According to US law, it is. In 1980, the Supreme Court heard the case of Diamond v. Chakrabarty, which became a landmark for genetic science in terms of being able to lay claim to certain parts of the genome. While working for GE, Chakrabarty had developed a strain of bacteria that could enzymatically digest crude oil, which the court found did not occur naturally and thus could be patented since the bacteria were created artificially via genetic engineering. This was a victory for genetic engineering and biotechnology, but the decision was not without controversy and has generated a multitude of bioethical and moral questions that have yet to be answered.
What does it mean to hold a patent, though? Well, in layman's terms, if you hold a patent for something, then that means that you have exclusive rights to make or sell that item or process. It also means that if someone else wants to use your item in any item that they produce or process that they develop, they have to ask for your permission first. You would likely charge that person a sum of money to use your item, which would generate an income stream for you and would allow that person to have a license to use your item/process--a win-win situation for both parties.
Indeed, segments of the very molecule that every single living thing on our Earth possesses is available to patent. But should it be legal to patent that which is present in all life? Of what benefit is it to patent genetic material? These questions are currently being debated in court, as a lawsuit has been filed by the ACLU against a company called Myriad Genetics. Myriad Genetics holds patents on two genes known to be involved in breast cancer, as well as the tests used to detect these genes. Currently there is only one test available for detecting the presence of the genes BRCA1 and BRCA2, and Myriad is the manufacturer of the test. So if a recently diagnosed patient, such as Genae Girard of Austin, Texas, want a second opinion, there's not one to be had. Girard, with the ACLU, decided to file suit against Myriad, claiming that because Myriad holds the patent on the genes, no other tests can be developed for those genes without Myriad's permission.
There are benefits to gene patenting, but there are also drawbacks. One benefit is that future research can be funded through licensing rights that the patent holder issues to others. This could be especially important to private companies who may not receive government funding through grants, or it could be important to public institutions whose government funding has been drastically decreased due to budget cuts.
A major drawback of patenting a gene sequence is that gene sequences can vary widely, even within the same species. Remember in the video "Journey of Man" when Spencer Wells was sampling DNA from the Indian men at Madurai? He later did an analysis on the DNA and found a singular difference in the sequence of one of the men that was significant. These small, individual differences in DNA sequence are called SNP's and they exist in all genomes, not just the human genome. What happens when a sequence is patented, but someone finds a SNP in the sequence of an individual and wants to utilize that sequence? Is this a violation of patent law, or the opportunity to file a new patent?
This apparent monopoly on the gene rights creates a myriad (ha!) of bioethical conundrums for biotechnology companies, patients and their health care providers. When does free enterprise stop and the free exchange of information start? Is it ethical for only one company to hold the knowledge about something as universal as a genome, or the information about that genome? How can companies protect their intellectual property rights in a situation such as this? How might gene patenting hinder health care for genetically-based illnesses?
Posted by scienceguru on May 15, 2009
Tags DNA, bioethics, dilemmas dilemmas!, discuss, genetics, science and society


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