Scintilla – a flash, a spark, an iota. Shorthand for creativity and an indicator of inventiveness under Australian law.

Thursday, October 8, 2015

High Court unanimously finds isolated genetic material not patentable

By Trevor Davies, Partner, and Linda Govenlock, Managing Associate

As the culmination of a hard-fought patent dispute, the High Court of Australia has unanimously ruled that Myriad Genetics' patent claims to isolated nucleic acid coding for the mutant or polymorphic BRCA1 polypeptide are not valid. This emphatic decision in D'Arcy v Myriad Genetics Inc overturns the previous decisions at trial and on appeal before the Full Federal Court, and effectively nullifies the long-standing practice that 'isolation' of material from a natural source was sufficient to meet the patentable subject matter threshold in Australia.

The High Court indicated that it was not concerned in this appeal with 'gene patenting' generally, but with whether the invention as claimed fell within established applications of the concept of 'manner of manufacture' which frames the fundamental issue of patent-eligible subject matter under the Patents Act 1990 (Cth). The High Court criticised the approach of the primary judge and Full Court for applying a 'verbal formula' adapted from the High Court's landmark decision in National Research Development Corporation v Commissioner of Patents to the question of patentable subject matter, namely, that to be patentable it was 'sufficient for a product to result in an ''artificially created state of affairs'', leading to ''an economically useful result'." The High Court found that approach was too narrow.

Myriad had argued that the claims were directed to a chemical compound and that there was no jurisprudential basis or normative principle upon which claims to isolated nucleic acids should be treated differently from any other product claims. The High Court did not accept this argument and found that the substance of the invention was the information embodied in arrangements of nucleotides that encode BRCA1 polypeptide. As this information was not 'made' by human action but only discerned, and was in effect identical to the information in the human body, the claims were not eligible for patent protection.

Consistent with the US Supreme Court in the related US proceedings, the High Court agreed with counsel for D'Arcy that Myriad's claims were simply not expressed in terms of chemical composition and did not rely on the chemical changes that resulted from the isolation of a particular section of DNA to identify a predisposition to breast and ovarian cancer. The High Court concluded that this characterisation, so far as it emphasised the focus of the claims on genetic information encoded in the BRCA1 gene was applicable in this case and, contrary to the view of the Full Court, was the characterisation that should be accepted. In doing so, the High Court has gone further than the US Supreme Court, finding that BRCA1 cDNA also is not patentable.

Whilst the decision may be disappointing to innovators and researchers within the biotech sector, all is not lost. Importantly, claims to diagnostic methods for detecting BRCA1 were not challenged and the High Court has sent a strong signal that claims to genetic tests and diagnostic methods remain eligible for patent protection.

Following this decision, innovators developing biological products by mere isolation from natural sources will no longer be able to protect the isolated products per se. If, however, the biological products are modified to alter their function or activity for particular uses, then this should meet the patentable subject matter threshold in line with the approach set out by the High Court.

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