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Are gene patents allowable? Progress in the Myriad gene case

We previously reported on the decision of a district court judge in New York, Judge Sweet, who ruled that claims relating to isolated genes in seven patents owned by Myriad were invalid. This decision was appealed by Myriad, and the Federal Circuit has recently heard oral arguments from each side.

Myriad owns 23 patents relating to two genes, BRCA1 and BRCA2, mutations of which have been linked to hereditary breast and ovarian cancer. Because of their intellectual property rights, they are the only company in the US that can carry out DNA testing on these genes to assess the risk of a patient developing cancer. The American Civil Liberties Union and the Public Patent Foundation, on behalf of researchers and public interest groups, brought an action against seven of Myriad’s patents after concerns were raised that the patents restrict science and make it difficult for women to obtain vital medical care.

The human genome is not patentable, however, the patents relate to isolatedsections of DNA. The issue in question was therefore whether an isolated section of DNA should also be excluded from patentability, or whether the human intervention required in isolating the gene means that it is fundamentally different from DNA in the body, and hence is patentable.

Judge Sweet ruled that there was no difference between DNA in the body and isolated DNA, and therefore that the challenged claims in seven Myriad patents were invalid. In the oral hearing before the Federal Circuit, each party has put forward their case.

The defendant

The defendant’s argument centres around the fact that isolated DNA does not occur in nature, and is functionally and structurally different to the same genes attached to a longer DNA sequence.

The claimant

The claimant argued that DNA is DNA, whether it is inside or outside the body, and that an isolated gene is no different to a kidney which has been removed from the body. Further, they pointed out that Myriad’s business model relies on the isolated material being identical to that in the body in order to successfully carry out its diagnostic test.

The government

A representative of the government, arguing as amicus curiae, stated that the question is one of whether the subject matter is manmade or naturally occurring. In the case of claims to cDNA, recombinant DNA and processes, they are clearly manmade. However, he contended that if you can patent isolated DNA, then you can also patent coal, lithium, iron etc since they too have simply been isolated from other materials. Thus, the mere fact of isolating a substance doesn’t make it a human invention.

The original decision by Judge Sweet was contrary to established US case law which states that, provided a use of the gene is disclosed, it is patentable subject matter. We can expect the Federal Circuit to issue their decision in the next few months, and it is probable that it will then be appealed to the Supreme Court. The outcome of this case could have major implications for biotechnology companies with US patents covering isolated genes.


12 May 2011

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