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Ãsa Hellstadius and Jens Schovsbo

This chapter addresses the rule in EU patent law that for patent applications pertaining to human biological material, the person from whose body the material is taken must have had the opportunity of expressing free and informed consent (FIC) in accordance with national law. We argue that the patent rules should be understood in the light of the development in health law and fundamental rights law where FIC has long been a central concept which is recognized in, for example, the EU’s Charter on Fundamental Rights. Against that basis, we suggest that patent law and patent practices have so far not fully recognized the importance and central role of FIC. For these reasons, noncompliance with the FIC requirement arguably has the potential to be used to challenge patent validity. Whereas patent law clearly should acknowledge the importance of the FIC obligations, we suggest that the effects of this should be measured carefully and with a view of maintaining the overall balancing of interests. We therefore recommend that even though noncompliance with the provisions on FIC does in fact have the potential to invalidate patents, this should only happen in those rare circumstances where such noncompliance would amount to not only a violation of legal rules but also amount to a serious violation of principles of ordre public or morality in line with current patent law standards.