Emerging and unresolved issues: the example of marine genetic resources of areas beyond national jurisdiction - Ocean Sustainability in the 21st Century - page 329

utility, and industrial applicability. For instance, in the case of gene sequences and the isol-
ation of proteins, and in some instances, even micro-organisms in their original state, the
mere isolation and characterization may be enough to satisfy the criteria for patentability,
in particular if significant inventive ingenuity has been required to isolate and characterize
them (Salpin and Germani, 2007 ) .
States still enjoy relative flexibility in defining the extent to which genetic inventions,
including inventions based on marine genetic resources, can constitute the subject matter
of patent protection. For instance, Article 53(b) of the European Patent Convention (EPC)
provides that plant or animal varieties or essentially biological processes for the production
of plants and animals do not constitute patentable inventions (Chiarolla, 2011 ) . However,
while plant or animal varieties per se constitute unpatentable subject matter, Article 3.2 of
the 1998 Biotechnology Directive provides that 'biological material which is isolated from
its natural environment or produced by means of a technical process may be the subject
of an invention even if it previously occurred in nature' (European Commission, 1998 ) .
Besides, the protection granted to biotechnological inventions may also encompass within
its scope plant and animal varieties in accordance with Article 4.2, which states that plants
and animals shall be patentable if the technical feasibility of the invention is not confined
to a particular variety. In the USA, at least in theory, three categories of inventions are not
patentable, namely: laws of nature, natural phenomena, and abstract ideas. In particular, the
product of nature doctrine, which sets out the boundaries of patentable subject matter for
genetic inventions under 35 USC Section 101, stands in the eye of the storm that surrounds
the debate on patentability of DNA and its alleged stifling effects on biological innova-
tion. 1
While a detailed account of the economic theories that have been elaborated to justify
the social function and coverage of the patent system is provided elsewhere in the literature
(Chiarolla, 2011 ) , it is useful to recall that some authors have argued that the world eco-
nomy may '… not benefit from a general broadening and strengthening of patent protec-
tion' because, in many technology areas, overbroad patents 'entail major economic costs
while generating insufficient additional social benefits' (Mazzoleni and Nelson, 1998 ) .