Biomedical Engineering Reference
In-Depth Information
matter would enter the public domain if published before patent claims were
fi led) or preliminary laboratory fi ndings ahead of publication.
9.3
INTELLECTUAL PROPERTY RIGHTS AND DATA
Data do not naturally fall under the four classes of IPR previously listed,
especially the sorts of data now emerging from contemporary high-throughput
life sciences laboratories. Measurements of cell activity, lists of gene sequences,
and protein crystal structures are not “expressions of creativity” but instead
purport to give us facts about the real world. They are not inventions or pro-
cesses. Data in the United States have a long tradition of being in the public
domain and of being protected at the database level by only a very thin layer
of copyright. A database may carry a copyright only on the elements of the
database related to the “selection and arrangement” of the data contained
therein and not on the data itself [12].
However, the U.S. approach is not an international standard. There are
varying laws in various countries that create protections similar to IP for ele-
ments, like data, that do not fi t the traditional regime, and indeed the European
Union (EU) does precisely this for databases. To be fair, the U.S. law protects
ship hulls, the French protect fashion, and the “mask works” used to design
semiconductor chips receive protection as well.
But the EU database directive, as it is known, is the most relevant to the
life sciences discussion. The directive was passed in 1996 in the goal of creating
a regional advantage for databases built in the EU. The holder of the database
rights can prohibit the extraction or reutilization of all the data in the database
or of a “substantial” subset of the data. Substantial can be calculated either
objectively or subjectively, and the owner is not allowed to restrict the users
who make “insubstantial” uses of the database [13].
EU database rights last for 15 years, dated from the publication of the
database, but can be renewed through substantial new investments in the
database. This means that any interesting database, one that is growing, is
legally allowed to have perpetual database rights under the EU system. To
make things more complex, database rights are orthogonal to and independent
of copyright, making it possible for different owners to assert copyrights and
database rights to the same product.
9.4
LICENSING AND CONTRACTS
9.4.1
Material Transfer Agreement
A material transfer agreement (MTA) is a contract covering the transfer of
physical research materials in which the transfer is intended to facilitate
research purposes at the receiving laboratory. MTAs are commonly associated
with biological materials, especially recombinant ones like stem cells, plasmids,
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