THE IMPACT OF GENE PATENTS
This chapter addresses terms of reference (a)(i) to (iv), which direct the
Committee to consider the impact that the granting of patent monopolies over genes
and genetic materials has had, is having, and may have had on:
the provision and costs of healthcare;
- the provision of training and accreditation for healthcare
- the progress in medical research; and
- the health and wellbeing of the Australian people.
Patents granted over genes and
Classes and numbers of patents
relating to human genes
One of the difficulties in assessing the impact of gene patents
concerned the number and character of patents being granted in Australia relating
to genes and genetic materials. At filing all patent applications are
classified according to the technical matter which they concern using the
International Patent Classification (IPC) system.
IP Australia noted that there are a number of IPC marks which cover
biotechnology; however, IPC subclasses C12N and C12Q are relevant to gene
patents as they cover most inventions relating to genes and genetic
Of the two subclasses C12N is most likely to contain applications that claim a
human gene sequence per se, derivatives of the sequence such as probes and
primers, and their use in diagnostic or therapeutic methods. C12Q is more
likely to contain applications directed to processes and methods that use gene
sequences, rather than claiming the gene sequence per se. In particular IPC
subgroups C12N15/12 to C12N15/28 are 'a good but not absolute indicator of
patents that claim a human gene sequence'.
There was particular concern expressed during the inquiry that patents which
grant exclusive rights to genetic testing are negatively impacting on the areas
covered in the terms of reference. IP Australia noted that gene patent claims
generally fall into two categories: product claims (such as isolated gene
sequences per se) and method claims (such as the use of a gene sequence to
diagnose diseases or disorders associated with the gene).
Similarly, the United States Secretary’s Advisory Committee on Genetics,
Health, and Society (SACGHS) final report on gene patents and access to genetic
tests identified several categories of patent claims which can serve as the
basis for exclusive rights to a genetic test. These included patents claims on
isolated nucleic acid molecules as well as patent claims on 'processes for the
detection of particular nucleic acid sequences or mutations' and 'processes
involving simply associating a genotype with a phenotype' (for example
associating a particular genetic sequence with the predisposition to a
A patent claim on an isolated gene sequence can give the patent holder
exclusive rights to a genetic test because typical methods of testing the gene
in question require the production of the patented sequences. The patent
holder’s capacity to exclude others from using the sequence gives them
exclusive rights to testing. A similar situation occurs where there is a patent
on the process or method involving testing for a particular genetic sequence
and then associating that sequence with a disease or condition. The SACGHS
A significant distinction between composition of
matter/manufacture claims to isolated nucleic acid molecules and method claims
is that claims to molecules cover all uses of the molecule, including uses
outside of diagnostics, while a claim to a method of using a molecule would not
prohibit one from using that molecule for another method.
IP Australia estimated there are 202 patents claiming an isolated human
nucleic acid molecule which remain current, most of which have a priority date
before the completion of the Human Genome Project in 2003.
There is no discrete IPC mark for human gene sequences, so the data provided by
IP Australia was inclusive of animal genes. However, IP Australia commented
that in their experience the majority of patents on gene sequences relate to
human genes. The Department of Innovation, Industry, Science and Research and
IP Australia joint submission stated that 'the inability to separate
applications covering human DNA instead of animal DNA is not unique to IP
IP Australia also made the point that, since the first publication of
the Human Genome Project in 2001, the filing numbers for methods or processes (sometimes
referred to as 'downstream applications') have surged compared to filings for
patents for gene sequences per se. IP Australia argued that this situation is unsurprising
because, as knowledge of the human genome increases, patentability requirements
(for example, the requirements that an invention is 'novel' and involves an
inventive step) become more difficult to satisfy.
IP Australia submitted that the number of patents on gene sequences—and thus
any adverse impacts that may have flowed from these patents—is diminishing. Mrs
Fatima Beattie, Deputy Director General of IP Australia, stated:
Concerns about the breadth of patents granted to the first
inventor is common in any new area of technology. As the technology develops
the scope of patent rights afforded get narrower and narrower and it becomes
harder to satisfy the threshold patentability requirements of novelty and
inventive step. This is due to the cumulative growth of prior art and skill of
persons working in the technology area...IP Australia’s data shows the number of
patents claiming isolated human nucleic acid molecules steadily declining since
the publication of the Human Genome Project. We expect only a small probability
of additional such patents. 
However, Dr Luigi Palombi submitted that IP Australia's assessment of
the number and character of gene patents did not fully encompass the scope of
the inquiry's terms of reference. He provided an alternative analysis of the
number of gene patents in Australia:
...when I examined IP Australia’s database in February this
year I found that there were over 15,000 patents and patent applications that
concerned both human and microbial genes and non-coding sequences, proteins,
and their derivatives. This is not an insignificant number.
In discussing the number of gene patents, Dr Hazel Moir focused on IPC
class C12N15, noting it was not the only class in which gene and related
patents may be found, but was the largest. Her submission outlined that there
had been 42,326 patent applications in subclass C12N15, with 14,306 patents
granted and a cumulative total of 8,352 patents being current as at 12 February
IP Australia noted that Dr Moir's assessment examined the whole C12N
subclass which includes biotechnological inventions that:
...although related to genetic engineering technology, are
unlikely to include claims to isolated gene sequences per se or diagnostic
methods based on the use of isolated gene sequences.
IP Australia argued that a more accurate way of estimating the number of
gene patents likely to claim an isolated sequence per se is by analysing the
CN15/12 subgroup. Patents claiming methods of using an isolated gene sequence
per se are likely to be given a class mark of C12Q 1/68.
The table of data Dr Moir provided was broadly consistent with the
argument by IP Australia that patent applications relating to gene sequences
peaked around the time the Human Genome Project was published and completed.
However, Dr Moir also noted that reasons for the fall in applications 'could include
a genuine fall in the volume of 'inventions' being produced, or applicants [may]
now be trying to avoid this class'.
Difficulties assessing the impact
of gene patents
Considerable time was devoted during the inquiry to discussing the
actual and potential impacts of granting patents on genes and genetic material.
While arguments were made for both the positive and negative impact of patents
over genes and genetic material, others argued that there is insufficient
evidence or research available to determine the issue. The lack of evidence
regarding the impact of gene patents was also a feature of the Australian Law Reform
Commission's (ALRC) inquiry in 2004. The ALRC noted that concerns about the
impact of gene patents 'were anecdotal or hypothetical, and evidence of
problems in practice—outside that small number of well-known examples—was more
difficult to verify'.
The Intellectual Property Research Institute of Australia (IPRIA) argued
...[there is] as yet no empirical work available that carefully
examines the relationship between gene patenting and the costs of providing
healthcare, the training and accreditation of healthcare professionals, and
progress in medical research.
Dr Kwanghui Lim, Associate Director of IPRIA, stated:
We are not saying that the policy should not be changed; what
we are saying is that, if you are going to base your arguments on fact and
prior work, there is not enough of it. It is too new a technology...There are a
lot of logical arguments that have been put in place, and they are valid ones,
but there is not enough actual data...
Dr Moir also considered that there is a lack of systematic evidence relating
to the impact of gene patents. She suggested that there are empirical
difficulties in assessing the impact of gene patents, including identifying all
the relevant patent monopolies granted; assessing each patent and the benefit
of innovation provided by the grant; and identifying whether there are competing
products available which provide effectively the same result.
Dr Moir also argued that the issue of gene patents is essentially one of
competition policy, as patent protection is a regulatory intervention into the
Dr Moir observed that the Competition Principles Agreement between the
Commonwealth, states and territories requires justification for any
interference in a market with the effect of reducing competition. However:
No such data...has been put
in front of this committee in regard to patenting genes. There has been a claim
that there is no evidence of any harm, but that is a completely different thing
from demonstrating that there is any good.
Improving the collection of data on
the patent system and its impacts
Dr Moir argued that 'the lack of information on the ways in which
granted monopolies are used in Australia is a major problem for the development
of sound policy'. She suggested that 'the government might now consider heeding
the advice of the Industrial Property Advisory Committee in 1984 relating to
the regular collection of information on how the monopolies it grants are used'.
This recommendation stated:
...that the Patent Office introduce procedures to collect more
data from applicants and patentees, particularly concerning the use of patents,
in a form which facilitates analysis for statistical and general policy
assessment purposes, the information so collected being treated as received and
held in confidence and subject to privilege.
Professor Peter Drahos noted that, while information about patents is
publicly available, it is not available in useful ways. He has suggested that
patent offices need to proactively promote the transparency and diffusion of
patented invention information, and should 'track and publish the patent
portfolios of patent owners, especially those with large patent holdings.'
Professor Drahos suggested that one way to deal with the complexity and
uncertainty generated by 'gaming behaviour' within the patent system would be
for regulatory agencies to establish 'patent transparency registers in areas of
technology where there were serious risk management issues'. Registers could
target specific areas, and companies would be required to use the registers to
make a full disclosure of the patents and patent applications surrounding the
targeted technology, if they wished to enforce their patent right. Registers
could also include disclosure of information relating to ownership and
licensing of patents, which is difficult to track. Other users of the patent
systems would be able to rely on the information in the register to make
informed decisions as to use of technology, innovation and research.
