“The issue that arises in this case is of considerable importance. It relates to the patentability of genes, or gene sequences, and the practice of gene patenting”.
So began the reasons for judgment of the Federal Court of Australia in Cancer Voices Australia v Myriad Genetics Inc, published last Friday.
Until now, there had been no Australian court decisions on the patentability of isolated DNAor RNA sequences. Myriad Genetics, claiming a patent related to the BRCA1 gene, won this recent case. The challenge to their patent was dismissed. Three things permit an understanding of why.
What is BRCA1? It is a human breast and ovarian cancer disposing gene. According to the disputed patent, mutation of the BRCA1 gene is thought to account for 45% of hereditary breast cancer, and at least 80% of hereditary cancer involving both breast and ovarian cancer.
Can genes as such be patented? No. Patents cannot be granted for products of nature. There is no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent.
Was this particular patent valid? This was the core of the debate. Myriad Geneticsargued that its patent related to isolated DNA and RNA, extracted from cells removed from human body and purged of other biological material with which it is associated in the cell.Cancer Voices Australia argued that there is no significant or material difference between nucleic acid in its natural and isolated states. Scientific experts gave evidence on these issues, to assist the Court.
In analysing the competing arguments, the Court said that a composition of matter may be patentable if it consists of an artificial state of affairs, with some discernible effect, of economic utility and the result of some human intervention. Quoting from the judgment: “The real problem lies in knowing, or rather not knowing, what degree of human intervention is necessary before it can be concluded that the requisite artificial state of affairs exists. It is an especially difficult problem in the present case, not so much because the authorities provide no clear solution to it, but because the problem has an almost metaphysical dimension to it.”
Ultimately the Court decided that there was the necessary artificial state of affairs, explaining:
- Earlier cases binding on the Court regarding similar issues had used expansive language.
- In the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and isolated nucleic acid does not exist inside the cell.
- It would lead to very odd results if a person whose skill and effort culminated in the isolation of an DNA sequence could not be independently rewarded by the grant of a patent
The Australian judicial system is transparent and reviewable. Transparent, so anyone can freely access online the full reasons for judgement in Cancer Voices Australia v Myriad Genetics Inc. Reviewable, so dissatisfaction with the outcome may be tested in an appeal from the decision – perhaps even two appeals, should the issues warrant determination by the High Court.
Changes to the law
The Patents Act is crafted by the Australian Parliament. Should it wish, the Parliament may amend its legislation to provide for a different balance between private and public rights. Reform in this area has been considered in the past. In Genes and Ingenuity: Gene Patenting and Human Health the Australian Law Reform Commission recognised that concerns could be raised in relation to patents for isolated biological materials. TheAustralian Government’s 2011 response accepted the recommendation that the legislation not be amended to exclude genetic materials and technologies from patentable subject matter, though some other amendments to intellectual property laws have recently been made.
Similar arguments about gene patients are soon to be considered by courts elsewhere.CNN quickly reported the recent Australian decision, noting that that the same gene along with BRCA2, is at the centre of a high-profile lawsuit set to be heard by the United States Supreme Court in April 2013.
The frontier of genetic medical research seems likely to remain on the Australian and international judicial and parliamentary agenda for some time to come.