On September 2, 2021, the Federal Government sanctioned Law No. 14,200/21, amending Law No. 9,279/96 (Brazilian Industrial Property Law) regarding the compulsory licensing of patents or patent applications in cases of national, international, or public interest emergencies, or public calamity.

This measure amends Art. 71 through new procedures for granting compulsory licenses for patents or patent applications, and it includes Art. 71-A, which provides for the licensing of patents or patent applications exported to countries with insufficient production in the pharmaceutical sector.

Among other propositions, the Law establishes that, within 30 days of the declaration of public emergency, the Executive Branch will publish a list of patents and patent applications that may be useful in dealing with the situation, and any public or private institution may request the inclusion of a patent or patent application to the listing.

President Jair Bolsonaro vetoed some of the bill’s proposals, declaring that they were against the public interest and could cause conflicts with the pharmaceutical industry, such as the provision that would oblige the Patent Owner to transfer know-how and provide the active ingredients of medicaments and vaccines to licensee. In addition, the article that established the Public Health Emergency of National Importance (ESPIN) as a result of coronavirus infection as a national emergency under the terms of the Brazilian IP Law was vetoed.

It should be noted that compulsory licenses will be made under case-by-case basis upon payment of an indemnity 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 needs.

Moreover, it should be also remarked that the Industrial Property Law had already foreseen compulsory licenses in the cases of national emergency or public interest, and the present alteration has expanded the legal hypotheses of compulsory licensing, establishing that it can also be adopted in cases of public calamity nationwide.

Overall, this alteration of the IP Law brings more transparency to the compulsory licensing process, by determining, for instance, that the list of patents or patent applications that could be object of license needs to be disclosed by the Executive Authority.

More information about the amendments in Law No. 9,279/96 can be accessed, in Portuguese, here.

 

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