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  • Molecules or Carriers of Biological Information: A Chemist’s Perspective on the Patentability of Isolated Genes

    The intense debate over the validity of gene patents has a widespread impact on biomedical research and public healthcare. By 2004, about 20 percent of known human genes, 4,382 out of 23,688 identified at the time, had been explicitly claimed in issued patents. In 2009, the U.S. Patent and Trademark Office (USPTO) had granted 50,000 patents containing at least one DNA-related claim, with some claiming isolated genes and others claiming therapeutic products, such as insulin, growth hormones, growth factors, antibodies, and other therapeutic biologics. Although patents claiming therapeutic products have been a subject of litigation, there has been relatively little media attention or public controversy. In contrast, patents claiming isolated genes, modified or unmodified, are more controversial and have attracted more public attention. To scientists in the field of biotechnology, being able to patent isolated genes is a form of societal recognition and financial reward for their achievement, which is part of the purpose of our patent laws. However, due to special properties of genes and their relationship to human life, both legal professionals and public opinions are divided on the issue regarding whether isolated genes are patentable. The recent rulings in AMP v. Myriad7 regarding BRCA1 and BRCA2 genes brought gene patents to the forefront of the debate over the scope of intellectual property protection. The present article attempts to analyze the patentability of isolated genes from a chemist’s point of view by focusing on three highly contested issues. First, is an isolated gene, such as BRCA1 and BRCA2 in Myriad’s patents, a biomacromolecule or a physical carrier of biological information? Second, are utilities of an isolated gene uniquely linked to its DNA sequence? Finally, is an isolated gene markedly different from its parental chromosome? As will be discussed in section IV, isolated genes function more like biomacromolecules than carriers of biological information. Their utilities are more dependent on their unique structures than their DNA sequences (section V). An isolated gene can have markedly different characteristics from its parental chromosome (section VI).