Intellectual Property ◾ 219
that is of great concern. According to the founders of Nordic Biotech,
“the present reality in drug development (…) is that almost any technol-
ogy or compound can rapidly be reverse engineered.
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” Adequate IP
protection becomes a means to ensure that biotechnology companies
can appropriate their R&D results and reduce the likelihood of imitation
by competitors.
3. Contrary to traditional industries, where there is a clear distinction
between the basic research performed in universities and public sector
R&D institutions on the one hand, and the applied R&D undertaken
by private enterprises on the other, in biotechnology, basic and applied
research are often profoundly inter-linked. Research undertaken in
academic research institutions is often the basis for the establishment of
biotechnology spin-offs. Similarly, biotechnology companies are often
involved in (and are actively patenting) what some consider to be basic
research.
4. The biotechnology industry, in most countries, consists mainly of
recently established SMEs, an important number of which have yet to
take a product to market. In many cases, biotechnology SMEs are estab-
lished based on one or more patents developed within, or in partner-
ship with, public research organizations or universities.
5. Finally, a point that derives from some of the issues discussed previ-
ously is that for some biotech companies intellectual property rights
are actually the nal product. It is not uncommon, in fact, to nd
biotechnology companies that develop innovative inventions, pat-
ent them, and then license them to larger companies that have the
resources to take the product to market. Such companies may actu-
ally never sell a product themselves in the traditional sense, but base
their revenues on their ability to develop, protect, and out-license their
innovations.
In addition, biotechnology patents are a breed unto themselves. For
example, you cannot obtain general patent protection for DNA sequences
of a novel gene in a number of species if you have only sequenced a single
vertebrate or invertebrate example. Description of the species usually does
not allow protection for the genus in patents in the biosciences. In addition,
DNA sequences for which no function has been demonstrated are gener-
ally not considered patentable. Many laws and regulations must be met, as
shown in the following.
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