The current Brazilian patents’ compulsory licensing scenario

Today, in the face of the chaos created by the advance of COVID-19, which has unleashed a worldwide pandemic, there is still no remedy that presents a specific cure and no vaccine that can create an immune system the population requires nor contain the disease’s advance.

Faced with this scenario, the search for such solutions has engaged the pharmaceutical market and raised doubts about incentives for research and development, regulatory releases for such products and also about the determination of patent’s compulsory licensing on drugs through measures adopted by the government.

The latter concern is not misplaced, as compulsory licensing is an exceptional measure designed to try to contain what is “abusive use” of a particular patent or used in cases of national emergency and public interest. The current moment can indeed be considered a state of national emergency by the Federal Government.

Likewise, some international entities, such a Doctors Without Borders, have been in favor of adopting this type of exceptional measure, even though there is currently no drug specifically designed to contain COVID-19’s advance.

Analyzing Brazil’s case, the provision for a compulsory license is present in Chapter VIII, Section III, arts. 68 to 74 of the Industrial Property Law (Law No. 9279 of 1998). Considering the present COVID-19 crisis, provision for its application can be found in the wording of article 71, which determines the following: “Article 71. In cases of national emergency or the public interest, declared in the act of the Federal Executive Branch, provided that the owner of the patent or its licensee does not meet this need, a compulsory, temporary and non-exclusive license may be granted, officially / officiated by the government, for the use of the patent, without prejudice to the rights of its respective owner”.

From the very wording of the article, one can notice the exceptional and extraordinary character of the measure, since it also depends on the patent holder’s inability to meet the national needs.

Furthermore, the granting of a compulsory license is such an extreme measure that, although the holder’s rights to be granted some remuneration for such permission are still respected, its application weakens national credibility in the eyes of foreign partners, international organizations and signatories to intellectual property agreements.

Currently, although there are bills in progress in the National Congress that foresee the ease for granting of compulsory licenses of patents in Brazil, most of them are tied to Bill 139 of 1999, which awaits the legal opinion of the Reporting Justice and Citizenship Commission (RJCC) of the House, since July 2019.

Moreover, considering the COVID-19 there are three bills in progress, PL 1.184/20, PL 1.320/20 and PL 1.462/20, all of them without any further legislative progress since the first week of April.



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