The Human Genome Project

  1: What is the public project for sequencing the human genome?
  2: Has the human genome been completely sequenced?
  3: How many genes do humans have?
  4: Why is it so difficult to find the genes in a human genome sequence?
  5: Where did the sequenced human DNA come from?
  6: Is the human genome “freely available”? If not, who owns it?
  7: Why was there a Human Genome Project What is its use?
  8: Who were the members of the international consortium What was the role of each of them?
  9: What was the French contribution to the Human Genome Project?
  10: How much did the Human Genome Project cost?
  11: With the end of the Human Genome Project, are the large sequencing centers still useful?

  The members of the consortium have agreed to deposit the sequences they obtain in public databases without delay. If the sequencing of the human genome had been entrusted to genomic companies, there would have been a great risk of the sequences being sequestered in private databases which could only be consulted by paying a high price. It was mainly in this sense that the public project avoided the “appropriation” of the human genome sequence. In divulging the sequence of a gene, the scientists of the consortium were in fact suppressing the element of novelty necessary for obtaining a patent, thus making patents on the sequence itself impossible. It is still possible, however, to patent an application derived from a knowledge of the sequence. Many are in agreement that free access to the genomic sequence is the best way to stimulate biomedical research, and the industrial competition should come in downstream of the sequence, toward the biological comprehension of the function of the genes in the organism.

Nevertheless, human genes have been patented, even before the beginning of the Human Genome Project. For example, sequencing programs for complementary DNA (copies of messenger RNA from gene expression) in the 1990s led to numerous patent applications from both biotechnology companies and public institutions. Furthermore, patents from the genomic DNA sequencing program have been granted. For example, the Celera Genomics Company took advantage of its human genome sequencing effort to submit patent applications for an indefinite number of human genes.

Not all of these patent applications will be successful. The criteria for the granting of a patent on a DNA sequence have become more severe, both in the United States and in Europe, as the progress in technology has made sequencing a routine process. In order to obtain a patent, the “invention” must fulfill criteria of inventiveness as well as utility (in the United States) or industrial application (in Europe). It has therefore become impossible to patent a “raw” sequence without characterizing the function of the gene and without a non-trivial description of the applications of the sequence, such as diagnostics, gene therapy or the creation of transgenic animal models. Moreover, once the patent is delivered, the content of its claims can be contested on these same points. Finally, it is important to remember that a patent is not title to a gene which is present in all of our bodies—it is above all a means of preventing a competitor from commercializing an application derived from the knowledge of the gene. In any case, the power to prohibit such utilization, when the claims have an abusive content, may have the effect of sterilizing research, especially if it is linked to an exclusive licensing strategy.

No one knows exactly what portion of the genome and its genes can be freely exploited for commercial purposes. As of the end of 2000, the US Patent Office (USPTO) had granted patents on over 6000 DNA sequences, including 1000 from humans, and more than 20 000 patent applications were pending. It remains to be determined how many of these will be granted, how many applicants will continue with their application and how many of these patents will hold up.