It has the potential to directly affect the operation of the healthcare and medical research industries, particularly with regards to cancer treatment and prevention, and may alter the accessibility of such therapies to patients.
[1] Genetic Technologies attempted to enforce its rights and stop other laboratories from performing the tests as recently as 2008, but was forced to back down following public protest.
[6] This would not have been difficult for Myriad Genetics to demonstrate in its BRCA patent applications, as its inventions were designed for the purposes of testing subjects for their susceptibility to breast and ovarian cancers.
[9] As a result, the company's monopoly may inhibit research and prevent the development of improvements in breast cancer testing technology.
[10] Myriad Genetics has used sequencing of the BRCA genes to develop a test for hereditary breast and ovarian cancers, which it markets to laboratories as BRACAnalysis.
[14]: p 108 In 2015, the High Court of Australia unanimously ruled that isolated nucleic acid does not qualify as proper subject matter for patent protection.
The effects of gene patents on development in the medical industry will become clearer when an Australian Senate inquiry report is released in June 2010.
As such he dismissed the case on a summary hearing in favour of the plaintiff, the American Civil Liberties Union, as being the 'longest of long shots'.
[19] Myriad Genetics has a number of possible arguments that it could put forward in any forthcoming appeals, and will likely be focussing on the law surrounding validation of gene patents based on their isolation.
The President and CEO of Myriad Genetics, Peter Meldrum, claims that the existence of gene patents and their granting to young start-up biotechnology companies is crucial for the development of the industry.
The US court decision will have no official bearing on Australian percent as the jurisdictions are entirely separate, and as such the doctrine of stare decesis will not apply.
However, the close alignment of the two countries' legal systems and business interests may signal knock-on effects in Australia, with the potential for the US verdict to establish persuasive precedent.
[22] Given the size and nature of the Australian biotechnology industry, such a conclusion was likely expected, as patent licensing is particularly important to facilitate further research.
Overall, the ALRC report's recommendations do not require legislative change, but rather they involve the development of revised guidelines or alternative action by the government and/or non-governmental organisations.
[24] The submission details how gene patenting can actively discourage scientific research and discovery to a larger extent that it rewards innovation.
While conceding that legislative action alone is not an effective long-term solution, the Cancer Council stresses the importance of increasing the availability of resources to the Australian Competition & Consumer Commission.
[25] The submission concluded that any proposed amendment to current legislation would prevent a significant proportion of the Australian biotechnology industry from protecting innovations, resulting in an adverse effect on potential commercialisation opportunities and reduced investment.
At the inquiry, Australia's Department of Health and Ageing presented evidence supporting the "intention" of the Bill, but not its specific language.
[27] In deciding whether to exercise this discretionary power, an examiner must have close regard to whether an invention is primarily intended for an unlawful use.
While TRIPS does offer some provisions for exceptions,[29] the full impact of these sections would adversely affect the level of domestic innovation and cross-country trading.