Senator the Hon. Bill Heffernan's submission to the inquiry also
recommended the establishment of a patent transparency register that would
track and publish patent portfolios and:
...develop databases in co-operation with user groups or other
interested government agencies so that the degree of concentration of ownership
of crucial technologies associated with that portfolio, and information about
the licensing and assignment of those technologies are easily and publicly
Provision and costs of healthcare
During the inquiry there was general agreement that patients, health professionals,
researchers and governments are increasingly reliant on medical knowledge
concerning the human genome to make decisions about healthcare, and that this
reliance is likely to increase in the future. The main issues raised in
relation to gene patents and the provision and costs of healthcare were:
restrictive patent licensing and access to genetic testing
innovation and healthcare;
- the importance of genetic counselling services; and
- the future of genetic testing.
Genetic testing services
As with the Australian Law Reform Commission's 2004 inquiry, the
evidence received by the Committee concerning the impact of gene patents on
healthcare focussed predominantly on genetic testing. However, it should be
remembered that patents on genes and genetic material may also impact on the
provision and costs of other types of healthcare, including gene therapy and
the use of stem cells.
Genetic tests are commonly used in a number of ways in healthcare. These
- preventative testing or screening of a patient for genetic
variations that may increase the likelihood they will develop a disorder or
- diagnostic testing performed to identify the cause of a patient's
- testing to target specific treatment to a patient.
While the Medicare Benefits Scheme funds a limited number of genetic
tests, state and territory governments fund and provide the bulk of genetic
testing and related clinical services in Australia. Many genetic tests are
arranged by clinical genetic services and carried out in public laboratories
attached to public hospitals. The Commonwealth Government contributes to the
funding of these genetic tests and services indirectly through the National
Healthcare Agreements. The Department of Health and Ageing also noted that the Pharmaceutical
Benefits Scheme funds pharmaceuticals, vaccines and other treatments developed
from genes, proteins and other related biological materials, 'assessed to be
both effective and value for money.'
The results of the Australian Genetic Testing Survey 2006 were
highlighted by a number of submissions. The survey found that 437 different
genetic tests were available across Australia in 2006. Of these, more than half
(55 per cent) were offered by only one laboratory and only five per cent of
genetic tests were provided by more than five laboratories. A total of 41,497
molecular genetic tests were rebated by Medicare in 2006. Genetic tests were
only a small part of the approximately 60 million pathology tests funded by
Medicare that year. A further 119,354
molecular genetic tests were provided by laboratories using non-Medicare
funding, presumably through state governments and privately-paying patients.
The Peter MacCallum Cancer Centre (PMCC) noted comments by the President
of the Royal College of Pathologists of Australasia (RCPA), Dr Bev Rowbotham,
describing genetic testing in Australia as 'uncoordinated, inequitable and
inefficient', predominantly due to the current funding mechanism. Dr Rowbotham commented
that most genetic services see their role as the 'rationer' of access to genetic
testing, mainly because of the expense of the tests and funding limitations.
Cancer Council Australia (CCA) highlighted the potential cost burden of
genetic testing on patients. They noted that state health departments and family
cancer centres provide limited funds for genetic testing from their budget
allocations for non-Medicare items. Where this funding is not available, patients
may be required to pay for their own tests.
The Committee heard that the costs for testing can vary considerably
depending on the type of test—from just over $100 to more than $2500 per test. Specialised
genetic testing is a characteristically complex process with low throughput,
and can take up to six months or longer. In some cases, samples are sent
overseas for analysis at additional cost.
CCA noted that, under the current arrangements, there is no adequate
legal protection to ensure that genetic testing for cancer risk remains freely
accessible at reasonable cost to the health system and consumers.
Many submitters and witnesses were concerned that the burden of increased costs
due to gene patents will be borne by patients, making access to genetic testing
A number of other groups commented on affordability and accessibility. The
NSW Government noted that the number of patients requiring or benefiting from
genetic testing is rising, and observed that 'there is a significant concern
that access to clinically appropriate testing may be reduced if prices exceed
the currently available budgets'.
The Medical Technology Association of Australia argued that access to
genetic testing in Australia 'may be impeded where there is no payment for the
test through Medicare' and highlighted that only a small number of tests are
covered by the Medicare Benefits Schedule.
However, Mrs Fatima Beattie, Deputy Director-General of IP Australia,
suggested the issue was more '[an issue of] the health funding arrangements for
those sorts of tests rather than an issue of the gene patent'. She stated:
...the price of the BRCA test, in particular, provided by the
exclusive Australian licensee, is on par with the cost of the test performed by
the publicly funded clinics. The only difference is about who pays that price,
whether it is the Australian government, through the health budget, or whether
it is the actual patient.
Patent licensing and access to genetic
The relationship between gene patents and the costs and provision of healthcare
was disputed during the inquiry. There were concerns expressed that patent
licensing over genetic testing could lead to restrictions on the number of
laboratories conducting genetic tests. This could potentially restrict access
to testing, delay results, influence the quality of test results and cause
costs to rise for patients and the community. For example Dr Palombi commented:
A patent monopoly over an isolated gene and its genetic
information means that anyone that does anything that comes within the scope of
that patent monopoly has infringed the patent and is liable to the patentee for
damages or an account of profits and can be enjoined from continuing to
infringe by the grant of an injunction.
That kind of power, which a patentee possesses exclusively,
is significant legally, economically and ethically. Legally because it provides
the patentee with the right to sue with respect to the unauthorised use for
damages, an account of profits and to seek an injunction. Economically because
it enables the patentee to control access, use and price, in the exercise of
their legal rights as a monopolist. Ethically because how the patentee
exercises those rights can impact upon how society functions.
The RCPA argued that the impact on the provision and costs of healthcare
of a gene patent largely depends on the licensing approach taken by the patent
owner. A number of models of licensing access were identified, including:
- the open access model, where no fee is charged by the patent
owner for testing the relevant gene but royalties can be earned through producing
and selling commercial test kits;
- the restricted access model, where the patent holder offers one
of two options. The first option is that laboratories are licensed to perform
their own in-house tests. This license consists of an up-front fee and ongoing
royalties for each test performed. The second option is that laboratories must
use a kit supplied (and method specified) by the patent holder (or sole
licensee). This allows the patent holder to limit the number of tests that can
be performed with each kit, and means the cost of the commercial kit may be significantly
greater than an in-house test developed by the laboratory; and
- the closed access model, where the patent holder does not offer licensing
and mandates that all testing be completed at a nominated laboratory.
The RCPA discussed the differences between these approaches and noted
examples where the use of a restricted or closed model by a patent holder had
influenced the provision and cost of genetic testing. In particular, where a
laboratory is allowed to develop or refine its own in-house test, it is able,
if required, to better meet the requirements of the local population, as
variations in the frequency of genetic errors mean that a genetic test may not
be accurate for all ethnic groups.
An example of the restricted model was IgH and TCR gene rearrangement
tests performed on cancer tissue from patients with lymphoproliferative
disorders or acute myeloid leukaemia. The United States based patent-holder,
InVivoScribe Technologies, approached all Australian laboratories currently
performing such tests and insisted they switch to the exclusive use of the
company's kit and method or obtain a sub-license to use their own tests. The RCPA
noted that the cost of the in-house test for laboratories was $28 per patient
(excluding labour and other costs) while the cost of the provided kit was $292
per patient (excluding labour).
The South Australian Government also outlined an example where a restricted
approach by a patent holder has had an impact on health provision. In 2005, a
company which claimed to be the exclusive licensee for genetic tests for
cytochrome P450 mutations wrote to the Institute of Medical and Veterinary
Science (now SA Pathology) and advised they would be exercising their exclusive
right on the licence. The company sought a one-off fee of £20,000 and five per cent of
any fees for tests performed. These additional costs were described as
'untenable' and the Institute ceased performing the test. The South Australian
government noted that similar situations had occurred for other tests.
The RCPA described Genetic Technologies's actions in seeking to enforce
its licence rights against public laboratories in Australia performing BRCA1
and BRCA2 genetic tests as an example of the closed model of gene patent
licensing. They considered this situation highlighted a number of problems with
the closed approach to licensing. These included that having only a single
provider of a genetic testing:
- limits opportunities for laboratory quality assurance;
- gives absolute control over the price of the test;
- allows the patent holder to develop an exclusive and private database
of the genetic variation for that gene in the population; and
- exposes the delivery of health services to the risk of instability.
The RCPA also noted that there is a risk that patent monopolies on
genetic testing may result in inappropriate standards of care, where they have
the effect of blocking access to appropriate testing or promoting use of
certain tests inappropriately.
Other witnesses and submissions argued that gene patents negatively
impact on equitable access to healthcare. For example, Dr Jennifer Leary argued
that patents inevitably lead to a 'demand for profit', and licensing fees or
lack of competition in the market will lead to increased testing costs. She
also noted that a monopoly on service provision leading to increased costs means
that those who cannot pay privately may not have access to genetic testing.
