title: The History of Patenting Genetic Material.
abstract: The US Supreme Court's recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc. declared, for the first time, that isolated human genes cannot be patented. Many have wondered how genes were ever the subjects of patents. The answer lies in a nuanced understanding of both legal and scientific history. Since the early twentieth century, "products of nature" were not eligible to be patented unless they were "isolated and purified" from their surrounding environment. As molecular biology advanced, and the capability to isolate genes both physically and by sequence came to fruition, researchers (and patent offices) began to apply patent-law logic to genes themselves. These patents, along with other biological patents, generated substantial social and political criticism. Myriad Genetics, a company with patents on BRCA1 and BRCA2, two genes critical to assessing early-onset breast and ovarian cancer risk, and with a particularly controversial business approach, became the antagonist in an ultimately successful campaign to overturn gene patents in court. Despite Myriad's defeat, some questions concerning the rights to monopolize genetic information remain. The history leading to that defeat may be relevant to these future issues.
authors.affiliation: Innovation Center for Law and Technology, New York Law School, New York, NY 10013.
authors.forename: Jacob S
authors.initials: JS
authors.lastname: Sherkow
authors.affiliation: Center for Law and the Biosciences, Stanford University, Stanford, CA 94305; email: hgreely@stanford.edu.
authors.forename: Henry T
authors.initials: HT
authors.lastname: Greely
mesh_terms: D000818:Animals; D030801:Animals, Genetically Modified; D019313:BRCA1 Protein / Q000235:genetics; D024682:BRCA2 Protein / Q000235:genetics; D001695:Biology / Q000331:legislation & jurisprudence; D005796:Genes; D005823:Genetics / Q000331:legislation & jurisprudence*; D049673:History, 20th Century; D049674:History, 21st Century; D006801:Humans; D010330:Patents as Topic / Q000266:history*; D030821:Plants, Genetically Modified; D011639:Public Opinion; D035521:Supreme Court Decisions; D014481:United States
chemical_list: D019313:BRCA1 Protein; C492913:BRCA1 protein, human; D024682:BRCA2 Protein; C551750:BRCA2 protein, human
keywords: BRCA; Myriad; genetics; history; intellectual property; law; patents