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PATENTING HUMAN STEM CELLS: an URGENT NEED for a CLARIFICATION

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Judge Christian BYK, Court of appeal, Paris, Secr.Gl International association ... The Warf referral relates to cell cultures comprising primate embryonic stem cells. ... – PowerPoint PPT presentation

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Title: PATENTING HUMAN STEM CELLS: an URGENT NEED for a CLARIFICATION


1
PATENTING HUMAN STEM CELLS an URGENT NEED for a
CLARIFICATION
  • Judge Christian BYK, Court of appeal, Paris,
    Secr.Gl International association of law, ethics
    and science, Member French Committee for UNESCO.

2
Introduction
  • Patenting human stem cells has become one of the
    most controversial issues of the bioethics field
    at the beginning of the XXI st century, at least
    in industrial countries. A series of good
    reasons may explain the importance of this on
    going controversy.
  • First, we may note that most of the issues
    related to patenting biotechnology have found a
    solution
  • Secondly, patenting human stem cells raised again
    the issue of their embryonic origin
  • Third, it concentrates the critics made against
    using the human body and parts of it as an
    essential tool of the new biology, with a
    particular attention on the commercialisation of
    the human body

3
Introduction
  • This confusion certainly finds some grounds in
    the very broad scope covered by the expression
    patenting human stem cells.
  • What kinds of cells does it include? What kinds
    of patents are concerned?
  • The margin of discretion left to the national
    laws by the European legislator has also
    effective consequences on the European
    harmonization
  • Finally who has interest in supporting an on
    going confused discussion? And who may
    efficiently help to clarify it?

4
What are we speaking about?
5
What are the stem cells concerned?
  • A stem cell can be defined as an
    undifferentiated somatic cell that is capable of
    either division to give rise to daughter stem
    cells, or differentiating into specialized cell
    type given the appropriate signals.
  • We may consider 3 types of distinctions
    regarding human stem cells

6
The first distinction
  • considers the sources from which the stem cells
    are originated adult, foetus or embryo. This
    distinction raises important questions may the
    patentability of stem cells be affected by their
    origin and are the consequences different
    regarding the various sources of human stem cells?

7
The second distinction
  • lies on the functionalities of human stem cells
    totipotent, pluripotent and multipotent stem
    cells
  • A totipotent cell is a cell that has an unlimited
    capability to create an entire new organism.
  • A pluripotent stem cell can give rise to any
    foetal or adult cell type but it cannot develop
    into an entire foetus.
  • A multipotent cell (a haematopoietic cell for
    example) can give rise to several other cell
    types but those types are limited in number. This
    distinction is extremely important when we have
    to distribute in legal categories the cells
    concerned. What is patentable is relying on this
    legal categorisation.

8
The third distinction
  • applies to the fact that the human stem cells may
    be modified or not. some analysts use this
    distinction for its legal consequences in the
    field of patent regarding biotechnological
    material.

9
Appreciating the ethical issues regarding the
different kinds of patents
  • A first classification is based on the 3 existing
    kinds of inventions products, processes,
    applications
  • A product is a determined material object with
    specific characteristics which makes it different
    from any other existing object.
  • A process is a mode of treatment which produce a
    given result (immaterial) or product (material).
  • An application refers to the application of a
    known process combined with the production of a
    product or a result and the novelty of the
    application The global question is to know if and
    how far stem cells can be covered by these
    different types of inventions and if such
    inventions can be protected under patent law.

10
Appreciating the ethical issues regarding the
different kinds of patents
  • A second type of classification based on patents
    national and European patents
  • National patents are delivered by national patent
    offices according to national patent laws. In
    European Union countries, those laws have to be
    in conformity with directive 98/44/EC of 6th July
    1998.
  • European patents are delivered by the European
    Patent Office (Munich) according to the European
    Patent Convention the main question is how the
    issue of patenting human stem cells may be
    affected by the existence of this dual system?