The Human Genetics Society of Australasia also stated that 'monopoly testing
removes competition, which may result in excessive pricing and restricted
access, particularly within the public health system which provides the
majority of genetic testing'.
The Society argued that such monopolies would create healthcare
inequities between those who rely on public services and those who can afford to
pay for tests privately.
The Victorian, South Australian and New South Wales governments used the
example of genetic testing for BRCA1 and BRCA2 to illustrate the negative
impact a closed approach to licensing could have on healthcare, funding and
access to genetic testing. The Victorian Government estimated that redirecting
predictive gene testing for breast cancer to an exclusive provider would cost
an additional $0.5 million per annum initially, an increase of 50 per cent on
current funding for testing. Increased costs would require governments to either
allocate additional funding to maintain service levels or reduce the number of funded
tests, resulting in increased waiting times for public patients and reduced
service equity as those able to pay would gain preferential access to private
services. They noted that these cost implications would increase if this
scenario were to occur across multiple genes and testing patents.
Similarly the South Australian Government stated that, if Genetic Technologies
had been successful in imposing a monopoly on testing for the BRCA genes, the cost
of testing would have risen significantly, 'meaning additional cost to
individuals, families and the South Australian Government'.
The New South Wales Government stated there is evidence the patent rights are
'adversely affecting medical care' and that healthcare providers feel that gene
patents will decrease the integrity of gene tests and increase the cost of
conducting genetic analyses. They noted 'there is a significant concern that
access to clinically appropriate testing may be reduced if prices exceed the
currently available budgets'.
Some witnesses and submitters were concerned that patenting genes and
genetic material could lead to commercial monopolies for gene testing
associated with cancer and therefore increased costs for patients. The key
concerns of the Cancer Council Australia related to the potential for
monopolisation of genetic material through gene patents to reduce public access
to predictive, diagnostic and therapeutic genetic technology in cancer control,
and to increase their cost to both government and the community.
This view was shared by Breast Cancer Network Australia:
In particular we are concerned that a private company holding
a gene patent could limit access to genetic testing for women by insisting that
tests are only conducted through specified laboratories, or that the cost of
the test could be increased in order to increase the profitability of the
testing process for the company.
PMCC argued that restricted and closed approaches to licensing genetic tests
could reduce the ability of public laboratories to offer genetic testing for
other genes. PMCC stated that 'common gene tests provide a critical mass for
laboratories, allowing them to undertake occasional testing for rarer mutations'
that are not commercially attractive to large companies. These rarer mutations could
become 'orphan diseases' with no genetic test available. PMCC also argued that
losing 'core screening work' could result in some public laboratories closing,
and that this would adversely affect clinical activity. PMCC noted that genetic
tests are often not clear cut and require close consultation between the clinicians
who manage the patients and the molecular pathology team performing the tests
and interpreting results.
This type of close consultation could be inhibited where a restricted or closed
approach to patent licensing is adopted.
There were also concerns raised about the misallocation of healthcare
resources. Some feared that if genetic testing is not accessible, affordable
and targeted to patients with high clinical need (because of the impact of gene
patents) then healthcare costs will increase as a result of illnesses which may
have been preventable.
For example, Dr Jennifer Leary considered that the health budget could be
burdened 'through the development of disease that may have remained undetected
without access to testing or through undergoing unnecessary surveillance and
Similarly, Associate Professor Judy Kirk advised:
If genetic testing is not available to all appropriate
families, it is likely that preventable cancers will occur in (unidentified)
high risk individuals, leading to increased costs that could be avoided. In
addition, if genetic testing is not available to all appropriate families, it
is likely that (unidentified) low risk individuals will have inappropriately
high levels of cancer surveillance, also increasing costs to the system.
Ms Heather Drum, a member of Breast Cancer Network Australia, also
highlighted the cost benefits for patients, the community and government of
genetic testing which may facilitate preventative healthcare measures. She
Bypassing a diagnosis of cancer means bypassing the expensive
costs of treatments such as chemotherapy and radiotherapy. My chemotherapy was
somewhere in the vicinity of $2,000-plus per cycle, then include doctors
appointments, hospital admissions, pathology tests, further drugs test treating
side-effects and the time out of work. I spent nearly 18 months in treatment,
working only sporadically—all unplanned.
However, many other submissions rejected concerns about the impact of
gene patents on access to genetic testing services. The Department of Health
and Ageing (the Department) noted that the 2004 ALRC inquiry found little
evidence that gene patents and licensing practices with respect to genetic
testing have had any significant impact on the cost and provision of healthcare
in Australia. The Department also highlighted that, since that report, neither the
Australian Health Ministers’ Advisory Group on Human Gene Patents and Genetic
Testing nor the National Health and Medical Research Council’s (NHMRC) Human
Genetics Advisory Committee had been advised of any systemic concerns about the
impact of gene patents on the cost of healthcare.
IP Australia also noted the lack of empirical evidence identifying
adverse impacts caused by gene patents. In particular, it observed that 'there
has been no evidence that patents have resulted in any person being denied
access to molecular genetic testing'. IP Australia suggested concerns about
gene patents generally 'related to anecdotal evidence and what hypothetically
could happen in future in terms of patentee licensing behaviour, costs and
availability of genetic tests'.
In response to particular concerns about the monopolisation of genetic
testing by patent holders, IP Australia observed:
On the issue of 'monopolisation' or single provider of tests,
we note that over 55 [per cent] of the 437 genetic tests performed in 2006/07
in Australia were offered by one laboratory. Our understanding is that the
provision of a single provider for these tests did not seem to be subject to a
patent in Australia...This statistic indicates that many market forces other than
patents and exclusive licensing arrangement determine whether tests are
provided by one laboratory and the prices charged for the tests. These factors
include demand and market size.
Genetic Technologies defended its role in providing BRCA genetic testing
services, describing the company as a 'positive contributor to improving the
health and well being of the Australian people'.
Genetic Technologies argued that, prior to its entry into the market, BRCA
testing was 'performed [using] all manner of different test protocols among the
state laboratories and many of these were slow and suboptimal in their
specificity and accuracy'. Genetic Technologies stated that it had improved the
accuracy, timeliness and efficiencies of the test process, and provided a
benchmark against which many of the public laboratory services can be measured.
Further, Genetic Technologies noted that it had never been requested to
participate in an open and transparent tender for the provision of genetic
testing services. According to the Genetic Technologies submission:
...we contend that our service has met a previously unfulfilled
demand in the Australian health care sector. We do not force any customer to
use our service and we charge a publicly published price. [Genetic
Technologies] contends that it operates the most cost effective BRCA testing
laboratory in the country and would welcome any subjective review of
efficiencies and costs-charges incurred for such testing across all
Genetic Technologies also highlighted the United States SACGHS public
consultation draft report on Gene patents and licensing practices and their
impact on patient access to genetic tests. They noted that the draft report
findings, which discussed gene patents and genetic testing in the context of
the United States healthcare system, indicated that patents covering genetic
tests and related licensing practices do not appear to be impeding patient or
clinical access to tests.
The SACGHS draft report found that the evidence from the case studies examined
during the inquiry:
...did not reveal widespread overpricing for genetic diagnostic
tests that were patented and exclusively licensed relative to tests that were
either unpatented or non-exclusively licensed.
The draft report concluded:
Based on its review of the literature, case studies, and
review of international policies regarding gene patents, SACGHS found little in
the way of broad or consistent evidence that indicates either positive or
negative effects of gene patents on patient access to diagnostic tests.
The SACGHS draft report also stated that instances in which patient
access to genetic tests may have been impeded were often caused not by the
patent itself but by the way it was licensed or used.
However, the SACGHS final report, released in April 2010, noted that, where
patents and licensing practices have created a sole provider of a genetic test,
patient access to testing had suffered in cases where:
the sole provider did not accept the patient's health insurance
and the patient could not otherwise afford the test;
patients wished to have a second-opinion from an independent
patent enforcement disputes delay or prevent testings.
The Johnson & Johnson Family of Companies (JJFC) noted that, while
many thousands of gene patents have been granted in Australia, only a small few
have raised concerns about the ability of public institutions to provide
testing. Furthermore, where there have been concerns, such as with the BRCA2
test, the parties 'have reached an amicable resolution that has not hindered
the effective screening of the gene'. JJFC argued:
...costs pressures can be more effectively regulated by the
market than by legislation governing the inventions themselves. Once again the
BRCA-2 case can be used as an example. The pricing for tests utilising the
BRCA-2 patent are varied in different countries, reflecting each environment's
individual market dynamics. Additionally, the recent announcement in Australia
that the tests could be conducted in public hospitals was brought about by
general market forces.
The Institute of Patent and Trade Mark Attorneys of Australia suggested that
some of the opposition to patents on genes and genetic materials was due to a
philosophical objection to gene patents. They also stated that:
Other groups opposed to gene patenting may be self serving in
that they wish to provide commercial services in the area of gene testing and
healthcare without having to pay royalties or legitimate fees to patent owners
The Committee received evidence from Professor Dianne Nicol and
Dr Jane Nielsen regarding their research in 2002-03 involving surveys
and interviews with Australian researchers, biomedical companies and genetic
testing laboratories. The research found that, while there was a great deal of
concern about gene and related patents, there was little evidence that such
patents were actively being enforced against genetic testing laboratories in
Australia at that time.
