INPI-ANVISA Inter-institutional Coordination Group (GAI)
Pursuant to Joint Ordinance No. 2 of October 20, 2017, published in the Federal Official Gazette (DOU) of November 9, 2017, the Inter-institutional Coordination Group (GAI) was created in order to review and suggest mechanisms, procedures, and possible formal instruments for cooperation between the Brazilian Health Surveillance Agency – ANVISA and the Brazilian National Institute of Industrial Property – INPI, aiming at compliance with the provisions in article 229-C of Law No. 9,279 of May 14, 1996, added by Law No. 10,196 of February 14, 2001.
On March 7, 2018, the first GAI meeting was held in the presence of the president of INPI, Luiz Otávio Pimentel, and the president of ANVISA, Jarbas Barbosa, as well as representatives of entities of the industry and Intellectual Property (IP) professionals.
The first technical meeting was held on March 26, by videoconference, and its main purpose was to establish the work methodology.
In order to give more transparency to GAI’s activities, the schedule of meetings, the meeting minutes, the documents produced, and any news shall be made available in this site from time to time.
SCHEDULES:
- Schedule for the 1st semester of 2020
- Schedule for the 1st semester of 2019
- Schedule for the 2nd semester of 2018
- Schedule for the 1st semester of 2018
MEETINGS
- MINUTES: 3/26/2018; 5/2/2018; 5/24/2018; 6/21/2018; 8/1/2018; 8/23/2018; 10/2/2018; 10/25/2018; 12/14/2018; 1/18/2019; 2/21/2019; 3/28/2019; 4/18/2019; 5/23/19; 6/18/19; 7/18/19; 8/29/19.
- NEWS: 7/3/2018; 5/24/2018, 8/17/2018, 8/24/2018;
- PRESENTATIONS: 5/24/2018, 8/23/2018, 3/28/2019 (ANVISA), 3/28/2019 (INPI), 3/28/2019 (priority), 10/21/19 (INPI presentation), 10/21/19 (ANVISA presentation);
- ATTENDANCE LISTS OF THE PUBLIC MEETING: 8/23/2018, 3/28/2019, 10/21/2019;
DOCUMENTS PRODUCED
- Information gathering on patent applications rejected by ANVISA for non-compliance with art. 229-C of Law 9,279/96;
- GAI Note on the proposed new provision of subsidies by ANVISA;
LAWS AND REGULATIONS OF INTEREST
1) Ordinance No.736 of May 2, 2014: Defines, for purposes of examination of ANVISA’s prior consent, pharmaceutical products or processes considered of interest for the medicine or pharmaceutical assistance policies within the scope of the Unified Health System (SUS).
2) Joint Ordinance No. 1 of April 12, 2017: Regulates the procedures for application of article 229-C of Law No. 9,279 of May 14, 1996, added by Law No. 10,196 of February 14, 2001, among other provisions.
3) INPI/DIRPA/CGREC Normative Instruction No. 1 of May 31, 2017: Establishes the administrative proceedings related to patent applications for pharmaceutical products and processes, pursuant to article 229-C of the Industrial Property Law (LPI).
4) RDC Resolution No. 168 of August 8, 2017: Provides for the administrative proceeding related to ANVISA’s prior consent for granting patents for pharmaceutical products and processes, regulated by ANVISA-INPI Joint Ordinance No. 01 of April 12, 2017.
5) DIARE/ANVISA Service Orientation No. 51 of July 5, 2018: Details the parameters for examination of patent applications for pharmaceutical products and processes in view of public health by ANVISA. Revokes Service Orientation No. 37 of September 25, 2017.