In Cancer Voices Australia v Myriad Genetics Inc the Federal Court recently confirmed that isolated genetic/biological material is patentable subject matter in Australia.
While Myriad dropped its attempt to enforce patent rights over the BRCA1 and BRCA2 genes in Australia following public backlash, CVA subsequently brought a test case against Myriad arguing that isolated genes / biological material are not patentable subject matter in Australia. In particular, it was argued that even in isolated form the genes are products of nature. The claims in contention defined isolated nucleic acids encoding mutant or polymorphic BRCA I polypeptides linked to breast and ovarian cancer.
In its judgment, the Court clarified that naturally occurring DNA and RNA as they exist in a cell are not within the scope of any of the contentious claims and could never, at least not until they had been isolated, result in the infringement of any such claim. In determining what constitutes a manner of manufacture the Court found that:
• the concept of ‘manner of manufacture’ has a ‘broad sweep’ intended to encourage developments that are by their nature often unpredictable;
• a product that consists of an artificially created state of affairs which has economic significance will constitute a ‘manner of manufacture’; and
• the relevant state of affairs must be the result of some human intervention.
The Court found that the defined isolated genes constitute an artificial state of affairs consistent with a ‘manner of manufacture’ since, 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. Consequently, patentability of such isolated genetic material does not depend on any changes in chemical composition, being isolated is sufficient even if chemically identical. Further, the Court considered that, in line with the wide ambit given by the NRDC decision, it was appropriate that the skill and effort that culminated in the isolation of the biological material should be rewarded by the grant of a patent.
