Biotech invention through which vulnerability to cancer can be detected held to be non-patentable

High Court of Australia: In a pivotal issue relating to claim of patent of isolated nucleic acid coding for BRCA1 protein with specifies mutations or polymorphisms indicative of susceptibility to cancer, the Court held them as non-patentable. The present petition was based on three claims i.e. (1); whether invention claimed is a patentable invention under Section 18(1);(a) of Patents Act 1990 (Cth); (2) whether invention claimed is a “manner of manufacture” within meaning of Section 6 of Statute of Monopolies and lastly (3) whether it is sufficient that invention claimed is artificially created state of affairs of economic significance. The fact that isolated nucleic acids cannot produce the natural polypeptide was held to be irrelevant. It was said that production of natural polypeptide is not a characteristic of claims 1-3. The term “manner of manufacture”, and the concept it embodies, was and is no more pregnant with rules and applications awaiting discovery, than is the common law. The Court while discussing further, said that Claims 1-3 are not claims to the fact that specific mutations and polymorphisms in the BRCA1 gene are indicative of a predisposition to breast cancer and ovarian cancer,  nor are claims 1-3 claims to applications of that fact. Instead, claims 1-3 are claims to a product: an isolated nucleic acid which has one or more specific mutations or polymorphisms in the BRCA1 gene. It was noticed that the methods of isolating the nucleic acid and identifying the mutations and polymorphisms in the BRCA1 gene were neither new nor claimed. Hence, it was held that the claims 1-3 are to any isolated example of the BRCA1 gene which discloses the characteristic – one or more specific mutations and polymorphisms in the BRCA1 gene that are indicative of a predisposition to breast cancer and ovarian cancer. [D’Arcy v Myriad Genetics Inc [2015] HCA 35, decided on 7.10.2015]

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