By Karina Daiha
Four recently published Guidelines shed light on ANVISA’s procedures related to prior approval analysis of patent applications.
In November 2020, the Brazilian Health Surveillance Agency (Brazilian FDA – “ANVISA”) published four guidelines disclosing the procedures adopted by ANVISA to analyze prior approval of patent applications related to pharmaceutical products and processes.
This is the first time ANVISA brings into view details on how the Agency examines patent applications remitted by the Brazilian Patent Office (BRPTO) for compliance with Article 229-C1 of the Brazilian Patent Statute.
Since the agreement reached by ANVISA and the BRPTO in 2017 (Joint Ordinance 01/2017), ANVISA can only deny prior approval based on public health matters. However, if the application relates to therapeutic matters of interest for the Brazilian health policies, ANVISA can perform a patentability analysis, which will be considered by the BRPTO as a third-party observation (TPO).
In Guidelines nº 1, it is disclosed how ANVISA identifies the applications remitted by the BRPTO that are indeed liable to prior approval analysis. Fifteen groups of subject matters that are not considered pharmaceutical product and/or process are disclosed, as follows:
|Subject Matters Not Liable To ANVISA’s Prior Art Approval|
|Health product and its processes
Substance, product or accessory that is not a pharmaceutical ingredient or medicament.
|Medical product and its processes
Health product intended for the prevention, diagnosis, treatment and rehabilitation that does not use pharmacological, immunological or metabolic means to perform its main function in humans.
|Diagnostic product for in vitro use and its processes
Reagents, patterns, calibrators, controls, materials, articles and instruments, which contribute to a qualitative, quantitative or semi-quantitative determination of a sample from the human body.
|Veterinary product and its processes
Any chemical, biological and biotechnological substance or manufactured preparation of which administration is applied individually or collectively, directly or mixed with food, intended for the prevention, diagnosis, cure or treatment of animal diseases.
|Cosmetic product and its processes
Products for external use, intended to protect or beautify different parts of the body. Special attention should be paid to sunscreens and insect repellents.
|Food and its processes
Any substance or mixture of substances (in natura, enriched, dietary, artificial, irradiated), in solid, liquid, pasty or any other appropriate form, intended to provide the human organism with the normal elements for its formation, maintenance and development.
|Non-active pharmaceutical ingredient and its processes
Pharmaceutical ingredients without pharmacological activity.
|Blood and derivative devices and their manufacture processes
Equipment and apparatus related to the activities of the blood production cycle, the components and transfusion procedures.
|Hygiene product and its processes
Products for external use, antiseptic or not, intended for cleanliness or body disinfection.
Somatic cells, human steam-cells, adult steam-cells, embryonic stem cells and induced pluripotent stem cells.
|Germinative cell and its processes
Mother cell responsible for the formation of gametes present in the female and male sex glands and their direct descendants in any degree of ploidy.
|Hematopoietic progenitor cells (HPC)/ Transplant of HPC
HPC are cells that remain in the placental veins and in the umbilical cord vein after delivery.
Products and agents of physical, chemical or biological processes purporting to alter the composition of flora or fauna, in order to preserve them from the harmful action of prejudicial living beings.
Substances or preparations intended for home hygiene, disinfection or disinfestation, in collective and/or public environments, in places of common use and in water treatment.
|General chemical processes
Chemical synthesis processes used in the preparation of general substances or production intermediates, which do not result in the active pharmaceutical ingredient.
(source: adapted from ANVISA’s guidelines)
A patent application disclosing subject matter integrally related to one of the fifteen categories above will not be analyzed by ANVISA and will be remitted back to the BRPTO for not falling within the dispositions of Article 229-C of the Patent Statute.
