BRAZIL

On September 3, the Executive Branch enacted the law that allows the temporary breakage of patents on vaccines and drugs to face health emergencies. It should be recalled that the law was passed by Congress on August 11. You can access the enacted law by clicking here.

According to the text of the regulation, a compulsory, ex officio, temporary and non-exclusive license may be granted to explore the patent or patent application. The same shall be used without prejudice to the rights of the holder, provided that he or his licensee does not meet the needs of the country. The holder will be entitled to 1.5% of the net sales price of the product until its value is effectively established.

In addition, the law determines that the Executive Branch will be empowered to publish the list of patents or patent applications potentially useful to face the situations foreseen within 30 days after the date of publication of the recognition of a state of public calamity. This list excludes drugs that are the subject of production technology transfer agreements or voluntary licenses capable of meeting domestic demand.

It is worth noting that the President vetoed some articles because he considered them difficult to implement or possible to generate legal uncertainty at the international level. Among the articles vetoed were:

• A provision that established that the holder of the patent or patent application subject to compulsory license must provide the necessary and sufficient information for the reproduction of the drug, as well as the results of the tests and other information necessary for the granting of its registration by the competent authorities.
• A section defining that the compulsory license could be granted by law.
• An article providing that the public health emergency of national importance (Espin) declared as a consequence of the human infection by the Coronavirus is characterized as a national emergency under the terms of the Industrial Property Law.