Moving towards the compulsory licensing for exploiting Brazilian pharmaceutical patents for the treatment of covid-19

On 6 May 2021, the Brazilian Senate approved draft bill 12/2021, which creates a two-step compulsory licensing process and amends the provisions of the Brazilian Patent Statue (9.279/1996) on compulsory licensing of patents in cases of national emergency or public interest. On 6 July 2021, the House of Representatives approved the draft bill, with some amendments.

In the first stage, the Brazilian Executive Branch must publish, within 30 days of the state of emergency declaration date, a list of patents related to essential products and processes that would help to counter such situation. In the second stage, compulsory licences would be effectively granted, but only for items on the list for which effective proposals emerged and based on objective market conditions, technological training and investments for production or reproduction in Brazil.

Such licences would be granted ex officio, for a specific period and on a non-exclusive basis without prejudice for the patent or patent application holder, who will be remunerated according to each case. For example, remuneration is provisionally fixed at 1.5% of the net sales price of the product or process covered by the patent or patent application until a final decision on the remuneration is made.

Among other key points of the draft bill, the rights holder must share sufficient and necessary know-how for the effective reproduction of the protected subject matter, as well as regulatory data, or the patent will be nullified.

As the House of Representatives has amended the draft bill, it will now return to the Brazilian Senate, where these amendments will be discussed. The next step is the sanction or veto of President Jair Bolsonaro. If the bill is vetoed, it will still be possible for the majority of the two houses of the National Congress to reverse the decision of the Brazilian president.