“Myriad Australia”

• 1. This case concerns the patentability of isolated nucleic acid sequences, that is, nucleic acid (DNA or RNA) that has been isolated from the cell nucleus. The primary judge stated the question at [1], as whether a patent may be granted for a claim that covers naturally occurring nucleic acid – either DNA or RNA – that has been “isolated”. His Honour said, that in this context, the word “isolated” implies that the naturally occurring nucleic acid found in the cells of the human body, whether it be DNA or RNA, has been removed from the cellular environment in which it naturally exists and separated from other cellular components also found there.

• 2. The particular gene with which Australian Patent No 686004 (the Patent) is concerned (BRCA1) is a human breast – or an ovarian cancer – disposing gene. Mutations that may be present in this gene have been linked to various forms of cancer, including breast cancer and ovarian cancer.

• 3. As Dixon CJ, Kitto and Windeyer JJ made clear in National Research Development Corporation v. Commissioner of Patents [1959] HCA 67; (1959) 102 CLR 252 (NRDC), the field of patentability in modern legislation that is rooted in Sec. 6 of the Statute of Monopolies is not ascertained by verbal or linguistic interpretation of the words and phrases therein: “manufacture” or “manner of manufacture”. Rather, the task is to ascertain whether what is claimed is a proper subject for monopoly by a patent according to the principles that have developed for, and informed, the application of Sec. 6. That task will, of course, require explication of those principles.

• 4. As a matter preliminary to that task and to the task of deciding the appeal, it is worth stating that care should be taken in resort to metaphor in analysis in this field. Metaphor can assist thought, in particular, by the evocation of structure and form by imagination; but it can also blind the eye of the mind by oversimplification. It may risk blinding real illumination that is achieved through analysis of the facts, including the scientific principles involved, by the utilisation of a striking evocation of a simplified structure of analysis that is derived from the metaphor chosen, rather than from the facts as existing.

• 5. So, here, the whole process of isolation of the nucleic acid might be viewed as equivalent to the creation (by well-known means) of a metaphorical microscope enabling one to see into the BRCA1 gene in order to view the exon sequence in the subject person. That metaphor may seem apt because the desire is to find a way of knowing what the person’s gene sequence is, so that vulnerability or susceptibility to cancer can be assessed. A metaphor to see may thus be apt, the desire being to know what is present in the body. This may be seen to assist in persuasion that the differences between the isolated nucleic acid, and what is contained within the body before isolation, are functionally irrelevant; and that what is being sought to be patented is the human body itself.

• 6. The argument is not without its attraction. It lay at the base of the customarily persuasive (if we may respectfully say so) arguments of Mr Catterns QC. We should not, however, be taken as characterising all those arguments as dependent upon metaphor. The reasons that follow reveal their careful detail. (The metaphors used in discussion in the field are not limited to the microscope.)

• 7. The impugned claims in suit should not, however, be determined by oversimplified analysis. They are for a product set within a context of invention described in the specification: a context of development, through research and work, of the knowledge of the mutations or polymorphisms in question, and of the finding of the gene in question.

• 8. In that context, humans intervene to isolate the nucleic acid that is different in chemical composition from its state in the body, and to assess whether that which is present in that (different) isolated product by way of exon sequence coincides with what has been found, by work and effort, to be a sequence (derived itself from a human-made product, cDNA) that bespeaks susceptibility to cancer, and so to be bring about a useful effect, being a state of knowledge for the person upon which to contemplate, or assess, treatment.

• 9. What are the principles and considerations relevant to the applicability of Sec. 6 of the Statute of Monopolies that inform the answer to the question whether the claims here are patentable? …

• 10. First, the boundaries of the conception of patentability are not dictated only by deductive logic from the linguistic premises formulated in the scientific knowledge of a particular age; rather, the boundaries must be such as to be apt to encompass the development of science and technology, and human ingenuity. This explains the broadening concept of patentability since the first quarter of the 17th century.

• 11. Secondly, human intervention that creates an artificial state of affairs that has some discernible effect is essential.

• 12. Thirdly, whilst notions of utility, ingenuity and invention have their place after one concludes that the claim is within the field of s 6, such notions also inform the context of analysis of patentability by assisting in describing the claims to processes or products that are claimed new results of principles carried into practice through human intervention and that create some claimed useful result by involving an artificial state of affairs.

• 13. Fourthly, expressions such as “the work of nature” or “the laws of nature” are not found in the statute; nor are they useful tools of analysis.

• 14. Fifthly, the distinction between discovery of a scientific principle or fact and a deployment of such to a useful end by a procedure is real.

• 15. These important informing principles and considerations assist in the conclusion that, for the reasons set out below, the relevant claims […] are patentable as within the meaning and boundaries of Sec. 6 of the Statute of Monopolies.