Federal Court starts hearing appeal against breast cancer diagnostics patent

The full bench of the Federal Court in Sydney has today begun hearing an appeal against a lower court decision by a single judge that genetic subject matter is patentable under Australian law. The case specifically relates to a patent owned by Myriad Genetics Inc., and licensed in Australia to Genetic Technologies Ltd and which is directed to BRCA1 and BRCA2 genes and their use in the diagnosis of certain types of breast and ovarian cancer. Paralleling a very similar case in the United States, much of the mainstream media reporting on the cases has been emotive and lacking in legal accuracy.

The argument of the Appellant runs that, since the genes ‘exist in nature’, and so were discovered and not invented, they should not be patentable subject matter. We have previously reported on the lower court decision.

The Appellant’s legal representative continues to state that the patent prevents other companies from doing research that might help save lives. This is incorrect. Section 119C of the Australian Patents Act explicitly exempts acts done for experimental purposes from a finding of infringement.

The US Supreme Court recently ruled that genes extracted from the human body are not eligible to be patented in all their various forms, but critically, that cDNA forms of genetic material are patentable subject matter. So far no reference has been made in the local appeal hearing to the US court’s decision.

The fact remains that US law and Australian set out different tests for patentable subject matter.

The Australian government has moved to address public disquiet over the patenting of genetic subject matter by proposing insertion into the Australian Patents Act of an exclusion from patentability for inventions, the commercialisation of which would be considered wholly offensive by the Australian public.