18 June, 2013

The US Supreme Court: Human DNA cannot be Patented

The long road of litigation has finally come to an end at the Supreme Court regarding the patentability of human genes. The Court was unanimous in its decision in the case (with Justice Scalia concurring in part but still agreeing with the decision), which came to a slightly surprising outcome, at least to this writer. The discussion on the possible outcome of the case based on the oral arguments a month or so ago on this blog can be found here.

The subject of patent desires
For those who haven't been fully introduced to the facts of the case, the Association of Molecular Pathology v Myriad Genetics dealt with patents relating to certain genomes; BRCA1 and BRCA2. These genes were patented by Myriad Genetics some 15 years ago, and they specifically relate to the identification of a potential heightened risk of getting breast or ovarian cancer for women. Analysis of the genes is used to identify potential mutations in those genes, causing the increased risk, and the only way to identify that potential mutation was controlled by Myriad. The Association of Molecular Pathology and others subsequently challenged the patentability of human genes.

The argument on the Association's part hinged on 35 USC § 101 which defines what subject matter can or cannot be patented. The Supreme Court's standing on what is excluded under section 101 was well stated in the case of Mayo Collaborative Services v Prometheus Labratories: "...laws of nature, natural phenomena, and abstract ideas". Whether the isolated genes could be seen as something that is not a natural phenomenon, they could be patented. A similar decision to the US Court of Appeals position prior to the Supreme Court have was handed down in Australia  (pending appeal to the Full Federal Court this Autumn), where the isolation of a human gene has been seen as a unnatural phenomenon, due to the isolation creating an artificial state of affairs. Myriad's contention to the appeal remained in that the locating and isolation of the gene (separating it from its natural state) from the human cell was enough to make that particular gene something which does not exist in nature by itself, attaining patentability.

The Supreme Court found against Myriad Genetics, and in a unanimous decision seems to have put this issue to bed with a firm stance. What was key in the Court's argument should be highlighted in itself to better appreciate why human genes, in this instance, couldn't be patented:
"It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them.  Nor did Myriad create or alter the genetic structure of DNA."
In locating and isolating the genes Myriad hadn't created anything new, or altered the existing genes in any way. The mere process of taking those genes out of the cell, although it did alter the physical space where the genes resided, didn't in itself change those genes enough for them to be patentable. Should Myriad have altered the genes some way in their structure for example, the genes could have potentially been a patentable subject matter. If simply looked at within the cell, after being located, the genes themselves would exist as exactly the same as the ones isolated from the cell. The Court did leave cDNA patentable, as it is an artificially created from RNA and therefor doesn't exist naturally.

So what does this mean in practice? Myriad Genetic's patents were both roughly 15 years old, with the patent term in the US being 20 years. With the patents being close to their terms' end, their financial value in them is probably very minimal. The appeal can largely be understood as one of principle, setting a precedent preventing future patenting of human genes by companies. As said, the decision doesn't outright prevent the patenting of genes, so should sufficient changes be made to the genes rendering them something that doesn't appear in nature, they potentially could be patented. Whether the decision will affect other jurisdictions such as Australia will remain to be seen, as US precedent is not binding on Australian courts. It would be incomprehensible that the case would not have any weight, so this writer will await the Australian decision with excitement.

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