Blue vs. White: Gene patents don’t mean species are in violation of copyright
Published: Thursday, April 18, 2013
Updated: Friday, August 23, 2013 17:08
Earlier this week, the Supreme Court heard oral arguments for Association for Molecular Pathology v. Myriad Genetics, a case on the issue of gene patents. For the most part the argument has centered on the legality of gene patents as it relates to patent law and whether gene patents are effective or detrimental in progressing medical research. By and large, gene patents are legal under current law and are a necessary part of enabling genetic research and any tests, drugs, and treatments that result from it.
The Supreme Court has ruled in the past that “products of nature” are not subjected to patents, so one could not patent a new species of turtles they discover for example. Since we are technically a part of nature, human genes are undoubtedly also part of nature. However the genes that are currently inside your cells aren’t what are being patented. A company isn’t going to come to your door and demand a royalty because your liver cells are using “their gene.”
So what is actually being patented? To understand this you need to look at the biological processes involved. Genes exist in our DNA as exons which are interrupted by sequences of “junk DNA” referred to as introns. These DNA sequences are then copied to form RNA. Introns are then spliced out of this RNA to form messenger RNA which is what is sent out into the cell to form the protein. Scientists isolate the mRNA and convert it into a DNA molecule called complementary DNA (cDNA). It is this cDNA that is sequenced and then patented. cDNA does not exist until it is isolated and synthesized by a scientist and thus it technically does not exist naturally. In the same way, one cannot patent oxygen, but the element americium is patented, because it does not exist in nature. Genes also meet the utility requirement of patent law as they can lead to a test or a drug.
So from a legal perspective, genes, in particular sequences of cDNA, fall into the realm of things patentable under current law. The other argument used against gene patents is that it inhibits research. Numerous patients haven’t been able to access certain genetic tests, such as the BRCA1 test in the Myriad case, because of the cost. Gene patents lead to a sort of monopoly that biopharmaceutical companies can have on certain genetic tests and thus charge thousands of dollars. However, this isn’t something exclusive to gene patents as patents in general can create monopolies. The larger issue is that while gene patents can appear to be evil in this situation, like most patents, they are also a necessity.
I would love if public organizations could do the research and development necessary to bring tests and drugs to market, but this isn’t feasible. The fact of that matter is that it is estimated that it costs close to $800 million to bring a drug to market and it costs roughly the same before any beneficial product comes from researching an individual gene. Private companies will have the resources necessary for the research and development. If a biopharmaceutical company is going to put in the necessary time and be able to raise the necessary funds from investors they need a patent. A patent is the only thing that provides a profit motive. Why would any sane investor or business put forth hundreds of millions of dollars if another individual could just copy all the research and profit themselves? And while many claim that it is impossible for others to research the gene, this isn’t the reality. Other companies can pay for a license to research a patented gene and patent holders will often allow non commercial research.
There are certainly adverse effects with gene patents, but think of it in this manner. Isolated B12 vitamin from beef muscle is patentable. Isolated erythropoietin from urine to treat dialysis patients is patentable. How is an isolated gene different from this? When it was written, patent law looked to deal with machinery and didn’t anticipate the field of genetics. So until changes come to the current law there is nothing that prevents gene patents since what is being patented is technically not found in nature. In addition to their legality, gene patents will continue to be an integral and necessary part of furthering genetic research.