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Human genes cannot be patented in the United States

RThe Supreme Court of the United States recently released its decision in Association for Molecular Pathology v Myriad Genetics Inc finding that human genes cannot be patented.

Myriad Genetics Inc is a molecular diagnostic company which discovers and commercialises tests to assess a person’s risk of developing a disease.  The company discovered the precise location and sequences of BRCA1 and BRCA2 genes.  If these genes mutate, they significantly increase the risk of breast and ovarian cancer.  This knowledge had the potential for tremendous commercial value through the commercialisation of tests for these cancers.  Myriad obtained several patents which would give it the exclusive right to isolate a person’s BRCA1 and BRCA2 genes and would give it the exclusive right to create the synthetic cDNA for the BRCA genes.  Several parties challenged the validity of those patents.

A unanimous Court found that, because the BRCA1 and BRCA2 genes are a product of nature, their mere isolation does not justify the recognition of a valid patent.

The Court found differently in regards to Myriad’s cDNA patents.  The Court held that because cDNA is not a product of nature, it does not present the same obstacles to patentability.  Significantly, this finding provides that Myriad’s particular test for the gene which utilises cDNA is patentable.

This decision appears to have found a compromise between two common arguments.  The protection of intellectual property supports commercialisation of the subject matter.  This provides incentives to expensive and lengthy research and development.  However, many believe that certain things should not be allowed to be the subject of IP rights.  These things include “human beings”, such as is mentioned in s 18 of the Australian Patents Act, or other naturally occurring substances such as genes.

Click here to read a CNN article on the topic, or for more information contact our office.