in Poland and Lithuania), and those that omit to regulate the area altogether (for
instance, in Ireland, which is not a signatory of the Convention or the Protocol).^17
4 Embryonic Stem Cell Patents in the EU
At the end of the 1980s, the biotechnology industry was dominated by the USA and
Japan. The European Commission considered that Europe has to strategically
position itself to exploit the possibilities generated by the biotechnology industry
concerning the creation of wealth and new jobs. The Commission was of the
opinion that patent law should play the main role in this. However, patentability
standards were unclear in the European patent system in relation to many biotech-
nology products, unlike in the USA and Japan. An additional problem was the
fragmentation of patent laws in Europe. Consequently, the Commission concluded
that it was necessary to clarify and harmonize the patent laws in Europe so as to
give an incentive to the biotechnology industry in Europe and eliminate legal
uncertainty, which was considered necessary for triggering the industry’s boom.
Taking into account these objectives, it was thought that the drafting and the
adoption of the Directive on Patents in Biotechnology would be relatively simple.
However, a full decade passed from the initial conception to the final adoption of
the Directive by the European Parliament in 1998, during which numerous heated
discussions took place about its contents.^18 After the European Court of Justice
rejected the Netherland’s application for the annulment of the Directive in 2001,^19
the last hurdle for implementing the Directive into the national laws of EU member
states was finally removed.^20 In the following sections, the provisions of the
Directive directly affecting the possibility to patent the results of human embryonic
stem cell research and the two interpretative decisions of the Court of Justice of the
European Union (hereinafter: the CJEU) that were issued so far in relation to the
patentability of human embryonic stem cell inventions are analyzed.
(^17) For information about the regulation of stem cell research in various European countries, see,
e.g., EuroStemCell ( 2012 ).
(^18) For the history of the Directive, see Porter ( 2010 ).
(^19) See ECJ ( 2001 ). For the comment of the case, see, e.g., Scott ( 1999 ).
(^20) The Directive on Patents in Biotechnology came into force on 30 June 1998, whereas the EU
member states had the obligation to harmonize their national legislation with its contents until
30 June 2000. However, in 2003, the European Commission had to submit claims against the seven
EU member state before the European Court of Justice, namely, Sweden in case C-518/03, the
Netherlands in case C-395/03, France in case C-448/03, Luxembourg in case C-450/03, and
Belgium in case C-454/03, because they failed to implement the Directive in time. Subsequently,
the Directive was implemented by all EU member states, the last one to do so being Luxembourg
on 23 April 2006.
Embryonic Stem Cell Patents and Personalized Medicine in the European Union 59