On Friday, the Federal Court released a landmark patent law decision, Cancer Voices Australia v Myriad Genetics Inc  FCA 65. The case was the first Australian decision on the issue of whether a valid patent may be issued for naturally occurring DNA (Deoxyribonucleic Acid) or RNA (Ribonucleic Acid) that has been 'isolated', namely, RNA and DNA which have been removed from human cells and separated from related biological material.
The contested patent was for the BRCA1 gene, a human breast and ovarian cancer-disposing gene. According to Myriad Genetics, mutation of the BRCA1 gene is believed to be the cause of 45% of hereditary breast cancer, and at least 80% of hereditary cancer comprising both breast and ovarian cancers. Cancer Voices Australia disputed the legitimacy of the patent on the footing that the 'manner of manufacture' requirement in section 18(1)(a) of the Patents Act 1990 (Cth) (Patents Act), was not satisfied because the isolated nucleic acid was not materially different to the nucleic acid that occurs in nature.
The High Court considered the phrase ‘manner of manufacture’ in the 1959 case, National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252. In that case, 'manner of manufacture' was found to include a product that consists of 'an artificially created state of affairs which has economic significance'. Here, Cancer Voices Australia acknowledged that the subject matter of the patent was of 'economic significance' and so whether the isolated DNA and RNA was 'an artificially created state of affairs' was the sole issue to be determined.
Ultimately, Justice Nicholas held that isolating nucleic acid created 'an artificially created state of affairs', and consequently was able to be patented. His Honour arrived at this conclusion after considering the following key matters:
The 'broad sweep' interpretation given to 'manner of manufacture' in the National Research Development Corporation case
The difference between 'isolated' and naturally occurring nucleic acid
The Patents Act’s purpose in rewarding the skill and effort of inventors
Law expert from the University of Tasmania, Professor Dianne Nicol, remarked:
“The manner of manufacture requirement has very few teeth. It is difficult to think of the circumstances where an artificially created state of affairs would not exist whenever there is some form of human intervention.”
His Honour specifically pointed out that Cancer Voices Australia abandoned an argument under section 18(2) of the Patents Act, which states that human beings and the biological processes for their generation are not patentable inventions, leaving the law undecided in that respect.
Sally Crossing AM, spokesperson for Cancer Voices Australia commented on the decision:
“We are extremely disappointed and it has far ranging impacts for people with cancer and researchers who want to be able to use these genes that have been patented. The more we restrict use and allow ownership of human genes to particular commercial interests, the more difficult and costly it is to undertake research.”
Cancer Voices Australia is currently considering the judgment, and has yet to reveal whether the organisation will launch an appeal.
Read more here.
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