by Gordon Wade '15
The answer to this seems obvious – no one owns life. It just is. Or in the case of livestock, plants, and pets, maybe one can own it. But can you claim ownership over an entire species or strain? Should individuals and companies be allowed to patent particular genes? What about genetically modified organisms? Or entirely synthetic organisms?
These questions are relevant in the current scientific landscape of genetic engineering and synthetic biology. The topic of intellectual property and genetics has only recently gained traction in United States courts and popular awareness.
Last summer, the Supreme Court overruled a patent on BRCA1 and BRCA2—genes associated with elevated risk of breast and ovarian cancer. Myriad Genetics, the company behind this case, was attempting to gain a monopoly on diagnostic tests and place restrictions on further research on the genes. The Supreme Court found that because Myriad had not created or modified these genes, they could not patent them. In this case, the Supreme Court aimed to keep research and development of related devices accessible. It is unclear how this ideal will be upheld in other cases, especially those involving modified or fully synthetic genes.
A month prior to this, the Supreme Court upheld Monsanto’s patent on modified soybeans. Monsanto holds a patent on soybeans modified for increased herbicide resistance. A farmer named Vernon Hugh Bowman bought some of these seeds from a third party and grew and replanted them without Monsanto’s permission. Monsanto argued that this violated the patent on the seeds, and the Supreme Court ultimately agreed.
The two key differences between these cases are the organism—human or plant—and the content of the genes. Myriad isolated but did not alter the BRCA genes while Monsanto modified the genes in its soybean patent. While this appears to be a straightforward difference, it does not offer a specific resolution—it is unclear how much modification is needed to justify a patent or whether human genes can be patented in any context.
Fully synthetic genes make these issues even more complex. The Venter Institute recently synthesized an entire bacterial genome and successfully implanted it into an enucleated cell. This genome is nearly identical to the naturally occurring M. genitalium genome, but contains “watermarks” with information such as the names of contributing scientists encoded into the DNA. Venter has filed patents for the creation of synthetic life, referring to any organism where the genome is designed and synthesized outside of the cell and then inserted. It is unlikely that these broad patents will be upheld due to the breadth of the claims and the large number of groups currently conducting research related areas. The decision on this, however, will have a huge impact on the direction of synthetic biology as a field.
There are many factors at play in addressing these issues. Human genes carry more ethical weight than those plant or bacterial genes. The likely trajectory of intellectual property is to disallow direct patents on human genes while encouraging patents on related medical devices. Modified genes will almost certainly continue to be protected, and synthetic genes will probably be protected as long as they differ from genes found in nature. It seems that life belongs to whomever creates it.