(Update (8 November): the paper is available at no charge via Fiona’s website.)

Writing in a recent issue of the journal Science (Vol. 310, 14 October 2005, pages 239-240), Fiona Murray and Kyle Jensen have reported the results of their research into ownership of patents in the human genome. Their findings are very interesting, providing needed empirical data on the extent to which the human genome has been patented, and by whom.

Readers with a subscription to Science might be interested in reading their paper. (Supporting material, including a description of the researchers’ methodology, is available for free online here.) For those without access to the paper itself, here is a summary of their findings:

— nearly 20% of human genes (ie, human protein-encoding nucleotide sequences) are the subject of U.S. patents (representing 4,382 of the 23,688 genes in the National Center for Biotechnology Information‘s database;
— these genes are claimed in a total of 4,270 patents;
— these 4,270 patents are owned by 1,156 different entities (with no adjustments made for acquisition activity since the study was conducted, subsidiaries, or spelling variations);
— approximately 63% of the patent assignees are private organisations;
— the patent assignee holding the greatest number of gene patents is Incyte Pharmaceuticals/Incyte Genomics, which holds patents covering 2,000 human genes; and
— of the top ten gene patent assignees, nine are based in the United States, and include the University of California, Isis Pharmaceuticals, SmithKline Beecham (now part of GlaxoSmithKline), and Human Genome Sciences.

In addition, of great significance is the concentration of patent activity that Murray and Jensen have observed. While large parts of the human genome remain unpatented, some genes have up to 20 patents asserting various rights with respect to them. In some cases, although less frequently, a single patent covered several genes. The most-heavily patented genes are those relating to particular human health applications, such as cancer treatment.

For the most part, they found that ownership of gene patents is highly fragmented. Of the 4,382 patented genes, at least 3,000 have only a single rights holder. With respect to those genes over which multiple patent holders have rights, Murray and Jensen examined market concentration, using the Herfindahl-Hirschman index method (explained in the context of antitrust analysis here). They determined that the genes with the most fragmented patent ownership had 12 assignees for 14 patents (BRCA1, the early onset breast cancer gene) and eight assignees for nine patents (PSEN2, the amyloid precursor protein connected to Alzheimer’s disease), observing that this spread of ownership may make access to these genes costly, implying that innovation may be hindered.

This study is an important first step in evaluating the effect of patenting gene sequences on innovation and research. It will be particularly interesting to look the market dynamics relating to genes over which multiple patents are asserted, and the extent to which licensing and otherwise allowing access to these genes is or is not taking place.

The debate as to whether genes should be patented in the first place appears to be of secondary consideration these days, although in general genes are not patentable until “isolated, purified, or modified to produce a unique form not found in nature“, which is consistent with the approach to the patentibility of chemicals generally.

If further research reveals that the patent system is not allowing sufficient access to patented genes, it will be interesting to see how this debate develops.