PATENTING HUMAN STEM CELLS: an URGENT NEED for a CLARIFICATION

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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.

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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

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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?

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What are we speaking about?
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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

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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?

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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.

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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.

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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.

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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?

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The dual system of norms a threat to a
consistent European policy
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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.

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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.

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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.

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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.

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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.

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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

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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.

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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

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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

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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) ?

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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.

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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

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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

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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.

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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.

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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