Australia could be about to ban the patenting of a wide range of
biological materials, if the new Patent Amendment (Human Genes and
Biological Materials) Bill 2010 is passed.
The Bill seeks to amend section 18 of the Patents Act
by extending the current prohibition on patenting human beings, and
the biological processes for their generation, to biological
materials including their components and derivatives, whether
isolated or purified or not and however made, which are identical
or substantially identical to, such materials as they exist in
"Biological materials" will include DNA, RNA,
proteins, cells and fluids – which is pretty far-reaching
by itself – but is not limited to these things.
Why is this Bill a problem for the biotech and pharmaceutical
According to the Explanatory Memorandum, the Bill is intended to
advance medical and scientific research by reducing the cost of
accessing biological materials. However, one might also argue that
the Bill will have the reverse effect and will discourage
investment in R & D if any biological product that is developed
can be copied by all and sundry.
While the cost of accessing otherwise patented biological
materials would be removed, the Bill would have two significant
an important incentive for doing research and development
– commercialisation via patenting – would be
the bill is not expressed to apply to future patents only. The
exclusion potentially operates retrospectively so that already
patented biological materials would lose their patent protection.
If so patent owners would lose a revenue stream which funds their
research and development. There are currently proceedings before
the High Court to determine whether a reduction in the scope of
intellectual property rights, in particular copyright, may be
unconstitutional (see Phonographic Performance Company of
Australia Ltd v Commonwealth of Australia). Similar issues may
arise in relation to this Bill, if it becomes law.
Only material that is "substantially identical" to
material that exists in nature is excluded. While this is a well
developed concept with respect to trade marks, the same cannot be
said for patents. It is unclear how the test would work in
practice, particularly given small changes in DNA sequences can
lead to significant differences in biological activity.
How likely is this to pass?
The Bill is a private member's bill, introduced by Senators
from the Liberal and Green parties, and one Independent. As the
current Federal Government does not have a majority (and depends
upon independents and Green MPs) in the House of Representatives,
or in the Senate, its prospects of becoming law are better than
those of the average private member's bill. However, much will
depend on the recommendations of the report of the Senate Committee
on the patenting of human genes, due to be delivered today.
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