Gene patents: an error in law, a community burden and a limitation on research
Professor Bernard Stewart, approaching the issue of gene patents as a cancer researcher and a lawyer, sees disadvantage for all if such patents are upheld.
Readers of incite were perhaps surprised that an
article sourced from the Institute of Public Affairs - Australia's
leading free market think tank - should advocate monopoly privilege
in the context of gene patents ('Genetic
innovation and the public interest' by Tim Wilson,
incite, issue 4). Advocacy on this matter must be based on
a clear understanding of both the legal and the scientific
issues.
The purpose of a patent system is to stimulate innovation by
granting limited monopoly rights to inventors. The
Patents Act 1990 (Cth) provides for granting of a
patent for 'an invention' which is a 'method of manufacture', is
'novel', involves an 'inventive step', and has not been 'secretly
used'; the grant is conditional upon 'complete disclosure'.
However, as also specified in the Act, granting of an
individual patent entails no guarantee of validity. Validity is
established by a court once a patent is challenged. From court
proceedings, definitive criteria are available ('common law') as a
basis for conjecture regarding what can and what can't be
patented.
In Australia, the validity of a patent for the BRCA1 gene
sequence is to be challenged, coinciding with a Senate inquiry into
the general issue of gene patents. Common law has long provided
that 'mere discoveries' are not patentable because of, amongst
other things, a desire to leave areas of research open to others in
the field. A discovery is not an invention.
Against this background, the patentability of gene sequences may
be considered. Suggestion of a legal distinction between 'a gene
isolated outside of its natural environment' (patentable) and 'a
gene that already exists in nature' (not patentable) is no help
because the distinction is meaningless assessed against current
technology. 'Outside the body' evokes distinction between in
vitro and in vivo sources, a distinction that is not
relevant to sequence data. Irrespective of source material, all
sequence data are gained consequent to cloning the gene in
question. That is, a gene that exists in nature is sequenced by
being isolated. Finally, disease (say, breast cancer) caused by
mutation in a given gene is not knowledge ancillary to the wildtype
sequence. Rather, disease-associated mutation is the means of
discovering the gene through chromosomal positioning and like
determinations.
The patent system
is not relevant to discovery of biological or similar processes.
Its misapplication in this context disadvantages the community and
researchers alike.
The ramifications of gene patents are the antithesis of those
applying to inventions. Generally, when a patent is ruled invalid,
there is financial benefit to marketplace competitors. If the BRCA1
sequence patent were struck down, no financial benefit would accrue
to any competitor. However, as distinct from any parallel that may
be drawn with patents generally, a financial benefit will accrue to
women, and their families, as those women will not be burdened with
a charge for relevant testing. More importantly, if gene sequence
patents are invalid, the limitations gene patents impose on
research cease. Such limitations are yet to be fully appreciated
and are not restricted to sequence data per se.
Development of low-molecular weight inhibitors or antibodies for
mediators of signal transduction would not be justified if the
relevant gene sequence was subject to patent.
Only a tiny fraction of the human genome is currently subject to
patent. There is a strong case that patents for particular gene
sequences should never have been granted. However, rather than the
financial burden, delay and possible uncertainty caused by multiple
court cases, amending legislation is appropriate to clarify the
matter. To assert that any such amendment must be predicated on
establishing that the present law has failed is to misunderstand
the situation.
Gene patents establish scenarios that are the antithesis of
those applying to inventions. There is no prospect of certain lines
of research being discontinued once gene patents are struck down.
There is no evidence that current genomic research is being
propelled by the prospect of sequence data being patented. Sequence
data will not be subject to trade secrets in the absence of gene
patents. There is no identifiable community benefit from those gene
patents that have been granted.
Inventors and the community gain benefits from the patent
system. But the patent system is not relevant to discovery of
biological or similar processes. Its misapplication in this context
disadvantages the community and researchers alike.
About the author: Professor Bernard Stewart
Professor Bernard Stewart is Head of the Cancer Control Program
at South Eastern Sydney Illawarra Public Health Unit and has a
professorial appointment in the School of Women's and Children's
Health, UNSW. His cancer research publications cover environmental
carcinogenesis, apoptosis and pre-clinical drug development. He is
a Fellow of the Royal Australian Chemical Institute.
Bernard has served on numerous NHMRC committees, one of which
drafted Australia's first legislation to prevent occupational
cancer. He has worked extensively with International Agency for
Research on Cancer and in 2003, co-edited the inaugural World
Cancer Report for WHO.
Bernard studied intellectual property in the context of gaining
basic legal qualifications. Following completion of a Graduate
Diploma of Legal Practice at NSW College of Law, he was admitted as
a lawyer in 2010.
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