11
The dual system of norms a threat to a
consistent European policy
12
European Union Patent Law legal uncertainty and
policy inaction
The interpretation of the exclusion clause
  • It is globally left to the margin of appreciation
    of Member States. the legal framework may be sum
    up as follows the 1998 directive on patenting
    biotechnology does not include specific
    provisions on stem cells but does include such
    provisions on the human body at its various
    stages.
  • The rules applying to the human body consists in
    one technical principle and one ethical
    principle.

13
The interpretation of the exclusion clause
  • The technical principle (art.5) draws a
    distinction between the unpatentability of the
    human body in natural state as against elements
    isolated from the human body which could
    constitute a patentable invention, providing they
    satisfy the patenting criteria of novelty,
    inventive step and industrial application.
  • The ethical principle (art.6) states that
    inventions shall be unpatentable where their
    commercial exploitation would be contrary to
    ordre public and morality and provides a
    non-exhaustive list of unethical inventions that
    would be excluded from patentability.

14
The interpretation of the exclusion clause
  • Are human stem cell inventions subject to the
    technical distinction which allows patents on
    elements isolated from the human body? If so, do
    such inventions, or some of them, nevertheless
    fall in the ethical exception of art.6?
  • Although the directive intended to harmonise
    patent law in the field of biotechnological
    inventions, its wording has left uncertain the
    precise legal scope in regard to human stem cells
    and acute differences have emerged in the
    interpretation of the exclusion clause by Member
    States.

15
The fragmented legal landscape
  • If the majority of the EU Member States follow
    the exact wording of article 6 in their national
    laws, some have changed the wording of art.6.2.c
  • Concerning the practice of national patent
    offices, opposed views have been adopted.
  • While the legislations may open broad
    interpretations of the exclusion clause, the
    practice of the national patent office seems to
    favour a narrow interpretation of this clause.

16
The wait and see policy of the European Union
  • This confused situation is reinforced by the
    views expressed by some European institutions,
    leaving the European Commission with an uneasy
    approach.
  • On one hand, some European institutions have
    called for a strict restrictive interpretation on
    the patentability of human stem cells.
  • On the other hand, the analysis of the
    jurisprudence of the European Court of Justice
    points in a direction of greater sensitivity to
    national perceptions of ethics and morality ,
    even in the field of protection of fundamental
    rights.
  • The ECJ will preserve national differences as
    part of the broad margin of appreciation of
    Member States within a common Community framework
    of fundamental rights.

17
The wait and see policy of the European Union
  • As a consequence, the European Commission adopted
    in its 2005 report on the implementation of the
    directive a very careful attitude.
  • the Commission concluded that in the light of
    its analysis totipotent stem cells should not be
    patentable, on grounds of human dignity but, on
    the other hand, it expressed the view that there
    is no immediate answer to the question of
    patentability of embryonic pluripotent stem cells
  • This is an implicit recognition that the
    leadership of the EU policy in the issue of
    patenting human stem cells is greatly challenged
    by other existing European norms

18
The challenge rose by other European norms
The European Patent Convention
  • The European Patent Office voluntarily
    transposed the wording of the provisions of the
    directive in the form of amendments to the
    European Patent Convention Implementing
    Regulations on 16th June 1999. But the ECJ has no
    authority in examining these regulations and
    consequently the interpretation of the exclusion
    clause is totally left to the organs of the EPO.
    Two cases are of specific interest concerning the
    issue of patenting human stem cells.

19
The European Patent Convention
  • The Edinburgh decision (31 July 2003) deals with
    methods of isolating and/or enriching and /or
    selectively propagating animal stem cells and
    with genetically modified animal cells for use in
    the methods.
  • The Opposition Division concluded that not only
    is the use of a human embryos exclude from
    patentability, but also the human embryonic stem
    cells retrieved therefrom by destruction of the
    human embryos

20
The European Patent Convention
  • The Warf referral relates to cell cultures
    comprising primate embryonic stem cells. the
    Examining Division was of the opinion that Rule
    23d ( c) should be interpreted broadly and
    therefore refused the application on the basis
    that the invention involved the direct and
    unavoidable use of human embryos.
  • On appeal, the Technical Board of Appeal referred
    (21st April 2006) the matter to the Enlarged
    Board of Appeal

