JUNE 2004

Editorial

In May two important rulings regarding the patenting of genes were made. The European Patent Office overturned its previous decision to grant Myriad Genetics a patent on certain genes that create a predisposition to breast and ovarian cancer. Myriad had previously used their patent to prevent testing for this gene outside licensed laboratories, forcing up the price of tests.

In the same week the Canadian Supreme Court ruled on an even more famous case, where farmer Percy Schmeiser appealed biotechnology company Monsanto's suit against him for using their patented seeds without paying a licence fee. The Court's ruling, explained in an article by Matthew Rimmer in this edition of Issues (pp.44-48), involved a partial victory for both sides, finding in favour of Monsanto but not awarding the company any consideration for damages.

As Justice Michael Kirby notes in his article (pp.17-20): "The right of scientists to have protection of their intellectual property was recognised in the Universal Declaration of Human Rights. However, the same instrument recognises competing human rights - such as the right to life, to health, to knowledge and sharing in the benefits of scientific advances." Balancing these rights is at the core of the challenges society needs to face in considering how advances in biotechnology should affect our intellectual property laws.

In Australia, concerns about the patenting of genetic material have led the Australian Law Reform Commission (ALRC) to undertake an inquiry into gene patenting and human health. "Interestingly, strong concerns about the adverse impact of patents on genetic R&D have even come from leading researchers who themselves hold numerous patents," ALRC President Professor David Weisbrot noted.

The ALRC's final report has yet to be submitted to the Attorney-General, and will not be made public until July at the earliest, but it appears unlikely the ALRC will be recommending the sort of radical change many people are calling for. Nevertheless, a number of significant reforms are likely to be proposed, although the forthcoming Federal election may put implementation on hold for quite a while. These changes will have consequences throughout the patenting system, rather than being specifically applicable to genetic technologies.

The sharpest controversy concerning the patenting of genetic materials relates to whether it should be possible to patent genes at all. Dr Graeme Suthers, a clinical geneticist with the South Australian Familial Cancer Service, says in his article (pp.23-26): "The patenting of genes represents a serious threat to the delivery of effective and equitable health care".

Rod Crawford of IP Australia counters that companies like Myriad are not simply patenting genes in their natural state but instead are being awarded patents "for the innovative and practical use of isolated genes" (pp.9-10). However, this claim is greatly disputed since many patents attempt to control any use to which the gene might be put.

Supporters and opponents also clash over whether gene patenting will promote genetic research by providing an incentive for investment or stifle it as researchers are caught in a web of conflicting patents that make research into particular genes too expensive to conduct.

The ALRC says in its article (pp.11-16) that its review will not attempt to confront the sort of issues that tend to arouse the most public concern, such as whether genes should be patentable at all. "The ALRC has not proposed any radical changes, believing that major change should be proposed only in response to demonstrated problems."

The ALRC's general approach - that patent laws are not the best place to deal with many of the ethical issues relating to gene patenting - was recommended by AusBiotech, the industry representative body (pp.41-42). Where controls are needed, Ausbiotech argues for other mechanisms to be applied.

However, Suthers believes that long-standing principles in patent law need to be challenged. "It is bizarre that a chemical can be patented on the basis of its concentration and location (unnaturally purified in a test tube), and that this patent extends to the atomic structure of the chemical itself." However, this precedent dates back to 1912 and would be hard to overturn now.

Instead Suthers pushes for a distinction to be made between the patenting of a "gene-as-chemical" (the isolated molecule) and a "gene-as-information" (the function the gene performs when operating within the human body). This would effectively eliminate most of the value of genetic patents.

The ALRC acknowledged that genes, including their information components, have been patented for some time, and considers it impractical to turn the clock back. It also noted that a ban on patenting might "have great detrimental effects on… Australia's international obligations".

Indeed the ALRC believes that no special legislation should be brought in to treat genetic materials differently from other patents. However, it agrees that issues arising from increasing numbers of gene patents should act as a spur to make changes to patenting laws in general, many of which may have implications for other areas of science.

