Raising the bar for gene patents

working draft of the human genome sequence, attention is turning once again to the controversial issue of gene patenting. In response to mounting criticism about the ease with which some groups have been able to apply for and receive patents on poorly characterized human gene sequences, the US Patent and Trademark Office (USPTO) has recently released new guidelines that will affect the outcome of gene patent applications. In order for a gene patent to be approved, a patent will have to not only provide an adequate description of a gene, but also link the gene with a specific, useful application. With the new guidelines, the USPTO again rejected all arguments against the patenting of genes. " The eligibility of genes to be patented is firmly based in legislative history and judicial law, " explains John Doll, director of biotechnology at USPTO. In the United States, a patent application directed to a genetic sequence has several hurdles to overcome: it has to be novel (for example, a genetic sequence that has not been previously published), not obvious to people working in the field, and useful. This final requirement — utility — is the central focus of the new guidelines. While it is clear that the description of a human gene encoding a medically useful protein is patentable whereas raw DNA sequence data are not, the new guidelines provide a framework for determining where to draw the line between the two extremes. Patent applicants must be able to show specific, credible, and substantial utility for gene sequences. Specific utility means that the applicant has to know what the sequence does. Credible utility means that the claim must be believable to people who know the field. Lastly, the substantial utility criterion, which was introduced with the new guidelines, states that the sequence must have a 'real-world' use — in other words, there has to be a clearly defined use for it in commerce. For example, an expressed sequence tag (EST) can be patented if it provides the basis for a diagnostic test. On the other hand, the argument that an EST is useful because it can allow scientists to find the entire gene and is thus a tool for further research is unlikely to meet the utility requirement. The scope of an EST patent would also be limited to the sequence included within the EST and not the sequence surrounding it (for example, …