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CASRIP 2002 High Technology Protection Summit Seattle, July 20, 2002 Ethical Issues in Patent Law Bi

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Once an invention becomes state of the art no patent protection available ... or to the place of production if the usual patentability criteria are met. [Art. ... – PowerPoint PPT presentation

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Title: CASRIP 2002 High Technology Protection Summit Seattle, July 20, 2002 Ethical Issues in Patent Law Bi


1
CASRIP 2002 High Technology Protection
Summit Seattle, July 20, 2002 Ethical Issues in
Patent Law Biotechnology and Research Ethics - A
European Perspective Joseph Straus, Munich
  • Ethical Considerations and Patenting in Europe
  • Ordre Public Morality vs. Patents Complex
    Relationship
  • Agreement on Trade Related Aspects of IPR (TRIPS)
    (1994) the Controlling Rule
  • EU-Directive on the Legal Protection of
    Biotechnological Inventions 98/44/EC (1998)
    Implementing Regulations to the EPC (1999)
  • Patenting of Human Stem Cells as Most Recent
    Example
  • Outlook

2
Ethical Considerations and Patenting in
Europe Exclusionary Provisions in EPC National
Laws
  • 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.

3
Ordre Public Morality vs. Patents Complex
Relationship
  • Ordre public and morality depending on
  • 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

4
Controlling TRIPS Rules
  • Patents must be available for any inventions in
    all fields of technology, without discrimination
    as to the place of invention or to the place of
    production if the usual patentability criteria
    are met.
  • Art. 27 (1)
  • WTO Members may exclude from patentability
    inventions if their commercial exploitation would
    violate ordre public or morality (protection of
    human, animal or plant life or health or
    environment) mere prohibition of exploitation not
    sufficient in any case, commercialisation of
    such inventions may not be allowed!!!
  • Art. 27 (2)

5
Controlling TRIPS Rules
continued
  • WTO Members may further exclude from
    patentability inventions of diagnostic,
    therapeutic and surgical methods for treatment of
    humans and animals, ....
  • Art. 27 (3 (a)
  • These principles of TRIPS are explicitly
    acknowledged in the EU-Directive 98/44/EC
  • Recital 12, Art. 1 (2)

6
EU-Directive on the Legal Protection of
Biotechnological Inventions 98/44/EC of 1998 and
Ethics
  • The Commissions European Group on Ethics in
    Science and Technology evaluates all ethical
    aspects of biotechnology.
  • Art. 7
  • The Group may be consulted only when
    biotechnology is to be evaluated at the level of
    basic ethical principles, including such patent
    law issues.
  • Art. 7 Recitals 19, 44

7
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-commercialisati
    on 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
  • Art. 6 (1) (2)

8
EU-Directive on the Legal Protection of
Biotechnological Inventions 98/44/EC of
1998 Excluded from Patentability
continued
  • Generally accepted rule Excluded only if this
    being the only possible (claimed) use
  • Ordre public and morality correspond in
    particular to ethical or moral principles
    recognized in a Member State
  • Recital 39
  • Consensus exists that the cloning of human beings
    offends against ordre public and morality
  • Recital 40

9
EU-Directive on the Legal Protection of
Biotechnological Inventions 98/44/EC of
1998 Excluded from Patentability
continued
  • Process for cloning human beings any process,
    including techniques of embryo splitting,
    designed to create a human being with the same
    nuclear genetic information as another living or
    deceased human being
  • Recital 41
  • Inventions for therapeutic or diagnostic purposes
    applied to the h-embryo and useful to it not
    affected by exclusions
  • Recital 42

10
EU-Directive on the Legal Protection of
Biotechnological Inventions 98/44/EC of
1998 However patentable
continued
  • Elements of the human body, including sequences
    or partial sequences of a gene if isolated or
    otherwise technically produced even if structure
    identical to the natural one
  • Art. 5 (2)
  • Prior free and informed consent of the donor, in
    accordance with national laws required
  • Recital 26

11
European Court of Justice (ECJ) on EU-Directive
98/44/EC Case C-377/98 of October 9, 2001
  • Confirmed the legality of the Directive
  • Observed that the ordre public or morality rule
    in principle allows patent offices and courts of
    the Member States a wide scope for manoeuvre in
    applying this exclusion
  • Observed that that scope of manoeuvre necessary
    to take account of the particular difficulties to
    which the use of certain patents may give rise in
    the social and cultural context of each Member
    State, a context which the national legislative,
    administrative or court authorities are better
    placed to undertake than are the Community
    authorities

