In
Oliver
Brüstle v Greenpeace (Case
34/10) the Court
of Justice of the European Union (CJEU) ruled that any non-fertilised but parthenogenically stimulated
human ovum constitutes a "human embryo" within the meaning of Article
6(2)(c) as it is capable of commencing the process of development of a human
being in the same way as an embryo created by fertilisation of an ovum.  Clarification of the scope term "human
embryo" is important as it will determine whether technologies involving stem cells obtained from parthenogenically
stimulated ova, but which cannot develop into a human being, are excluded from
patentability as "human embryos" under the Directive.

The
UK High Court has now referred this question to the CJEU.  The referral stems from the UK Intellectual
Patent Office's decision to refuse two patent applications filed by International Stem Cell Corporation (ISCC) relating
to human stem cells.  The technology
covered by the patent applications related to unfertilised human ova, subject to division and further development only
by parthenogenesis (a form of asexual reproduction whereby embryos can grow and
develop without fertilisation).  The ova produced
by the methods covered by the patent applications only contained pluripotent
cells.  These cells undergo division as
would an embryo formed by fertilization, but are incapable of developing into a
human being.  The patent
applications were refused by the UKIPO on the grounds that the inventions were
excluded from patentability under paragraph 3(d) of Schedule A2 to the Patents
Act 1977 as covering the use of human embryos.

ISCC argued that
the UKIPO had incorrectly applied the test of "capable of commencing the process of development of a human being"
not only to technologies involving embryos formed by fertilisation but also to technologies
involving parthenogenesis and other processes such as somatic-cell nuclear
transfer in non-fertilised ova.  ISCC argued
that the correct application of the test was to exclude only technologies that
enable the commencement of development which leads to a human being and not
those technologies which enable the commencement of a process of development
even if that process is incapable of leading to a human being.

The UKIPO
considered that the test laid down by the CJEU may apply only on the start of a
development process but the exclusion did not necessarily require completion of
the process which results in the birth of a human being in order for the method
to be excluded.  However, the UKIPO
submitted that the test developed by the CJEU was unclear and supported the
referral of the question to the CJEU for clarification on the matter.

When considering
the Oliver Brüstle v Greenpeace case, the
evidence before the CJEU was that parthenotes (bundle of cells produced
following parthenogenises of an ova) have the potential to create a human being.  This is in contrast to the present case
where it was accepted by all parties that the parthenotes produced by the
methods of the invention were incapable of normal development.

On appeal, the
Judge was persuaded by the view that parthenotes were not the same as
fertilised ova at any stage and that if the process of development was
incapable of leading to a human being, then it should not be excluded from
patentability as a 'human embryo'.  The Judge
therefore allowed the referral to the CJEU to seek clarification of the test.

It is
apparent that the ISCC case turns on different facts to the Brustle decision since
the technology covered by the ISCC patent applications produce parthenotes
which cannot develop into a human being.  The UK High Court Judge stated that "excluding processes of development
which are incapable of leading to a human being from patentability would not
strike the purported balance sought by the Biotech Directive."

We will report
again when the CJEU's judgement is handed down.

This
report comes from European Patent Attorneys at WP
Thompson & Co., 55 Drury Lane, London UK.  Further details and
commentary can be obtained from Gill Smaggasgale,
a partner at the firm.