The Myriad Genetics gene patenting saga has officially shaped international jurisprudence, with the Federal Court of Australia upholding the patents for BRCA1 and BRCA2. In Cancer Voices Australia v. Myriad Genetics, NSD643/2010, Federal Court of Australia (Sydney), the first Australian case to deal with the issue of gene patents, the Court took a similarly liberal and divisive approach to that of the American Courts (pending appeal).
The criticisms from Australia concerning the patenting of genes echo those expressed throughout the North American battle. The primary attack on assigning patents of genetic materials to a company surrounds the invention component of the patent. Australian patent lawyer and proponent for ‘free trade’ of genetic materials, Luigi Palombi, likens companies such as Myriad to ‘cartels’, emphasizing that the genes are not something that anyone has invented. Palombi cautions that allowing gene patents will permit patents on any biological materials that are artificial, irrespective of their source.
In an extremely accessible and well-organized decision, the Court surveyed the biological principles necessary to consider gene patents (this comprises more than half of the decision, and I strongly recommend it to anyone without a strong background in biological or medical sciences). The Court accepted the arguments of Myriad’s Australian lawyers, who leaned heavily on the arguments put forward by Myriad in the American case (although it noted that due to differences in the patent legislation and jurisprudence the American case itself was neutral, benefitting neither party). It was held that:
(1) because the genes are not naturally occurring DNA or RNA as they exist within the cells of the human body (which are not patentable, per s. 18(2) of the Patents Act 1990), they are not precluded from being the subject of a valid patent, and
(2) the patent claims to the genes are indeed to a manner of manufacture as required by s. 18(1)(a) of the Patents Act 1990.
With respect to (1) above, the Court was very conscious of the legislative intentions in drafting s. 18 of the Patents Act. In para 112 of the decision, it was acknowledged that a proposal was brought and subsequently rejected that would have included isolated DNA and RNA in the s. 18(2) provision. As such, it was left to the Courts to deal with the issue of gene patenting by establishing jurisprudence.
The Court found that because the patented nucleic acid sequences for BRCA1 and BRCA2 are independent and isolated for native DNA, it is patentable. Furthermore, because the sequences could not exist in isolation without human intervention, the patented matter consists of “an artificial state of affairs” (see paras 101-110), a necessary condition for invention in the Australian legislation. Even if it has been removed from a biological cell, the Court held that it is reasonable to deem the isolation ‘artificial’, emphasizing the process of isolation rather than the extracted material. Addressing broader concerns, Myriad’s counsel also emphasized that the screening process of the patent, which includes the diagnostic component of comparing normal and mutated genes, could not be used to “build another human being”. However, in my opinion, this does not address the important issues of access to medicine and the potential detriment that the patents pose to scientific progress.
The present case was in the form of a lawsuit brought by a national organization representing cancer patients, Cancer Voices Australia, and a Brisbane cancer survivor concerned with the impact that the gene patents will have on breast cancer diagnosis and treatment. I share these concerns. Indeed, I have written at length about the concerns about Myriad’s monopolization of the market and the conflation of trade secrets and patents, so I would direct your attention there for this discussion. However, for those opposed to the patenting of genetic codes and the processes for isolating genes, this Australian decision certainly gives reason for concern. That said, Myriad’s victory down under may be short-lived, as Cancer Voices Australia announced on March 3, 2013 that they have filed an appeal to the decision of the Federal Court.
Ryan Heighton is a JD candidate at Osgoode Hall Law School.