Ethics of Patents in Stem Cell Research Status and Implications of the Discussion in Europe Dr. Heinz Goddar and Dr. Jan Krauss Patent Attorneys Boehmert & Boehmert

Overview What is stem-cell research? Specific methods relating to stem-cells Laws related to stem-cell research Stem-cells in patenting Should stem cells be patentable? Boehmert & Boehmert 2

What is stem cell research? “stem-cell” - non-finally differentiated cells of an embryo, foetus or born individual totipotent embryonic cells, pluripotent cells, embryonic stem-cells (ES-cells), embryonic germ-cells (EG-cells), adult stem cells (AS-cells) uses of stem-cells “reproductive” cloning; “therapeutical” cloning, transplantation medicine, development of pharmaceutics Boehmert & Boehmert 3

Sources of stem-cells Source Effect - Embryonic stem-cells derived from Embryo dies in vitro-fertilisation (IVF) - Embryonic stem-cells obtained by Malformations transfer of the nucleus of the cell, expected - Embryonic germ-line cells from abortions, Embryo dies - Neo-natal stem-cells from cord-blood, no effect - Adult stem-cells (AS-cells). no effect (limited potential) Boehmert & Boehmert 4

Law related to stem-cells European Convention for the Protection of Human Rights and Fundamental Freedoms (Rome, 11/4/1950, introduced in the EC Treaty in Article F(2)) European Patent Convention (EPC) National EC member state laws (e.g.) Germany: German Constitution (Grundgesetz) Research with respect to embryos (Embryonenschutzgesetz; ESchG) Patentability of research results (German Patent Law, PatG) EC Directive 98/44/EC (Biotech Directive) Boehmert & Boehmert 5

The law for the protection of embryos National provisions for the protection of embryos Very different situations in Europe DE: High standard of the protection of embryos (Embryonenschutzgesetz; ESchG) three different categories of protection: no research at all or only for protection of individual embryo: AT, CH, DE, IE, IT, LU and NO use of research must be beneficial/applicable for other embryos: DK, FR and SE research within the first 14 days after fertilisation possible: ES, FI, GR, GB and NL Boehmert & Boehmert 6

Stem-cell research in GB Great Britain: research on embryos: until 14th day after fertilisation with informed consent of both genetic parents; admission of HFEA; no other suitable methods for research available research on human ES-cells: admissible therapeutical cloning: admissible obtaining cells from foetuses: admissible Boehmert & Boehmert 7

Stem-cell research in DE Germany: research on embryos: illegal (embryo and totipotent cell regarded as legally equal) research on human ES-cells admissible, obtaining ES-cells illegal therapeutical cloning: illegal (legal “gaps”) obtaining cells from foetuses: admissible Boehmert & Boehmert 8

Stem-cell relevant patent provisions in DE EC Directive 98/44/EC Ethical reasons (consids. 16, 19, 38-45) Exclusions from patentability (consids. 20, 21, 29, 34, 35, 37, 38-45) Articles 5 and 6 of the Directive EPC Articles 52(4) (therapy) and 53 (morality and ordre public) Rules 23b-e, in particular 23d (exclusions) and 23e (the human body and its parts) PatG (Geman Patent Act) § 2, No. 1 (morality and ordre public) and § 5 (2) (therapy) no other biotech specific regulations, yet Boehmert & Boehmert 9

Exclusions from patentability Inventions against morality and ordre public (Art. 53 EPC, Rule 23d EPC), Methods of medical treatment (Art. 52(4)) The human body and the discovery of its elements (Rule 23e(1) EPC) Plant and Animal Varieties Essentially biological processes for the production of plants or animals Boehmert & Boehmert 10

Scope of Rule 23d-e EPC Exclusions (Clarifications) Inventions being contrary to ordre public Cloning of Humans Modifying the Germ Line Use of Human Embryos for Industrial or Commercial Purposes Modification of the genetic identity of animals without medical benefit The human body at the various stages of its formation and development (...) cannot constitute patentable inventions Boehmert & Boehmert 11

The “hot” Issues in patents on stem cells “No Patents on Life” (Proprietary rights on biological parts in situ) Cloning of Humans Germ line modifications Industrial “production” of embryos for commercial and industrial purposes Boehmert & Boehmert 12

“No patents on life” Boehmert & Boehmert 13

Should stem-cells be patentable? - The “pro-side” TRIPS: “Patent protection for all areas of research and technical development”, Stem-cells are valuable tools for the treatment of diseases and the research related thereto - patents would encourage development in this area, There are different regulations for different types of stem-cells (ES, EG, and AS-stem cells), The laws relating to patents and the human body are sufficiently taking into account both morality and ethical aspects of stem-cells. Boehmert & Boehmert 14

Should stem-cells be patentable - the “con-side” Should this viable area of research be commercialised by having patents? Research on embryos and therefore human life in its earliest form is justifiable? Do the laws provide enough control and security, and who enforces such laws? What about countries that do not have such laws? Boehmert & Boehmert 15

Merciments Biotech department at Boehmert & Boehmert: Dr. Ilka Preuss, Munich Dr. Markus Engelhard, Berlin/Munich Dr. Jan Krauss, Berlin/Munich Dr. Thomas Winkler, Munich Dr. Jörk Zwicker, Munich Dr. Heinz Goddar, Munich Biotech@Boehmert.de Boehmert & Boehmert 16