology that has indeed effective results against COVID-19 can generate cannot be denied. It would be global sales, in unimaginable amounts, like never seen before. Talking about money at this moment may sound insensitive or inhuman, but pharmaceutical R&D are extremely expensive, and at least some financial gain is needed to run the engine for searching new technologies. Those who work directly or have knowledge of the industrial field know that it is not feasible to do science and to develop innovations without a strong injection of qualified human resources and very high investments.
Imagine who is successful in developing these new treatments, equipment and vaccines, and patenting them, that is, having the right to prevent competitors and any third parties from manufacturing and marketing them for 20 years, without it/he/she prior authorization? In addition to the gain from an own and exclusive production, the patent owner could still “rent” its/his/her patent to authorized third parties, upon payment of royalties, and/or transfer the related technical knowledge, in combination with production factors, through patent licensing and technology transfer agreements.
For example, at the end of March, a DNA oligomer targeting COVID-19 already had its patent application filed by a researcher in South Korea. What if this biotechnological product proves to be effective and the respective patent is granted?
Looking ahead to most countries in the world, the Federal Government, through the National Institute of Industrial Property (INPI, which is the Brazilian Patent and Trademark Office), published on April 07, 2020 a special procedure for those patent applications whose object is related to the prevention and/or treatment of COVID-19. Those applications must be submitted to the Institute by June 30, 2021, and will receive a differentiated treatment at the Institute, prioritizing prosecution steps to obtain the patent. The experience in this type of differentiated treatment has shown patents being granted by INPI within six months to 4 years, while pharmaceutical patents issued by regular procedures take 10 to 12 years.
INPI’s focus here is to try to encourage researchers and companies to intensify R&D against COVID-19, in order to achieve any solution that slows or even ends pandemic of the new coronavirus.
Also in this line, INPI launched additionally, in March, the Observatory of Technologies Related to COVID-19. In this platform, the most varied technologies can be found to contribute to challenge the new coronavirus, such as for instance vaccines, drugs, medicines, diagnostic tests, masks, health equipment, among others.
It is worth remembering that, in the pharmaceutical industry, development of new and improved products, production processes and equipment is typically classified as a radical or incremental innovation. The definitions and limits of each type of innovation are controversial and uncertain, but in general there is a consensus that radical innovations comprise totally new or revolutionary technologies (for example, new molecules) and incremental ones include improvements in existing and established technologies (for instance, new therapeutic indications and improved equipment). Both types can be patented in Brazil according to the Patent Law currently in force.
COVID-19 is under checkmate around the world. Crises also generate commercial opportunities and, especially within the pharmaceutical field, the patent system plays an important role in leveraging the development of a solution against the virus, aiming at social interest and technological and economic development of society, without prejudice to protection of health of the population.