Health sciences underwent a radical transformation from the discovery, in 1953, of the structure of DNA. Since then, scientists have made important advances in relation to understanding the functioning of DNA. In 1990, was created the Human Genome Project in order to coordinate research that aimed to identify all genes in human DNA and determine the order of the three million pairs. On 2001, the first draft of the human genome map was published, the one that identified most of the human genes.
From this discovery, patents on human genes have multiplied year after year and have been, since the first ones were granted, subject of debate. The economic interests that are at stake in this field, especially in regions such as North America and Europe, have led to a considerable increase in the number of patents on materials and processes used in biomedical research in recent years. The protection of knowledge applied to human genes has been achieved mainly through the patent system, although it should be noted that other devices, such as trade secret and confidentiality agreements have also played an important role.
Patents on genes, human cells, stem cells and proteins are contemplated by international laws. However, many countries limit its scope as a way to minimize the negative impact that its capacity can have on health care costs, to reduce inequality in access to treatments that arise from these discoveries and preserve the Free flow of information in research. One of the most resonant cases of patent limitations on human genetic material is that of patents on the BRCA-1 and BRCA-2 genes.
BRCA1 and BRCA2 are human genes that belong to a class of genes known as tumor suppressors. In normal cells, the BRCA1 and BRCA2 genes affect the stability of the cell’s genetic material (DNA) and help prevent uncontrolled cell growth. Mutation of these genes has been linked to the development of hereditary breast cancer and ovarian cancer, so the identification of mutations is important for early diagnosis and follow-up of women who have higher risks.
Myriad Genetics Inc., a molecular diagnostic company, in collaboration with the University of Utah, in the United States, were the first to sequence the BRCA-1 gene and applied for patent protection in 1994. In 1997, along with the CHUL Research Center in Canada and the Japan Cancer Institute, granted them a patent on an isolated DNA sequence encoding a polypeptide, thus asserting their rights over a series of mutations in the gene and about the diagnostic methods associated with its detection. Other applications of the patent were together with the second gene, BRCA-2.
But appear oppositions to patents on the BRCA-1 and BRCA-2 genes and their derived applications. The first of the rejection requests was filed against the European patent filed by Myriad on the isolated BRCA-1 gene.
On this occasion, the claim was presented by a large group of associations and representatives from different states, who opposed the permit: the Social Democratic Party of Switzerland, Greenpeace Germany, the French Curie Institute, the Association of Public Hopistals of Paris, the Society Belgian Human Genetics, the Netherlands (represented by the Ministry of Health) and the Austrian Federal Ministry of Social Security, among others.
The central argument of his claim against the fact that Myriad Inc. was granted the requested patents consists in a challenge to their validity on the basis that it did not meet the patentability criteria of the European Patent Convention. They argued that the invention lacked both novelty and industrial application and that, in addition, the patent did not disclose the invention sufficiently for one skilled in the art could replicate it.
Following this resonant case, the European Parliament expressed concern in a 2001 resolution against the patents of Myriad Inc., encouraging the European Patent Office to the principle of non-patentability of human beings, their genes or cells in its natural environment and stating that the human genome would be fully available for research purposes. This case influenced the evolution of the French Patent Law.
The Myriad case has aroused more than a decade ago a debate that continues today. This case, like no other, attract public attention, in addition to the international scientific community, towards the need to delineate clear policies around the patenting of human genes in general and, more specifically, in the patenting of genes used in the diagnosis of certain inherited diseases.
Criticisms against the validity of patents obtained by Myriad can be classified into different groups. The most important is that which focuses on the idea that human genes, in general, and especially the BRCA-1 and BRCA-2 genes do not have the patentability criteria that require an invention to occur. Patents have been for over a century to protect a wide range of inventions, including new medicines, new materials and new machines. Natural phenomena such as electricity or wild plant or animal species are not considered inventions but discoveries, so they are not eligible to be patented.
The detractors of these patents indicate that in the case of granting permits to Myriad Inc. it was a discovery and not an invention, since no intervention by researchers is needed for gene mutations to possess the functions that they possess.
However, proponents of these patents argue that the very fact of patent laws affected in several countries patenting human genes implies that the action of isolating a particular gene is implicitly a sufficient intervention to qualify genes as inventions. While the products of nature, in the way they are presented in it, are not patentable, if they are the results of the processes of isolation, purification or modification of genes and gene sequences.
Proponents of gene patents argue that one of the biggest advantages of these is precisely that they generate income that encourages the development of new treatments that ultimately improve the lives of people in need. The development of these investigations, the final result of which is often uncertain, depends on the investment of a large capital, for which a compensation is legitimately intended: companies engaged in biotechnology are held under the expectation of future benefit
However, patents in themselves do not have an improvement in global health. High market prices limit access for people who need to have patented treatments and treatments for diseases that primarily affect people living in poor countries and that do not represent the most profitable markets: the price of these tests It has risen despite the technological advances that are available today.