In the latest issue of the journal Science Translational Medicine, Dr. Mildred Cho and three colleagues from the Stanford Center for Bioethics expressed concern that access to prenatal genetic tests that use maternal blood may be limited due to a convoluted licensing situation on this technology. These diagnostic tests use fetal DNA circulating in a pregnant women's blood to identify genetic disorders of the developing child. Essentially, prenatal genetic tests can be done with a simple blood test of the mother.
The particular patent concern is an expansive 2001 patent that Sequenom acquired in 2005. This intellectual property may put Sequenom in a position to exclude competitors and, "to decide which of the many technologies to employ in the commercialization of noninvasive prenatal testing." Sequenom stated this quoted objective in a 2008 Fact Sheet from the company that discussed a published study using similar technology from Dr. Stephen Quake's lab at Stanford. The technology from the Stanford study was subsequently licensed to a Verinata Health, which is now competing with Sequenom in developing these non-invasive prenatal tests. Dr. Quake serves on Verinata's scientific board. Sequenom has filed infringement lawsuits against Verinata and two other competitors, Ariosa Diagnostics and Ravgen, and is seeking to have their tests removed from the market.
The article from Cho and her colleagues makes the point that much of the research to develop this technology was publicly funded by grants from the NIH and National Science Foundation. There are sixteen patents covering aspects of this technology awarded to at least four different research groups. Basically, all the companies involved purchased different intellectual property that covers closely related techniques. The intent of patent legislation such as the Bayh-Dole Act is to enable commercial development to encourage practical use of publicly funded research. In this case, though, with multiple companies pursuing similar goals with what appears to be overlapping patents on similar technology, exclusive licensing of this research may result in hindering the development of the tests.
The article's main concern, of course, is a potential monopoly by Sequenom on this very defined and beneficial niche of non-invasive prenatal genetic tests. Some of their fears may be warranted. They point out that the Sequenom kit for Down's Syndrome is priced at $1,900, whereas a test to genetically determine the fetal Rh blood group based on virtually the same technology is $250, and that a recent study suggested that Verinata Health's test may be more accurate than Sequenom's. If Sequenom's intellectual property gives it a monopoly, it would set these standards for the whole market.
The article suggests that, to avoid these conflicts, more attention should be paid before granting companies exclusive rights to patents based on publicly funded research. Something the article remains silent on, however, is the fact that it appears several overlapping patents were awarded to various research groups in the first place. It is, of course, unclear how the claims will sort out and whether all the patents will remain valid. This is something that will likely be played out in the courts over the next several year. However, perhaps a more careful review of the patents applications before they were issued could have entirely avoided much of the problem .