There has been a great deal of controversy lately concerning intellectual property, mainly the downloading of copyrighted music. But an equally interesting and important issue is the patenting of genes.
This area of research has important applications in the treatment of disease. Genes consist of a code that is translated into a protein. This protein may have a specific function in what is called a biochemical pathway, in which chemicals interact in the body to carry out some sort of process. These pathways are very complicated, so if the protein is defective this can set off a chain of events that leads to disease. Since the 1970s scientists have been patenting the gene sequences that they discover for various proteins, such as insulin (which is involved in diabetes).
Recently there has been more controversy surrounding this practice. For example, when a gene sequence is patented, it essentially means that whoever wants to use this sequence to design a drug-or test somebody’s blood sample to see if they have that gene-must pay royalties. The gene that leads to an increased risk for breast cancer may reside in your body, but you must pay fees to the biotechnology company that owns the right to that genetic sequence in order to see if you have it.
Some experts believe that genes should be patented, but that there should be more research done on the legal aspects of this practice. Rebecca S. Eisenberg, a law professor at Michigan Law School, spoke at U of T recently. In the 1970s, patenting gene sequences was similar to patenting drugs or “naturally occurring products that were isolated and purified” such as vitamins or aspirin, which comes from willow bark. Essentially, a gene or protein that is discovered can be patented as though it were an invention.
However, scientists soon began sequencing entire genomes, meaning the list of all the genes in a species. In 1980 the U.S. Supreme Court “extended the patent protection to anything under the sun made by man.” The ruling benefited biotechnology companies in one sense, because research is costly and patents on genes help generate money from user fees. On the other hand, if a biotechnology company patents a disease pathway involving particular gene sequences, then a pharmaceutical company that wants to make a drug that acts on this pathway has lower profits because they have to pay the biotechnology company.
In addition to legal problems, gene patenting raises many ethical questions. Genes found in nature are not the only genes that can be patented-biotechnology companies can create genetically modified organisms, and patent that entire organism, not just the gene. Scientists can for example add genes to seeds that makes them resistant to pesticides. The company that provides the money for this research can patent the seeds and charge farmers who want to use them. This is what Monsanto has done with canola seeds, creating a strain called “Roundup Ready,” which has a high tolerance for weed killers.
This poses a problem because seeds can easily blow from one farmer’s field into another. In a now famous case, in 1998 Monsanto sued a Saskatchewan farmer named Percy Schmeiser for illegally using these seeds. However, Schmeiser argued that he used seeds from his previous canola harvests, and that Monsanto canola seeds must have found their way into his fields. It would have been impossible for Schmeiser to distinguish Monsanto canola from his own because genes are not visible to the unaided eye. However, lab testing done at the University of Saskatchewan showed that a significant proportion of the canola growing on Schmeiser’s land contained genes constructed by Monsanto, more than could be accounted for by seed blown onto his fields. In 2001, three years after the trial began, the judge found Schmeiser guilty.
As the current patent laws were developed before some of the recent advances in genetics, perhaps they should be modified to better deal with the unique ethical problems they raise.