21
The European Patent Convention
  • The four questions raised are as follows
  • Does Rule 23d (c ) EPC apply to an application
    filed before the entry into force of the rule?
  • Does Rule 23d(c ) EPC forbid the patenting of
    claims directed to products (here human
    embryonic stem cells cultures) which as
    described in the application- at the filing date
    could be prepared exclusively by a method which
    necessarily involved the destruction of the human
    embryos from which the said products are derived
    , if the said method is not part of the claims?
  • Does Art. 53 (a) EPC forbid patenting such
    claims?
  • In the context of questions 2 and 3, is it of
    relevance that after the filing date the same
    products could be obtained without having to a
    method necessarily involving the destruction of
    human embryos ( here e.g derivation from human
    embryonic stem lines) ?

22
The European Patent Convention
  • The current approach of the EPO is still unclear
    because on one hand, the decision of the
    Opposition Division is not binding on the other
    first instance divisions and, on the other hand,
    the referral to the Enlarged Board of Appeal is
    still pending.

23
The European Human Rights Conventions
  • It is essential, as recital 43 of the directive
    to refer to the legal obligations of the Member
    States as arising from European conventions on
    human rights, the European Convention on Human
    Rights (1950), the European Convention on
    Biomedicine (1997) and its Protocol on Human
    Cloning (1998).
  • The European Convention on Human Rights
    clarifies what are the rights of the embryo in
    Europe.
  • the European Court of Human Rights has
    consistently held that the question whether the
    human embryo has a right to life comes with the
    margin of appreciation of Member States.
  • In the 2006 Evans v.U.K case, the court extended
    this approach to the human embryo in vitro.
  • The conclusion is easy under the European
    Convention on Human Rights, there is no legal
    basis to establish a uniform norm of
    interpretation in this area that may be used in
    the perspective of applying article 6 of the
    directive

24
The European Human Rights Conventions
  • The biomedicine convention has limited effect on
    the status of the human embryo.
  • Although art.18.1 states that where the law
    allows research on embryos in vitro, it shall
    ensure adequate protection of the embryo, the
    expression adequate protection is vague and its
    implementation is anyway a matter of national
    law.
  • Regarding art.18.2, which states that the
    creation of human embryos for research purposes
    is prohibited, we can remark that none of the
    States which allow such creation have ratified
    the convention
  • Furthermore, in a July 2003 report the working
    party on the human embryo concluded that a
    consensus could not be reached on a protocol on
    the human embryo in vitro.
  • May art.21 which stipulates that the human body
    and its parts shall not, as such, give rise to
    financial gain , imply a ban on the
    commercialisation of the human embryo the
    explanatory memorandum gives a negative reply to
    this question

25
The European Human Rights Conventions
  • The 1998 Protocol to the Biomedicine Convention
    prohibits human reproductive cloning.
  • Both the intention of the Member States and the
    wording of art.1 of the Protocol make it
    unambiguous that the text does not concern human
    embryos and therapeutic cloning.

26
Conclusion
  • The present legal situation the implementation
    of the EU directive does not encourage a
    harmonising process regarding the exclusion
    clause of article 6.
  • The EPC system creates an obligation for the
    European Patent Office to decide what is
    patentable or not but the process can not rely on
    common European view.

27
Conclusion
What could be then the solutions to this issue?
  • One would be to modify the directive and
    consequently the EPC Implementing Regulations to
    introduce the appropriate provisions regarding
    human stem cells.
  • A second solution would be that the EPO takes
    into consideration the fact that only toti-potent
    stem cells may develop into human embryos and
    accepts granting patents for pluri- and
    multi-potent embryonic stem cells
  • A third solution would invite the EPO to operate
    a distinction between inventions involving stem
    cells which were retrieved by destruction of the
    embryos from cells obtained by other means
  • As the Enlarged Board of Appeal could not wait
    for the modifications of the European norms, its
    coming decision will certainly be inspired by one
    of the last two solutions
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