Intellectual Property Protection for Clinical Trial Data

Abdelrahman, Doaa 


Researchers who conduct clinical research with human subjects face a profound problem related to the protection of their work throughout the study and before reaching the final result. Clinical trial processes are one of the most important and perilous scientific processes, particularly from the legal perspective. There are various legal instruments embodying the legal and ethical principles, rights and obligations of research subjects and investigators, and procedures relating to the clinical trial process. Current protection under intellectual property rights (IPRs) does not provide appropriate legal coverage of the clinical trial process. In order to ensure a suitable degree of protection, a new form of IPR is required that would be compatible with the nature of the data and information collected. The form of IPR proposed in this Paper will be known as the Clinical Trials Right (CTR). The CTR would protect all data and information stemming from the drug development process. It would also cover the work carried out by investigators before and during the trial. Creating a new form of clinical trial data and information protection would encourage investments in the field of pharmaceutical inventions and provide an effective process for the circulation of information. In addition to enhancing pharmaceutical research and industries, it would also ensure a balance of benefits between the sponsor and investigators on the one hand, and the competitors on the other.

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Keywords Clinical trials, works of investigators, new form of intellectual property rights, data protection
Issue Date 1-Nov-2015
Publisher World Intellectual Property Organisation (WIPO) / World Trade Organisation (WTO)

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