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Home arrow Research Projects arrow IP9 - Biotechnology arrow NCCR Publications arrow Prior Informed Consent to Patenting and Human Donors
Prior Informed Consent to Patenting and Human Donors Print
Human Rights in the Patent Procedure: Prior informed consent and human donors, NCCR Trade Regulation Working Paper 2007/36, July 2007.

Abstract

Concern about the roles of ethics and human rights in patenting biotechnology has been particularly serious over the past decade.
In Europe, Directive 98/44/EC has established several ethics-based exclusions from patentability in the field of biotechnology and has adopted numerous non-binding principles in this regard. One of these is the principle of prior informed consent (PIC) of donors to patenting of human genetic material.  
The United States on the other hand, in line with their common law tradition, has not chosen to enact specific legislation; emphasising the limited nature and effect of the patent system and deciding on the matter in case-law.
The question this paper addresses is how human rights can play a role in very limited, specific questions of patent law such as PIC; which human rights could concretely apply in relation to PIC; how they are to be balanced with one another; and how this is to be assessed in view of the utilitarian nature of the patent system.

Keywords

Patents; biotechnology; donors; human genetic material; prior informed consent; PIC-Directive 98/44/EC; TRIPS.

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