Gene Patent

Tune in to news programs regularly and you will probably become aware of the considerable debate over the patenting of genes. This controversy is fueled largely by the work of the Human Genome Project and the biotechnology industry. Despite numerous meetings and publications on the subject, Congress has not used U.S. patent laws to shape a policy that allows maximum innovation from biotech inventions. The first gene patents, issued in the 1970s, were granted for genes whose full nucleotide sequence, protein product and function were known. Since then, genome projects have produced new ways of finding genes. Short sequences, only 25 to 30 nucleotides in length, called expressed sequence tags can be used to identify genes but doesn’t provide information about the entire gene, the product, function of the product, or its association with any genetic disorder. Using gene-hunting software, researchers can take a short sequence of DNA and use it to search gene databases, turning up theoretical information about the sequence.

For example, the sequence may belong to a gene encoding a plasma membrane protein or may be similar to one in yeast that is involved in cell–cell signaling. At the present time, there are tens of thousands of ESTs and gene-hunting patent applications filed at the U.S. Patent Office. The unresolved question at the moment is how much you need to know about a gene and its usefulness to file a patent application. How should utility be defined? The diagnosis of disease certainly meets the definition of utility. Many discoveries have identified disease-causing genes, such as those for cystic fibrosis, fragile-X syndrome, breast cancer, colon cancer, and obesity. Many of these discoveries have patents based on diagnostic utility. An increasing number of patent applications are being filed for discoveries of hereditary-disease-causing genes.

These discoveries frequently lack immediate use for practical therapy, however, because gene discovery does not always include knowledge of gene function or a plan for developing a disease therapy. Pharmaceutical and biotech companies have invested millions of dollars in identifying genes to be used in developing diagnostic tests and drugs. Without patents, it is unlikely that companies will invest in developing these drugs. However, patenting genes can lead to royalty-based gene testing accompanied by exorbitant fees and licensing arrangements requiring payment to companies that own the patent on a particular gene. A DNAcase now before the courts about the patents on two genes used to test for breast cancer may determine much of the future of patented genes. As the results of the Human Genome Project redefine health care, these issues take on importance for everyone.