Following-up our previous article on new compulsory licensing rules for patents in Brazil, the present short article aims to provide an update on President Bolsonaro´s main vetoes (Veto 48/2021) related to Law 14.200/2021 that was sanctioned on 02 September 2021. It is worth remembering that said law established a two-step compulsory licensing process, amending therefore the provisions of the Brazilian Patent Statute in this regard.
After an intense debate within the Congress, Veto 48/2021 was fully upheld by the majority of votes in July 2022.
The main vetoed provisions concerned the following subject matters:
- Provision on knowledge transfer and biological material: it was originally established that the owner of the patent would be compelled to provide the necessary and sufficient information for the reproduction of the object protected by the patent or patent application, as well as other technical aspects applicable to the case, test results and other data necessary for the granting of its registration by the competent authorities.
Additionally, it was originally established that in the presence of biological material essential for the practical realization of the object protected by the patent or patent application, the patent owner would be obliged to provide such material to the licensee.
- Provision on the grant of compulsory license by law: it was originally established that in the case of a public health emergency, the compulsory license for patents or patent applications useful in preventing and combating the causes of the emergency could be granted by law, with a term limited to the period corresponding to the one of the declared state of emergency.
Hence, Law 14.200/2021, which is still in force with the text approved on 02 September 2021, does not comprise the provisions above mentioned that were definitively vetoed. The patent owner will not be compelled to provide information (e.g.: know-how, technical aspects, biological material, test results and other data) for the effective reproduction of the object protected by the patent or patent application. Moreover, a final decision on compulsory licensing will be under the responsibility of the Executive Branch instead of the Legislative one.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.