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Bill #12/21 amends the Brazilian Patent Statute (Law #9,279/96) and authorizes the Federal Government to grant compulsory license for products or processes essential to face public health emergencies.

The Brazilian House of Representatives approved yesterday (July 6, 2021) the draft of Bill #12/2021, introduced on January of 2021 by Senator Paulo Paim (PT-RS), based on the grounds of speeding up the national vaccination plan due to the Covid-19 pandemic. The matter will return to the Brazilian Senate, in which the changes made by the House of Representatives will be discussed.

After being addressed by the Brazilian Senate, the Bill is yet to be sanctioned or vetoed by President Jair Bolsonaro. The Government Leader in the Chamber, Ricardo Barros (PP-PR), stated that the government does not agree with the bill's merits. However, even if the Bill is vetoed, State Representatives and Senators can override the presidential veto if there is a majority vote.

According to the draft:

• The Brazilian Executive Branch must publish, within 30 days after the state of emergency or public calamity declaration date, the list of patents or patent applications which technologies may be useful to manage these situations. There is an exception for patents or patent applications subject to a technology transfer agreement or voluntary licensing capable of ensuring internal demand;
• The Brazilian Executive Branch will perform – within 30 days, extendable for an equal period – individualized evaluation of the listed technologies and will grant compulsory licenses only to manufacturers having production capacity;
• The patent or patent application holder must provide information for the reproduction of the protected subject matter and other applicable technical aspects, as well as tests results and other necessary data, under risk of the patent being declared revoked;
• The compulsory license may also be granted by the Brazilian Congress, regardless of the Brazilian Executive Branch act, having a validity term limited to the period in which the state of emergency lasts;
• The holder of a patent or patent application subject to a compulsory license will receive 1.5% of the net sales price of the product associated with it, until the compensation to the holder is effectively established. The compensation will be due only if the patent is granted;
• The BRPTO will prioritize the examination of patent applications that are subject to compulsory licensing;
• Products subject to sanitary surveillance regime may only be marketed after authorization has been granted by Brazilian FDA, whether for use on an emergency basis or definitively;
• Regardless of granting a compulsory license, the government will prioritize the execution of technical cooperation agreements and contracts with the patent holder for the acquisition of productive technology and the transfer process thereof;
• For humanitarian reasons, compulsory licensing may be granted for patents on products intended to be exported to countries with little to no manufacturing capacity in the pharmaceutical sector.

More information on Bill #12/21 pending actions may be found at Brazilian House of Representatives and Brazilian Senate websites.

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