Human Embryonic Stem Cell (Wikipedia Commons)On 8 October 2011, the Court of Justice of the European Union's
(CJEU) handed down a landmark judgment on the correct interpretation of Article
6(2)(c) of the Biotechnology Directive (98/44/EC) relating to the patentability
of human embryonic stem cells.

The Court of Justice's judgment

The
decision excludes an invention from patentability where the technical teaching
which is the subject-matter of the patent application requires the prior destruction
of human embryos or their use as base material, whatever the stage at which
that takes place and even if the description of the technical teaching claimed
does not refer to the use of human embryos.

The EPO's position

Until
recently, there has been a degree of uncertainty surrounding the EPO's stance
on the CJEU's judgment, and whether the Office will align their practices by
shifting to the more restrictive interpretation of the human embryonic stem
cell exclusion.  A review of the EPO's recently-revised Guidelines for
Examination appears to have settled the debate.  The Guidelines advise that:

A claim directed to a product, which at
the filing date of the application 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 under Rule 28(c),
even if said method is not part of the claim.  The point in time at which such
destruction takes place is irrelevant.

The UK IPO's position

Perhaps
less surprising is the reaction of the UK IPO, which, in recognizing that it is
bound by the guidance provided by the CJEU, has recently issued a Practice
Note
for inventions involving human embryonic stem cells.  The relevant
passage of the Note advises that:

[T]he Office practice will now
recognise that where the implementation of an invention requires the use of
cells that originate from a process which requires the destruction of a human
embryo, the invention is not patentable according to paragraph 3(d) of Schedule
A2 [corresponding to Article 6(2)(c) of the Directive].  For example, where the
implementation of the invention requires the use of a human embryonic stem cell
line the establishment of which originally required the destruction of a human
embryo, the invention is not patentable.

The future

The recent guidance
provided by both the EPO and the UK IPO does little more than paraphrase the
Decision of the CJEU.  It is therefore hoped that the situation for biotech
innovators operating in this area will become clearer as individual cases are
deliberated by the EPO's Boards of Appeal and National Courts.

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.

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