Opinion special: Gene patenting

In this opinion special, Ian Olver, CEO of Cancer Council Australia, and Trevor Davies, of the Institute of Patent and Trade Mark Attorneys of Australia, debate the merits and dangers of gene patents. Each were given the opportunity to state their arguments, and both given a right of reply to each other's piece.

Playing gene monopoly

By Ian Olver

Gene patents became the subject of a Senate inquiry last year after an Australian company sought to enforce a monopoly over testing for genetic risk of breast and ovarian cancers. The company, Genetic Technologies, withdrew its claim, but the issue remains unresolved. And the competing interests and complexity of the issue are manifest in the 72 submissions made to the Senate inquiry.

Biotechnology companies claim that the public interest is adequately protected by the existing legal framework covering patents. However, this is not the case. When Genetic Technologies withdrew its demand that public laboratories cease testing for the presence of the BRCA1 and BRCA2 genes – which are associated with breast and ovarian cancer risk – it was a company decision.

There was nothing in patent law to protect the public; the only comfort was the company’s voluntary assurance that the cost of tests would not increase. We cannot run public health policy on the basis of assumed good intentions. We need clarity and certainty in the law – particularly as last year’s experience related only to BRCA1 and BRCA2, just two of hundreds of genes that may hold keys to cancer control.

A pivotal problem is that Australian patent law is based on a 17th century framework, designed to reward innovation and protect inventions. But genetic sequences are not inventions. Isolation of a gene or genetic mutation is based on established sequencing techniques and does not involve innovation – it is a simple process of discovery.

However, because genetic technology accelerated with such great pace from the late 1990s, the anachronistic system applied to patenting the gene sequences could not keep up. So biotechnology companies, keen to exploit the commercial benefits of playing gene monopoly, are in the laboratory equivalent of a gold rush to stake their claims to our DNA. Patent offices, applying the outdated legal framework, rubber-stamp the claims – while cancer clinicians concerned about the public interest look on in distress. Our concerns cannot be overstated. We sit on the cusp of what is arguably the most exciting development in the long history of cancer science. Genes and genetic products will be the keys to new ways of predicting, diagnosing and treating cancer. This will include therapies based on microarrays able to directly target an individual patient’s cancer cells, maximising benefit and minimising side effects.

But legalising commercial interests to lock up the genes or mutations essential to the technology’s development, for 20 years until their patents lapse, will suppress innovation and competition – which patent law was established to encourage and which have long been cornerstones of health research.

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The argument in favour of gene patents is that without them, investment in research will decline; the lure of patent royalties drives research and development. This is clearly flawed. Much research, indeed the sequencing of the human genome itself, is done for the common good. The legitimate financial incentive is in developing – inventing – cancer treatments based on genes and genetic products, for which patents should indeed be awarded.

So I strongly believe that the law must be changed. While we wait, non-commercial use of genes should be made freely available, particularly for research and diagnostic purposes. And a whole-of-government approach should be taken to gene patenting – adding public health interests to an arena dominated by patent attorneys and their clients.

The potential for genetic technology to save, improve and extend the lives of many of the two million Australians who are expected to get cancer over the next 20 years must not be locked up by individual commercial interests. Patent the inventions, but not the discoveries.

Professor Ian Olver, CEO of Cancer Council Australia, is a medical oncologist and former head of the Royal Adelaide Hospital Cancer Centre. He has a PhD in bioethics, is the author of two books and numerous research articles, and sits on a number of advisory boards and holds several honorary academic and clinical posts.

Reply from Trevor Davies

I agree there is great promise for medical advances through life science research. Australia’s present patent system allows innovators to protect these advances and patents play a crucial role in the process of developing new products and bringing new treatments and diagnostics to market.

Without patent protection, it is questionable whether commercial tests for BRAC1 and BRAC2 gene screening would have been developed and made available to women around the world. A patent for this invention has not stopped screening of women for associated breast and ovarian cancer risk in Australia. Crown use and compulsory licensing provisions in the patent legislation are available to ensure access of inventions to the public.

Patent Offices and courts around the world have applied their respective national laws and have deemed inventions relating to isolated nucleic acids and other biological materials to be suitable subject matter for patents. Each invention, however, is judged on its own merits at the time the patent application was filed as to whether it is actually patentable. Patents issued for biological materials result from considerable research effort and it is incorrect and simplistic to dismiss this innovation as mere discovery.

No change to the patent legislation is required to preclude biological materials from patentability. Patenting of genetic technology should be subject to the same criteria as any other technology. Patents have not suppressed innovation and competition nor prevented the development of new products or services.

