Brazilian PTO and ANVISA's rules regarding the examination of pharma patent applications
On April 12, 2017, Brazilian PTO and ANVISA (Brazilian Health Surveillance Agency) signed the Joint Ordinance # 1/2017, which regulates the procedures for the application of Article 229-C of Brazilian IP Law # 9,279/1996 inserted by Law # 10,196/2001. This Joint Ordinance will come into force on June 12, 2017.
Such Ordinance establishes the procedures to be adopted by the Brazilian PTO and ANVISA concerning the analysis of pharmaceutical patent applications, and clarifies some issues extensively discussed in the past related to the allowance/denial of prior approval from ANVISA. According to this Joint Ordinance, ANVISA’s attribution is to analyze whether a subject matter of a patent application represents risk to health, whereas the Brazilian PTO’s attribution is to analyze patentability requirements of the subject matter.
The steps related to the flow of examination of pharma patent applications are detailed in said Joint Ordinance and the main points are summarized below:
- After the examination is requested, the Brazilian PTO will publish a notification in the Brazilian PTO’s Journal indicating that the patent application is being forwarded to ANVISA;
- ANVISA will analyze such application based on public health issues and will consider it contrary to the public health if the pharmaceutical product or process contained therein represents risk to health. Risk to health is understood as pharma product comprising, or pharma process resulting in substance whose use is prohibited in Brazil, such as narcotic substances (ANVISA’s Decree 344/1998). Therefore, if ANVISA denies the prior approval for this patent application, the case will be sent back to the Brazilian PTO that will be responsible for the publications of ANVISA’s decision denying prior approval and final dismissal thereof;
- For the patent applications containing pharmaceutical product or process considered of interest to policies of medicines and pharmaceutical assistance concerning the Brazilian Public HealthCare System (“SUS”), besides indicating the prior approval, ANVISA may issue technical opinions based on patentability requirements. Nevertheless, such opinions will be considered by the Brazilian PTO as observations for aiding the examination, based on Article 31 of the Brazilian IP Law. The opinions formulated by ANVISA will be published in the Brazilian PTO’s Journal, that is, they will be made available to the public;
- Following Item III above, upon analyzing the opinions issued by ANVISA, if the Brazilian PTO disagrees with them, they must technically justify the reasons of such disagreement; and
- For the patent applications that received the prior approval from ANVISA, once the Brazilian PTO concludes the examination of the patent application and decides that the subject matter contained therein meets all the patentability requirements, the Brazilian PTO will officially send a list of the allowed patent applications to ANVISA along with the final claim set thereof.
The provisions of this Ordinance are also applied to patent applications that are currently pending at the Brazilian PTO or ANVISA and those whose ANVISA’s administrative phase has been closed.
In addition, with the purpose to discuss technical issues and harmonize lines of thoughts, a group involving participants from the Brazilian PTO and ANVISA will be created.
In view of the above, it is expected that patent applications that are currently in limbo awaiting the Brazilian PTO’s positioning, and that are not contrary to the public health, have their examination resumed.