In a major decision that is sure to have enormous effects in the United States and beyond, the US Supreme Court has ruled that human genes are not patentable. The Court rules that the genes are naturally occurring and therefore a discovery, not an invention.
This decision does not directly impact artificially inserted or manipulated genes, as in genetically modified organisms, but it is likely to have major impacts on both human and non-human genes in the fields of testing screening for diseases or conditions. Although the case deals with human genetics, the language of the decision seems to make it apply to all genes that exist in an organism in nature.
Although this is only applicable to the US, it is an important precedent that may well effect other countries. If nothing else, it will certainly change how companies go about protecting or attempting to protect their discoveries, if only because the US is such a huge market.
Supreme Court Rules Human Genes May Not Be Patented
WASHINGTON — Human genes may not be patented, the Supreme Court ruled on Thursday. “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” Justice Clarence Thomas wrote for a unanimous court. But manipulating a gene to create something not found in nature is an invention eligible for patent protection.
The case concerned patents held by Myriad Genetics, a Utah company, on genes that correlate with increased risk of hereditary breast and ovarian cancer.
The central question for the justices in the case, Association for Molecular Pathology v. Myriad Genetics, No. 12-398, was whether isolated genes are “products of nature” that may not be patented or “human-made inventions” eligible for patent protection.
The patents were challenged by scientists and doctors who said their research and ability to help patients had been frustrated.
The court’s ruling will shape the course of scientific research and medical testing, and it may alter the willingness of businesses to invest in the expensive work of isolating and understanding genetic material.
After much thought, I have to say that I agree with the court. The reason is that the detection of a given gene for something like breast cancer risk or another condition is not itself a unique procedure, but rather it is common genetic sequencing with a knowledge of the existence of that gene. In other words, if the gene could be patented, then any genetic laboratory would still be able to “see” the gene any time they sequence the genes of a human subject, but they would be either required to not look at that piece of chromosome or not report that the gene was detected, at least not without paying a royalty or license fee.
Applying this logic to other areas of medicine, I have come up with the following hypothetical circumstances:
1. A new bacteria is discovered that contributes to human disease. The bacteria is easily detected in cultures taken from any number of parts of the human body. It has a characteristic shape which is very obvious under a microscope and it produces an easily identifiable culture. The discoverer, however, has patented the bacteria and its detection. Hence, if the bacteria is detected by a doctor, the doctor cannot report to the patient that it has been detected unless they have paid the licensing fee. If, for example, a laboratory is screening for strep throat, but happens to see the bacteria in the process, it would be illegal for them to report it, despite the fact that the test is not specific to the bacteria in question.
2. Some humans are known to have heart valve detects, but these are not detected in routine tests. A researcher discovers a very simple way to detect the heart valve defect, which is as accurate as complex diagnostic tests like echo-cardiograms. It is realized that if a person holds their breath and a doctor listens to their heart with a stethoscope, a faint, and previously unnoticed thudding sound can be heard after each beat, indicating the heart valve defect. Any doctor with good ears and a knowledge of the sound can detect it.
The discoverer of the sound has patented it and therefore requires that doctors either make an effort not to hear it, by, for example, advising their patients to breathe hard such that the sound will not be noticeable, or to ignore it, even if they can recognize it. Without paying the license fee, hearing the sound, identifying it as a heart valve defect and informing the patient is illegal.
Obviously, both these situations are the kind of thing we would NOT want in medicine, and as such, it’s important that discoveries be treated separately from technologies and inventions. Indeed, new medical discoveries continue to be made and provided freely to the medical community. For example, recently, a previously unknown layer of the cornea was discovered. The discovery has implications for eye surgery, but if it could be patented, surgeons might be prevented from taking into account the layer when deciding how to operate.
This entry was posted on Thursday, June 13th, 2013 at 12:44 pm and is filed under Bad Science. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.
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