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 .
Comments
A patent is not a monopoly. The US tried the situation where public funded research could not be patented and the result was no one spent the money to develop the research into useful products. This is a red herring for groups who do not want to pay for other people’s property rights or its just an manufactured excuse for an anti-patent tirade.
That’s a semantical argument. A patent is essentially a short-term monopoly. Competition is only possible if others can circumvent the patent in question, which is not always possible. I do agree that there is a general misconception about biological based patents, with many people assuming they impede research and innovation. However, in this particular case the complexity of these very similar technologies could indeed hinder innovation of and access to this particular type of testing.
Have you seen the money Sequenom has spent (their own) on developing this technology and the patents they have secured. The ‘competition’ is all 2010 and newer piggy backers infinging. They merely took Sequenom science and used an inadequate patent system to muddy the technology. None of the competition would have a leg to stand on had it not been for Dennis Lo’s discovery of maternal ccfDNA (Sequenom’s technology). To say Sequenom has a monopoly? Where would we be without their technology? Perfecting the amnio, that’s where we would be.
Sequenom’s patent is years earlier than any other. This gives them a strong position in who’s patent is authentic. All the other copy-cat testers can continue doing whatever they want as long as they pay Sequenom a royalty for their using Sequenom’s technology. That’s what patent protection is all about. This is what Lifecodex did in Europe. These late to the party intruders are stealing someone elses IP and then claiming they didn’t know. Too bad. A patent is suppose to protect one’s investment of time and money. Someone should ask How much Naters, Ariosa and Verinata invested and when. That would shine a light on whether they were late to the party.
The same argument can be made about any seminal patent. There is, of course, a short term gain to society if such a patent were disallowed because it allows competitors to come in and drive the price down. But there is a long term cost to society because such a policy would greatly lower the incentive for companies to invest in disruptive ideas. Your argument that this patent is hindering the field is weak. I see how a case can be made that the Lo patent is too broad, though I happen to disagree on this point. But to say the patent should be overturned for the greater good is silly.