12
European Court of Justice (ECJ) on EU-Directive
98/44/EC Case C-377/98 of October 9, 2001
continued
  • 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

13
Opinion No. 15 of the EU Group on Ethics in
Science and New Technologies (EGE) of November
2000
  • EGE recommended as regards human stem cell
    research and its uses
  • To set up a strict public control by centralized
    authorities, on human embryo research where it is
    allowed
  • To take measures to prevent commercialisation of
    human embryos or cadaveric foetal tissue
  • To ensure the respect of ethical principles
    through the control of public authorities,
    concerning import of human stem cells.

14
Opinion No. 16 of the EU Group on Ethics in
Science and New Technologies (EGE) of May 2002
  • EGE observed that it would be contrary to public
    (and especially patients) interests, if patenting
    of stem cells or stem cell lines would be
    forbidden
  • Isolated stem cells which have not been modified
    do not, as product, fulfil the legal requirements
    for patentability. Moreover, such cells are so
    close to the human body, to the foetus or to the
    embryo they have been isolated from, that their
    patenting may be considered as a form of
    commercialisation of the human body
  • Unmodified stem cell lines can hardly be
    considered as a patentable product. They do not
    have a specific use but a very large range of
    potential undescribed uses

15
Opinion No. 16 of the EU Group on Ethics in
Science and New Technologies (EGE) of May 2002
continued
  • 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

16
Opinion No. 16 of the EU Group on Ethics in
Science and New Technologies (EGE) of May 2002
continued
  • Donors should be informed of the possibility of
    patenting and they are entitled to refuse such
    use
  • Apart from justified compensation, donors should
    not get a reward which could infringe the
    principle of non-commercialisation of the human
    body
  • In addition to the research exemption, it is
    essential to secure that patents on stem cell
    lines are not too broad
  • EGE-considers that there may be also a need to
    make ethical evaluations in the course of the
    examination of patent applications involving
    specific ethical dimensions

17
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

18
UK Human Fertilization and Embryology Act (HFE
Act 1990) and German Embryo Protection Act (EPA
1990) Two Extremes
continued
  • 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 tissues or organs

19
UK Human Fertilization and Embryology Act (HFE
Act 1990) and German Embryo Protection Act (EPA
1990) Two Extremes
continued
  • 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

20
UK Human Fertilization and Embryology Act (HFE
Act 1990) and German Embryo Protection Act (EPA
1990) Two Extremes
continued
  • 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 scientific, therapeutical, or
    diagnostic purposes
  • Sec. 6,8 DFG interpretation

21
Patent DE 197 56 864 C1 of April 29,
1999 Inventor Dr. O. Brüstle
  • Neural precursors, method of production and use
    for therapy of
  • neural defects
  • Claims
  • 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

22
Patent DE 197 56 864 C1 of April 29,
1999 Inventor Dr. O. Brüstle
continued
  • Cells according to one of the Claims 1-4, whereby
    the embryonic stem cells are obtained from
    embryonic germ cells
  • Cells according to one of the Claims 1-6, whereby
    the cells are mamalian cells
  • Cells according Claim 7, whereby the cells are
    from the group encompassing mice, rat, hamster,
    pig, beef, primates or human being were isolated
  • .....
  • Method for the production of purified precursor
    cells ...., encompassing the following steps
  • a) culturing of ES cells to embryoid bodies,
  • ....

23
Patent DE 197 56 864 C1 of April 29,
1999 Inventor Dr. O. Brüstle Definitions
  • ES-cells can be obtained, e.g. from very early
    embryos in the blastocyst stage. These are
    totipotent cells, which can be kept in
    undifferentiated stage through many passages, and
    which possess the ability to differentiate in all
    tissues and cell types
  • Specification p. 4 l. 33-36
  • The term toti-, pluri-, multi- and bipotent cells
    stands for precursor cells which differenciate in
    all (totipotent), many different (pluri- or
    multipotent) or two (bipotent) mature cell types.
  • Specification p. 4 l. 53-55

24
Patent DE 197 56 864 C1 of April 29,
1999 Inventor 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

25
Patent DE 197 56 864 C1 of April 29,
1999 Inventor 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

26
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

27
Perspectives of Ordre Public and Morality in
Future European Practice in Biotech Area
continued
  • 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 patentability
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