1. Ethics of Patents in Stem Cell Research
Status and Implications of the Discussion in Europe
Dr. Heinz Goddar and Dr. Jan Krauss
Patent Attorneys
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2. 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?
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3. 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
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4. 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)
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5. 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)
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6. 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
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7. 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
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8. 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
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9. 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
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10. 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
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11. 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
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12. 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
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13. “No patents on life”
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14. 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.
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15. 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?
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16. 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
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