TY - CHAP

T1 - You told me, Right? - Free and Informed Consent in European Patent Law

AU - Hellstadius, Åsa

AU - Schovsbo, Jens Hemmingsen

PY - 2019

Y1 - 2019

N2 - 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.

AB - 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.

M3 - Book chapter

SN - 9781788116183

SP - 92

EP - 116

BT - Global Genes, Local Concerns: Legal, Ethical and Scientific Challenges in International Biobanking

A2 - Minssen, Timo

A2 - Rothmar Herrmann, Janne

A2 - Schovsbo, Jens

PB - Edward Elgar Publishing

CY - Cheltenham

ER -