The Bill proposes a ban not just on patenting human
genes, but a wide range of biological materials.
The Senate appears likely to reject the proposal to exclude
"biological materials" from patentable subject matter in
Australia, following a recommendation from the Senate Legal and
Constitutional Affairs Legislation Committee.
On 21 September 2011, the Committee delivered its report on the
Patent Amendment (Human Genes and Biological Materials) Bill 2010.
Recommending that "the Senate should not pass the Bill",
the Committee expressed concern that the Bill could have "a
large number of unintended consequences across the entire patent
system with indeterminate impacts on a range of industries and
sectors". Three Senators, all of whom had originally sponsored
the Bill, disagreed with this majority decision of the Committee
and released a separate dissenting report.
The Bill proposed to amend section 18 of the Patents Act (which
defines the subject matter that can be protected by a patent).
Currently section 18 includes a provision that human beings and
biological processes for their generation are not patentable. Under
the key amendment, this exclusion would be extended to add that
"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 appear in nature" are not patentable. "Biological
materials" would be defined to include DNA, RNA, proteins,
cells and fluids.
The proposed amendments would change the patent landscape in
Australia dramatically. Biotechnology is a core area of activity
for many research organisation in Australia, and the proposed
changes would profoundly affect the viability of such work. The
Bill contains no transitional provisions limiting the restriction
to future patents and so also has the potential to invalidate the
many existing patents in Australia that include genetic material as
part of their subject matter.
Submissions opposing the Bill highlighted that, while much of
the public debate has focused on whether human
gene sequences ought to be patentable, the proposed biological
materials exception in the Bill is far broader. For example, the
Bill would affect the patentability of genetically modified plants,
with the potential to inhibit developments in an area that has
become very valuable to Australian agriculture. In its report, the
Committee acknowledged that this was a concern:
"The evidence received by this Committee indicates that
this exclusion is likely to have significant implications for a
broad range of sectors and industries in Australia including
healthcare, pharmaceuticals, agriculture, food manufacturing and
biotechnology. Extensive enquiries... have not revealed any
persuasive evidence that would justify this type of broad exclusion
from patentability for all biological materials."
The Report also notes that "there was no evidence received
by the committee that patents on human genes or biological
materials are systematically leading to adverse impacts in the
provision of healthcare in Australia." Nor, says the Report,
would excluding biological materials from patentability impact upon
freedom to research (an issue which is addressed in separate draft
legislation currently before the Parliament).
Opponents to the Bill also believed that the drafting of the
amendments (and, in particular, the inclusion of words and phrases
such as "derivative" and "substantially
identical") would result in further uncertainty in the Act as
to what subject matter is patentable. The Committee agreed with
this concern and noted that the uncertainty could inhibit research
and development and result in increased litigation.
In light of the Committee's recommendation, it now seems
unlikely that the Senate will pass the Bill, although supporters of
the Bill have indicated in the media that they will continue to
pursue the issue.
Clayton Utz communications are intended to provide
commentary and general information. They should not be relied upon
as legal advice. Formal legal advice should be sought in particular
transactions or on matters of interest arising from this bulletin.
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Liability was apportioned between the VMO, Dr.Brown, and the hospital on an 80/20 basis in favour of the hospital.
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