New provisions expand the statutory authority to issue compulsory licenses and could be used in PDP projects for public non-commercial use.
February 26, 2018
Since February 22, 2018 the Protocol Amending TRIPS Agreement, adopted by the WTO in 2005, has been in force in Brazil as municipal law. The Protocol enlarges compulsory license scope, allowing its use in new contexts and potentially weakening the Brazilian patent protection system.
Following the 2001 Doha Declaration on the TRIPS Agreement and Public Health, the Protocol has created a mechanism to favor WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector, enabling them to make “effective use of compulsory licensing”. As highlighted in the Chairman’s statement, the flexibilization approved by WTO “should be used in good faith to protect public health” and “not be an instrument to pursue industrial or commercial policy objectives”.
Notwithstanding, the implementation of the Protocol into the Brazilian legal system is cause for concern, especially since it occurred at the same time the Government establishes numerous agreements (“PDP projects”) with biosimilar and generic manufactures for purchase of patented drugs still enjoying exclusivity in Brazil.
It is also worth remembering that Brazilian authorities have already publicly advocated the use of compulsory licenses (for public non-commercial use) to make feasible PDP projects without the patent owner’s participation or consent (an article on the matter was published in Presidency Law Journal by government officials, for example). Furthermore, some extensive PDP projects have been signed with companies other than the patent owners, even when there is a substantial exclusivity term forthcoming (about 10 years).
Although Brazil is not on the list of least developed countries, any WTO Member may benefit from the Protocol. It is enough that the interested Government notifies the Council for TRIPS of its intention and the reasons, such as a national emergency, other circumstances of extreme urgency or, most relevant, in cases of public non-commercial use. Based on other provisions, Brazil has granted and renewed a compulsory license for Stocrin (an AIDS drug), even though the country was not experiencing outbreaks caused by the pathology.
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The original Portuguese version of Decree #9.289/2018, which has implemented the Protocol Amending the WTO TRIPS Agreement, is available on Brazilian Government official website. The English version, by Licks Attorneys, is available here.