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In the EU, stem cells unpatentable if an embryo is destroyed
November 2011
SHARING OPTIONS:
Oliver Brüstle is the patent holder for isolated and
purified neural precursor cells
produced from human embryonic stem cells
(hESCs) used to treat neurological diseases.
The case raised very interesting legal and ethical issues,
in particular how the right to human dignity related to
the dispute. Although a
fundamental right under German constitutional law and jurisprudence, the right
to human dignity has been recognized as an
unwritten principle of EU law, and
undoubtedly played a significant part in the outcome of this case.
The development from conception begins with a few totipotent
cells. Each cell has the capacity to develop into a complete human being. The
court
viewed totipotent cells as representing the first stage of the human
body, and ruled they must therefore be legally categorized as embryos.
The court emphasized that whether this categorization must
be recognized from before or only after
implantation is irrelevant. This means
that every totipotent cell, whatever the means by which it has been obtained,
is an embryo, and that any
patentability must be excluded. This definition
covers unfertilized ova into which a cell nucleus from a mature cell has been
transplanted.
The court ruled that characterizing a totipotent cell as an
embryo does not resolve the issue, as an
embryo quickly develops into a
blastocyst made up of pluripotent cells that can develop into all kinds of
cells to form all the organs of the human
body. These cells cannot develop
separately into a complete human being. While the court found that blastocysts
as a whole must be categorized as an
embryo, it said individual pluripotent
cells in isolation are not.
Most of the EU member states
take the view that pluripotent
stem cells are not human embryos given that hESCs, taken in isolation, are no
longer capable of developing into a
complete individual. However, the court
said it is not possible to ignore the origin of this pluripotent cell. The
court interpreted Article 6.2.c. of
Directive 98/44/EC on the legal protection
of biotechnological inventions as an invention that must be excluded from
patentability where the
application of the technical process for which the
patent is filed necessitates the prior destruction of human embryos or their
use as base material,
even if the description of that process does not contain
any reference to the use of human embryos.
The exception to the non-patentability of uses of human
embryos for industrial or commercial purposes concerns only inventions for
therapeutic
or diagnostic purposes that are applied to the human embryo and are
useful to it. If you read the ruling as saying that any invention based on
hESCs is
unethical and therefore cannot be patented, then the ruling will have
major implications for the commercialization of stem cell-based technologies in
the EU, especially if it fosters the idea that stem cell research is inherently
immoral.
It
will take several years for the European Patent Office,
national
patent offices and various courts to take up the issue and interpret
the decision. In one view, companies may end up relying on keeping
manufacturing
processes a trade secret instead of relying on patents since the
European Medicines Agency keeps data submitted for regulatory approval private
for
eight years and blocks others from using this information for two
additional years.
While the
decision could spur development of
therapies—because it could free up hESC research from patent infringement—it
could still prove to be harmful, as the
far-reaching decision bans patents on
any downstream products using cell lines that required the destruction of human
embryos for violating respect for
human dignity.
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