The ‘Myriad’ with the Golden ‘Gene’: Australia Upholds Breast Cancer Gene Patents
March 8, 2013 by Ryan Heighton (IPilogue Editor)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.
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Ever since the Myriad litigation began a number of years ago, I haven’t been able to pick a side of the argument. I feel I may be on Dr. Palombi’s side where the patenting of genes will only contribute to the creation of monopolies or “cartels”. The monopoly may already have begun since the cost of breast cancer screening has nearly tripled since Myriad patented the BRCA genes. The alternative argument is that companies like Myriad may be unlikely to take on the costly endeavour of researching and uncovering potential cancer markers if they are not adequately compensated. I guess this is the age-old tug-of-war or balancing act we have grown accustomed to in intellectual property law.
Since s. 2 of the Patent Act defines an “invention” as “any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter,” it’s clear that there are limitations on what can be patented. These limitations were noted by the court in Harvard College v. Canada where it was held that the definition of “invention” in the Patent Act demonstrates Parliament’s intention to include certain subject matter as patentable and exclude other subject matter as being outside the confines of the statute. Since one of the earliest dogmas of patent law was premised on the fact that “anything under the sun made by man” is patentable, one can assume that genes, proteins, and living matter that exist naturally within living organisms would not be patentable subject matter. Clearly, the U.S. and now Australia do not agree.
In the U.S. case, Merck & Co., Inc., v. Olin Mathieson Chemical Corporation, the court held that DNA and protein sequences were deemed patentable so long as they are isolated and purified. After considerable public outcry and political pressure, it was not surprising that the U.S. Patent Office released the “Utility Examination Guidelines” which made patenting DNA and protein sequences more difficult. The Guidelines stipulated that a DNA or protein sequence patent would only be awarded if the function of the sequence was known. The U.S. Myriad case is the landmark decision in this area. The court held that isolated genes are patentable subject matter because DNA isolated from the body is “markedly different” from the DNA that exists naturally in chromosomes. It seems that Australian courts are following a similar pattern of reasoning since they feel that isolated genes are patentable because they are “not naturally occurring DNA or RNA as they exist within the cells of the human body.”
An argument can be made that Canada is headed down the U.S. and Australian path of gene patenting. The court denied a patent on the Oncomouse in Harvard College v. Canada; however, in Monsanto Canada Inc. v. Schmeiser, the court held that a patent covering the commercial rights to genetically-modified cells in canola plants extended rights to the patent holder over the entire plant. The holdings in Harvard College v. Canada and Monsanto v. Schmeiser are clearly contradictory, but this just may reflect how Canada is adopting the trend seen in other jurisdictions.
These cases bring to the forefront the unresolved social, biological, political, ethical and economic issues surrounding this area of patent law. The courts are likely influenced by various non-legal factors such as the economy, investments, and international competitiveness. As a result, these non-legal factors have taken priority over established legal doctrines. It’s definitely clear that the commercialization of genomic research will continue to grow. Allowing research and patenting to progress uninhibited might be the right choice for some; however, this approach may permit too much naturally occurring material to become the property of a few large companies. I’m not sure if limiting scientific research to only a select few will contribute to or stifle innovation. Likely the latter, but only time will tell.