Prior to the 1996, the Industrial Property Law (from now on, referred to as LPI), pharmaceutical products were excluded from patent protection in our country. In April of 1997, under the above-mentioned law, chemical pharmaceutical inventions and transgenic microorganisms came under the protection of this law. There followed a heated debate about granting exclusive rights and its impacts on the price of medication versus the positive effects of covering the investments made in research to develop new drugs. Information pertaining to patent requests to the Brazilian Patent and Trademark Office (from now on, referred to as INPI) and the benefits to the economy as a whole were made public.
If, on one hand, the granting of patents establishes proprietary rights and exclusive use in production – a right of temporary monopoly of ideas and their refinement, it also protects the creativity involved. On the other hand, it is acknowledged that granting such exclusivity stimulates the competition among companies. The pharmaceutical and biotechnological companies are no exception. Intellectual property assets, including patents, are exponential values to modern companies. These assets are sometimes superior in value to the sum of all other of the company’s assets. Consequently, they become an important standard to the price of the company’s stock on the stock market or related financial transactions, of type I,merger or plain sale.
Current legislation allows granting patents to pharmaceutical products and processes, as well as, transgenic or microorganisms, i.e., through genetic engineering, as long as they fulfill the requisites of novelty, inventive step (not something obviously due to a technique) and industrial. However, elements found in nature are excluded here.
Once our legislation is aligned with the dominant international system, our country can begin to foster innovation in this field as well. The Brazilian pharmaceutical market, as we write this, is estimated at 102 billion Reais, which includes retail and institutionalized market sales. Brazil is the 15th largest market in this segment. Our industrial production of medication – drugs – is extremely significant, whereas our per capita consumption is less than 10% of that in some of the richer countries. The potential for growth in this sector is enormous. This explains the continuous entry in this market of large numbers of new Brazilian and foreign laboratories.
There are still some persistent blockages in patent concession. Some blockages are ideological and others simply bureaucratic. Our National Sanitary Supervisory Agency (from now on, referred to as ANVISA) and its current role has been a subject of concern under discussion. A Provisional Measure (Executive Act) 2.006/1999, was added to the LPI, in article 229-C. It states that “The concession of patents to pharmaceutical products and processes will depend on the previous consent from ANVISA”. The debate is over the interpretation of “previous consent” and where it applies. The question is: are we considering Brazilian legislation and interpretation or are we considering agreements Brazil has with World Trade Organization (WTO) and maxims of TRIPS (The Agreement on Trade-Related Aspects of Intellectual Property Rights)?
Many hold that there was no intent in this legislation to remove the INPI from its original competency: to examine requests for pharmaceutical patent. Nor was it to set up a second examination for patentability, but simply to protect social interests in specific cases. The truth of the matter is that this article 229-C has blocked the necessary agility in examining pharmaceutical patents. This has led to a judiciary discussion as to ANVISA’s role.
The Federal Senate approved amendments to the original text of the Provisional Measure (executive act) number 1040, (MPV 1040/2021), in the beginning of August 2001. These amendments were intended to modernize the business environment in Brazil. Among these legislative proposals to amend the original text MPV and its article 57 (XXVI) is to revoke article 229-C of the LPI. These proposals have gone to the House of Representatives to be voted by August 26, 2021. If they are approved and eventually become law, the “previous consent” from ANVISA in the patent process in examining pharmaceutical patents will be dispensed.