Innovation and healthcare
Submitters and witnesses also discussed the impact of gene patents on
the provision and costs of healthcare more broadly, with many focusing on the
extent to which gene patents promote or discourage research and innovation in
IP Australia commented that the access and cost issues related to
gene patents are not limited to the prices incurred by individual patients. For
example, it argued that the patent system promotes innovation in healthcare
and, without this strong incentive to companies and researchers, 'there may be
no or much slower access to newer and better tests'.
IP Australia also noted that innovations in human genetic research had
benefited society through the availability of new and better healthcare products
and services, such as the Gardasil vaccine against cervical cancer.
This line of reasoning was supported by a number of other submissions,
which emphasised the positive impacts of gene patents on the costs and
provision of healthcare. The Institute of Patent and Trade Mark Attorneys of
Australia, for example, stated that significant innovation in biotechnology had
resulted 'in numerous new treatments, prevention, diagnostics and health
The Victorian Government acknowledged that, while genetic tests are a cost
pressure for governments, 'gene technologies may ultimately reduce healthcare
costs through earlier and more accurate diagnoses and the ability to determine
the suitability of individuals to therapeutic interventions'.
Similarly, the Law Council of Australia suggested:
While patent protection can be expected to result in
increased cost to the consumer during the period of exclusivity, this perceived
disadvantage is to be compared with the alternative option, which, in practice,
may be that the product is not available to the consumer at all.
However, others argued the impact of gene patents was likely to be
negative on healthcare innovation. This was particularly the case because 'once
the gene sequence for a particular disease related gene has been identified and
isolated, the development of a diagnostic test is not particularly onerous'.
Senator the Hon. Bill Heffernan's submission to the inquiry outlined the
adverse impacts of four patents on the cost and access to healthcare in
Australia and overseas. In relation to the polypeptides of erythropoietin
patent he stated the 'most immediate and significant impact of this patent
monopoly was on the cost of provision of healthcare in Australia'. The patent
had other impacts including that 'Australian scientists and researchers were
directly inhibited for research purposes'.
CCA commented that the monopolisation of genetic testing eliminates competition
and carries the risk of sole providers having no incentive to find more efficient
and affordable ways to undertake tests and make other use of the genetic
information they control.
The RCPA stated that patent holders can block further development of a
genetic test, either by restricting analysis to one laboratory or by requiring
laboratories to use a commercial kit. The RCPA described a situation where
patent rights over a genetic test effectively blocked the delivery of
supplementary testing which would have increased the accuracy and usefulness of
the test for patients. While the supplementary method had been described by
research scientists, other laboratories could not offer the test because they
were not licensed to analyse the relevant genes.
PMCC recognised that patents have played an important role in protecting
and facilitating 'the transfer of novel intellectual property for the benefit
of the community at large and the creators of that property', but considered
genes to be a special case which should not be subject to patents. They argued
that permitting gene patenting meant that there is no incentive for the gene
patent holder to continue to improve their commercially available genetic test and
particularly not to reduce the cost or improve the efficiency of the test. They
highlighted variable pricing of the BRCA1 and BRCA2 genetic tests in different
countries and noted that the cost of this test has not reduced appreciably in
the United States despite the continuing reduction in the cost of genetic
sequencing over time.
Genetic counselling and family cancer
There was considerable support expressed for the current approach to
genetic testing in the public sector where 'patients receive their results and
advice through a structured and considered clinical service with a holistic
view to their healthcare'.
In particular there was support for family cancer centres, especially from
patient groups associated with this disease.
In general, family (or familial) cancer centres provide genetic testing,
medical advice, genetic counselling and psychological support to patients and
their families who have health issues associated with cancer. Some feared that
this comprehensive and supportive approach to genetic testing for cancer and
other conditions could be at risk if patents restrict genetic testing to a
limited number of laboratories.
The NSW Government noted that the impact of genetic test results on
patients can be challenging and complex. Test results can indicate risk but do not
indicate if and when symptoms will develop. Certain results can impact on a
person’s ability to obtain life insurance or employment and can have
implications for health decisions. The NSW Government argued that it was therefore
'vital that supportive clinical processes, including provision of information
and counselling, are provided to assist individuals with informed
The Victorian Government also commented on the benefits of an integrated
approach to genetic testing:
For human genetics services, there are risks in separating
diagnostic testing from expert interpretation, counselling and support. All of
these functions are critical in ensuring that individuals are accurately and
fully informed of the implications of their test results.
Genetic counselling was also seen as important because of the wide
implications of genetic testing for family members.
Associate Professor Judy Kirk commented on some of the challenges facing those
undertaking genetic testing:
...before a family goes ahead with testing, they need to understand
what the implications would be for the men and the women of the family. They
need to understand the health implications, what it might mean for their
children and what it might mean in terms of accessing insurance. They need to
think about what sort of screening and prevention measures we would have in the
event of a positive genetic test which shows a high risk and how they would
communicate that to the rest of the family, and notify at-risk family members.
The importance of genetic counselling was highlighted by witnesses from
Breast Cancer Network Australia (BCNA), who described their experiences of
obtaining genetic test results and the impact it had on their subsequent
healthcare decisions. These decisions could include preventative surgery such
as prophylactic mastectomies intended to reduce the risk of cancer.
The BCNA representatives noted that, without adequate communication,
information and support, the results of a genetic test can be highly
distressing and confronting for patients. They were concerned that, if gene
patent rights were used restrictively, the genetic counselling component of
current genetic testing processes could be lost and replaced by a commercially
cheaper approach, where, for example, relevant samples are sent to external laboratories
for testing and test results are then sent directly to the patient.
Similarly, the Country Women's Association of NSW was concerned that
gene patent monopolies may threaten the ability of healthcare authorities in
Australia to deliver high-quality genetic testing services. In particular, the
Association was concerned that:
...one-on-one friendly counselling would be lost if public
hospitals lost their right to do testing on a privately patented gene and the
entire nation’s testing done through one commercial centre'.
Misgivings about the potential for gene patents to alter the current
public sector approach to genetic testing were also expressed by the Human
Genetics Society of Australasia (HGSA). Under the current model, access to
testing in the public sector is targeted to individuals assessed as being at
high risk. Testing is conducted through specialist genetics and associated
medical services in conjunction with appropriate genetic counselling. The HGSA noted
that this approach limits unnecessary testing and ensures patient consent to
testing is well informed and valid. The HGSA was concerned that:
Exclusive intellectual property rights may encourage
commercialisation and direct marketing [of genetic tests] to the wider,
generally low risk, community, and thus may exploit anxiety, have questionable
clinical utility and be costly to individuals.
Genetic tests with health implications should not be
available in direct to consumer form but through request by a qualified health
care professional in an appropriate clinical setting, in order to provide the
person with the relevant information and counselling so that consent to testing
is well informed and valid. This is especially the case with patented tests,
where lay individuals may have unrealistic expectations of the potential of
such tests. Patenting does not guarantee efficacy or clinical utility in all
Dr Jennifer Leary also warned that patent monopolies 'have the potential
to result in an increase in 'direct to market' advertising of genetic tests'.
Dr Leary stated:
The U.S and Canadian experience of 'direct to market'
advertising has resulted in the exploitation of breast cancer anxiety and
increased private testing of those for whom the clinical utility of the test is
questionable. Market driven access to testing also has the potential to reduce
the spectrum of tests available.
The future of genetic testing and
While the Committee's terms of reference were directed at the impact
that the granting of gene patents 'has had, is having and may have had', many
submissions and witnesses were more concerned about future impacts,
particularly on the cost and provision of healthcare. There was a general
consensus that the trend in genetic testing and treatment would move toward
testing multiple genes or whole patient genomes as testing techniques improve
and the cost of testing decreases. The results of these tests would then be
used to personalise treatment for each patient and effectively target
Professor Ron Trent argued that the focus should be on genomics rather
than genetics, noting the possibility that in five to ten years whole genome
sequence tests may be completed for $1000. He highlighted that tests involving
multiple genes were more likely to encounter problems with gene patents. Professor
We are now in the genomics era...We have had a discussion today
about single genes, yet we know that there are tests that will test 20, 30 or
40 genes at once. Goodness knows what sorts of patent issues are involved in 30
or 40 genes in one test.
The United States Secretary's Advisory Committee on Genetics, Health and
Society final report on gene patents also dealt with this issue. It noted that
developing whole-genome sequencing will likely depend on acquiring multiple
rights. Negotiating licences to all the relevant patents could be expensive and
the cumulative cost of these licenses could make these products unmarketable.
These concerns are more than hypothetical. Patents are
already hindering the development of multiplex tests [which test multiple
genes]. Laboratories utilizing multiplex tests are already choosing not to
report medically significant results that pertain to patented genes for fear of
Training and accreditation for healthcare professionals
While the use of genetic testing was described as increasingly common in
a broad range of healthcare areas, the health professionals most closely
involved in genetic testing and services were identified as being:
- clinical geneticists (specialist medical practitioners);
- genetic pathologists;
- geneticists (specialist medical laboratory scientists); and
- genetic counsellors.
