Last year, the Federal Court of Australia ruled that human genes are patentable, specifically the BRCA1 gene associated with an increased hereditary risk for breast cancer.  In a case involving Myriad Genetics and patient advocacy group Cancer Voices Australia (CVA), the court ruled in favor of the molecular diagnostic company, upholding its patent on the BRCA1 gene and diagnostic methods, claiming that its reference to isolated DNA made it a patentable “manner of manufacture.” 

The U.S. Supreme Court, however, has a different opinion.  In June of 2013, the Supreme Court made the official decision that BRCA1 is not patentable and stated that patents on human DNA will simply “impede the flow of information that might permit, indeed, spur invention.”  Myriad was first awarded patents on the gene back in the 1990s, and claims to have helped roughly a million people learn more about their risk for cancer since then. 

Despite the two “final” rulings, the question of whether isolated genes are “products of nature that may not be patented or human-made inventions eligible for patent protection” remains.  In the U.S. Supreme Court ruling, Justice Clarence Thomas wrote for the unanimous court that, “Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued.”

The Federal Court of Australia, however, stands firm in its decision, though it’s not a popular one.   Those in opposition of the ruling may appeal to the High Court, but many feel now that their best bet may be to start looking at Australian patent law in general. 

As published in an article on MedCityNews, Director of Advocacy Paul Grogan said in a statement that, “The ruling puts Australia out of step with the US, where the Supreme Court invalidated the Myriad patents…If the difference is in the way Australian patent law is interpreted, then there is a strong case to change the law.”