Intellectual Property Rights to the Results of Genetic Research Involving Human Biological Material

Advances in biotechnology challenge the adequacy of classical legal institutions as applied, e.g., to genetic research involving human biological material. Such studies frequently lead to the creation of protectable intellectual property; however, existing legal frameworks fail to safeguard the interests of individuals who provide their biological material. This problem is particularly relevant in cases where the biological material is unique and its specific properties contributed to the created intellectual property. The author argues the feasibility of granting specific intellectual property rights to providers of biological material. Although such individuals should not be granted authorship status, their contribution warrants legal acknowledgement in situations where their biological material plays a decisive role in the creation of protectable intellectual property. This primarily concerns property rights that assume the possibility to receive compensation or a portion of the income from the use and exercise of exclusive rights to the intellectual property created with and/or using the biological material. The work is structured as a sequential analysis of fundamental questions: the legal nature of biological material, the legal basis for its use, the admissibility of intellectual property rights in respect of objects created using such material, and legal mechanisms for safeguarding the interests of the owner of the biological material. A differentiated approach is proposed for cases where the biological material lacks unique characteristics and is used solely as a means for scientific research, and cases where the biological material possesses characteristics that enable the creation of protectable intellectual property. In the latter situation, particular attention should be paid to ensuring adequate protection of the property rights of the owner of the biological material.

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