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Patenting of biological materials

By Trevor J Davies

Patent protection supports innovation and development of basic research into products and services and provides an incentive for investors to recover costs over the life of a patent. A robust patent system is also essential to ensure that innovation developed overseas is made available in Australia.

A patent provides an exclusive right to the patentee to exploit the invention in Australia for up to 20 years. For an invention to be patentable in Australia, it must be a ‘manner of manufacture’ (suitable subject matter), novel, involve an inventive step and be useful. In order to obtain a patent, an inventor must fully disclose the invention and provide the best means of carrying out the invention.

Full disclosure and early publication of patent applications informs the public of potential pending patent rights and expands the knowledge in the field. When a patent expires, the invention is returned to the public and anyone is free to use the invention.

Australia’s flexible patent system adapts to new technologies and provides opportunities to protect valuable scientific and technical advances. In addition, there are provisions for third parties to oppose the grant of a patent or challenge the validity of a patent at the Patent Office or the Federal Court of Australia.

There are also existing safeguards such as the Crown use and compulsory licensing provisions that can be used to ensure that access to essential services and treatments is not blocked by patents.

Patents granted for isolated nucleic acid molecules that encode a protein, commonly called ‘gene patents’, do not result in ownership or control of the genetic information of individuals. ‘Gene patents’ do not cover genes as they exist in nature. Actually, patents to biological materials, including ‘gene patents’, protect large chemicals (nucleic acids and proteins) that have been altered or modified to provide a useful product or process.

There is no empirical evidence that the grant of patents for biological materials per se in Australia is hindering or preventing academic research or causing any adverse effects on the Australian biotechnology industry or the medical system.

The patent system has allowed important Australian innovation to be successfully developed and commercialised. An example is the Gardasil vaccine directed against human papilloma virus. Professor Ian Frazer and Dr Jian Zhou, while at the University of Queensland, filed their first patent application in 1991 for a papilloma virus vaccine which included claims to papilloma virus-like particles and related nucleic acid molecules.

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To ensure sound protection for this innovation and protect improvements, subsequent patents have been granted, many of which include claims to biological materials including protein encoding nucleic acid molecules.

In response to the Senate Inquiry into Gene Patents, Cancer Council Australia has recently proposed a broad amendment to the Patents Act 1990 to exclude: “Biological materials, including recombinant materials (including but not limited to their components, parts or derivatives, whether isolated or purified or not and regardless of their state and processes used in their production) which are identical or substantially identical, individually or collectively, to those that exist in nature.”

Restricting patent protection in Australia as proposed by Cancer Council Australia is not necessary and would have an adverse impact on potential commercialisation opportunities in Australia, reduce investment in the Australian biotechnology industry, potentially limit the availability of new therapies based on biological materials such as hormones and antibodies, and breach a number of International Agreements.

Biological materials continue to play an increasing role in medicine, veterinary science, agriculture, industry, food science and renewable energy. Patentability of inventions relating to biological materials should not be treated any differently from inventions in other technologies. If an invention is novel, involves an inventive step and is useful, it should continue to be patentable in Australia.

Dr Trevor Davies is a patent attorney and councillor of the Institute of Patent and Trade Mark Attorneys of Australia (IPTA) and heads up the life science and pharmaceutical patent registration practices of Allens Arthur Robinson. He has a BSc (Hons) majoring in Microbiology and Biochemistry, and a PhD in Microbiology.

Reply from Ian Olver

Dr Davies’ defence of the patent system ignores the fact that patents are about ‘inventions’. Whatever the merits of the patent system, there is no empirical economic evidence that patents induce medical innovation. Pasteur’s rabies vaccine and Florey’s penicillin were not patented, and until 1978, it was not possible to patent medicinal substances in Europe.

The Senate’s Inquiry into Gene Patents is not about the merits of the patent system. It simply seeks evidence on whether it is being properly applied within the limits of patent law. The Inquiry heard evidence that patents on the BRCA1 and BRCA2 genes had interfered with medical research in Australia.

The simple scientific truth is that isolated biological materials that are identical or substantially identical to those that exist in nature are not inventions. No one conceived or created them. They are natural phenomena.

Dr Davies’ reference to Professor Ian Frazer’s human papillomavirus vaccine is a red herring. Ian Frazer created a vaccine, which meets the definition of an invention. He did not patent isolated papillomavirus. Acknowledging this distinction, Ian Frazer (who is Cancer Council Australia’s president) also calls for abolishing gene patents, recently telling The Australian newspaper that there was no more invention in isolating and characterising biological material “than in collecting and arranging a set of postage stamps”.

Cancer Council Australia, Clinical Oncological Society of Australia, the Royal College of Pathologists, the Human Genetics Society and others call for an end to gene patents because gene sequencing is not inventive.