The patentability of human pluripotent embryonic stem cells and stem cell lines

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The patentability of human pluripotent
embryonic stem cells and stem cell lines
Tuesday, 6th June 2006

• Paul Van den Bulck
• Partner at Ulys Law Firm (Brussels)
• Lecturer at the University of Paris XII and at R.
  Schuman University (Strasbourg)
• www.ulys.net
• paul.vandenbulck_at_ulys.net

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Structure

• I. Introduction
• II. European legal framework
• (A.) Directive 98/44/CE
• (B.) European Patent Convention

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I. Introduction
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• At the European level, several bodies have
  addressed the issue of the patentability of
  human pluripotent embryonic stem cells and stem
  cell lines
• the European Commission (two 16c reports)
• the European Commission Experts Group
  (preparation of the second 16c reports)
• the European Group on Ethics
• the European Patent Office (case law)

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II. Community legal framework
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• Article 5 (1)
• The human body, at the various stages of its
  formation and development, and the simple
  discovery of one of its elements... cannot
  constitute patentable inventions.

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• In application of article 5(1)
• totipotent stem cells unpatentable (since they
  are capable of developing into a human being)
• embryos unpatentable (common position of the EC
  Council of 26 Febr. 1998)
• germ cells unpatentable (recital 16)

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• What about pluripotent stem cells? Complex
  situation
• Article 5 (2)
• An element isolated from the human
  body...including the sequence or partial sequence
  of a gene, may constitute a patentable invention,
  even if the structure of that element is
  identical to that of a natural element.

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• Article 5 (2)
• allows the patentability of human stem cells
• allows the patentability of human stem cell lines
• (if the invention is new, involves an inventive
  step and is susceptible of industrial
  application)

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• Article 6 of the Directive
• Inventions shall be considered unpatentable where
  their commercial exploitation would be contrary
  to ordre public or morality
• ...the following, in particular, shall be
  considered unpatentable (...) (c) uses of
  human embryos for industrial or commercial
  purposes...

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• Article 6(2) is non exhaustive
• Recital 42
• article 6(2)c) does not affect inventions for
  therapeutic or diagnostic purposes which are
  applied to the human embryo and are useful to it

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• If one reads article 6(2)c) and recital 42
  together then, according to the European
  Commission experts group
• Unpatentable if the embryo is the source of the
  invention
• patentable if the embryo is the aim of the
  invention

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• Article 6(2)c) does the unpatentability
  concerns
• an embryo as a whole?
• or
• every invention concerning stem cells?
• No consensus.
• Importance of the interpretation of the concept
  of embryo in the national legislation of the
  Member States

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B. European Patent Convention

• Article 53(a)
• Any invention, the publication or exploitation
  of which would be contrary to ordre public or
  morality, is specifically excluded from
  patentability.

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• Rules
• Rule 23(d) European patents are not to be
  granted in respect of inventions which
  concern(c) uses of human embryos for industrial
  or commercial purposes
• Rule 23(e) the human body, at the various
  stages of its development

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• EDINBURGH PATENT- case
• Patent granted in December 1999
• patent for animal transgenic stem cells
• EPO Opposition Proceedings (July 2002)
• amendment to exclude human embryonic stem cells
• adopted broad interpretation of Rule 23(d)(c)
  (6(2)c of directive)
• does this mean that human embryonic stem cells
  are unpatentable ?
• The decision of the Board of Appeal is awaited
  (end 2006)

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Questions Answers

• Paul Van den Bulck
• Partner at Ulys Law Firm (Brussels)
• Lecturer at U. of Paris XII and U. R. Schuman
  Strasbourg-)
• www.ulys.net
• paul.vandenbulck_at_ulys.net