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• Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body – not however products, i.e. substances or compositions, for use in any of these methods.*
[Art. 52 (4) EPC]
• Inventions the publication or exploitation of which would be contrary to „ordre public“** or morality*** - simple prohibitions of exploitation not sufficient
[Art. 53 (a) EPC]
* Thus methods employed and products used in and resulting from somatic gene therapy and somatic cell therapy patentable.
** To be construed as referring to the most fundamental rules of the relevant legal order.
*** To be construed as embracing only high-ranking and generally accepted ethical principles.
– Actual state of science and technology (e.g. feasibility, safety, etc.)
– Social acceptance of technology at hand
– Can be changed and adapted accordingly at will
• Patents
– Exclusive rights granted for 20 years
– No license to use the patented invention
– Once an invention becomes state of the art – no patent protection available
– Traditionally – no specific exclusionary provisions, but general clauses only – ordre public and morality – allowing flexible response – specific exclusions – allow no flexible response – if removed – no retroactive effects
EU-Directive on the Legal Protection of Biotechnological Inventions 98/44/EC of 1998
Excluded from Patentability
• The human body at various stages of its formation and development – principle of non-commercialisation of the human body Art. 5 (1)]
• Inventions, the commercial exploitation of which would be contrary to ordre public or morality – mere prohibitions not sufficient - as such considered, in particular:
– Processes for cloning human beings– Processes for modifying the germ line genetic identity of
human beings– Uses of human embryos for industrial or commercial purposes– Processes for modifying the genetic identity of animals likely
to cause them suffering without any substantial medical benefit to man or animal and the resulting animals
European Court of Justice (ECJ) on EU-Directive 98/44/EC
Case C-377/98 of October 9, 2001
• The scope left to Member States not discretionary, its limits:
– Prohibition of exploitation not sufficient
– Four specific – mandatory – exclusions
• Fundamental Rights to human dignity and integrity observed and guaranteed [Art. 5 (1) (2), Art. 6]
• Observed that the prior free and informed consent of the donor and recipient outside the scope of the Directive and to be dealt by other laws
• Clarified that the Directive does not preclude legal limitations and prohibitions applying to research into patentable products or the exploitation of patented products – i.e., research exemption
Opinion No. 16 of the EU Group on Ethics in Science and New
Technologies (EGE) of May 2002
• Stem cell lines which have been modified by in-vitro treatments, or genetically modified so that they have acquired characteristics for specific industrial application, fulfil the legal requirements for patentability
• Processes involving human stem cells, whatever their source, patentable
• Applicants for a patent involving human stem cells should declare which is the source of the stem cells
• Patenting of inventions allowing the transformation of unmodified stem cells from human embryonic origin into genetically modified stem cell lines or specific differentiated stem cell lines for specific therapeutic or other uses – ethically acceptable
UK Human Fertilization and Embryology Act (HFE Act 1990) and
German Embryo Protection Act (EPA 1990) – Two Extremes
• HFE Act administered by Human Fertilisation and Embryology Authority (HFEA)– prohibits cloning involving "replacing the nucleus of a cell of
an embryo with a nucleus taken from a cell of any person"– permits licensed research on human embryos of up to 14 days
of development
The following constitutes criminal offence:carry out any treatment using h-embryos outside the body- use donated gametes- store any oocytes, sperm or embryos, or- undertake any research on h-embryo without a license from
the HFEA
Somatic Cell Nuclear Transfer (SCNT) involving nuclear substitution into an unfertilized egg - not an embryo - not covered
UK Human Fertilization and Embryology Act (HFE Act 1990) and
German Embryo Protection Act (EPA 1990) – Two Extremes
Guidelines (DOH, MRC) exist for using pluripotent stem cell lines (imported into or developed in the UK)
HFEA may license such research only if necessary or desirable for either of the following purposes:- promoting advances in the treatment of infertility- increasing knowledge about the causes of congenital disease- increasing knowledge about the causes of miscarriage- developing more effective contraception techniques- developing methods for detecting the presence of gene or
