1. The patentability of human pluripotent embryonic stem cells and stem cell lines Paul Van den Bulck Partner at Ulys Law Firm (Brussels) Lecturer at the University of Paris XII and at R. Schuman University (Strasbourg) www.ulys.net paul.vandenbulck@ulys.net Tuesday, 6th June 2006

2. Structure I. Introduction II. European legal framework (A.) Directive 98/44/CE (B.) European Patent Convention

3. I. Introduction

4. At the European level, several bodies have addressed the issue of the patentability of human pluripotent embryonic stem cells and stem cell lines: –the European Commission (two 16c reports) –the European Commission Experts Group (preparation of the second 16c reports) –the European Group on Ethics –the European Patent Office (case law)

5. II. Community legal framework

6. Article 5 (1): “The human body, at the various stages of its formation and development, and the simple discovery of one of its elements... cannot constitute patentable inventions”.

7. In application of article 5(1): –totipotent stem cells = unpatentable (since they are capable of developing into a human being) –embryos = unpatentable (common position of the EC Council of 26 Febr. 1998) –germ cells = unpatentable (recital 16)

8. What about pluripotent stem cells? Complex situation Article 5 (2): “An element isolated from the human body...including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.”

9. Article 5 (2): –allows the patentability of human stem cells; –allows the patentability of human stem cell lines (if the invention is new, involves an inventive step and is susceptible of industrial application)

10. Article 6 of the Directive: 1.Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; 2....the following, in particular, shall be considered unpatentable: (...) (c) uses of human embryos for industrial or commercial purposes;...

11. Article 6(2) is non exhaustive Recital 42: article 6(2)c) does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it

12. If one reads article 6(2)c) and recital 42 together then, according to the European Commission experts group: –Unpatentable: if the embryo is the source of the invention –patentable: if the embryo is the aim of the invention

13. Article 6(2)c): does the unpatentability concerns: –an embryo as a whole?; or –every invention concerning stem cells? No consensus. Importance of the interpretation of the concept of “embryo” in the national legislation of the Member States

14. B. European Patent Convention Article 53(a): “Any invention, the publication or exploitation of which would be contrary to ordre public or morality, is specifically excluded from patentability”.

15. Rules: –Rule 23(d): “European patents are not to be granted in respect of… inventions which concern…(c) uses of human embryos for industrial or commercial purposes” –Rule 23(e): “the human body, at the various stages of its development…”

16. ‘EDINBURGH PATENT’- case :  Patent granted in December 1999  patent for ‘animal transgenic stem cells’  EPO Opposition Proceedings (July 2002):  amendment to exclude human embryonic stem cells  adopted broad interpretation of Rule 23(d)(c) (6(2)c of directive)  does this mean that human embryonic stem cells are unpatentable ?  The decision of the Board of Appeal is awaited (end 2006)

17. Paul Van den Bulck Partner at Ulys Law Firm (Brussels) Lecturer at U. of Paris XII and U. R. Schuman –Strasbourg-) www.ulys.net paul.vandenbulck@ulys.net Questions & Answers