Approved Brazilian Law 14,200 of 2021 which authorizes temporary breach of patents on vaccines and medicine

The Law 14,200 of 2021, makes it possible to temporarily break patents on vaccines and medicines to face health emergencies.

On September 3, 2021, the Brazilian Government published Law 14,200 of 2021, which makes it possible to temporarily break patents on vaccines and medicines to face health emergencies, such as the current covid-19 pandemic.

The new Law amends the Industrial Property Law (Law 9279, 1996) to establish the compulsory license of patents or patent applications in cases of national or international emergency or public interest (declared by the Executive Branch) or state of national public calamity (declared by the Congress).

Compulsory license

A compulsory license – ex officio, temporary and non-exclusive – may be granted to explore the patent or patent application, 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.

The law determines that the Executive Branch must publish the list of patents or patent applications potentially useful to face the foreseen situations within 30 days after the publication date of the emergency or public interest declaration, or the recognition of a state of calamity public. This list excludes drugs that are the object of production technology transfer agreements or voluntary licensing capable of meeting domestic demand.

For the production of the list, public entities, educational and research institutions and other entities representing society and the productive sector should be consulted. Any public or private institution may submit a request for inclusion of a patent or patent application in this list, which will have to present the specification of the objectives for which each compulsory licensing will be authorized.

After the publication of the list, the Executive Branch will have another 30 days, extendable for an equal period, to evaluate each item, and will only grant the compulsory license, on a non-exclusive basis, to producers who have proven technical and economic capacity for production of the input.

Source: Senate Agency

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Rafaela Mattos



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