Nicol Dianne
J Law Med. 2016;24(1):72-88.
Tangible research materials and data sets are integral to biomedical research and diagnostic genetic testing. Patents over genes and other research tools have been blamed for restricting access to these tools, potentially slowing the pace of biomedical research and reducing availability of diagnostic genetic testing options. Given that many of these patents are expiring or being invalidated by the courts, this article suggests that attention should now be focused on how the materials and data themselves might be used where access is blocked. Access is critical to the effective conduct of future biomedical research and clinical practice, yet the availability of legal causes of action to facilitate this has not previously been analysed. This article explores possible legal mechanisms and concludes that the outlook for compelling access in the absence of patents is pessimistic. Paradoxically, patents may actually provide a mechanism to gain access to these critical tools, rather than constituting a hindrance.
有形的研究材料和数据集是生物医学研究和诊断性基因检测不可或缺的一部分。基因及其他研究工具的专利被指责限制了对这些工具的获取，这可能会减缓生物医学研究的步伐，并减少诊断性基因检测选项的可及性。鉴于许多此类专利即将到期或被法院判定无效，本文认为现在应将注意力集中在当获取受阻时，这些材料和数据本身可能如何被利用。获取对于未来生物医学研究和临床实践的有效开展至关重要，但此前尚未分析过促进获取的法律诉讼理由的可利用性。本文探讨了可能的法律机制，并得出结论：在没有专利的情况下强制获取的前景不容乐观。矛盾的是，专利实际上可能提供一种获取这些关键工具的机制，而不是构成障碍。
