From James Beck, Ph.D., Director of Research Programs
Should or could a human gene be patented? On June 13th, the Supreme Court of the United States delivered their unanimous ruling regarding what has been called the Myraid Genetics case. The plaintiffs in this case sought to invalidate Myriad’s patent on two genes that when mutated can lead to a significant increased risk of breast and ovarian cancers. Because of the patent for these two genes, Myriad, a clinical diagnostic testing company, was the only entity that was permitted to perform the clinical tests that can both inform women if they carried mutations in these genes and if they are at an elevated cancer risk.
In their ruling, the Supreme Court concluded that naturally occurring genes, like the ones in the patent held by Myraid, are a product of nature and therefore are not eligible for patent protection.
The emphasis of the Court is on naturally occurring genes and that is important because the Court made clear that almost any modification to that naturally occurring gene would be eligible for patent protection—provided it met all the regular standards of a patent. The example the Court provided was for the ‘cDNA’ sequence of a gene.
When a Gene is Not Natural
So what is cDNA anyway?
It may helpful to think of the genes found in most animals as magazine stories. These stories are constantly interrupted by advertisements, forcing them to span dozens of pages instead of just a few. These interruptions to the gene story are called introns and, just a like a real magazine story, they get skipped by the body as it reads the gene when making a protein in a process called transcription. In the laboratory, this “ad-free” or more precisely “intron-free” version of the gene can be converted back to DNA (the cDNA) for later use in a biotech setting. Because this edited version of the gene did not appear in nature, it is eligible for patent protection.
What Does This Mean?
In general, this decision will not really affect much in the normal operation of science and business. Whenever a gene is patented, the ad-free cDNA version is almost always included as part of that patent. Importantly, it is this cDNA version that is really of the utmost value to a company because the naturally occurring sequence is often so large and unwieldy it is not practical to use—this is because the cDNA form can easily be just one-fifth the size of the naturally occurring gene. That is a lots of ads that were cut!
For companies that have a product that relies almost exclusively on the naturally occurring sequence, say for a diagnostic test, this ruling will be more disruptive. In fact, several competitors have just announced that they will offer the same cancer gene test for less than what Myriad charged.
Ok, so what does this mean for Parkinson’s disease?
Again, not much really. There are several companies that have been trying to develop gene therapies for treating Parkinson’s. While the patents these companies may hold on the naturally occurring gene sequence is likely not enforceable anymore, the shortened version of the gene still has a valid patent and that is what counts—it is this shortened form that is actually used in the experimental therapy.
While the Court’s ruling that naturally occurring genes are not patentable is certainly historic, I think the initial effects are relatively limited, especially for Parkinson’s. Time will tell how this ruling will be applied to other areas of intellectual property law.