On September 25, 2017, the Director of the National Sanitary Surveillance Agency (ANVISA) issued internal guidelines (Orientação de Serviço #37/2017) regarding the procedures to be used by the agency when examining patent applications claiming pharmaceutical products and processes in light of public health (in accordance with Article 229-C of Patent Statute #9,279/96, Resolution RDC #168, of 2017, the Joint Ordinance ANVISA/INPI #001, of 2017, and Ordinance GM/MS #736, of 2014). According to these guidelines, ANVISA will follow the following procedures when reviewing applications claiming pharmaceutical products and processes.
- Upon receipt of a patent application from the Brazilian Patent Office (Instituto National da Propriedade Industrial (INPI)), ANVISA will assess the subject matter of the application to verify compliance with the provisions of Article 229-C of IP Law #9,279/96. Article 229-C provides that pharmaceutical patent applications shall receive a prior approval by ANVISA (often referred to as “prior approval” or “prior consent”). Specifically, Article 229-C provides that: “The grant of patents for pharmaceutical products and processes shall depend upon the prior approval from the National Sanitary Vigilance Agency.”
- Once it is determined that prior approval or prior consent by ANVISA is required, an application is assessed with respect to its (1) health risk; and (2) interest under the drug or pharmaceutical assistance policies within the Brazilian Unified Health System (SUS).
- The health risk of the application is assessed by determining whether the pharmaceutical product or process claimed comprises or results in substances included in List E (which is a list of prohibited plants which may give rise to narcotic and/or psychotropic substances) or List F (a list of substances banned in Brazil) based on Ordinance SVS/MS #344, of 12 May 1998, which relates to plants and substances (including salts and isomers thereof) that are prohibited for use in the country. Applications which do not claim a pharmaceutical product or process that comprise or result in substances included in Lists E or F are not considered to present a health risk. If the application is considered to present a health risk, ANVISA will deny prior consent or prior approval and return the application to INPI, which will dismiss the application.
- After determination of the absence of health risk, the application is reviewed to determine whether or not the pharmaceutical product or process is of interest to the drug or pharmaceutical assistance policies under SUS. An application is determined to be of interest to the drug policy or pharmaceutical assistance policy under SUS when:
- The subject matter is related to one of therapeutic applications defined by Ordinance MS/GM #736, of 2014 as listed in Annex I (provided below); or
- It is related to a product incorporated into SUS (except for drugs that are part of the Basic Component of Pharmaceutical Assistance (CBAF), which is guided by the National List of Essential Medicines (RENAME) in force); or
- It is related to a product of potential interest to the SUS according to Annex II (provided below).
If the application is of no interest to the healthcare policy, ANVISA will grant prior consent or prior approval and send the application back to INPI for further processing. However, if an application is determined to be of interest to the drug or pharmaceutical policies under SUS, ANVISA will send the application back to INPI for further processing along with a report providing an analysis of the patentability requirements to be used by INPI during examination.
An important take away is that according to the service guidelines, ANVISA is able to provide an opinion addressing the patentability requirements of applications claiming pharmaceutical products or processes. Regrettably, this is a continued attempt by ANVISA to try and work around case law that has clearly established that the agency is not allowed to evaluate the patentability requirements of such applications under Article 229-C.
Viral Diseases (antiviral and antiretroviral diseases)
Rocky Mountain spotted fever
Mental diseases (antipsychotics/anticonvulsants)
Psychosis / Schizophrenia
Neoplasias / Cancer (Oncology products)
Products obtained by biological routes
Provided that the therapeutic application is included in ordinance GM/MS 736/14
Vaccines and sera
Vaccines of the National Immunization Program
Hepatitis B vaccine
Diphtheria, tetanus, pertussis, hepatitis B and Haemophilus Influenza B vaccine
Diphtheria, tetanus and pertussis vaccine
Polio vaccine (VIP / VOP)
Pneumococcal vaccine (Pneumo 10, PN 23)
Human rotavirus vaccine
Meningococcal C vaccine
Yellow Fever vaccine
Hepatitis A vaccine
Measles, mumps and rubella vaccine
Measles, mumps, rubella, and varicella vaccine
Diphtheria and tetanus vaccine
Vaccines for sexually transmitted diseases
Vaccines for neglected diseases
Vaccines for cancer
Plasma concentration of factor VIII
Von Willebrand factor
Prothrombin complex (partially activated or human)
Recombinant activated factor VII concentrate
Plasma and recombinant factor concentrate
Plasma concentration of factor IX
Factor XIII concentrate
Excluded: Fibrinogen, Tranexamic Acid and Desmopressin Acetate
Roadmap to identify patent applications of potential interest for SUS
- The patent application, to be identified as of potential interest to SUS, in addition to complying with Article 6 herein, should also comply with at least one of the following criteria:
- Be related to a product registered with a sanitary authority of any country or region;
- Be related to a substance under an active phase II clinical trial or higher, in any country or region, for a therapeutic application of interest to SUS;
- Be related to high-cost drug that is part of the Specialized Component of Pharmaceutical Assistance (CEAF);
- Be related to the drug provided in Partnership for Productive Development (PDP) or equivalent;
- Be related to a request for priority examination made by the Ministry to Health to the INPI;
- Has been filed with INPI less than six years ago.
- The patent application included in item A above may be exempted from a patentability examination for the purposes of supportive data if the application satisfies any of the below:
- The product has its incorporation into SUS denied by the National Commission for the Incorporation of Technologies (CONITEC); or
- The product is excluded from SUS; or
- The invention is unlikely to be incorporated into SUS after conducting a prospective analysis.
Please continue to watch the BRIC Wall Blog for further updates on ANVISA and prior approval or consent in Brazil.
This post was written by Lisa Mueller and Roberto Rodrigues of Licks Attorneys.