There are approximately 24,000 human genes encoding every protein and structure in the human body, including the metabolic enzymes, the proteins and structures of cell division, the keratin protecting skin cells, the plasma proteins carrying nutrients through the blood, the synaptic structures of the brain, and enzymes that respond to the electrical signals the brain interprets for actions and reactions.
The sequencing of the human genome and research studies isolating variant gene sequences have opened the door to questions of propriety and to debate over who owns the information. Some of these concerns are based on ethical questions of who should receive funds from patents and whether appropriate research can be done when one institution or company controls the information about genes involved in disease susceptibility. The main problem with patenting human genes is that the information is new, but the genes are not a unique development by the scientists. Patenting human genes would be like patenting a new species discovered in the rainforest. Though it is considered a way to raise funds and encourage the biotech industry, patenting human genes would be detrimental to both patients and science.
Biotech and Big Pharma Interest
Every gene is copied when cells divide, though not every gene sequence is decoded to produce gene products (proteins). The portion of the genome translated depends on the need of the cell, tissue, organ, and/or the whole organism in a delicately balanced process maintained by the genetic products themselves. Because of this intricate balance, many genes have been associated with diseases and are the target of pharmaceutical therapies or dietary manipulations. For example, high blood pressure is often a problem with the genes encoding proteins of the renin-angiotensin system. These genes are turned on or off by certain environmental factors, such as salt or water balance. Manipulating these factors through diet or blocking the interaction of these factors with medication are two types of therapy for patients with hypertension. There have been a number of genes found to have mutations that affect the activity of this system and others, indicating potential screening methods for disease.
If genes are patented in a process bestowing copyright to the researcher(s) who discerned the sequence of the original gene or any of the variants involved, then any treatment such as that described above would be subject to royalty payments. This would be a huge blow to all those requiring treatment for any genetic disease. Currently, researchers are beholden to the organizations for which they work, and many corporations would find themselves the benefactors of such a policy.
Complexities of Patenting Genes
Another problem is the volume of details that would have to be addressed should patenting be allowed for human genes. It would have to be outlined if derivative sequences are covered and to what extent. Which type of manipulations and treatment that is allowed would also have to determined, can a researcher work on the sequence without paying royalties? How will the different regulations affect the progress of curing disease? Then there’s the question of how much the royalties should be and what access other researchers should have to the information or if they would even be allowed to determine the sequence themselves. These questions and their inevitable answers towards protecting copyright would slow research dramatically and cause politics to enter scientific research to an even greater extent as countries who disagree with each other hold gene sequences hostage from their researchers, leaving their citizens vulnerable.
The argument for not patenting human genes is more than a question of ethics and discerning the human entity. It is time for the scientific, legal, and business communities to get on the same page, for the sake of scientific progress, medicine, and patients.
Precedent for Patenting Human Genes
The U.S. Bayh-Dole Act, in an attempt to increase research with business incentives, opened the door for researchers to earn royalties from their discoveries. Recent years have found this approach to be detrimental to research. In an April 2008 issue of Nature, one of the top scientific research journals in the world, an editorial questioned business model-driven science, indicating the detriment it has had on AIDS vaccine research.
The awarding of U.S. patents for human genes is leading to international dissent and may be a point of contention between researchers in the U.S. and other countries. A 2005 study published in Science reported that 20 percent of human genes, approximately 4,000, have been patented, primarily by private firms and universities. The first patent was issued in 1978 for human growth hormone. The top patent holder is a California-based drug firm, which holds patents covering 2,000 human genes. This is extremely surprising because taxpayer money was used for the Human Genome project (according to the Institute on Biotechnology & The Human Future at Illinois Institute of Technology) and the fact that U.S. law prohibits patents on products of nature, physical phenomena, and scientific formulas.
