On June 13, 2013, the Supreme Court ruled that isolated genes occurring naturally in the human body can not be patented. As commented by NIH Director, Francis Collins, MD, PhD, this is a win for those awaiting more gene-based approaches to medical care and innovation. He goes on to note that this allows for patients to benefit from the rapidly growing area of personalized medicine; opening the door for tailored approaches to the diagnostics, treatment and preventative strategies. In the case reviewed by the Supreme Court, Myriad Genetics acquired patents on two genes that are strongly correlated with breast and ovarian cancer. As a result, the cost of testing for those genes has been pushed to a cost too expensive for many middle- and low-income women to learn if they were at risk for these cancers. It is clear that the patients will be the first to benefit from this ruling, but is there anyone else that can count this as a win?
Start-up biotech companies may be the next group counting this ruling as a victory. Prior to this ruling, over 20 % of human genes were being covered by patents, according to the National Society of Genetic Counselors. Large pharmaceutical companies such as DuPont and GlaxoSmithKline, are leading the patent pack. Biotech startups can not financially compete against these heavy hitters in court. Now, companies other than Myriad Genetics can offer genetics testing that could identify those genes that correlate to these types of cancers, at even cheaper prices to the consumer. Additionally, Arthur Caplan, a bioethicist at New York University, notes that the ruling also applies to patents over plant, animal, and microbial genes, leading to potential upheavals in parts of the biotech world.
Clinicians that provide care and conduct research at hospitals and universities are also scoring this ruling a win. These type of patents that the Supreme Court overruled, allows for multi-gene test panels for the presence or absence of hundreds mutilations that could potentially predict if therapies will be effective. Researchers at the University of Washington, developed a test to check a cancer sample for mutations in 194 genes to help improve the accuracy of diagnosis. This ruling allows for researchers to report genetic results that “might be important to a patient or family even if the mutation is not related to the conduction for which we are seeing them”, notes Gail Jarvik, professor and head of the Division of Medical Genetics in the UW Department of Medicine.
The Courts decision does not allow for patents on genes that are not found in nature, these are known as cDNA, or complementary DNA. This is an area of more synthetic genetics, where improvements are being made upon nature. Complementary DNA is used for producing protein-based drugs and is considered a billion-dollar market.
What are your thoughts on patenting genes? Do you think that this ruling is monumental? Please share your thoughts here.
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