The Full Court of the Federal Court in D’Arcy v Myriad Genetics Inc  FCAFC 115, upheld the decision of the primary judge who found that isolated nucleic acids are patentable subject matter. Such mutations dispose humans to breast and ovarian cancer.
Importantly, the question to be determined on appeal was whether a claim to isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide could be considered a patentable invention within the accepted principles articulated inNational Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252. That is, whether it is a product that consists of an artificial state of affairs that brings about an economically useful result.
The Full Court in dismissing the appeal, found the following:
- the subject matter of the claims is a product and not a claim for information;
- the claimed product is an artificial state of affairs;
- an isolated nucleic acid is a chemical molecule which is chemically, structurally and functionally different to what occurs in nature. An example of a functional difference that was given was that isolated DNA cannot produce a protein without artificial intervention, unlike genomic DNA which can be the subject of cellular processes like transcription and translation; and
- the claims to the isolated nucleic acid led to an economically useful result being the treatment of breast and ovarian cancer
The outcome of this appeal does not change the current law but confirms that isolated nucleic acids are patentable subject matter.
Finally, even if the claims to an isolated nucleic acid was not considered to be patentable subject matter, Myriad Genetics Inc would still be in a commercially sound position as the invention also encompasses use of mutations of the BRCA1 gene including methods for diagnosing a predisposition to breast and ovarian cancer.