In what is being hailed as a victory for both scientific research and patients' rights, the Supreme Court ruled unanimously yesterday that human genetic material cannot be patented. The case, Association for Molecular Pathology v. Myriad Genetics, has been working its way through the court system for a number of years now, led by plaintiffs including the ACLU, the American College of Medical Genetics, the American Society for Clinical Pathology, and numerous prominent genetic research scientists. The verdict invalidates the patents Myriad Genetics has held on breast cancer genes BRCA1 and BRCA2 since the 1990's and allows other labs besides theirs to test for mutations in those genes which, when present, strongly indicate a genetic predisposition to cancer. It also means that scientists can move forward in their genetic research without threat of being sued for copyright infringement. While the case was brought against Myriad specifically, the decision to disallow human gene patenting has profound implications for both scientific discovery and individual rights of ownership over our own genetic material.
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At Georgetown University's Lombardi Comprehensive Cancer Center, researchers have announced the results of an important study showing that high levels of estrogen in the mother during pregnancy can increase a daughter's susceptibility to breast cancer later on. Specifically, the BRCA1 gene is disabled in an estrogen-rich environment, preventing it from carrying out its DNA repair tasks and leaving an opening for cancerous cells to grow. The research was presented at the 2013 American Association for Cancer Research (AACR) meeting by Dr. Leena Hilakivi-Clarke (right). The Hilakivi-Clarke Lab is on the same floor of the Research Building as that of Dr. Robert Clarke, who collaborated on the study; the Clarkes both carry out hormone-related cancer research, and Robert Clarke is the Dean for Research at the Georgetown University Medical Center (GUMC).
Last year in a blog of ours on the future of genome sequencing we referenced a July appeals court ruling that protected Utah's Myriad Genetics' patent on two genes known to be indicators of breast cancer risk. Now, in a recent Supreme Court ruling on that same case, the previous ruling has been overturned and the case returned to the lower court for rehearing. This decision follows another important high court ruling on the patentability of genes: Mayo vs. Prometheus Labs (San Diego), which also just ruled against a company's right to hold patents on human genes, and which was quoted as a precedent in the latest Myriad judgement.