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Human genes that have been isolated from the human DNA cannot be patented in the United States. This landmark decision was made on 13 June 2013 by the highest court of the United States, the United States Supreme Court, in Association for Molecular Pathology v Myriad Genetics 569 US 12-398 (2013).
The bad news is that, unfortunately, this decision does not extend to ‘synthetic’ genetic material that can still be patented even though ‘synthetic’ genetic material, when examined closely, is not artificial at all. It is still something that exists in nature and should therefore not be patentable.
The good news is that at least the so-called ‘non synthetic’ genetic material may no longer be patented in the United States. This decision will have a profound effect on existing US patents that have been granted to biotechnology and medical companies over the last few decades. These patents will now be void in the United States - a win for public interest groups and humanity at large, and a loss for biotech.
How does this US Supreme Court decision affect the many thousand Australian patents that IP Australia has issued over genes and other biological materials over the years? Most people who have thought patterns based on common sense would argue that these Australian patents have been wrongfully issued, since one of the fundamental rules of patent law in Australia is that patents can only be granted over inventions, not mere discoveries of something that already exists in nature. Humans are yet to invent genetic material. This simply has not happened.
As discussed in the writer’s previous article “March Against Monsanto 2013 - Patenting of Genes and GMOs” of 25 May 2013, the relevant court in Australia, the Federal Court of Australia, was first asked to decide in 2012 whether isolated human genes can be patented - in the Federal Court of Australia case Cancer Voices Australia v Myriad Genetics Inc  FCA 65. In that case, Myriad Genetics had obtained a patent on a breast cancer gene, the BRCA1 gene.
In the writer’s view, the BRCA1 gene is not an invention. It is something that exists in nature. It was discovered, not invented. Therefore, it should not be patentable.
Judge Nicholas, the Federal Court of Australia judge who handed down the Myriad Genetics decision on 15 February 2013, acknowledged that a gene that is in the human body, cannot be patented. However, Judge Nicholas then turned around and held that once the gene is isolated, that is, removed from the human body, it can be patented.
The second applicant, Yvonne D’Arcy, a cancer survivor, then appealed the Myriad Genetics decision to the Full Federal Court, where the appeal was heard in August 2013. The Full Federal Court decision is pending, and both, biotech and public interest groups are waiting in suspense whether the Full Federal Court will follow the decision of the United States Supreme Court - Association for Molecular Pathology v Myriad Genetics 569 US 12-398 (2013).
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If you would like to find out more about the problems arising from patenting of genes, please contact us on 0410 583 550 or by email: email@example.com.
Beatrice Ludwig is the Principal Solicitor at Ludwig Lawyers.