US Supreme Court rules human genes not patentable
Passed 9 to 0 on June 13, 2013, the New York Times and Science Magazine reported that the US Supreme Court has ruled that human DNA sequences (genes) which are "naturally occurring" and extracted from tissues can not be patented. Quoting Science on Justice Clarence Thomas, "...separating that [BRCA1 and BRCA 2] gene from its surrounding genetic material is not a act of invention." Therefore, no one can hold exclusive rights to them.
The case focused on the BRCA1 and BRCA2 patents which were held for almost 16 years by Myriad Genetics. It was reported in the Times article that the Salt Lake City firm made over $100 million in revenue in the most recent quarter on BRCA genetic testing alone. More specifically, one of the most lucrative businesses of Myraid Genetics was to test the BRCA genes for mutations that might render the patients at risk for break or ovarian cancer -- a type of test that could not be performed by any other group without Myriad consent. I recall as a senior undergraduate, my professor of Cancer Biology, who was personally afflicted by breast cancer and had mutations in her BRCA genes, first brought it to my attention about the long-time conflict surrounding these patents. On the one hand, these patents financially benefit the patent-holders and are supposed to "protect the integrity of scientific discovery." On the other, they drastically increase the cost of the said discoveries. For instance, Myriad charged $3000 to $4000 per diagnosis test. In addition, no one else could perform the test, at the threat of lawsuits from Myriad.
However, even though the high court ruled that extracted DNA could not be patented, cDNA derived from these sequences can be because they are synthesized from the lab. Myriad interpreted this ruling [on cDNAs] as a win for them because, as most geneticists and molecular biologists know, creation is cDNA today is a crucial step to working with genes in the lab for a multitude of experiments. All this calls for is the need for labs around the world to continue pushing forward on cost-effective sequencing technologies that require minimal DNA amounts. As the cost of sequencing has decreased at an astonishing rate over the past decade and new ways of doing the sequencing has been invented, I would not be surprised that this concern becomes obsolete in the near future. However, many lab experiments which require large amount of cDNA for cloning might be a tougher hurdle to navigate. A question comes to mind: how different can we make the cDNA before it is determined to be significantly different from the original, patented cDNA?
Nevertheless, the ruling may prove to be an impetus for uncertainity for intellectual patent lawyers in the near future. Other areas of influence will probably be for stem cells, "lower" organisms' genes, and crop genes. Another Times article, underscores the parallel between the Myiad case and that for genetically-modified crops whereby, once a crop has been introduced into the "wild", when can its genes be considered non-patentable, natural products?
The ownership of biological entities, especially genes, are very important for molecular biologists. Our work relies entirely on the free ability to study what's out there. More of these landmark cases are bound to arise in the near future and it would be in our best interests to keep tabs.