In particular, proposals to clarify the situation regarding research exemptions will come as a major relief to many scientists. In many countries researchers working on patented material cannot be sued or forced to pay licence fees as long as their work fulfils certain criteria.

A study conducted by Dianne Nicol and Jane Nielsen at the University of Tasmania found that most patent-holders have no intention of suing institutions such as universities for conducting basic research, but that this attitude may be changing. Many scientists think they are safe from such suits, believing an exemption exists for non-commercial research.

However, Nicol notes in her article (pp.21-22): "In Australia, the law is particularly uncertain because there is no clear exemption in our patent legislation and the courts have not yet had to deal with this issue." Overseas institutions have been hit with huge licence fees for work they thought was exempt.

The ALRC recommends that this situation be clarified. In particular, the discussion paper proposes a distinction between "research on a patented invention (for the purposes of testing or improving the invention or making a new invention) and research involving the use of a patented invention (providing a service or delivering a product using the patented invention)". Research on inventions would be protected by an experimental use defence.

A commonly expressed concern is that patents are being taken out with doubtful legal standing. No company or individual has enough of an interest to spend the extraordinary amounts of money it would take to challenge such a patent in the courts, so the holder of the patent can feel confident it will not be challenged, however weak its claim may be.

The ALRC's preliminary recommendation is that the government should take a greater role in challenging patents, particularly as test cases. However, it has rejected a proposal that this role should be given to IP Australia, the body that registers patents, or to some newly created department. Instead the ALRC believes the best arm of government to launch a challenge is the department most directly connected with the patent's use - principally health and agriculture in the case of genetic patenting.

Among other reforms the ALRC proposes is "that the existing 'usefulness' requirement, and the standard of proof needed to meet the requirement, be clarified in the legislation". Patent law requires that inventions be "useful", and this rule could be used to prevent companies that attempt to patent particular genes with unknown functions on the basis that they may prove useful some day.

The ALRC suggests a number of ways in which the staff at IP Australia can become better informed about developments in the increasingly specialised areas in which they work. Increased ongoing training is obviously a part of this, but a more innovative suggestion is the creation of expert panels to assist "in areas such as human genetics, where constant new developments require an increasingly detailed grasp of the scientific context and background".

The ALRC has also proposed that guidelines be created on what should and should not be considered patentable, rather than leaving individual staff of IP Australia to make the decision as an application comes up.

Many of the problems raised regarding ownership of genetic materials are outside the scope of the ALRC inquiry. For example, there is growing concern about claims of "biopiracy" by multinational corporations, usually based in wealthy nations, that patent genes from plants or animals collected in the developing world. Indigenous communities that often recognised the value of these species generations ago, and may even have led scientists to the product, usually go unrewarded in these cases.

According to Del Weston, a student of public policy at Murdoch University and Executive Officer of the Huntington's Disease Foundation (WA) (pp.34-35): "The knowledge of the poor is being converted into the property of the global corporations, creating a situation where the poor will have to pay for the seeds and medicines they have evolved and have used to meet their own needs for nutrition and health care".

Australia is one of the few nations on Earth that has both a substantial biotechnology industry and is considered "megadiverse", being host to many species that do not exist anywhere else in the world. As such Australia could play a role in establishing rules for bioprospecting that set a global standard. A Biotechnology Benefit-Sharing Agreement between the Queensland Government and the Australian Institute of Marine Sciences (AIMS) over valuable chemicals derived from species found in Queensland's waters marks a step towards such a system.

"Happily, there has been enormous progress over the past 5 years," says AIMS researcher Elizabeth Evans-Illidge in her article (pp.36-39). "Access to biological resources and benefit-sharing has been a major issue in the work program of the Convention on Biological Diversity, which developed and, in 2002, adopted the 'Bonn Guidelines' to help parties implement access and benefit-sharing regimes."

The ALRC's preliminary opinion is that issues of benefit-sharing are best addressed outside the patent system.

Rather than being the end of the debate, the ALRC inquiry should mark a beginning in an examination of wider questions about how we should use and control genetic technologies.

Stephen Luntz
Editor