Post-Map Workplan

Mining for I.P. gold

Last week's revelation that the human genome may contain two-thirds fewer genes than once thought raises the possibility that patent applications have already been filed on all of them. But the U.S. Patent and Trademark Office says that only 1,000 full length human gene sequences have actually issued as patents. And the PTO's guidance on utility suggests that existing applications relying on low-level utility could be abandoned in favor of new ones as more information about each gene becomes available.

Add to this that genes commonly correspond to more than one protein and it becomes clear that genome-related i.p. is far from locked up. But more important, the real value in intellectual property probably lies downstream in patents on compounds that treat diseases rather than those covering targets, so that gene sequence patent holders will have only limited ability to block research with their genes that can yield such treatment-related patents.

Regardless of whether patent applications have been made covering all human genes, the number described by the International Human Genome Sequencing Consortium and Celera Genomics Group (CRA, Rockville, Md.) - approximately 30,000 human genes - is still in dispute.

William Haseltine, chairman and CEO of Human Genome Sciences Inc., contends that the numbers reported by CRA and IHGSC are so low because genes cannot be identified without experimentation in living systems. According to Haseltine, HGSI itself has discovered 90,000 novel human genes and believes there are up to 120,000 in total.

This suggests that even if most human DNA sequences have been filed at the PTO, applications on all full length genes may not have been. Indeed, Lance Ishimoto, vice president of intellectual property at Lexicon Genetics Inc. (LEXG, The Woodlands, Texas), said that many purported full length gene patents pending at PTO could turn out to be partial sequences.

In any case, without related functional information, sequence patents have limited value, and, indeed, that value will diminish over time as efforts to determine function increasingly bear fruit.

The race for utility

"Gene patenting won't be ending, because you have to know the utility of the gene to obtain a patent, and function in significant part is not known for most genes," said Michael Lytton, general partner at Oxford Bioscience Partners.