1. The patentability of biotechnological inventions: The European Commission’s second 16c report Paul Van den Bulck Partner at Ulys Law Firm (Brussels) Lecturer at R. Schuman University Strasbourg (France) Friday, 5th May 2006 WWW.ULYS.NET

2. Structure I. Introduction II. Content of the second 16c report (A) latest developments occurred since the publication of the first 16c report (B) the scope of patents on sequences or partial sequences of genes which have been isolated from the human body (C) the patentability of embryonic human stem cells and cell lines obtained from them

3. I. Introduction

4.  Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions  Article 16c of the Directive: “The Commission shall send the European Parliament and the Council […] annually as from the date specified in Article 15(1), a report on the development and implications of patent law in the field of biotechnology and genetic engineering.”

5.  the first 16c report (http://europa.eu.int/eur-lex/en/com/rpt/2002/com2002_0545en01.pdf) dealt with:http://europa.eu.int/eur-lex/en/com/rpt/2002/com2002_0545en01.pdf  the implementation of the Directive in Europe;  the compatibility of the Directive with the relevant international agreements ;  the patentability of inventions relating to plants and animals;  the patentability of inventions relating to elements isolated from the human body;  exclusion from patentability of inventions whose commercial exploitation would be contrary to ordre public or morality.

6.  the second 16c report of 14 July 2005 (http://www.europa.eu.int/smartapi/cgi/sga _doc?smartapi!celexapi!prod!CELEXnumd oc&lg=en&numdoc=52005DC0312&model =guichett)http://www.europa.eu.int/smartapi/cgi/sga _doc?smartapi!celexapi!prod!CELEXnumd oc&lg=en&numdoc=52005DC0312&model =guichett  involvement of the Group of Experts and the European Group on Ethics

7. II. The second 16c report

8. A. latest developments occurred since the publication of the first 16c report  the European Commission draws the state of progress regarding the transposition of the Directive into the national legislation of the EC Member States: 21 Member States have notified the Commission their legal instruments implementing the Directive

9.  Setting up of a group of Experts to advise the Commission on the preparation of 16c reports.

10.  The European Commission reports that the adoption of Council Regulation amending Regulation 2100/94 on Community plant variety rights in order to render Article 29 of Regulation 2100/94 and Article 12 of the Directive mutually compatible. These provisions deal with cross-licenses on patent and plant variety rights.

11. B. the scope of patents on (partial) sequences of genes which have been isolated from the human body  The European Commission addresses the question on whether patents on DNA sequences should be allowed according to:  the classical model of patent claim, i.e. the inventor claims an invention which covers possible future uses of that sequence; or  the “purpose-bound protection” model, i.e. a restriction of the patent so that only the specific use disclosed in the patent application can be claimed?

12.  Laws implementing Directive 98/44 in France and Germany provide for purpose-bound protection:  France: Art. L 613-2-1, Code de la propriété intellectuelle  Germany: S. 1a (4), Patentgesetz  In the second 16c report, the European Commission does not take position on the validity of transposition of the Directive, by the Member States, according to the choice between classical and limited scope of protection for gene sequences.

13. C. the patentability of human embryonic stem cells and cell lines obtained from them  General context : patentability of human stem cells and cell lines.  Article 5 (2) of the Directive: “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.”

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

15.  As regards to human embryonic stem cells, one has to distinguish:  totipotent stem cells which are capable of developing into a human being  pluripotent stem cells which are not so capable

16.  Article 5 (1) of the Directive: “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.”  totipotent stem cells = unpatentable (since they are capable of developing into a human being)  What about the patentability of pluripotent stem cells? According to the European Commisson: a more complex situation

17. 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;...

18.  Article 6(2)c): does the unpatentability concerns (i) an embryo as a whole or (ii) every invention concerning embryonic stem cells? No consensus within the Group of Experts.  Importance of the interpretation of the concept of “embryo” in the national legislation of the Member States

19.  the European Commission refrains from giving a further definition or to provide for further harmonization in the area of Article 6(2)c)  the European Commission concludes that “there is no immediate answer to the question of the patentability of embryonic pluripotent stem cells.”

20. ‘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)

21. TO BE CONTINUED……

22. Paul Van den Bulck Partner at Ulys Law Firm (Brussels) Lecturer at R. Schuman University Strasbourg (France) & Q uestions A nswers WWW.ULYS.NET