January 1, 1970 (Vol. , No. )
Taralyn Tan Ph.D. Curriculum Fellow Harvard Medical
t sounds like the makings of a science fiction story – patients unable to access genetic tests, researchers restricted in their investigations…and why? Because the genes of interest to the patients and scientists – the naturally occurring genetic material found within you, me, and all of our human friends – have been patented. Alas, this is not a glimpse of a possible future society. In the case of approximately 20% of all human genes, this is the present reality.
The general patentability of genes has its roots in the 1980 Supreme Court case of Diamond v. Chakrabarty. The court ruled in favor of Ananda Mohan Chakrabarty, a genetic engineer seeking a patent for a bacterium he developed to break down crude oil. Yet, I find this case to be a rather erroneous precedent for the matter of gene patenting. The dispute was not whether Chakrabarty had, in fact, invented something “useful”, “nonobvious”, and “novel”, as stipulated in U.S. patent law, but rather, whether an invention comprised of living matter could be patented. In Diamond v. Chakrabarty, it was decided that living matter can be patented, but there still needs to be an actual invention somewhere in there, right? This doesn’t appear to hold true for the patenting of genes, as one need only isolate and purify something that nature has already bestowed upon us in order to obtain a patent. I believe that should fall under the category of “identification,” not “invention.”
The problem with patenting genes, of course, is that in an effort to protect the “inventor” (again, a misnomer, since said patent holder did not actually “invent” anything), the patents greatly restrict access to the genes. This is especially the case when the patents are held by biotechnology or pharmaceutical companies (indeed, the majority of gene patents do belong to such companies) that have financial incentives to monopolize research or testing in relation to their genes. And they really are “their genes”, as many of the patents granted give exclusive rights to the company, oftentimes preventing researchers from studying the patented genes or laboratories from performing genetic testing in relation to the patented genes without the company’s consent. This seems to contradict the original spirit in which patents were (and supposedly still are) provided – to encourage innovation and provide an incentive for discovery.
While defenders of gene patents argue that the patents do promote further research or development of different diagnostic tools, I disagree. Take the case of diagnostics. A patent for a specific genetic test for Gene X would encourage other research groups to devise new tests for that gene, for although they can’t use the particular, patented method, they are still allowed to study Gene X and develop new approaches. (There is more than one way to skin a genetic cat, you know.) Analogously, a company patenting a drug to lower cholesterol does not prevent other companies from developing and subsequently patenting their own drugs that have slightly different chemical structures or mechanisms of action.
However, the practice of exclusive gene patents does not promote research like the above example. In the current system, I don’t just patent a specific genetic test for Gene X, but I patent Gene X itself. How can other researchers hope to develop new technologies or make new discoveries in relation to Gene X when they need my permission to even study it? Keeping with the pharmaceutical analogy, this is akin to being able to patent “cholesterol-lowering drugs” as a class, as opposed to a particular compound. Do you think we would benefit from the wide variety of cholesterol-lowering drugs that we have in today’s marketplace today if this was the case? I don’t think so.
And I have the U.S. Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) on my side. At its meeting earlier this month, the SACGHS provided its recommendations regarding gene patents. The committee concluded that “Patents do not serve as powerful incentive to conduct genetics research, to disclose genetic discoveries, or to invest in the development of genetic tests,” and recommended the creation of exemptions from patent infringement liability for 1) anyone making, offering, or selling a test developed under the patent for the purpose of patient care, and 2) anyone using the patent-protected genes in the pursuit of research. I believe these would be positive steps towards undoing some of the damage that has been caused by gene patents. Let’s increase patient access and stop restricting scientific research. Let’s make room for the innovations and discoveries that actually merit recognition under U.S. Patent Law.