Biomedical Engineering Reference
In-Depth Information
as a reaction towards national patent laws that imposed restrictions
on foreigners obtaining patents in much of Europe (Guellec, 2007: 25).
'The Paris Convention' of 1886 was the first step towards a principle
of reciprocity, where any individual would receive the same treatment
under patent law as they do in their own country (Guellec, 2007:
25). The Paris Convention also established the 'first to file' rule as
part of international harmonization that is now a recognizable part
of international patent law (Guellec, 2007: 25).
Biotechnology patenting in the European Union, however, has
faced more hurdles than in the US. This stems from the European
Patent Convention of 1973 that explicitly states that patents should
not be granted for anything that violates the 'ordre public' or public
morality (Drahos, 1999). Some commentators (e.g. Drahos, 1999;
Crespi, 1997) argue that this particular clause has added a moral
dimension to questions of patenting that are strictly speaking actually
outside the operation of patent law. One suggestion is that patenting
is 'ethically neutral' but the public morality clause has enabled
activist groups and those with moral oppositions to patenting
biotechnology to challenge patent law through the European Courts
(Crespi, 1997). It has been further argued that such moral values
operate as a de facto regulation of patent law (Drahos, 1999).
In particular, the European Parliament ruled in 1998 that hESCs
should be specifically excluded from patenting. Directive 98/44/EC
'On the Legal Protection of Biotechnological Inventions' was
initiated as a means of clarifying patent law around some of the
more contentious issues that had arisen around biotechnology over
the preceding decade and of achieving international harmonization
across the EU member states (Leskien, 1998). Although Directive
98/44/EC recognized several forms of biotechnology patents that
had been previously contested, it excluded various uses of human
tissues, including the use of human embryos for commercial or
industrial purposes (Leskien, 1998). Yet the Directive is not binding
for the European Patent Office (EPO), causing a range of political
tensions for patenting decisions around stem cells for the European
Community and ultimately leading to the EPO Director's 2005
decision to suspend the granting of hESC patents until these issues
could be resolved (Salter, 2007).
