The recent news that Angelina Jolie tested positive for the
BRCA1 mutation and has consequently undergone a prophylactic double
mastectomy to guard against developing breast cancer has increased
the intensity of the spotlight on the gene patent debate currently
playing out in both the United States Supreme Court in
Association for Molecular Pathology v. Myriad Genetics,
Inc, and in the Full Federal Court of Australia in Cancer
Voices Australia v Myriad Genetics Inc.
In April 2013, the US Supreme Court heard arguments in relation
to the patentability of isolated human genes, which are claimed in
patents held by Myriad Genetics, Inc. A decision by the Supreme
Court is expected in June 2013. Earlier this year, we reported on
the landmark decision of the Federal Court that confirmed the
patentability of isolated nucleotide sequences (genes) in
Australia. This decision is currently under appeal. For more
information, refer to the article at the following link.
The reporting of the gene patent debate in the popular press has
heavily centred on the provocative ethical quandary: should a
company be entitled to own a person's genes? However, a point
that seems lost on the proponents of gene patent reform is that
gene patents do not confer ownership of anyone's genes because
they are directed to isolated gene sequences not gene sequences
that exist in humans. This point was clearly made in the Myriad
Federal Court decision in Australia where the Court emphasized
that: "naturally occurring DNA and RNA as they exist in a cell
are not within the scope of any of the disputed claims and could
never, at least not until they had been isolated, result in the
infringement of any such claim". This statement clearly
counters the emotive comments put forward by those in favour of
gene patent reform who persistently argue that patentees should not
be entitled to own an individual's genes.
Much less attention has been given to a consideration of the
benefits of gene patents which allow for investment in innovation
that is required to bring a product to the public. Specifically,
Myriad invested 200 million dollars in raising doctor awareness
about hereditary breast and ovarian cancer in addition to the money
invested in developing the BRCA tests and characterizing a
patient's susceptibility to developing cancer. For taking these
risks and providing a test that will potentially save women's
lives, Angelina Jolie included, Myriad's pioneering work has
been attacked on the basis of flawed ethical arguments. Without
patent protection it is arguable as to whether the BRCA predictive
tests for hereditary breast and ovarian cancer would have been
commercialized and thus made available to the public.
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