chromosome abnormalities in embryo before implantation- other purposes as may be specified in regulations by the
Secretary of State, e.g. - developing methods of therapy for mitochondrial diseases- developing methods of therapy for diseased or damaged
UK Human Fertilization and Embryology Act (HFE Act 1990) and
German Embryo Protection Act (EPA 1990) – Two Extremes
• German EPA – Basic Principles
– The prohibitions aimed at safeguarding human dignity and protection of life from its inception
– Embryo any fertilized egg (oocyte) capable of development, from the fusion of nuclei, i.e. the fusion of chromosomes of an oocyte and a sperm cell leading to the formation of a novel individual genome
– As embryo considered also all totipotent cells removed from an embryo, which have the innate capacity to divide and develop into an individual being provided that suitable further requirements are met
UK Human Fertilization and Embryology Act (HFE Act 1990) and
German Embryo Protection Act (EPA 1990) – Two Extremes
• Cloning a criminal offence: artificial generation of a human embryo with the same genetic information as another embryo, foetus, or human being, whether living or dead
• Interference with the development of an embryo permitted solely if it serves the welfare of the embryo
• Prohibited:– the preparation of ES cells from blastocysts – nuclear transfer into enucleated oocytes because a totipotent
cell is generated
• Allowed:– the removal of primordial germ cells from dead foetuses for
Neural precursors, method of production and use for therapy of
neural defects
Claims:
1. Isolated, purified precursor cells with neuronal or glial characteristics from embryonic stem cells1)2) containing at most about 15% of primitive embryonic and non-neural cells, obtainable through the following steps:
a) culturing of ES-cells to embryoid bodies
b) ....
5. Cells according to one of the Claims 1-4, whereby the embryonic stem cells from oocytes are obtained after a nuclear transplantation
Patent DE 197 56 864 C1 of April 29, 1999Inventor: Dr. O. Brüstle
Interpretation by the German Patent Office
• Production of totipotent cells by nuclear transfer - not covered by Sec. 8 EPA, because neither a fertilisation takes place nor is a totipotent cell removed from an embryo
• The point in time of accomplishment of reprogramming of nucleus corresponding to fusion of nuclei cannot be established - whether this has taken place can only be demonstrated by later development into a mature individual
• This does not apply here because purified precursor cells with neural and glial properties are produced and no viable individuals
Patent DE 197 56 864 C1 of April 29, 1999Inventor: Dr. O. Brüstle
Interpretation by the German Patent Office
• The "totipotent" cells of the invention are actually not totipotent because they were removed from the inner cell mass (Embryoblast) which without foreign blastocyst cannot develop into a mature individual
• Embryonal germ cells of the invention are cells of Embryoblasts, which can differentiate into all tissues and cell types, but cannot form Trophoblasts and have, thus, lost the capability to develop into an individual
• Inventor is not obliged to strictly observe legal definitions. Decisive is the meaning which an expert can derive from the description and whether the expert can successfully repeat the invention
Perspectives of Ordre Public and Morality in Future European
Practice in Biotech Area
• Direct linking of patentability with specific prohibitions of exploitation based on ethical considerations – doubtful approach
• Harmonized interpretation of Article 6 EU-Directive 98/44/EC and the respective national patent law provisions needed - otherwise the Directive cannot achieve its goals
• This includes the interpretation of such terms as "cloning", "human being" and "embryo" according to a "European Standard"
• Key role of the European Court of Justice in future setting of standards
Perspectives of Ordre Public and Morality in Future European Practice in Biotech Area
• Since a patent not a license to use - national regulatory provisions will continue to control the use - exploitation of the technology - but should also be harmonized
• To avoid, or at least, reduce negative economic impact resulting
from possible future changes of regulatory provisions (deletion of
prohibitory provisions), patent law exclusions should be
interpreted narrowly
• Stem cell technology should be used as an example why the
legislator should refrain from specific exclusions from