With the COVID-19 pandemic getting more and more serious, known drugs are being heavily tested aiming to find a safe and effective treatment.
Chloroquine / chloroquine phosphate (Resochin), favilavir / favipiravir (Avigan), lopinavir & ritonavir (Kaletra), rintatolimod (Ampligen), danoprevir, (Ganovo), remdesivir and others are now being studied for use against COVID-19.
Some of these drugs have granted and/ or pending patents in many jurisdictions, including Brazil*.
*it is very important to note the patent term in Brazil is 20 years from filing and not less than 10 years from the date of grant. This minimum 10-year protection allows for some patents expired in many countries be still valid in Brazil.
Brazilian IP Law establishes several possibilities given to private parties to seek the compulsory license of a patent. One of them is for non-exploitation of a patented product in the Brazilian territory, defined as the lack of manufacturing or of the incomplete manufacturing.
In addition, there are two provisions granting discretion to the Government to issue a compulsory license, under Article 71: (a) In cases of national emergency; (b) Public interest for public non-commercial use, declared in an act of the Federal Executive Authorities.
Based on the current Patent Law No. 9,279/96, there is only one case of granted compulsory license in Brazil. On May 4, 2007, Brazil officially issued a compulsory license for the antiretroviral drug efavirenz based on public interest for public, non-commercial use. In some other events, however, Brazilian authorities have used the compulsory license provisions as a threat.
In the current crisis, if a patented drug is found efficient for COVID-19, Article 71 of the IP Law may be used by an act of the Executive Authorities to obtain a temporary non-exclusive compulsory license for exploitation of the patent.
Although countries such as Chile are already discussing resolutions that would facilitate the government to issue compulsory licenses for any medicines, vaccines, or diagnostics for combating the pandemic, the tendency is that pharma companies will reach an agreement with the local governments; similar to what recently happened in Israel, which approved licensing for a generic copy of Kaletra.