One of the greatest Brazilian writers, Luiz Fernando Veríssimo, once wrote in one of his chronicles that “Brazilians have a craving for hindrances”. What he, in fact, did was to reflect in his creation the irrefutable truth that, in Brazil, if it is possible to makes things more difficult, there is no reason to simplify them.
The expression, in Latin, that serves as the title to this article is, so to speak, a translation of what is done in Brazil, in different areas, in order to complicate the life of people and companies that function in the country. Anyone who has ever worked in the opening of a company in Brazil knows exactly what I am talking about. Translated into English the expression means “twice the same thing”.
To illustrate the point, let us examine the confusion created by Provisory Measure 2.006/99, later converted into Law 10.196/2001.
The peculiar article 229C
This vivid example of work duplication was created with the enactment of the above mentioned legislation, which added to the Industrial Property Law (Law 9279/96) among other, the article 229C.
This article set forth that any patents related to pharmaceutical products (just this industrial sector) could only be granted by the National Institute of Industrial Property – INPI after being reviewed and receiving a consent form the National Agency of Sanitary Surveillance – ANVISA.
In practical terms a patent filing for a pharmaceutical product is examined by the INPI and, in case it is considered OK to be granted, under the terms of the Industrial Property Law, before the granting of the patent is published, the INPI has to sent the files to ANVISA for review and consent.
It should be pointed out here, that Law 10.196/01, which has never been regulated, does not set forth the basis and directives, according to which ANVISA decided to grant, or not, the necessary consent.
It is worth noticing that the text of the law has generated a series of legal discussions that are still pending a solution or consensus.
First because article 229C is within the chapter of the “final and transitory dispositions” of the law, that is, in the part of the law use to regulate temporary situations that have arisen from the enactment of the new law.
Besides, Law 9.782/99, which created the National Agency of Sanitary Surveillance and set forth its competence, did not include within the competence of the agency the review of patent filings for pharmaceuticals, let alone the consent for granting the patent. It does not include the mentioned competences for obvious reasons, since the Agency exists to protect the health of the population by having the sanitary control over the production and the commercialization of pharmaceuticals and other health related products.
On the other hand, in 1970 a Federal Institute was created – The National Institute of Industrial Property (INPI) - linked to the Ministry of Development, Industry and Commerce,, replacing the then existing National Department of Industrial Property and, by definition of the law, this new institute shall implement and execute, in the national territory, the rules and regulations pertaining to industrial property, considering its social, economic, legal and technical function.
It is odd, to say the least, that a governmental agency, linked to the Ministry of Health, responsible for sanitary surveillance, which is what ANVISA is, is given an attribution that is the competence of a different institution, in this case the INPI, linked to the Ministry of Development, Industry and Commerce.
In the 2006 National Seminar on Industrial Property, held in Brasilia, the representative from ANVISA said that such reexamination is necessary because: “as Brazil did not accept pharmaceutical patents since 1945 and did not accept patents on manufacturing processes since 1971, INPI did not have the necessary know-how for this type of patent examination”!!!!!!!!
Really; if this was the case, wouldn’t it be much more efficient and rational to train INPI employees instead of placing any of its decision under suspicion and give it a “foreign” supervisor?
Article 8 of the Industrial Property Law sets forth the necessary requirements for any invention to be considered patentable. These requirements, which are exactly the same found in patent legislations and intellectual property treaties, are as follows:
1- Novelty;
2- Include an inventive activity and;
3- Have an industrial application.
The law also includes a section on inventions that are not patentable, such as those contrary to moral.
These requirements are known as “patentability requirements”, and are part of a rigid rite, which well defined milestones in the law and, during the entire procedure, any and all acts practiced are published so that any interested party may present reasonable opposition or discuss in an administrative or judicial procedure, the nullity of the patent even after it is granted.
As mentioned before, the implementation of the law is a competence of the National Institute of Industrial Property – IPNI, the institute created for this and structured with all the necessary competencies and personnel to carry on that task.
For no other reason this is the same all over the world. Agencies or institutes specialized carry on that task. The more obvious examples are the United States Patent and Trademark Office and the European Patent Office in the European Community.In Latin America we find the “Instituto Mexicano de la Propriedad Industrial” – IMPI -, and the “Administración Nacional de Patentes” – ANP in Argentina.
The mentioned offices and agencies, in the same form as the Brazilian INPI, are organized in departments that are responsible for the examination of different types of Patents, Trademarks, Industrial Design or Utility Models.
Patents, may be relative to the most different types of knowledge areas, such as, mechanics, electronics, chemical, pharmaceutical, etc. These filings, as it is obvious, are examined by different technicians and experts in the area to which the filing belongs, in order to be certain that they comply with all requirements needed for the granting of a patent.
This being the case, which then would be the rationale behind the “previous consent“ by ANVISA on pharmaceutical products? Why isn’t there a similar requirement for patents in the area of food, chemicals, mechanics or electronics? Could it be that the Ministry of Health (or ANVISA) believe that the Ministry of Development Industry and Commerce (and IPNI) are not competent and diligent in the development of their activities?
One clearly important issue, is to try to understand why the Ministry of Health (and ANVISA) spend their limited resources in the maintenance of a team of technicians to revise work that is the competence of a different governmental agency, instead of applying them in its specific function which is Sanitary Surveillance?
The fact is that, as it is easily verifiable by what we read, see or hear in the media, issues relative to the pharmaceutical industry are usually treated with a “high dose” of emotion, almost always much stronger than reason, which leads to the conclusion, never well founded, that any type of control which can be exercised over the pharmaceutical industry will always be good. History has shown, over and over, that apart for not being true such controls will almost always have disastrous effects in the long term.
It is curious to note that the agency that grants or not the “previous consent” is the same agency (ANVISA) that grants to third parties registrations (certificate of free sales) to copies of patented drugs, which patents are still valid, sometimes for another Five or 6 years.
As, according to the Sanitary Surveillance Legislation (Law 6360/79 and Decree 79097/77) the registration has the only purpose of authorizing a company to place its product in the market, by granting registration to copies of patented products, ANVISA is, in fact, fostering the violation of the law.
Questioned about this procedure, ANVISA “innocently” answers that patents are not their problem and that the owner of the patent can always go to court to seek its rights.
Much more than discuss the legality of the “previous consent” set forth by article 229C, in face of the constitutional rights to intellectual property and in face of the international treaties signed by Brazil, this article questions the absurd waste of public Money in a totally unnecessary re-work, and the apparent incentive of ANVISA to the violation of industrial property law.
