NCCR International Trade NCCR IP9 WORKSHOP 28 th March “Prior Informed Consent in European Patent Law: Overview and Options” - Michelangelo R.P. Temmerman

NCCR International Trade World Trade Institute Joint Center of the Universities of Berne, Fribourg and Neuchâtel Hallerstrasse Berne, Switzerland Tel Fax Recital 26 of EU Directive 98/44/EC “Whereas if an invention is based on biological material of human origin or if it uses such material, where a patent application is filed, the person from whose body the material is taken must have had an opportunity of expressing free and informed consent thereto, in accordance with national law” (emphasis added)

NCCR International Trade World Trade Institute Joint Center of the Universities of Berne, Fribourg and Neuchâtel Hallerstrasse Berne, Switzerland Tel Fax Recital 26 of EU Directive 98/44/EC Only appeared at a fairly late stage into the text of the Directive under initiative of the Group of Advisers on the Ethical Implications of Biotechnology to the European Commission: “The ethical principle of informed and free consent of the person from whom retrievals are performed, must be respected. This principle includes that the information of this person is complete and specific, in particular on the potential patent application on the invention which could be made from the use of this element. An invention based on the use of elements of human origin, having been retrieved without respecting the principle of consent will not fulfil the ethical requirements”

NCCR International Trade World Trade Institute Joint Center of the Universities of Berne, Fribourg and Neuchâtel Hallerstrasse Berne, Switzerland Tel Fax Recital 26 of EU Directive 98/44/EC Proposal for an Article rejected; Recital accepted in amended form Has only been implemented by Italy in Article 5 of Decreto Legge 10 gennaio 2006: “la domanda di brevetto relativa ad una invenzione che ha per oggetto o utilizza materiale biologico di origine umana deve essere corredata dell'espresso consenso, libero e informato a tale prelievo e utilizzazione, della persona da cui è stato prelevato tale materiale, in base alla normativa vigente“ (English text not available yet)

NCCR International Trade World Trade Institute Joint Center of the Universities of Berne, Fribourg and Neuchâtel Hallerstrasse Berne, Switzerland Tel Fax PIC at the EPO-Level? National countries implementing Recital 26 only do so as regards their national patents: at the EPO, it remains without value to. Incorporation into the EPC?

NCCR International Trade World Trade Institute Joint Center of the Universities of Berne, Fribourg and Neuchâtel Hallerstrasse Berne, Switzerland Tel Fax PIC at the EPO-Level? Integrating the concept of prior informed consent through EPO jurisprudence: Ordre Public and Morality? Article 53 (a) EPC, Shall not be patentable: “inventions the publication or exploitation of which would be contrary to “ordre public” or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States”. (emphasis added)

NCCR International Trade World Trade Institute Joint Center of the Universities of Berne, Fribourg and Neuchâtel Hallerstrasse Berne, Switzerland Tel Fax Ordre Public and Morality Under EPO case law: “the belief that some behaviour is right and acceptable,…, is founded on the totality of the accepted norms which are deeply rooted in,…, the culture inherent in European society and civilisation Accordingly, inventions the exploitation of which is not in conformity with the conventionally-accepted standards of conduct pertaining to this culture are to be excluded from patentability as being contrary to morality” (Tech. Board of Appeal, Plant Genetic Systems, 1995, emphasis added). However: exceptions need to be construed narrowly (!)

NCCR International Trade World Trade Institute Joint Center of the Universities of Berne, Fribourg and Neuchâtel Hallerstrasse Berne, Switzerland Tel Fax Ordre Public and Morality How to prove that on the totality of norms deeply rooted in European society and civilisation, the exploitation of an invention based upon the genetic identity of one single person or a small group of people, without having their prior informed consent is contrary to morality?

NCCR International Trade World Trade Institute Joint Center of the Universities of Berne, Fribourg and Neuchâtel Hallerstrasse Berne, Switzerland Tel Fax Is the Patent Procedure the Right Place? Germany and Austria: Constitutional, Civil & Penal Law However: consent to taking genetic material is not equal to informed consent (about the potential economic value) Moreover: civil law, etc., only come into play in trials and so not specifically provide in a prior informed consent regime Many patents cover inventions never commercialised: prior informed consent to commercialisation?

NCCR International Trade World Trade Institute Joint Center of the Universities of Berne, Fribourg and Neuchâtel Hallerstrasse Berne, Switzerland Tel Fax Thanks for listening Debate!