The Brazilian FDA (ANVISA) published on November 19, 2020, four manuals regarding the analysis of prior consent of patent applications related to pharmaceutical products and processes.
These manuals aim at providing guidance to the prior consent procedures within the Agency by describing the specific steps to be used by its professionals in the examination of the patent applications forwarded from the Brazilian Patent Office (BPO) to ANVISA.
The analysis criteria as established in the manuals shall be followed by ANVISA under the prior consent scope, in accordance with Article 229-C of Law 9.279/1996 (IP Law), in order to provide transparency to the society.
MANUAL No. 1: IDENTIFICATION OF PATENTS APPLICATIONS OF PHARMACEUTICAL PRODUCTS AND PROCESSES UNDER PRIOR CONSENT
Manual No. 1 aims to standardize the steps of the admissibility and classification procedure for patent applications sent by the BPO to ANVISA.
The patent application must refer to a pharmaceutical product or process, for human use, which can be recognized as such, in view of ANVISA’s regulations to be considered apt for the examination. In this manual, ANVISA determines which would not be included in ANVISA’s patent application’s prior consent such as, for example, product for diagnostic in vitro uses, veterinary product, cosmetic product, food, non-active pharmaceutical input, hygiene product, pesticides, among others.
Once admitted, it will be assessed whether the patent application is related to the therapeutic destinations defined in Ordinance MS/GM nº 736/2014 of interest for the policies of medicines or pharmaceutical assistance under the Unified Health System (SUS). If so, it will be classified as “for issuance of subsidies”. Subsequently, a “risk examination” will be carried out and checked if there are any claims in the PI related to substances/plants banned in Brazil (Ordinance MS nº 344/98).
MANUAL No. 2 – HEALTH-RISK ASSESSMENT IN PHARMACEUTICAL PATENT APPLICATIONS UNDER ANVISA’S PRIOR CONSENT ANALYSIS
ANVISA has issued this manual with the sole purpose of standardizing its internal procedures for the assessment of risk posed by pharmaceutical patent applications to public health, which is undertaken during the prosecution of patent applications as determined by Article 229-C of the IP Law.
This newly published guidelines do not change the analysis procedure currently in place, which consists of checking whether the claimed scope embodies items outlined on Lists E (LIST OF PLANTS PROHIBITED FOR BEING POTENTIALLY USEFUL TO PRODUCE SUBSTANCES OF ABUSE AND/OR PSYCHOTROPIC SUBSTANCES) and F (LIST OF SUBSTANCES OF PROHIBITED USE IN BRAZIL) published with the Health Ministry Ordinance SVS/MS n° 344/1998 and its further updates. As already established in the current practice, the said risk assessment may result in a (1) notice of prior consent, (2) a notice of denial of prior consent, (3) or an official action; applicants have the right to respond both (2) and (3). If the applicant’s response to the notification of denial of prior consent or to the official action properly addresses ANVISA’s objections, ANVISA issues a notice of prior consent. Otherwise, a report of denial of prior consent is issued and the applicant has a last opportunity to address ANVISA’s requests. If, at this stage, the applicant successfully complies with ANVISA’s requests, a prior consent report is issued and the application is forwarded to the BPO to proceed the regular prosecution pathway. Otherwise, ANVISA maintains the denial of prior consent and forwards the application to the BPO for its definitive shelving.
MANUAL NO. 3 – IDENTIFICATION AND ANALYSIS OF PATENT APPLICATIONS OF PHARMACEUTICAL PRODUCTS AND PROCESSES UNDER PRIOR CONSENT SUBJECT TO THE OFFER OF SUBSIDIES TO THE BPO
Manual directed to the identification and classification of patent applications submitted by the BPO for compliance with Article 229-C of the IP Law considered of interest for the drug or pharmaceutical assistance policies under the Unified Health System (SUS), for the purpose of submitting subsidies. According to the manual, to be considered fit for the filing of subsidies, the application must refer to a pharmaceutical product or process, of human use that can be recognized as of interest to the policies of medicines or pharmaceutical assistance within the scope of the SUS. It is understood that the Application is of interest for the SUS when its scope is directed to the following objects: Viral Diseases, Neglected Diseases, Degenerative Diseases, Immunosuppressants, Mental Diseases, Neoplasms/Cancer, Products obtained by biological routes, Vaccines and sera and Blood Products.
To check whether the application relates to these purposes, at least one of the application sections may be examined. The Document also states that commercial databases may be used to identify which products/compounds the Application is related to. Once the compounds covered by the application have been identified, the Examiner must consult the National List of Essential Medicines (Rename), the technological recommendations of the National Commission for the Incorporation of Technologies in the Unified Health System (CONITEC) and the Clinical Protocols and Therapeutic Guidelines (PCDTs), Partnerships for Productive Development (PDP) or equivalent and verify if there is a request for priority examination required by the Ministry of Health (MS).
In cases where the patent application does not comprise/result in a product that is related to the sources of information consulted, ANVISA’s examiner should return the application without subsidies to the examination. The remainder of the Applications should be selected to be evaluated for the purpose of offering subsidies to the examination. The following exceptions are pointed out, which will always be selected for receiving subsidies: Compounds/products for cancer, Pharmaceutical combinations (wherein at least one of the compounds meets the above criteria), Immunoconjugates, recombinant fusion proteins, Bispecific/multispecific antibodies.
MANUAL No. 4 – PATENTABILITY EXAMINATION IN PRIOR CONSENT OF PATENT APPLICATIONS OF PHARMACEUTICAL PRODUCTS AND PROCESSES
The purpose of this manual consists of standardizing the examination of the patentability requirements by the Agency in order to prepare the Third-Party Observations (the so-called "subsides") to the technical examination to be conducted by the BPO.
In this manual, ANVISA provides a comparative table showing the differences in the analysis of the patentability requirements conducted by the Agency and the BPO for certain subject matters, such as: selection inventions; salts, N-oxides, esters, ethers, metabolites and prodrugs of the compound; enantiomers; medical uses or new uses of compounds and biological products, nucleotide or peptide sequences; antibodies and hybridomas.
The patentability requirements as set forth in the IP Law, the BPO’s normative instructions, resolutions and guidelines for the examination of patent applications in the field of pharmacy and biotechnology were considered by ANVISA upon preparing this manual.
In case you wish to receive further information on these manuals, our legal and technical teams are available and can be reached in our offices in Rio de Janeiro and São Paulo, as well as through the email firstname.lastname@example.org.