The Department of Health and Ageing noted that the training and
accreditation of healthcare professions is a responsibility shared between the university
sector and a range of professional bodies, such as the Australian Medical
Council, specialist medical colleges, nursing registration boards, and the
Australian Psychology Accreditation Council. Specialist medical education is
delivered by specialist colleges, faculties and chapters. A National
Registration and Accreditation Scheme for a number of professions including medical
practitioners, nurses and psychologists commenced on 1 July 2010. The Division
of Paediatrics and Child Health in the Royal Australasian College of Physicians
and the Royal College of Pathologists of Australasia are particularly involved
in genetic testing and services.
The Medical Technology Association of Australia highlighted that tests
not covered by Medicare—which represent the majority of genetic tests
conducted—have not been subject to significant regulatory oversight in
Australia, and laboratories performing these tests have not necessarily been
accredited by the National Association of Testing Authorities. However, it
noted that this lack of certainty about genetic testing quality will change
with the arrival of regulatory oversight of genetic testing through the in vitro
diagnostic regulatory framework to be administered by the Therapeutic Goods
The Department of Health and Ageing commented that the new framework would
'ensure the quality of all therapeutic devices, including in vitro diagnostic
kits used for genetic testing, and reduce the risk of test kits producing
The new framework commenced on 1 July 2010. The Department's submission stated:
The framework is being introduced to address concerns that
many of these technologies are available on the Australian market with no
regulatory oversight and no certainty that they perform as intended. Of key
concern is genetic self-testing whereby people may order tests via the internet
or direct from a provider, without essential information, counselling and
support needed to deal with the results.
Several submitters to the inquiry did not consider that the granting of
patents for genetic materials could have an adverse impact on the provision of
training and accreditation of healthcare professionals.
The Walter and Eliza Hall Institute of Medical Research (WEHI) noted there was
a current shortage of molecular pathologists in Australia. However they
considered this was due to a lack of funding and career attraction, and the rapid
growth in molecular diagnostics, rather than gene patents. The WEHI did not
believe that expressly prohibiting gene patents would have a positive impact on
Australia's skill base, and pointed out that the most skilled countries in this
area are those that allow the patenting of human genes.
Others considered that, if gene patents caused genetic testing to be
limited to private laboratories, or led to samples being sent overseas for
testing, this could negatively impact the training and accreditation of
healthcare professionals in Australia. For example, the Human Genetics Society
of Australasia stated:
Enforcement of patents may take testing off-shore or to a
sole licenser resulting in the loss or lack of development of local expertise
and opportunities for training...
Monopoly rights may create disenfranchisement of other
laboratories, usually public hospital/research laboratories, through loss of
expertise and trained staff, which may further negatively impact on skill and
scientific developments transferable across the range of laboratory tests.
The Victorian Government stated that the current genetics workforce is
predicted to be insufficient to meet future demand. It was concerned that a
concentration of genetic testing in private laboratories could reduce the
opportunities for student training and professional accreditation. It also
noted that higher licensing costs on public laboratories could translate into
fewer enrolments and increased course fees for genetics courses.
CCA also noted the importance of academic institutions maintaining internationally
competitive standards, 'particularly at a time of medical workforce pressure
and when the scope of genetic medicine is on the threshold of significantly widening'.
A number of submissions commented on the potential risks for training
and accreditation in the event that restrictive licensing approaches by patent
owners cause public laboratories to reduce the number and variety of genetic
testing services offered. The National Coalition of Public Pathology argued
that patenting a process that provides exclusive access to a gene will hinder 'the
transfer of knowledge and expertise among health professionals in new areas of
knowledge and professional development'.
Similarly, the RCPA argued:
By restricting testing to one laboratory, the training of the
next generation of pathologists and laboratory scientists in the area covered
by the patent will be impaired. Further it will limit the number of
knowledgeable and trained individuals who can assist in the diagnosis and management
of at-risk patients.
The importance of laboratories sharing testing results and expertise to
improve professional development was emphasised in several submissions.
Associate Professor Judy Kirk described data exchange amongst professional
peers, benchmarking and continuous improvement as 'fundamental to the optimal
training and accreditation of healthcare professionals'.
Dr Jennifer Leary observed:
Training and subsequent accreditation of scientists in the
molecular genetic discipline depends on access to the experience of others,
availability of DNA and clinical resources to expand knowledge and the sharing
of scientific information. The granting of patents will have a negative impact
on the ability to train molecular genetic scientists and clinical trainees
specialising in molecular pathology...
...[if] DNA resources for testing become concentrated in
laboratories with the monopoly rights to test, scientific skills will degrade
through a lack of opportunity to undertake such training across the broad range
of tests required.
The RCPA noted that long complex genetic testing, such as for the BRCA1
and BRCA2 genes, allows professionals performing this work to gain skills that
are applicable in other areas of genetic testing. The RCPA submitted that, if such
testing were done in a single laboratory 'the loss of volume, complexity and
training opportunities would significantly compromise the operation and
sustainability of the public sector laboratories'.
Further, the RCPA felt that testing in multiple laboratories assists the
assessment of diagnostic tests by benchmarking performance against peers and
having independent assessment of external quality assurance.
Progress in medical research
As outlined in Chapter 2, the main policy rationale for the patent
system is to provide incentives for individuals and organisations to invest in
research, development and innovation.
In order to receive protection, patent applicants must publicly release details
of their inventions, allowing other researchers to utilise and build on the
knowledge which has been disclosed. However, patents can also act as a brake on
innovation where patent monopoly rights are used to impede the research of later
During the inquiry the Committee heard arguments highlighting these conflicting
perspectives on the impacts of gene patents on medical research.
Incentives for medical research
Patent system driving innovation
A number of submissions noted that Australia's intellectual property system
has supported innovation and research in medicine, and claimed that patents act
as an incentive for investment, development and innovation in medical research.
This was seen as being true in the particular case of patents relating to genes
and genetic material.
The close relationship between intellectual property protection and
funding for medical research was outlined by a number of companies and publicly
funded research institutions. The Association of Australian Medical Research
For medical research institutes, a significant proportion of
the income derived from the licensing of these innovations flows directly back
to the institutes which fostered them, thus perpetuating a cycle of research
WEHI outlined the importance of intellectual property to its ongoing research
and commercialisation program. Three of approximately 300 patents held by WEHI
generate significant revenue. WEHI receives around $2.6 million in royalty
income from patents annually, with $1.3 million of this being derived from
patents on human gene sequences. This income supplements the substantial public
funding provided by the Australian Government (approximately $48.1 million per
annum) and overseas funding.
WEHI advised that it had filed 30 patent applications in Australia claiming
gene sequences, with 21 of these being commercialised through licensing. WEHI highlighted
a number of inventions derived from their genetic research which would not have
'been progressed to their current stage within the pipeline leading to clinical
adoption' without patent protection.
The role of patent protection in offsetting the large investment costs
of medical research for investors was seen as particularly important by some
Medicines Australia argued that guaranteeing a period of market exclusivity
through the patent system was necessary to mitigate the extraordinary risks for
companies in investing in research and development and bringing new therapies
It was noted that many start-up companies relied on patent protection as a means
of attracting capital, including direct foreign investment.
The Johnson & Johnson Family of Companies emphasised the high costs
associated with developing genetic medical research:
Patent protection provides investors with a high level of
assurance that they will be able to recover the cost of development. This is
particularly crucial in the biotechnology sector...[In order to] ensure return on
investment a high level of importance is placed on eliminating
Genetic Technologies also emphasised the positive impact of patents in
the biotechnology area. They noted that products in this area generally take
about ten years of research and development to bring to market. They argued
that patents provided certainty for innovators and investors over these
Inventors and investors need an appropriate system under
which they have faith that the product that they plan to market will justify
the cost of the research and development they are required to commit to in advance...
The importance of the patent system in providing a stable framework which
protects the intellectual property of innovators and facilitates technology
transfers was also emphasised.
For example, IPRIA highlighted research showing how intellectual property
protection assists 'upstream' biotechnology firms to sell or licence technology
to 'downstream' pharmaceutical companies, who are then able to develop these
technologies through the commercialisation process.
Patent system hindering innovation
However, some stakeholders did not consider that the relationship between
patents and incentives for progress in medical research in genetics was clear-cut.
Cancer Voices NSW (CVNSW) argued that there is no evidence 'that
offering patents is necessary to encourage the identification or isolation of
human genes', given the potential outcomes of other models for promoting
innovation. As an example it pointed to Australia's funding contribution to the
International Cancer Genome Consortium (ICGC), a voluntary scientific
organisation which aims to create a catalogue of genomic abnormalities in
tumours of different cancer types. Countries in the ICGC share information,
allowing the comparison of different cancers. The NHMRC, which has contributed
to the ICGC, describes it as one of the most ambitious biomedical research
efforts since the Human Genome Project.
