Innovation Center for Law and Technology, New York Law School, New York, NY 10013.
Center for Law and the Biosciences, Stanford University, Stanford, CA 94305; email:
Annu Rev Genet. 2015;49:161-82. doi: 10.1146/annurev-genet-112414-054731. Epub 2015 Oct 6.
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.
美国最高法院最近在 Association for Molecular Pathology v. Myriad Genetics, Inc. 一案中的裁决首次宣布,孤立的人类基因不能获得专利。许多人想知道基因怎么会成为专利的主题。答案在于对法律和科学历史的细微理解。自 20 世纪初以来,除非“天然产物”从其周围环境中“分离和纯化”出来,否则它们没有资格获得专利。随着分子生物学的进步,以及从物理和序列上分离基因的能力成为现实,研究人员(和专利局)开始将专利法逻辑应用于基因本身。这些专利,以及其他生物专利,引起了广泛的社会和政治批评。Myriad Genetics 公司拥有 BRCA1 和 BRCA2 这两个基因的专利,这两个基因对评估早期乳腺癌和卵巢癌风险至关重要,并且该公司的商业方法颇具争议,成为最终成功推翻基因专利的法庭诉讼中的反派。尽管 Myriad 败诉,但关于垄断遗传信息权利的一些问题仍然存在。导致这一失败的历史可能与这些未来的问题有关。