Is There Light at the End of the Tunnel?

By Jenny Donald —

It
is clear from an emerging practice of the European Patent Office (EPO) that
they were not widely impressed by the controversial Brüstle decision issued by
the Court of Justice of the European Union (CJEU).

The
EPO has adapted its practice to be consistent with the Brüstle decision.  However, it has also taken a position that
will allow companies working in the area of stem cell research to obtain patent
protection for their products and methodologies, by indicating that it will
allow inventions that utilise human embryonic stem cell lines that have been
established using a method that does not destroy the human embryo.

This
emerging practice of the EPO could have a great impact on the future of stem
cell research in Europe.

EPO previous practice

In
Europe, inventions that necessitate the use of human embryos have been excluded
from patentability for some time.

Prior
to the issuance of the Brüstle decision the EPO's practice was that:

• a
product, which could be exclusively
obtained by a method which necessarily involved the destruction of human
embryos from which the said product is derived is excluded from
patentability

• a
product, which could be obtained from an established human embryonic stem cell
line is patentable, provided the product fulfils the other requirements of
patentability, because obtaining the product did not directly involve the
destruction of a human embryo

Brüstle
decision

The main purpose of the Brüstle decision was to
clarify the meaning of the term 'human embryo'. 
However, the CJEU also stated that the exclusion of human embryonic stem
cells, and other products, was relevant to the destruction of a human embryo at
any point in history.

EPO
current practice

The EPO has stated, when adapting its practice in
line with the Brüstle decision, that the exclusion to patentability can no
longer be avoided by exclusively obtaining the stem cell/product
indirectly from an established human embryonic stem cell line that required the
destruction of a human embryo.  At some
point in history a human embryo has been destroyed to establish the cell line
and any products derived, either directly or indirectly, are now excluded from
patentability.

Accordingly, the EPO has changed its practice to:

• a
product, which could be exclusively
obtained by a method which necessarily involved the destruction of human
embryos from which the said product is derived is excluded from patentability; the
point in time at which such destruction takes place is irrelevant

There
have been great concerns that this change in practice will severely limit the
scope of protection available in the area of stem cell research and for other
products obtained from human embryos.

EPO emerging practice

It
appears that all may not be lost!

A
new technology, Single Blastomere Biopsy (SBB), published for the first time in
2008 enables stem cells, and other products, to be obtained from a blastocyst that
does not result in the destruction of the human embryo.

Based
on the existence of this technology, at least one examining division of the EPO
has stated that inventions directed to products obtained from cell lines established
using this technology are not excluded from patentability.

The
reasoning behind this new stance is that the human embryonic stem cell lines
have be established using a non-destructive methodology; and the
existence of such established cell lines means that the claimed invention does
not constitute a new use of a human embryo.

In
contrast, any method directed at manufacturing such cell lines would be
excluded from patentability because, despite that fact that the methods are
non-destructive, the methods are a new use of a human embryo.  Hence, it is only once a cell line has been
established that stem cells, products and associated methods that are derived
from such established cell lines are not excluded from patentability, provided
they meet the other requirements of patentability.

This article was reprinted with permission from Forresters.