The last few days I have been reading through a legal decision. Not my standard reading material. The decision, however, grabbed my attention. In this case you see so much of what is right or wrong in the US today, whether you look at our economy or our health care system. The case involved the ACLU, the US Patent and Trademark Office (USPTO), Myriad Genetics and Directors of the University of Utah. In short, the ACLU had filed a petition contesting multiple patents given to Myriad Genetics by the USPTO. These patents were for various genes that indicated a predisposition to breast cancer. The University of Utah was listed as a defendant as the discovery of these genes was made in their facilities by faculty member, who went on to form Myriad.
The ACLU were arguing that one cannot patent a piece of DNA. They argued that genes are found in nature and not something created or invented by man. One cannot own a gene sequence. The claim that one owns a gene is perhaps equivalent to the discoverer of oak trees claiming he now owned all oak trees. I caught several discussions of this case on the cable news outlets and the News Hour and kept thinking that Myriad cannot own the gene but rather must own the method of identification for thee genes. It seems, however, that my hunch was wrong. Myriad used fairly standard methods to locate and discover these genes, and now when someone wants to confirm if they have a predisposition for these cancers, they must go to Myriad.
For the next seven years Myriad has a monopoly on these genes as they did the work and determined which sequence predisposes one to these cancers. In that time, if you want to know if you are predisposed to these cancers, you have to go to a Myriad lab. What differentiated Myriad from other groups offering such services, at least in my quick read of the decision, was that they were not offering access to their product to lower income patients. With that, the ACLU intervened and Myriad of course argued that this was not the case in regard to access. In short, it seems you are given ownership of genes and the fruit of those genes, as long as you make them accessible to those who are in need of such diagnostic tools.
This legal decision, however, challenged that deal now as it claims that genes are found in nature and cannot be patented. Myriad will appeal the decision and I will bet that in the end they will continue to hold the patents for these genes. In one article it was stated that 20% of the human genome is owned by such firms. I cannot believe that 20% is already owned, but no doubt pharma companies and researchers are wasting no time.
Again, this case reveals something about the American system, our economy, our health care system, and the relation between public and private institutions. Front and center is the disparity of wealth. The ACLU filed this case on behalf of a woman who was not able to afford Myriad's diagnostic test. On the other hand, if it were not for Myriad, the diagnostic tool to determine her predisposition for certain cancers would not exist. One of the key reasons for rising health care cost is the cost of the R&D associated with such diagnostic tools and other advances.
So far I have tried to point to two areas of interest. First there was the issue of whether you can own a gene, or does one own a method to determine a gene. Then there is a second issue-the social justice of making such diagnostic tools available to all, and likewise the need to properly compensate the researchers who discovered this process and/or gene sequence. There is, however, a third area that grabbed me in this case. The research was conducted at the University of Utah, but the group that owns these genes is Myriad.
If you read the decision, you get some idea of the relationship between basic research and the process of bringing research-based products to market. The US has the best university systems and it is at these institutions that basic research is conducted. The US also has the best system of venture capital. This case allows you to get a glimpse of the nexus between basic research, happening at our universities, the researchers who see the possibilities of this research, and the venture capitalist who provide the capital to facilitate bringing the product to market.
The venture capitalist, will do this, if and only if there is a potential for a return. In short, venture capitalist and the researcher, require the ownership of the product, in this case a gene. They are gambling that their investment of time and money will pay off. And not only do they have the cost of bringing the product out of the lab, from what was basic research, they also need to license the research from the university. The University basically becomes a partner in the ventures their researchers pursue, which involves the results of work done in the university's labs.
So from public universities doing basic research you have all kinds of new products being brought to market. Genes slices just happen to be the topic of this article and case. This case mayb not be cloth from which movies are made, but it is, very much the cloth from which our political debates regarding social justice, and the the relation of public and private institutions is being cut.
For the New York Times article on this case, click here
And for the judge's decision or opinion, to which I refer click here, again courtesy of the NY Times
Thursday, April 8, 2010
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