Brazilian Ministry of Health Accelerates Examination of Pharma Patent Applications

“More than 60 patent applications related to COVID-19 have been submitted under the fast-track route at the request of the Ministry of Health. Among the substances of interest to the Brazilian Public Health System, Tocilizumab is in top place.”

Pharma patent, prioritize, fast-track Brazilian Patent and Trademark Office (BPTO) presently offers more than 15 programs to speed up examination of patent applications. The prioritization of certain patent applications by means of Patent Prosecution Highway (PPH) programs and other fast-track options has been very effective in reducing pendency. Brazil’s backlog has already been reduced by around 40% and the BPTO estimates an additional 40% reduction by August 2021.

Prioritizing Pharmaceutical Patents

The opportunity to have a patent application allowed within one year from the accelerated examination request has increasingly aroused the interest of investors in the Brazilian market and encouraged patent filing in Brazil. The country has improved the patent protection system to keep up with the growth of local industrial development. Among various technology-based industries, pharmaceutical technologies play a central role in the fast-track programs currently available by the BPTO; for instance, it is possible to accelerate examination of patent applications related to cancer, HIV/AIDS, rare and neglected diseases. The latter includes a group of around 20 diseases listed by the World Health Organization (WHO), reflecting products directed to local tropical and subtropical neglected diseases, such as, for example, dengue, Zika, Chagas disease, leishmaniosis, lymphatic filariasis, malaria and tuberculosis.

When discussing possibilities of accelerated examination for pharmaceutical technologies, it is important to highlight that related requests can be made by patent applicants or by the Ministry of Health of Brazil if the technology is considered to be of great importance to the Brazilian Public Health System (SUS) and may result in available products at prices that patients in Brazil can or are closer to being able to afford. Pharmaceutical patent applications that can be fast-tracked by the Ministry of Health are not limited to applications originating in Brazil, but also extend to those originating from other countries (Patent Cooperation Treaty [PCT]and non-PCT countries).

The country’s sanitation situation, as well as the conditions of the SUS and increase in certain diseases in the population, have always been on the radar of the Ministry of Health.

In 2016, the Brazilian Ministry of Health interfered in the patent application examination process, specifically with respect to those applications aimed at treating hepatitis. By means of a request made by the Oswaldo Cruz Foundation (FIOCRUZ), which is linked to the Ministry of Health and is the most prominent institution of science and health technology in Latin America, the BPTO received from the Ministry of Health an official request for expediting examination of patent applications covering the drugs sofosbuvir, simeprevir, daclatasvir and ledipasvir, which comprised a list of more than 40 patent applications owned by various applicants.

Effects of the Pandemic

Today, as expected, worldwide attention has shifted to the pharmaceutical and biotechnology industries due to the COVID-19 pandemic, and a new fast-track examination program was promptly launched by the BPTO covering technologies directed to pharmaceutical products and processes, as well as equipment and/or materials used in health for diagnosis, prophylaxis and treatment of coronavirus, aimed at stimulating development of new technologies in this area and expediting applications.

Although COVID-19 is a new disease, drugs and technologies to combat it and its attendant symptoms already exist; thus, in order to request accelerated examination, there is no need for the invention to be specifically geared to combatting SARS-CoV-2. One need only explain the relationship of the claimed matter of the application with the treatment of COVID-19 and/or its symptoms.

The BPTO published on its website a collection of studies divided into stages, under the title “Technology Observatory Associated with COVID-19,” which presents a compilation of published scientific studies, as well as a result of searches carried out in databases using International Patent Classification of patent applications and patents related to diagnostic technologies and keywords directed to coronavirus and other viruses causing respiratory disorders. The collection of studies encompasses the detection and status of Brazilian patent applications and patents related to respiratory viruses’ diagnostic methods and kits, lung ventilators and specific drugs, such as, for example, remdesivir, ritonavir, lopinavir, interferon, favipiravir, tocilizumab and sarilumab. A summary of the BPTO’s findings on the cases related to these seven drugs is provided in the table below:

By the beginning of September 2020, the BPTO had already received more than 100 requests for accelerated examination of patent applications related to COVID-19, as can be seen in Figure 1 below:

(Source: Figure prepared by the author, based on data obtained from BPTO’s website, accessed on September 10, 2020)

More than 60 patent applications related to COVID-19 have been submitted under the fast-track route at the request of the Ministry of Health. Among the substances of interest to the SUS, Tocilizumab is in top place, as illustrated in Figure 2 below:

(Source: Figure prepared by the author, based on data obtained from BPTO’s website, accessed on September 10, 2020)

Many applicants view the possibility of having their patent applications granted quickly as a positive. On the other hand, however, having a patent application pending for a while can sometimes be the most viable option for a company from a strategic standpoint, so there are many considerations.

Although the Ministry of Health’s interference is based on a national public health issue, close monitoring of the company’s patent portfolio is essential, as patent applications originating in any country can be subject to an accelerated request by the Brazilian Ministry of Health.



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