If that is not the case, ANVISA will analyze the patent application in light of the matters of interest to the Brazilian heath policies. If the application is inter alia related to neglected diseases2, Alzheimer’s, Parkinson’s, Rheumatoid arthritis, epilepsy, psychosis, cancers, or hemoderivatives, and (i) is a product offered by the Unified Health System (SUS); (ii) is a medicament included in the Partnerships for the Productive Development (PDP)3 program or (iii) is related to a fast-track examination requested by the Ministry of Health, it will be subjected to a patentability analysis. The application will receive prior approval and will be remitted back to the BRPTO with ANVISA’s opinion on the patentability, which will be issued and offered to the BRPTO as a TPO. The procedures are detailed in Guidelines nº 3 and 4.
On the other hand, if the application is related to substances/plants of which use is forbidden in Brazil, ANVISA will issue an official action grounded on Article 18, item I4, of the Patent Statute. It is worth noting that the mention to the forbidden product may be explicit (a claim cites an specific forbidden substance – e.g., desomorphine) or not (a claim cites a generic class of substances that may include a forbidden substance – e.g., opioid pain reliever).
According to Guidelines nº 2, Applicant will be invited to amend the application so as to rule out any possibility of protecting such forbidden substances/products. If the official action is satisfactory complied with, the application will receive prior approval. On the contrary, ANVISA will deny prior approval (this decision may be appealed).
Recent decisions show that ANVISA is usually satisfied if the forbidden substance is deleted from the claims of the patent application or if the generic class is limited to allowed substances, regardless if they are mentioned in an independent or dependent claim.
Specific orientations for ANVISA’s internal use on how to search for the forbidden substances/products in application are established in Guidelines nº 2. The searches are conducted with specific chemical names, as well as generical chemical structures (Markush).
Especial attention should be given to Guidelines nº 4, which sets forth ANVISA’s position on the patentability of biotech and pharmaceutical subject matters. Particularly, it is now clear that ANVISA disagrees with the BRPTO’s understanding on several topics, such as selection inventions and second medical uses.
While the BRPTO considers that selection patents are patentable whenever the state of the art provides a generic disclosure of the claimed invention, ANVISA is categorical in affirming that the grant of selection patents are an undue flexibilization of the novelty requirement. According to the Agency, selection patents are not patentable for lacking novelty.
As to second medical uses, ANVISA is even more restrictive than the BRPTO. The patentability of second medical inventions is already quite limited in light of the BRPTO’s Guidelines5, which only deems novel an invention that treats or prevents a disease different from that known in the state of the art. Features related to the use of the compounds, therapeutic scheme and/or group of patients do not confer novelty to the known use of the compound according to the BRPTO. To be inventive before the BRPTO, the new medical use must refer to the treatment of a disease with a different etiology; cannot be inferred from the structural analogy with other compounds that present the same activity; cannot be inferred from adverse effects known for the drug; and cannot be inferred from the use of the compound for the treatment of a symptom of a disease already revealed in the prior art, even though the claimed use refers to a different disease. ANVISA is of the opinion that second medical use claims are not patentable for being an undue flexibilization of the requirements of novelty and/or inventive step.
Furthermore, different from the BRPTO, ANVISA understands that antibodies defined by their hybridoma, as well as the hybridoma per se are barred from patent protection.
Despite such discrepancy, as ANVISA’s patentability analysis is remitted to the BRPTO as a TPO only, the final decision rests with the BRPTO, which means that BRPTO’s opinion prevails.
The following workflow summarizes ANVISA’s procedures:
(source: translated from ANVISA’s guidelines)
The Guidelines, in Portuguese, are available in the following link.
1. Art. 229-C: The granting of patents for pharmaceutical products and processes will depend on the prior approval of the Brazilian Health Surveillance Agency – ANVISA.
2. Neglected diseases listed in Guidelines nº 1: Dengue, Chagas’s disease, Schistosomiasis, Malaria, Leishmaniasis, Rocky Mountain spotted fever, Filariasis, Leprosy, Systemic mycoses and Tuberculosis.
3. PDP is a program that aims to expand access to medicines and health products considered strategic for the Unified Health System (SUS), by strengthening Brazil’s industrial complex.
4. Art. 18: The following is not patentable: I -what is contrary to morals, good customs and public security, order and health.
5. Guidelines for Examination of Patent Applications in the Chemistry Field – Rule 208/2017.