For years researchers have patented human genes, which for biotechnology companies have provided a gainful source in the sale of certain pharmaceuticals, including those that fight anaemia and prevent heart attacks. Officially, the right to patent human genes is granted only if a gene has been isolated and purified in a way that cannot exist in nature. Until recently the patents were issued only after researchers claimed certainty in a gene's function in the human body. The patenting of undeciphered genes may threaten important medical research, as scientists may focus on commercial competition and monopoly instead of collaboration with other scientists in fighting human disease.
In the early 1990's, the National Institutes of Health applied for a patent covering the rights to 340 pieces of genetic code, the majority of which were undeciphered. Concurrently, officials claimed a pending application for 1,500 more genetic patents.
In December 1999, the Munich-based European Patent Office granted a patent on altering cells and human embryos to Edinburgh University. The patent office later said it had made a mistake and had overlooked the patent's potential use on humans. Edinburgh University and an Australian biotech firm, Stem Cell Sciences, applied to the office for a patent to genetically alter the cells of mammals, which could then be used to create embryos. A spokesman for the patent office said officials did not notice a reference to human cells in the 235-page application. Despite the admission of error, and despite the fact that European guidelines barred patents on human genetic alterations, the patent remained valid. Only a formal protest could reverse the decision, but appeals could drag out the process for years. The Italian government was evaluating the possibility of appealing against the Munich-based patent office. The government would take this decision collectively, as there were many ministries involved. Germany, especially sensitive to the issue because of Nazi efforts to create a master race, taking a hard stance on genetic engineering and having tight rules on scientific research, objected to the patent and planned to launch a formal challenge in coming months.