On Thursday, June 13, 2013, the Supreme Court of the United States issued a highly anticipated decision in the case of Association of Molecular Pathology v Myriad Genetics, Inc. Myriad Genetics owns the patent to the BRCA1 and BRCA2 genes, mutations of which can create a higher risk of breast and ovarian cancers. Myriad owned the exclusive use of these genes, as well as the testing, essentially prohibiting other scientists and researchers from doing any significant research.
Myriad’s argument was they found the genes, isolated them and then made copies of them. Specifically they:
1. Discovered the exact location of the genes (on chromosomes 17 and 13 if you’re wondering)
2. Determined the exact sequence (meaning the order in which the molecules occurred) of the genes.
3. Created synthetic copies of these two genes (called complimentary DNA, or cDNA)
Chromosomes are made up of neucliotides, which are the biological molecules that make up DNA and RNA. Chromosome 17 and Chromosome 13 are made up of about 194 million of these molecules. Myriad discovered that the sequence of the two genes covered about 80,000. Broken down even further (excluding other scientific info not necessary for those of us without a PhD in molecular biology), the two genes consist of about 15,700 molecules combined.
With this knowledge, Myriad created patents that said they own the exclusive right to find the genes and to isolate any part of the genes, including ones that consisted of 15 or more of the molecules. Furthermore, Myriad claimed that the synthetic copies of the genes were also theirs. Therefore, no one could use the synthetic copies, nor could anyone make their own copies out of the genetic material.
According to Myriad, your DNA is subject to the rules of a four year old: finders, keepers!
In other words, in the sandbox of the human genome, Myriad claimed if you found and built a sandcastle with more than fifteen of the 194 million grains of sand of these two genes, they would sue you for patent infringement, including the making of the actual sandcastle.
And they did.
In a unanimous decision (yes, all the justices agreed on something!), the court ruled that Myriad did not have a right to patent the simple act of discovering something occurring in nature (I see it! It’s mine!), or to patent naturally occurring things (no, you cannot patent oxygen). In the opinion written by Justice Clarence Thomas (wait, he writes?), they ruled that “Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy” the requirements of patentability.
As for the synthetic copy, or cDNA, the justices agreed that Myriad had, in fact, created a product not of nature. The lab technician removed part of the molecular structure that, while still dictated by nature, does not naturally occur in nature and, is therefore, patentable.
In other words, they created a unique sandcastle and that meets the standards of patentability.
This was a very narrow ruling specific to the claims against Myriad, but it opens the doors wide open in genetic research. Myriad’s (and possibly thousands of others’) patents no longer stand. Therefore, others are now allowed to find those genes themselves (psst, look on chromosomes 17 and 13) and create their own synthetic copy. This will allow more entities to offer testing, lowering the cost considerably, and making it accessible to women who can’t afford the thousands of dollars Myriad commands.
Human invention and ingenuity is still rewarded with this ruling, but scientific research is no longer stymied in this area due to short sighted greed.
In 1955, Jonas Salk, the creator of the polio vaccine, rhetorically asked, “Could you patent the sun?”
Now we know for certain, the answer is no.