By Jenny Donald —

Two
UK applications were rejected by a UK examiner on the ground that they
constituted the 'use of human embryos for
industrial or commercial purposes', which is excluded from patentability.  The applications met the other requirements
for patentability.

A
final decision on these applications was suspended until the referred questions
on the Brüstle case were answered by the Court of Justice of the European Union
(CJEU), because the decision would have a direct bearing on these applications.

Both
applications are directed to methods for producing human stem cells/tissues
that use parthenogenesis to activate the oocyte.  The key issue is whether or not the activated
oocytes produced by the claimed methods fall within the definition of a 'human
embryo', and hence whether or not the claimed methods fall within the excluded
category.  The UK examiner's position was
that the activated oocytes fell within the definition of a 'human embryo'.  The CJEU's decision confirmed the examiner's
position, and stated that although such activated oocytes had not, strictly
speaking, been the object of fertilisation; due to the effect of the technique
used to obtain them they are capable of
commencing the process of development of a human being.

The
applicant argued that the CJEU's decision was based on factually incorrect
information because such activated oocytes are not capable of developing into a
human being.  On this basis, and in line
with established case law, the applicant argued that the CJEU's decision should
not be binding on the UK IPO.

The
UK IPO agreed, based on evidence provided by the applicant that the activated
oocytes could not develop into a human being due to inherent biological
limitations.  However, they noted the
distinction that the CJEU's decision merely indicated that they were capable of commencing this
developmental process, rather than completing
this process.  Therefore, they reached
the decision that the CJEU's decision could not be ignored and refused the two
applications.

The
case has been appealed to the UK High Court.  It will be interesting to see if a UK national court believes that they
can depart from the findings of the CJEU based upon the specific facts of the
case in question.

This article was reprinted with permission from Forresters.