CVNSW was concerned that such approaches could in fact be undermined by the
patenting of genes and genetic material:
We are concerned that if genes and genetic material can be
patented and if those patents are enforced this vital area of medical research
will be more costly, slower and less translatable to the end beneficiaries: us.
The SACGHS final report on gene patents found that the prospect of
patent protection does not play a significant role in motivating scientists to
conduct genetic research. While the report found that patent protection does
stimulate some private investment in genetic research, it also found that
patents could harm genetic research. It states:
Although the patent law requirement of disclosure and
description of a claimed invention is meant to expand the public storehouse of
knowledge and stimulate follow-on research, there is evidence to suggest that
patents on genes discourage follow-on research
Senator the Hon. Bill Heffernan using the example of a patent on
associated with the hepatitis C virus (HCV) stated that evidence received
proved that 'Chiron’s patent monopoly over the HCV biological materials impeded
the development of diagnostic tests that were necessary for the continued
health and wellbeing of the Australian people'. He argued that 'gene patents
can so easily overreach, with unintended consequences on medical and scientific
The significant role of public and charitable funding of medical
research was highlighted in relation to this issue. Dr Lim of IPRIA noted that
one of the arguments made against gene patents was that much of the research in
the area is publicly funded through government grants or completed at
universities. Where this is the case, the granting of gene patents could be
perceived as privatising a public good.
Dr Hazel Moir also noted that a large part of the funding for the basic
medical research on which patented products are based is often provided by
governments or non-profit foundations. Dr Moir pointed to the apparent inequity
of granting patents derived from research funded in this way, commenting that '[it
seems harsh that] health departments should then have to pay monopoly prices
for products whose development was largely funded by taxpayers or
Furthermore, Dr Moir observed that the patent system pre-dates the
widespread use of publicly funded incentives for medical research—such as
public financing of research and taxpayer subsidies for private investment in
research. However, the scope of the monopolies rights granted by the patent
system has not been reassessed to take these forms of public funding into
Professor Ian Olver argued that competition is in fact the driving force
for commercial medical research, and that allowing patent monopolies on genetic
products or sequences actually hinders this competition. Professor Olver also noted
that 'a lot of the great discoveries in the past have not relied on commercial
interests', citing the achievements of the Human Genome Project as an example.
Similarly, Dr Anne Ronan stated that medical research is 'not always
driven by profit', and that the research breakthroughs in medical knowledge can
provide other benefits to companies 'in terms of status, staff development and
Dr Ronan observed that:
The absence of patents in other areas of medical research has
not hampered medical research development. Most medical research is carried out
because people have started off caring for patients and they desperately want
to find answers.
The Committee also heard many concerns that patents on genes and related
materials are detrimental to innovation and medical research. In particular,
submissions referred to the 'tragedy of the anti-commons', which describes situations
where the existence of numerous rights holders prevents socially desirable
outcomes. In the case of gene patents, this can occur where the number and
scope of patent rights inhibits research and innovation because of concerns
about infringing patents or the difficulties of obtaining licences to use
Professor Nicol and Dr Nielsen commented that gene patents may have a greater
impact on medical research because genes and related inventions are 'particularly
powerful tools in biomedical research and product development'. Professor Nicol
and Dr Nielsen argued that, where access to basic research is restricted, there
is likely to be a detrimental effect on subsequent downstream research and
Despite the continuing advances in biomedical research and development, there
remains potential for the scope and number of gene patents to adversely impact
on this area:
Owners of patents claiming broadly applicable foundational
technology could refuse to license or license on a restrictive basis, blocking
off whole areas of downstream innovation. And if the patent landscape is too
cluttered, necessitating entry into licence negotiations over multiple patents,
innovation could be further impeded or delayed, creating what has become known
as a tragedy of the anticommons. Such negative impacts on innovation would be likely
to have flow on effects in terms of consumer access, and could extend to basic upstream
research as well...
A number of submitters pointed to concerns about the fragmentation of
ownership of patent rights in genes, and the potential for this to frustrate
medical research. In particular, this could create uncertainty and impose
additional transaction costs on researchers attempting to negotiate access to
patented genetic inventions. Dr Graeme Suthers of the RCPA commented:
...many genes that are patented currently have multiple patents
on the one gene. If you track the ownership of each individual patent applying
to this gene, you end up with a dense thicket of arrows [patents].
The fragmentation of patent rights over genes and genetic material could
lead to situations where a researcher, for example, will need to secure the
consent of multiple rights holders in order to undertake research on a number
of genes. In such cases, the refusal of any single one of those rights holders
can effectively prevent the entire research project. Associate
Professor Webster of IPRIA commented that there is 'little evidence that the
anti-commons exists in Australia'. However, she noted that the state of
empirical knowledge on this issue is poor, and the law may well need to account
for the potential for the anti-commons to arise.
WEHI did not consider that the available data supports the view that there
is an anti-commons effect relating to gene patents in Australia. WEHI pointed
to research in the US in which only one per cent of biomedical researchers
reported having had to delay, and none had to abandon, a project as a result of
patents. Conversely, the research found that 25 per cent of pathology
laboratories had abandoned a genetic test as a result of patents. WEHI suggested
that this was probably due to a lack of willingness to accept the market price
and access terms. WEHI concluded:
These observations suggest neither the anti-commons nor
restrictions on access are seriously limiting academic research – despite the
fact that biomedical researchers operate in a patent-dense environment, without
the benefit of a clear research exemption. Fears of widespread anti-commons
effects blocking the use of upstream discoveries have largely not materialised.
IP Australia also commented that available data shows 'a rise in patents
claiming downstream uses of isolated human nucleic acid molecules'.
Mrs Fatima Beattie stated:
This indicates to us that basic research and innovation are
not being stifled by patents. The evidence so far is that licensing issues are
often resolved in the market through commercial negotiations, except for
isolated instances like BRCA.
Professor Peter Drahos argued that the patent system has 'increasingly
generated tremendous amounts of uncertainty' for medical researchers because of
the volume of patent applications and new patents being granted. This uncertainty
about breaching patent rights could cause medical researchers to become 'risk
Professor Drahos's research found:
Companies are often not sure that they have found all the
patents relevant to a product on which they are working. They frequently have
doubts about the scope of the patents they have found. Patents, unlike blocks
of land, do not come with settled boundaries. These kinds of uncertainty are
especially dangerous from the point of view of the public management of risk...
However, Mr Hamer of the Law Council of Australia observed that, in his
experience, research scientists are generally well informed about the patent
system. Mr Hamer noted it was standard practice for researchers to '[conduct] searches
before they engage in their research to ensure that they are not reinventing
the wheel and to ensure that there is freedom to operate'. 
The Committee heard that patent attorneys regarded freedom-to-operate
searches as a common practice to identify what patents may exist in relation to
a given field. Such searches are commonly undertaken in the early stages of a
Davies Collison Cave suggested that apprehensions about the adverse impacts of
patent protection on genetic research 'to large extent [arise] from a lack of
understanding by researchers of the patenting process as well as a lack of
experience and expertise to commercial exploit research'.
In contrast, the Committee also received a submission from Ms Naomi
Hawkins, a UK researcher with an interest in patent issues, who described the
main legal challenge of gene patents as being the difficulties of effectively
conducting due diligence and the associated problem of a potentially crowded
patent landscape. Despite this, Ms Hawkins suggested that patents in fact have
a minimal impact on researchers. This is not because patents are being
appropriately managed but because 'patents are essentially ignored by those who
develop genetic tests in the public sector, and patent holders do not tend to
take any enforcement action'.
Dr Luigi Palombi commented that, in his experience, restrictions caused
by gene patents can interfere with the ability of scientists to undertake
research. While most scientists ignore these restrictions, Dr Palombi noted
that '[when] someone does decide to enforce those patents, all hell breaks
CCA observed that there is significant investment in cancer research in
Australia, and was concerned that gene patents might in fact be acting as a disincentive
to cancer researchers. This is because:
...[patents] give a patentee the ability to impose conditions
on the use of these materials in the conduct of that research, including a
requirement to share ownership of intellectual property that may result from
The 2004 ALRC report discussed such far-reaching or 'reach-through'
license conditions, in which patent holders retain rights over future
discoveries made by licensed researchers. The report noted that, while
reach-through licence agreements may offer some advantages—for example, by
permitting researchers to defer payment until research yields valuable results—they
are perceived by researchers as benefiting patent holders disproportionately.
The ALRC report stated that there is 'little evidence' that gene patents
have had any significant adverse impact on the conduct of genetic research in
Australia. It cited international studies which suggested that patent holders
and researchers are capable of developing working solutions for dealing with
problems. These solutions 'sometimes take time to work out, and may not be
optimal, but research generally moves forward'. However, the report also noted
that 'the current position may change, particularly if patent holders become
more active in enforcing patent rights'.
An example of a situation where restrictive licensing approaches have
had significant impacts on medical research was described by PMCC. PMCC had
planned to conduct tests on a large cohort of women to determine the frequency
of BRCA1 and BRCA2 mutations. The study was being conducted in collaboration
with a commercial partner, Myriad Genetics, who was to conduct the testing.
