The US Supreme Court on June 13 2013 handed down its much awaited decision in Association for Molecular Pathology v Myriad Genetics Inc.
The US’s highest appellate court held that although cDNA (that is to say artificially synthesised) molecules are eligible for patent protection, a sequence of DNA molecules isolated from their natural state by known techniques is not.
In reaching its conclusion the Supreme Court placed heavy emphasis on the findings that:
- the genetic information encoded in the isolated gene sequence was the same as that in the naturally occurring gene;
- the nucleotide location and order in the claimed gene sequence existed in nature before Myriad isolated the genes;
- Myriad did not alter the genetic structure of DNA.
The Court was not persuaded by the argument that, in isolating DNA from its natural environment chemical bonds were severed thereby creating a non naturally occurring molecule.
Justice Thomas of the US Supreme Court noted that the decision was a limited one in that it did not involve (a) method claims, (b) patents on new applications of knowledge about the BRCA1 and BRCA2 genes (which were the subject matter of the case) or (c) the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.
It is too early to speculate about the full effects of the decision but it has the potential to have a chilling effect on innovation in the biotechnology sector. The decision can be contrasted with the decision of the Australian Federal Court in the comparable case that was recently decided in favour of the patentability of isolated gene sequences in Australia. That decision is currently on appeal to the Full Court of the Federal Court of Australia and no doubt the decision of the US Supreme Court will feature prominently in the Australian appeal.