Gene patent enquiry triggers calls for law reform

A Senate Committee in Australia is hearing arguments for and against gene patenting with a view to propose future legal reforms in this area. Opponents of gene patents argue that they can restrict access to vital diagnostic techniques, such as breast cancer screening, which identify certain genes that indicate the presence of a disorder. On the other hand, many researchers highlight the need for patents to ‘incentivise’ innovation, which in turn creates such diagnostic tests in the first place.

Some argue that as patents confer a monopoly on holders then it can deter the sharing of information in the scientific community. Addressing the Committee, Heather Drum, of the Breast Cancer Network Australia and herself a survivor of breast cancer, said: 'If someone owns a patent to one gene and someone else owns a patent to another gene associated with breast cancer, my question is, will they ever talk?' She further points out the tension between the altruistic act of donating tissue samples for scientific research and the commercial nature of patents. 'I would feel really devastated if the tissues I have donated and my sister has donated are used... to make money. If you discover a treatment or cure, then patent that. Don't patent the gene. Patent the cure,' she told the Committee. Opponents say that instances of possible restrictive behaviour arising from patents have occurred in Australia. The Age newspaper has reported that Genetic Technologies, a private company based in Melbourne, had asked health centres to cease testing for a certain gene which it held a patent over that indicated the presence of breast cancer.

In the other camp, supporters of gene patenting argue that patents are crucial to research and development. Julian Clark, head of business development at the Walter and Eliza Hall Institute, told the Committee that patents 'maximised the chance of transition' of inventions from the laboratory to a point where they are available to end-users. 'In order to maximise the invention reaching the clinic, you have to have sound intellectual property protection... Patenting is an integral part of research and setting the scene for results... no one is going to go close if they are not assured some monopoly for a certain period,' he said. He defended gene patents saying that the process of isolation and developing the gene for therapeutic use illustration them to be inventions rather than discoveries, which are not patentable.

Not everyone is convinced, however. Sally Crossing, speaking to the Committee on behalf of Cancer Voices, said: 'As an ethical principle, we do not believe that genes, as natural parts of the human body, should be patentable. We strongly recommend that Australian patent law be amended so that no part of the human body can be patented.' Dr Clark said that rather than scrapping patents the law could be reformed to set the price of licences at a reasonable level to ensure wide access to gene therapies and diagnostic testing.

The Committee will continue to hear submissions and is due to publish its report on 26 November 2009. In other developments, an organisation named the American Civil Liberties Union has filed a lawsuit in New York against against Myriad Genetics, the University of Utah Research Foundation and the US Patent and Trademark Office challenging the validity of two breast cancer gene patents: BRCA1 and BRCA2. The case is ongoing.