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

Thursday, June 27, 2013

A step backward for patentable subject matter?

By Senior Associate Tom Reid and Law Graduate Israel Cowen

In February we reported that a Federal Court of Australia decision holding that isolated nucleic acid encoding a gene was patentable represented 'a step forward for patentable subject matter'. Now, the US Supreme Court has ruled in a corresponding case that isolated genomic nucleic acid is not patentable, prompting the question: does this decision represent a step backward?

The US Supreme Court decision in Association for Molecular Pathology v Myriad Genetics Inc, which was handed down on 13 June 2013, involved claims in Myriad's US patents relating to the isolated BRCA genes that were at issue in Australia in February. To recap, mutations in these genes indicate a predisposition to breast and ovarian cancers.

The unanimous reasoning of the US Supreme Court was that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. Under US law, natural phenomena, like laws of nature and abstract ideas, are unpatentable per se.

The fact that Myriad had expended considerable effort and resources on identifying the gene and its mutations did not affect the analysis. Essentially, the US Supreme Court was looking for (in the words of the US statute) a 'new and useful…composition of matter'. The way in which the claims were interpreted was central to the court's analysis. Had the claims focused on the chemical changes that resulted from physically isolating the segment of DNA, the isolated genomic nucleic acid may have been considered a 'new', or different 'composition of matter', and therefore patentable.

Importantly, the court held that by contrast, because synthetic 'complementary' DNA (cDNA), was not naturally occurring, it is patentable subject matter under US law. Therefore, the claims of the patents directed to cDNA were upheld by the court.

Despite initial appearances, this decision is not necessarily a 'step backward' for patentable subject matter, in either the US or Australia.

First, as in Australia, the Myriad decision in the US concerned only those claims of the Myriad patents which related to the isolated nucleic acid itself. It left all the claims concerning the use of that isolated nucleic acid (for example, through testing for genetic predisposition to breast and ovarian cancers) unaffected, and therefore enforceable.

Secondly, biotech innovators have, in any case, been moving away from patent claims addressed to isolated genomic nucleic acid alone.

Thirdly, Australian law, as set out by Justice Nicholas in the Australian decision in February, is substantially different from that in the US – at least at present. The appeal of Justice Nicholas' decision is to be heard shortly.

For more, read our forthcoming Focus on the decision.

No comments:

Post a Comment