The Supreme Court’s recent ruling that companies cannot patent parts of naturally-occurring human genes represents a game-changer for healthcare and the medical and biotechnology industries.
To date, close to 25% of the 22,000 human genes have been patented, and those patents have kept competing researchers and companies from developing innovative and less expensive medical tests, treatments, and therapies based on the gene that is patented. As of today, all of those patents are now invalidated. This will quickly open the door to increasing competition and innovation in genetic testing, as well as new therapies for the more than 4,000 known genetic diseases, including muscular dystrophy, certain types of heart arrhythmia, and many forms of cancer.
The ruling was based on a case involving patents held by Salt Lake City-based Myriad Genetics Inc. for an increasingly popular breast cancer test that actress Angelina Jolie brought into the public eye with her revelation that she had a double mastectomy because of one of the genes involved in this case.
Up until now, that test (and tests by other patent holders) was expensive, ranging in the $4,000 bracket. Within 24 hours of the court ruling, another company, Houston-based genetics testing company DNATraits, a division of Gene by Gene, said it would offer the same test Myriad Genetics sold for $4,000 for $995.
During the trial, Myriad’s lawyers argued that the patented DNA it isolated from the body for its proprietary breast and ovarian cancer tests were patentable, but Supreme Court Justice Clarence Thomas, who wrote the court’s decision, stated “We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” Thomas went on to say, “Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”
It is important to note that the ruling also sates that when anyone creates a synthetic form of DNA—called cDNA—and it is particularly useful in conducting experiments and tests, such as cancer screening, that work does deserve patent protection. As a result, 24 patents containing more than 500 valid claims will remain in effect by Myriad.
Because of this ruling, patients will have greater access to genetic testing at a competitive price, and scientists will be free to engage in research on all human genes without fear of being sued.
It’s also interesting to note that Lawrence Brody of the National Human Genome Research Institute stated that the bulk of the biotechnology industry’s products are not affected by the ruling. In other words, this is indeed a game-changing moment, but it does not put the majority of biotech companies out of business. Rather, it frees them to innovate, and the beneficiary will by you—now and in the future.