However, it became apparent that Myriad Genetics would be in breach of a licensing
agreement with Genetic Technologies if it did in fact conduct the tests.
Professor Bowtell explained:
We went to [Genetic Technologies] and told them this was a
research study and it had implications for understanding the frequency of these
mutations in the population and could actually be good for their business in
the end. We asked whether we could go ahead and do this [BRCA testing] with
Myriad. It was an extraordinarily hostile reaction and...[Genetic Technologies] shut
it down. Myriad was unable to move and that avenue completely collapsed.
IP Australia noted that many comparable industries, such as 'software,
electronics, organic chemistry and pharmaceuticals', have managed to deal with
cross-licensing issues; there was no reason the biotechnology industry would not
be able to deal with these issues in a similar way.
Professor Nicol noted that research results suggested that practical strategies
to work around patents are being found in biomedical research and other areas that
are impacted by gene patents. These strategies included:
- licensing and other collaborative arrangements;
- ignoring patents;
- working around patents; and
- challenging the validity of patents.
Professor Nicol stated that there 'are many reasons' driving the type
and nature of the strategies being employed, including the difficulty for
patent holders in pursuing infringers, the practical benefits of cooperative
strategies and the uncertain validity of certain patents.
The view that 'working solutions' had been developed to mitigate the
negative impacts of patents on genetic medical research appeared to be supported
by Pfizer Australia. Pfizer Australia advised that it licensed use of gene
patents in the development of new medicines, and regarded licensing fees as
part of normal business costs. These costs had not been a barrier to the
development of new medicines.
Pfizer Australia stated that their own policy was explicit that gene patents
must not impede research. The quoted policy stated:
...gene inventions and, in particular, research tools should be
readily available for non-commercial purposes consistent with the advancement
of biomedical research. This may be achieved through scientific publications or
patent licensing. In the latter case, patents should be available for licensing
on a voluntary basis for non-commercial purposes. Such licenses should be
available on a non-exclusive and non-discriminatory basis and under fair terms
consistent with the advancement of biomedical research.
Research tools and databases
A number of submitters and witnesses expressed concern that gene patents
would restrict the development of genetic medical research by preventing researchers
from accessing genetic materials, samples and data held by companies.
For example, the BCNA saw a risk that:
...gene patent holders may choose to charge a fee for access to
data and samples, which could be prohibitive for publicly funded researchers,
or which could place considerable additional burdens on their research budgets.
There were also concerns that monopoly testing may create restricted
knowledge bases and remove opportunities for shared knowledge in research and
improved result interpretation.
Dr Jennifer Leary warned that the monopolisation of testing due to gene patents
could result in information on genetic variants being 'locked up' by companies,
which would treat such data as a valuable commercial asset. Dr Leary also
highlighted the importance of information sharing for genetic research and
Sharing knowledge of mutations is essential to understanding
the clinical significance of the rare variants that can be observed in genes.
Access to unpublished experimental data, knowledge of the frequency of
observations, knowledge of instances of co-occurrence with other variants in
addition to robust exchange of ideas amongst a variety of scientists can all
help to unravel the complexity faced in the interpretation of the variants.
With particular reference to the BRCA genes, Dr Luigi Palombi argued
that the cost of allowing gene patents to be enforced includes 'the opportunity
cost for Australian laboratories to gather important scientific data'. Dr
Palombi described this data as vitally important to improve the reliability of
BRCA gene testing. This is because the genes are complex and lack universally
applicable genetic markers, which means there is a need for the data to be
shared among laboratories.
The importance of accessible databases of genetic testing was also raised by
the RCPA, who argued patents on genetic materials could create exclusive
databases of genetic variants. The RCPA submission explained:
If genetic testing is provided by multiple laboratories, they
will often pool their records of genetic variants in public databases. As more
data accumulate about the frequency of variants and their association with
disease, this information will help laboratories to interpret variants and provide
useful information to requesting clinicians and patients. These databases are
in the public domain and are a resource for other laboratories, researchers,
companies, and policy makers.
If testing of a gene is provided by a single laboratory,
there is no incentive to create a public database of variants. In effect, the
information about genetic variants becomes the property of the patent-holder,
with no opportunity for this information to be reviewed by independent researchers,
or made available for public analysis.
Other stakeholders were concerned that gene patents could jeopardise
successful relationships established between clinical care and medical research
entities. HGSA argued that gene patents may limit the further investigation
that currently occurs in public hospital laboratories as new variants are
identified, and stressed that 'the line between service and research is not
HGSA also emphasised the importance of the relationships between
patients, healthcare professionals and medical researchers. In many cases,
samples taken from patients for genetic testing are held by laboratories to
enable further research. As new medical data becomes available, laboratories
can return to stored samples for further testing. The results of new tests can
then assist the healthcare of patients and feed back into ongoing medical
Ms Heather Drum, a member of BCNA, was concerned that there is potential
for patent holders to enforce their rights over the BRCA genes and affect the
ability of researchers to continue to conduct research on tissues and samples
donated by individuals and families.
Ms Drum commented:
We have been confident to donate various tissues from the
surgeries, secure in the knowledge that it will be used in research by Peter
Mac. We have been assured our tissues will continue to be used in research and
even retested for the BRCA1 and 2, should further discoveries be made.
...we are one of those families where the tissue is really
important to the researchers. I would feel really devastated if the tissues my sisters
and I have donated were used to make money out of patenting thereby excluding
other women from being treated appropriately on the basis of future breast
The South Australian Government stated that private sector research is
published much less frequently than research done in the public sector. The South
Australian Government submission suggested that if genetic testing is concentrated
in the private sector 'there is a risk of genetic data residing with this
sector, making it difficult for staff with the public health system to access
data for population health studies'.
However, WEHI noted that it had not experienced any restrictive licence
requirements that have prevented it from conducting further research. Nor had
it experienced any infringement or enforcement challenges. Further, WEHI's patents
have not impeded rapid publication in the public domain.
The WEHI submission commented that:
...gene patents have had no negative impact on WEHI's research
activities and ability to innovate. Furthermore, we believe that rather than
hindering dissemination of research results, patents actually reduce the
possibility of information being kept as trade secrets.
The general research exemption
Patents confer monopoly rights that exclude others from using the
invention, including those who wish to use the invention for research (unless
they obtain a licence from the patentee). There is no specific exemption for
research or experimental use in the Patents Act 1990, and it is
unclear whether a defence of research or experimental use is available under
Australian law (because it has not been tested in the courts).
However, the committee heard that there is a widespread belief in
research institutions that a general research exemption exists in Australia, which
allows research to be conducted on patented materials.
Many institutions rely on this belief to conduct research or to experiment on
patented materials, despite being unsure as to the scope and limits of any such
The Committee heard that IP Australia is in the process of public
consultation over a proposed statutory experimental use exemption.
This issue is discussed further in Chapter 5.
Health and wellbeing of the Australian people
The broad scope of the term of reference relating to the 'health and
wellbeing of the Australian people' invited evidence covering a number of
issues. Much of this evidence repeated or elaborated on the matters discussed
above relating to the provision and costs of healthcare, training and
accreditation of healthcare professionals and the progress of medical research.
A number of submitters and witnesses felt that the granting of patent
protection in respect of genetic materials has not had any direct impact on the
health and wellbeing of the Australian people.
Several submissions focussed on the economic and employment benefits of
the fields of biotechnology and medical research which are supported by patent
protection. For example, the Tasmanian Government noted that healthcare issues
need to be balanced against the economic benefits of the 'biotechnology and
pharmaceutical industry, which can produce highly successful companies'.
IP Australia commented that, while it is difficult to isolate the
contribution of gene patents, the Australian pharmaceutical industry employs
40,000 people and was Australia’s second largest exporter of manufactured goods
IP Australia submitted research which attempted to calculate the 'patent
premium' in Australia—the implicit subsidy provided to innovators through the
patent system. Although this did not address the specific impact of gene
patents, the overall patent premium was estimated to be $12 billion, which is 'much
larger than the support to innovators via direct transfers from the government
or fiscal incentives'.
The Institute of Patent and Trade Mark Attorneys of Australia (IPTMAA) highlighted
the number of patent applications filed in the area of biotechnology by
Australian research institutes. IPTMAA argued that, without the possibility of
obtaining patent protection, a number of well-known Australian biotechnology
innovations may not have achieved commercial success. IPTMAA also noted that 33
of the 90 companies listed on the Australian Securities Exchange (ASX) in the
Pharmaceuticals, Biotechnology and Life Sciences Industry Group had applied
for, or obtained, patents in the area of biotechnology.
Genetic Technologies identified itself as an Australian company 'built
on so-called gene patents' that employs 61 people in Australia and generated
$16 million revenue in 2008. Genetic Technologies argued that it is a significant
contributor to the Australian economy and has made a positive contribution (in
the order of $60 million) to Australia’s balance of payments.
The Committee also heard about the emotional and financial stress experienced
by patients and their families undergoing genetic testing. For example, Dr Belinda
Coyte advised that there was a considerable financial burden in obtaining
complicated genetic testing for her son, including tests which were only
available overseas and subject to considerable delay.
