Biomedical Engineering Reference
In-Depth Information
on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in
the mid-1990s, the US system is argued to have become the minimum
standard for international patent regimes (Allred and Park, 2007).
Patenting rights in biotechnological inventions in the US were
created in 1980 with the
Diamond
v.
Chakrabarty
legal ruling that
'anything under the sun that is made by man' could be patentable
(Gallini, 2002).
Diamond
v.
Chakrabarty
concerned the development
of a genetically modified bacterium that was ultimately deemed
patentable because it was in fact a new material that was the result
of human intervention (Eisenberg, 1990). It has been suggested that
the original rejection of the patent application was based on a ruling
dating back to the late nineteenth century that products of nature
could not be patented (Kevles, 1998). This is seen as evidence,
moreover, that ongoing debates around patenting in biotechnology
reflect the political and economic stakes at work in shaping the
biotechnology industry (Kevles, 1998).
One of the more high-profile cases around stem cell patenting
concerns the patents awarded to the Wisconsin Alumni Research
Foundation (WARF). The awarding of several patents to WARF, and
the large number of stem cell patents being filed more generally, is
thought to be potentially stifling to innovation, making licensing
costs and access to technology prohibitively expensive for other
players (Bergman and Graff, 2007). One commentator specifically
states that the WARF patents are thought to be too broad, thus
unfairly restricting future ownership of any discoveries or inventions
based on hESC research, and that the inclusion of some of the
WARF stem cell lines on the NIH registry of approved stem cell lines
suitable for use with federal funding under a Memorandum of
Understanding shows clear recognition that the patents have future
implications for the successful commercialization of any subsequent
innovations that are yet to unfold (Herder, 2006).
Patenting rights in the European Union are similar to those in the
US. Although having a long tradition of recognition of ownership of
intellectual property in individual member states, a community-wide
approach to patenting was not recognized until the European Patent
Office was established in 1978 (Allred and Park, 2007). The push
for international harmonization began in the late nineteenth century
