Pierce Brandon L, Carlson Christopher S, Kuszler Patricia C, Stanford Janet L, Austin Melissa A
Institute for Public Health Genetics, University of Washington, Seattle, WA, USA.
Genet Med. 2009 Mar;11(3):202-9. doi: 10.1097/GIM.0b013e3181948faf.
Fragmented ownership of diagnostic gene patents has the potential to create an "anticommons" in the area of genomic diagnostics, making it difficult and expensive to assemble the patent rights necessary to develop a panel of genetic tests. The objectives of this study were to identify US patents that protect existing panels of genetic tests, describe how (or if) test providers acquired rights to these patents, and determine if fragmented patent ownership has inhibited the commercialization of these panels.
As case studies, we selected four clinical applications of genetic testing (cystic fibrosis, maturity-onset diabetes of the young, long QT syndrome, and hereditary breast cancer) that use tests protected by > or =3 US patents. We summarized publically available information on relevant patents, test providers, licenses, and litigation.
For each case study, all tests of major genes/mutations were patented, and at least one party held the collective rights to conduct all relevant tests, often as a result of licensing agreements.
We did not find evidence that fragmentation of patent rights has inhibited commercialization of genetic testing services. However, as knowledge of genetic susceptibility increases, it will be important to consider the potential consequences of fragmented ownership of diagnostic gene patents.
诊断基因专利的分散所有权有可能在基因组诊断领域造成“反公地”现象，使得组装开展一组基因检测所需的专利权变得困难且成本高昂。本研究的目的是识别保护现有基因检测组的美国专利，描述检测供应商如何（或是否）获得这些专利的权利，并确定专利所有权的分散是否阻碍了这些检测组的商业化。
作为案例研究，我们选择了基因检测的四个临床应用（囊性纤维化、青年发病的成年型糖尿病、长QT综合征和遗传性乳腺癌），这些应用所使用的检测受到≥3项美国专利的保护。我们总结了关于相关专利、检测供应商、许可和诉讼的公开信息。
对于每个案例研究，主要基因/突变的所有检测均获得专利，并且至少有一方通过许可协议等方式持有开展所有相关检测的集体权利。
我们没有发现证据表明专利权的分散阻碍了基因检测服务的商业化。然而，随着对基因易感性的认识增加，考虑诊断基因专利分散所有权的潜在后果将很重要。
