AIRR Data Under the E.U. Trade Secrets Directive: Aligning Scientific Practices with Commercial Realities

Jacob S. Sherkow, T. Minssen
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Abstract

Whether the E.U. Trade Secrets Directive sufficiently and appropriately covers cutting-edge complex technologies is of critical interest to policy-makers, scientists, and commercial developers alike. One such technology — adaptive immune receptor repertoire sequencing, or AIRR-seq — raises difficult questions concerning what information is and should be protected under the new Directive, and how to best align scientific practices with commercial realities. The ‘raw’ form AIRR-seq data — massive genetic datasets of hundreds of millions of individuals’ immune cells — tends to be freely shared among academic researchers, thus typically destroying the protectability of the underlying information. But follow-on data — essentially, information interpreting that data — is nonetheless protectable under the Directive because it is both economically valuable and not readily available from an examination of the raw data itself. Protecting this follow-on information while encouraging the free sharing of AIRR-seq data best accords the purpose of the Trade Secrets Directive. Lessons from the case of AIRR-seq data also sheds light on other puzzles concerning the tensions between disclosure and various forms of legal protections, such as the mutual exclusivity of patents and trade secrets, the sharing of clinical trial data, and protecting genetic diagnostics.
欧盟商业秘密指令下的AIRR数据:将科学实践与商业现实结合起来
欧盟商业秘密指令是否充分和适当地涵盖了尖端的复杂技术,这对政策制定者、科学家和商业开发商都至关重要。其中一项技术——适应性免疫受体库测序,或AIRR-seq——提出了一些难题,涉及哪些信息是以及应该在新指令下受到保护,以及如何最好地将科学实践与商业现实结合起来。“原始”形式的AIRR-seq数据——数亿个人免疫细胞的大量遗传数据集——倾向于在学术研究人员之间自由共享,因此通常破坏了基础信息的可保护性。但是后续数据——本质上是解释数据的信息——仍然受到指令的保护,因为它既具有经济价值,又不易从原始数据本身的检查中获得。在鼓励免费共享AIRR-seq数据的同时保护这些后续信息最符合《商业秘密指令》的目的。从AIRR-seq数据案例中得到的教训也揭示了其他一些难题,这些难题涉及披露与各种形式的法律保护之间的紧张关系,例如专利和商业秘密的相互排他性、临床试验数据的共享以及基因诊断的保护。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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