During the ’60s, biology was not patentable. Genetic engineering started during the ’70s, but it was called recombinant DNA technology back then. Investments made in this area demanded a solution for intellectual property (IP) rights being applied to biology.
Though living organisms were not patentable before, genetic engineering and particularly applications in the pharmaceutical area gave rise to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, which allows patent protection to be accorded to inventions in the area of Pharmaceuticals. (The TRIPS Agreement is Annex 1C of the Marrakesh Agreement under the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994.)
Brazil signed the agreement, with 13 other WTO members. When Brazil signed TRIPS, it automatically had to reorganize its patent regulatory system. Brazil then approved a patent law in 1996 (Law 9279) and the next year approved a plant variety protection law (Law 9456). These adjustments came a few years after TRIPS, and the Brazilian patent law incorporated what was minimally required in the TRIPS Agreement.
Our patent law offered the possibility to patent (recombinant) microorganisms that satisfied what was required for granting patents — a not-obvious invention. But it also provided the option to adopt a sui generis system (the UPOV system) to avoid patenting genetically engineered plants and animals – both not required by TRIPS. Patent law and the plant variety protection are hardly compatible (See Castro L.A.B. Revista da ABPI , March/April 2011). Those who have genes and protect the gene technology by the Patent Law also want to have the ownership of whole genomes of plants. The negotiation with agribusiness has progressed, however, since in Brazil farmers can measure the benefits and thus pay for the technology fees, mostly charged by large corporations. This has made Brazil second in the world to the USA in biotech crops.
The big disagreement came in pharmaceuticals. The Brazilian law incorporated TRIPS-endorsed principles that were never accepted by the international pharmaceutical sector, particularly compulsory license. The Brazilian law allows for patented products to be manufactured in Brazil if it’s deemed that prices established by pharmaceutical companies (mostly multinationals) are abusive.
Next the Brazilian government, under the stimulus of the health public sector, modified the Patent Law and established with ANVISA (equivalent to FDA in the USA and to EMEA in Europe) that those willing to patent in pharmaceuticals, and having applied for this purpose at the National Institute of Intellectual Property, needed an agreement from ANVISA. This rule makes the Brazilian process longer than any other in the world, and it is under judicial dispute.
The Brazilian Patent Law is very restrictive, as we can see in the Article 18 of the Law, which deals with biology matters. The Law 9279 prevents patenting parts of organisms, be it microorganism, plant or animal. Cells are not patentable .Genes are not patentable, unless essential for a patented process.
Biopharmaceuticals are not patentable. Molecules derived from the huge Brazilian biodiversity are not considered inventions even if these molecules are isolated and their function demonstrated. As a result Brazil has not one molecule patented from our biodiversity. In addition the general patent performance of Brazil, as compared to Korea, for instance, is extremely weak. The almost nonexistent number of patents from Brazil deriving from our biodiversity has been previously discussed on this blog.
Patenting is an essential instrument for partnerships, which is an absolute requirement for the pharmaceutical industrial sector in Brazil, that is funded with national money, to partner with large corporations (which have been in Brazil for decades, some for a century) to ascend to the large international market. This strategy is the only one that will allow these “native” pharmaceutical companies to become relevant actors in the international scene. Fortunately, the private sector is aware of the importance of patents as an instrument for partnerships. Thus partnerships are occurring in Brazil, despite of our patenting restrictions in biology. As result the Brazilian pharmaceutical industry is growing and is responsible today for 40% of the market in Latin America. The demand for pharmaceuticals is growing at 10% per year. In fact Brazil is leading an emerging biotech boom in Latin America. But it could do a lot better if our regulatory patents system was reviewed.
Patents granted by the USPTO for selected countries – " pedidos" = deposits ; " concessões " = granted.**