Patents enabling and supporting medical research and resulting tests, vaccines and treatments

Patents are at the core of enabling genetic tests, treatments, vaccines and cures resulting from medical research, says AusBiotech - contrary to reports stemming from last week’s Federal Court decision in the D’Arcy v Myriad Genetics case that claim research is being stifled.

The Full Court of the Federal Court of Australia Court unanimously dismissed the appeal, upholding the previous court’s decision affirming that isolated genes remain patentable subject matter under Australian law. 

While AusBiotech welcomed the court’s decision to uphold the patent, it also acknowledges the complexity of the debate and remains concerned about misinformation claiming that the existence of patents hinders medical research.

Patents support medical research reaching the community in the form of tests, vaccines and treatments as they enable medical research institutes and companies to attract funding to further develop the technologies. A test, treatment or vaccine can take more than a decade to develop and cost more than $1 billion. Patents are a primary incentive for investment in R&D and secure investors for a fixed period of time in which to protect or recoup their investment. Without investment, Australian companies developing new technologies are unlikely to survive, let alone continue their R&D.

Contrary to some public commentary, a patent does not hide technologies but instead places them on the public record, giving researchers access to that information. To further ensure access for researchers, the ‘Raising the Bar’ Bill was passed into law by the Australian Parliament in 2012 to provide even greater comfort to the community and researchers alike. It increased the patentability thresholds applicable in Australia, created an exemption from patent infringement for the research use of an invention and significantly broadened the regulatory approval activities in respect of which patented technology could be freely used. The Bill heralded an improvement in IP management in Australia, providing more certainty for researchers and harmonising Australian patent standards with the higher international standards.

For a patent to be granted it must meet several eligibility criteria, of which the requirement for technology to be “patentable subject matter” is just one. The technology must also be new (ie, novel), inventive (ie, not have been obvious to have been developed by someone of knowledge and skill in the technological field of the invention) and have utility. Under Australian law as it existed before this decision, it was virtually not possible to obtain a patent on a gene anyway due to the publication of the human genome, which destroyed the novelty of any subsequently identified genes.

For more information about the Federal Court decision, please see here for an update published by Watermark