Cancer Voices Australia v Myriad Genetics Inc in the Federal Court of Australia

Tuesday 28th February 2012

A landmark case which could have major implications for the Australian biotechnology sector was launched last week in the Australian Federal Court against patent holder Myriad Genetics and its Australian licensee, Genetic Technologies. 

The case relates to a patent on isolated sequences of the breast cancer susceptibility gene, and their use in diagnostic testing for the presence of the BRCA1 gene.  The gene is associated with a significantly increased risk of breast and ovarian cancers in women. 

This case will consider the question whether a naturally occurring biological material, when isolated in a purified form from its natural environment, is an “invention”.  To date, no Australian court has considered whether isolated genes are patentable subject matter. 

Cancer Voices Australia seek to completely prohibit gene patenting and are challenging the grant of Australian patent 686004 on the ground that relates merely to the discovery of the genetic mutation.  Under Australian law, discoveries are not considered patentable subject matter.   

A similar case was heard in the US in 2010.  A New York District Court judge ruled that Myriad’s US patent was invalid as DNA in an “isolated” form, where the DNA sequences are “substantially separated from other cellular components which naturally accompany native human genome sequences”, showed no marked difference from the sequences found within the human body.  The case was later appealed to the US Court of Appeals for the Federal Circuit, which overturned the decision of the New York District Court.  At the present time, the US patent remains in force. 

The basis of the patent system lies in providing a fixed-term monopoly over an invention, in exchange for public disclosure of the invention.  This in turn encourages research and innovation and allows researchers to recover some of the costs of carrying out such research.  If the validity of patents covering gene sequences is called into question, this has the potential to cause significant detriment to the biotechnology research sector.  Companies and research institutes may have less desire and impetus to invest in research and development if they are not able to obtain patent protection for their inventions.

The biotechnology sector will no doubt be watching this case with interest.

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