President Jair Bolsonaro (non-party) signed a bill that allows for the temporary breaking of patents for vaccines and medicines to deal with health emergencies. Now converted into law, which will still be published in the Official Diary of the Union, the proposal amends the Industrial Property Law, known as the Patent Law.
The new law establishes guarantees on the temporary nature of patent infringement, protects the holder against undue exploitation and sets minimum parameters for remuneration.
By the text approved in Congress and now sanctioned, the license for production will be granted to companies that may have proven technical and economic capacity to manufacture vaccines and medicines. The holder, in turn, will receive the equivalent of 1.5% of the net sale price of the products associated with the patent until the value is established.
“Compulsory licensing is done on a case-by-case basis and upon payment of compensation to the patent owner. In addition, compulsory licensing will only be determined by the Government in the exceptional event that the patent holder refuses or is unable to meet the local need”, says the General Secretariat in a note released recently. Thus, according to the government, the measure will not be applied, at the present time, to fight the covid-19 pandemic, “since the vaccines are being duly provided by international partners.” “However, in the future, if there is a shortage in the local market, there is a legal provision for the possibility of applying the measure, in an extreme case”, he completes.
The General Secretariat also clarifies that the current Intellectual Property Law already provides for compulsory licensing in cases of national emergency or public interest. But the new law expands the legal possibilities for this compulsory licensing.
The law is being sanctioned with vetoes. As informed by the General Secretariat, the provisions that required the patent owner to transfer know-how and provide supplies of medicines and vaccines are being vetoed. “Although meritorious, these measures would be difficult to implement and could create legal uncertainty in the scope of international trade, in addition to discouraging investments in technology and the formation of strategic commercial partnerships, with less onerous means to ensure that this type of crisis is dealt with” , justifies.