On June 13, 2013, the United States Supreme Court decided the case of Association for Molecular Pathology v. Myriad Genetics, Inc. This case has put to rest for now the controversial issue of whether isolated deoxyribonucleic acid (DNA) sequences can be eligible for patent.
Myriad Genetics has several patents for isolating DNA sequences based on its discovery of the location of specific genes. These genes are known as BRCA1 and BRCA2 and are responsible for tumor suppression. If a woman has specific inherited mutations in BRCA1 and BRCA2, then she will be at higher risk of developing breast and ovarian cancers. A woman who has the BRCA1 has around a 60 percent risk of developing breast cancer and almost 40 percent chance of developing ovarian cancer. With the BRCA 2 mutation, a woman has a 45 percent chance of getting breast cancer and around 15 percent chance of getting ovarian cancer. Myriad developed a test called the BRACAnalysis for determining if a woman has these inherited mutations. It should be noted that Myriad made no changes to the DNA of BRCA1 or BRCA2.
The question before the Supreme Court was whether DNA could be patented under the current patent statute. The Supreme Court held that Myriad did not create a “new composition of matter” and thus, its discovery of BRCA1 and BRCA2’s locations were not patentable. However, synthetic DNA known as cDNA could be patented because unlike the isolated DNA, it was not naturally occurring. The patentability of cDNA will add another dimension to research and development of genetics testing because now the these companies will have to isolate a gene and create a synthetic version of it.
I believe that the Court was correct. In regards to research and development related to DNA and medical advancements, companies will have to create synthetic DNA in order to have it patent eligible. This will cause added expense, but if the companies believe that there is profit to be gained from this patent, I think companies will spend the additional research and development costs.
This ruling will make tests like BRACAnalysis more available to the public because other companies besides Myriad will be able to locate the DNA involved in mutated genes and create tests for determining if patients have these mutations.
Who owns my genes? According to this ruling, I still do.