The Future of Stem Cell Patents in Europe after WARF Regenerative Medicine

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The Future of Stem Cell Patents in
Europeafter WARFRegenerative Medicine Stem
CellsClifford Chance, London, 13th February 2009

Aurora Plomer, BA, MA, LLB, PhD Professor of
Law and Biotethics Director of SIBLE University
of Sheffield (UK)

S.I.B.L.E
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Moral Exclusions in the Directive

• Article 6(1) /Article 53(a) EPC
• Inventions shall be considered unpatentable
  where their commercial exploitation would be
  contrary to ordre public or morality
• Article 6(2)(c)/Rule (23)d(c)now 28(c) EPC
• Uses of human embryos for industrial or
  commercial purposes.

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• does rule 23d(c) now 28(c) EPC forbid the
  patenting of claims directed to products (here
  hESC 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?
• Referral of Technical Board of Appeal to EBA(T
  1374/04)

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E.B.A. WARF ruling

• Legislative purpose
• was to prevent a misuse in the sense of
  commodification of human embryos with one of
  the essential objectives of the whole Directive
  to protect human dignity (para. 18).
• Case G 002/06

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• EU objective was to prevent destruction of human
  embryos, as evidenced by Commissions funding
  policy under the FP7 programme.

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• Scope of exclusion
• not confined to claims but includes the
  technical teaching of the invention as a whole as
  to how the invention is to be performed..

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• Application
• Here the only teaching of how to perform the
  invention to make hESC cultures is the use
  (involving their destruction) of human embryos.
  (Para. 22)

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• Making the claimed product remains commercial or
  industrial exploitation of the invention even
  where there is an intention to use that product
  for further research
• (para. 25).

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• It is not the fact of the patenting itself that
  is considered to be against ordre public or
  morality, but it is the performing of the
  invention, which includes a step (the use
  involving its destruction of a human embryo) that
  has to be considered to contravene those concepts
  (para. 29).

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Beyond WARF?

• .... This decision is not concerned with the
  patentability in general of inventions relating
  to human stem cells or human stem cell cultures.
  It holds unpatentable inventions concerning
  products (here human stem cell cultures) which
  can only be obtained by the use involving their
  destruction of human embryos.
• (para. 35)

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The EBAs Raising of the Moral Bar

• Drift of key legal definitions/rules from
• Use Destruction
• Scope of Exclusion
• practice/teaching of the invention
• Uses for Commercial/Industrial Purposes
• Research purposes
• Morality of the patent
• Morality of the invention

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Legally (un)justified?

• EBAs construction
• Takes no notice of the jurisprudence the ECJ
  and the EPO boards distinguishing between a
  moral reading of the general exclusion clause
  and a literal reading of the specific list of
  exclusions.
• Does not advert to the broader legal architecture
  of the EU and State autonomy on moral exclusions
  .
• Overlooks the existence of permissive EU
  regulatory controls on uses of human embryos.

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The Broader EU Legal Context

• EU controls on uses of human tissue/cells vary
  depending on the nature of the activity and
  whether it relates to research or
  commercialization.
• - Directive 2004/23/EC not applicable to in
  vitro research or animal models.
• - Regulation (EC) 1394/2007 not applicable to
  non-routine or custom made products.
• In all cases, hESC based products may be made and
  commercialized in the EU subject to State
  autonomy on moral exclusions.

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Systemic Tensions

• hESC research is lawful in the EU.
• hESC based products may be manufactured,
  produced on an industrial scale and licensed,
  marketed and commercialized in the EU.
• hESC inventions are lawful/moral in the EU
• But EU patent on hESC inventions excluded on
  moral grounds???

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The Future in Europe

• EU law has supremacy over national laws.
• National patent laws and policy/practice must be
  aligned with EU law.
• Narrower interpretation(s) of Article 6(2)(c) may
  be adopted consistently with the jurisprudence of
  ECJ.

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Updated UKIPO Policy

• Human Embryonic Pluripotent Stem cells
• the Office will continue to grant patents
  for inventions involving such cells provided that
  at the filing or priority date, the invention
  could be obtained by means other than the
  destruction of human embryos.
• 3rd February 2009

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Practical Options

• Applicants should file directly with national
  patent offices with a more permissive policy,
  i.e. UKIPO.

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• Thank You