Gene patents under the microscope

The Senate Community Affairs Committee recently announced that it has again extended the reporting time for the Gene Patents Enquiry. The committee was previously expected to hand down its report in mid-March 2010, but the report is now expected by 2nd September 2010. The committee stated that:

“whilst it has had some discussion over the conclusions and recommendations that it may reach in its report... it requires further time to give more detailed consideration to the complex issues involved and to assess the range of opinions that were expressed in evidence.”

This announcement is perhaps no coincidence. On 8th June 2010 a well-known Australian law firm announced that, acting on behalf of a consortium, it had lodged an application in the Federal Court of Australia against four companies seeking revocation of the Australian patent that protects the breast and ovarian cancer marker genes BRCA1 and BRCA2 (Australian Patent 686 004).The consortium includes Cancer Voices Australia, an advocacy group for cancer sufferers, the law firm running the case and an Australian woman suffering from breast cancer. In this last respect the suit mimics the construction of a case in which the US Federal District Court of New York handed down its decision in March 2010 concerning the patentability of corresponding US patents owned by Myriad Genetics Inc. In that case the patent was held to be invalid because the subject matter was considered unpatentable under 35 USC §101 of the US Patent Code. The same argument will be made in Australia under Section 18 of the Patents Act 1990. The four companies against which relief is sought include Myriad Genetics Inc and Genetic Technologies Ltd, which holds an exclusive licence from Myriad to exploit the patent in Australia. The legal team considers it a test case and is providing its services pro bono. While the law firm handling the matter has little specialist IP expertise, the queen's counsel who will be the advocate in court for the plaintiff’s case is one of Australia’s most eminent IP barristers. The University of Sydney is also supporting the legal team.

In contrast to the situation in the United States, Australia has a universal healthcare scheme and strict government control of the cost of all forms of medicine. In 2003 and 2008 the pressure of public opinion forced Genetic Technologies to back away from forcing two organisations not under licence from using BRCA1 and BRCA2 diagnostically, and it is understood that royalties are not currently charged for the non-licensed exploitation of the patent. The patent is co-owned in Australia by Myriad, The Cancer Institute and the Centre De Recherche Du CHUL, and would normally expire in August 2015.

A total of 72 submissions were received by the Senate Community Affairs Committee, which is charged with determining the impact of granting of patents over human and microbial genes and non-coding sequences, proteins and their derivatives, including those materials in an isolated form, with particular reference to the impact that such patents have on:

• The provision and cost of healthcare.
• The training and accreditation of health professionals.
• Progress in medical research.
• The health and well being of Australians.

The committee is also expected to comment on whether the Patents Act should be amended to exclude patentability for certain subject matter.

At present, Australian patent law has a liberal approach to patentability, excluding under Section 18(2) only human beings and biological methods for their generation. This liberal approach follows from the landmark Australian High Court decision in NRDC v Commissioner of Patents ((1959) 102 CLR 252), in which it was held that as long as the invention results in an artificially created state of affairs, the subject matter is patentable. The Australian scientific community is divided over whether genes should be subject to patent protection and this has been reflected in submissions to the committee. Representatives of the Walter and Eliza Hall Institute for Medical Research, which is the seat of some of the most significant Australian scientific breakthroughs in medical science and which owns patents on gene sequences, have expressed their support for gene patents. Other eminent medical practitioners, including the presidents of the Royal College of Pathologists of Australia and the Clinical Oncology Society of Australia, have spoken out in favour of a ban on patenting genes.

The Federal Court of Australia has scheduled the first hearing of the revocation proceeding on the Myriad Genetics patent for early July 2010. This will be a directions hearing: the main hearing of the arguments is likely not to occur for 12 to 18 months.