Ms Trish Carey, whose daughter died of a complication of Marfan Syndrome,
explained genetic testing for her granddaughter in relation to this condition could
cost approximately $3000. The point was made that restrictive enforcement of
patent rights in relation to genetic testing could add to the stress and the costs
incurred by patients and their families.
Others noted that the impacts of gene patents are potentially very broad,
and extend beyond the realm of healthcare to other industries, including agriculture
and conservation. For example, Dr Rimmer noted the potential of current gene
research in the field of energy and global warming:
J Craig Venter, who did shotgun sequencing of the human
genome, is now applying that same technology to shot gun sequencing the world’s
micro-organisms in the oceans under the Sorcerer II Expedition. His synthetic genomics
project is very much focused on developing novel minimal genomes to address
certain concerns about biofuels, partly funded by the department of energy.
The privacy of genetic test results and the potential for discrimination
based on those results, particularly in the area of healthcare and life
insurance, were also issues raised with the Committee. Reference was made to
decisions made by the European Patent Office, which upheld the rights of Myriad
Genetics over particular mutations in BRCA2 associated with a predisposition to
breast cancer among the Ashkenazi Jewish community. Consequently, in certain
overseas jurisdictions patients with this ethnic background were likely to pay
more for this type of genetic testing.
The BCNA argued that strict rules need to be put in place to ensure that
genetic data is not treated as a commodity and that the privacy of patients
using genetic testing services is ensured. The BCNA observed:
...the granting of gene patents could increase the risk of
discrimination against women and men who test positive to a genetic mutation such
as the BRCA 1 or BRCA 2 gene mutation. We are concerned that a company that
holds the sole right to test for the presence of a gene or gene mutation would
also hold a significant amount of personal genetic information.
The Department of Health and Ageing noted that the management of privacy
issues in healthcare has been challenged by the implications arising from
genetic technologies. It commented that insurers are currently not able to ask,
or indirectly coerce, applicants for insurance to undertake genetic testing.
However, the Department also noted:
Currently, the position is that an insured person’s duty of
disclosure to his or her insurer includes an obligation to disclose knowledge
which that person has acquired through genetic testing Moreover, insurers are
not prevented from requesting family history and genetic testing results, from
which they can make decisions about whether to insure individuals or not, and
if so, upon what terms.
While scientific understanding of genetics has progressed over the years
since the report by the ALRC into gene patents, the indications concerning the
impacts of gene patents in Australia appear to have remained largely the same. The
actions of Genetic Technologies in relation to BRCA1 and BRCA2 have renewed
many of the concerns about gene patents held by government officials, healthcare
professionals, researchers and patient groups. However, the evidence the
Committee received concerned only isolated examples of impacts from gene
patents on healthcare, training and accreditation of healthcare professionals,
medical research and the health and wellbeing of the Australian people.
Although evidence of negative impacts caused by gene patents was relatively
sparse, significant potential impacts were highlighted during the inquiry. The
Committee was concerned that there do not appear to be strong mechanisms in
place to effectively monitor the impacts of gene patents. Without this
information it is difficult for policy makers and regulators to respond to the
potential impacts of gene patents, should they occur.
Despite such concerns, the Committee could not therefore conclude that
gene patents have caused significant impacts on the provision and costs of healthcare
in Australia to date. The Committee also acknowledges that it is possible that
patent protection has, at least in some cases, encouraged innovation and thus had
positive impacts on the delivery of health services through the development of
better testing and treatments. This may have led to lower healthcare costs, for
example, by introducing genetic testing to target expensive treatments.
The granting of patent monopolies has been associated with some
accessibility and affordability issues for patients. However, it is difficult
to determine the contribution gene patents have made to these issues, which are
also subject to other factors such as the rapid development of, and increased
demand for, genetic testing and treatment, and the level and structure of
The evidence received clearly identified the use of closed, restrictive
or exclusive licensing models by gene patent holders as a key potential risk to
the accessibility, affordability, accuracy and timeliness of genetic testing services.
While there is theoretically no limit to what a patent holder might seek to
charge for a licence, commercial realities mean that the more usual outcome is
that negotiated licence agreements will result in a level of charge that
reflects what potential licence holders can afford and are willing to pay.
However, the Committee notes that patent regulators and regulation should be
robust enough to ensure that they can respond to instances where commercial influences
fail to ensure broad licensing of patents which are important to the health and
wellbeing of Australians. These licensing issues are considered further in
The potential impact of gene patents on the current integrated public
sector approach to genetic testing was highlighted by a number of submissions
and witnesses. It was clear to the Committee that this poses risks in several
areas which will need to be closely monitored by IP Australia and health
departments around Australia. The possible affected areas include the number and
capacity of public laboratories conducting genetic testing, the relationship
between genetic testing and standards of clinical care, and the provision of
medical advice and genetic counselling to patients using genetic testing
The Committee received little evidence concerning the impacts of gene
patents on the training and accreditation of healthcare professionals. However,
restrictive approaches to licensing by gene patent owners were again identified
as a key potential risk. Genetic testing being conducted in a restricted number
of laboratories, or samples required to be sent overseas for testing as a
consequence of patent rights, would clearly reduce opportunities for training
and limit the development of expertise for Australian healthcare professionals.
The evidence presented to the inquiry revealed that there are few
instances in Australia where enforcement of a patent has restricted medical
research. However, examples where gene patent licensing has impeded research,
including the incident described by the Peter MacCallum Cancer Centre,
indicated this could be a problem area in the future. The lack of impacts on
medical research may be due to researchers ignoring patent rights or assuming
that an exemption exists for medical research and experimental use. Patent
protection was seen by many as an important incentive for the encouragement of
research and to offset the large investments required to undertake research and
development. Again, restrictive licensing approaches by patent owners were perceived
as a key potential risk through reducing access to research tools and databases,
contributing to anti-commons scenarios which restricted research, and by
creating uncertainty for medical researchers.
Evidence to the inquiry indicated that there is a lack of accessible
data in relation to gene patents. The Committee notes that many witnesses and
submitters argued that policy in relation to gene patents should be based on
evidence and research rather than apprehensions regarding circumstances which may
occur in the future. Others highlighted the lack of research and empirical
evidence available concerning the impacts of gene patents.
The Australian Genetic Testing Survey 2006 was undertaken in
response to the lack of available data on the level of demand and supply of
genetic testing. The RCPA undertook the survey in consultation with the Human
Genetics Society of Australia and with funding from the Department of Health
and Ageing. This collaborative approach to data collection and analysis in
relation to genetic testing and healthcare should be encouraged, expanded and
regularly updated. The debate over gene patents would benefit from increased
empirical evidence and research concerning the costs and provision of genetic
testing and treatment.
The ALRC's report considered that the impact of genetic technologies
needed to be closely monitored by health policy makers in Australia. The ALRC
recommended that the Australian Health Ministers' Advisory Council should
establish processes for (a) economic evaluation of medical genetic testing and
other new genetic medical technologies and (b) examination of the financial
impact of gene patents on the delivery of healthcare services in Australia.
The Committee agrees that better information in relation to the use of gene patents
in Australia is needed.
Professor Drahos and others have also suggested the establishment of a
patent transparency register, whereby companies would be required to disclose
patent holdings in designated subject matter areas. The system would be
intended to promote transparency and to overcome some of the issues relating to
accessibility of information regarding gene patents, which may act as barriers
to research and innovation. A proposal was also made by Dr Moir to include a
requirement in the patent renewal process to regularly require patent owners to
disclose the use of their monopoly rights.
This would be an additional administrative burden on patent owners but would
allow policy makers to track the use and enforcement of patents. While the
Committee considers these suggestions to have merit, it notes that other
submissions, particularly those from research institutes and relevant companies,
have not highlighted this as an area of reform.
Given the lack of comprehensive, systematic and accessible data and
information on the impact of patents generally, and of the impacts of gene
patents on healthcare and medical research in particular, the Committee
considers that the Government should support the development and maintenance of
better systems to collect patent data and information as per Recommendation
19-1 of the 2004 ALRC report, which states:
The Australian Health Ministers’ Advisory Council (AHMAC)
should establish processes for:
(a) economic evaluation of medical genetic testing and other
new genetic medical technologies; and
(b) examination of the financial impact of gene patents on
the delivery of healthcare services in Australia.
This information will facilitate assessments regarding the
costs and benefits of gene patents in relation to healthcare and medical
research in Australia.
The Committee also endorses the need to establish a patent transparency
register. The Committee considers that these initiatives will also support the
activities of an external oversight body for the patent system in Australia
(see Recommendation 15 and related discussion in Chapter 5).
Collection of patent data and
The Committee recommends that the Government support and expand on the
collection of data, research and analysis concerning genetic testing and
treatment in Australia, in line with recommendation 19-1 of the 2004 Australia Law
Reform Commission report Genes and ingenuity.
Establishing a patent transparency
The Committee recommends that the Government conduct a public
consultation and feasibility study regarding establishing a transparency register
for patent applications and other measures to track the use of patents dealing
with genes and genetic materials.
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