You Told Me, Right? Free and Informed Consent in European Patent Law

24 Pages Posted: 1 Nov 2017 Last revised: 17 Nov 2017

See all articles by Asa Hellstadius

Asa Hellstadius

Stockholm University - Faculty of Law

Jens Schovsbo

Centre for Information and Innovation Law (CIIR)

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Date Written: March 16, 2017


This paper concerns 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 e.g. recognized in 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, non-compliance 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 non-compliance with the provisions on FIC does in fact have the potential to invalidate patents, this should only happen in those rare circumstances where such non-compliance 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.

Keywords: patent, free and informed consent, health law, fundamental rights

Suggested Citation

Hellstadius, Asa and Schovsbo, Jens, You Told Me, Right? Free and Informed Consent in European Patent Law (March 16, 2017). Faculty of Law, Stockholm University Research Paper No. 30, Available at SSRN: or

Asa Hellstadius (Contact Author)

Stockholm University - Faculty of Law ( email )

S-106 91 Stockholm
+46 8 16 36 68 (Phone)

Jens Schovsbo

Centre for Information and Innovation Law (CIIR) ( email )

University of Copenhagen
Karen Blixens Plads 16
Copenhagen, 2300

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