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Landmark decision made on the patenting of genes

Can DNA be patented?

Well-known intellectual property cases can affect future patent registration decisions and have their place in history in the same way other legal disagreements do.

Recently, the High Court released its decision regarding the much anticipated Yvonne D'arcy v Myriad Genetics legal dispute. The case revolved around the ability to patent an isolated nucleic acid sequence, which the United States has deemed legal.

Australia has chosen not to follow in the foot steps of the United States when considering whether companies can patent biological material. The landmark decision has altered the way patent law in Australia can be applied.

Can genetic code be patented?

The case was between a Queensland cancer patient, Yvonne D'arcy and a leading American molecular diagnostic company, Myriad Genetics, Inc. The dispute revolved around Myriad Genetics attempt to patent an isolated DNA extract containing the breast cancer gene BRCA-1. 

A similar dispute reached the United States Supreme Court in 2013, with the court ruling that Myriad Genetics could in fact apply a patent to the extraction of the single DNA containing the protein. 

The firm argued that they were not simply patenting a naturally occurring gene, but an isolated nucleic acid coding for it, which is not native to the human body. 

Natural v manufactured

Ms D'arcy and her team had already pursued extensive legal action, losing twice at the Federal Court over their five year legal battle. A patent requires a unique invention and the court originally decided that the act of isolating a nucleic acid results in an element that is "chemically, structurally and functionally different" from a nucleic acid that is naturally found inside a human cell.

However, on October 7, the High Court determined that nucleic sequences (including DNA and RNA) are not patentable as they do not fit within the scope of patentable inventions.

More specifically, the court found that these sequences do not fall within the scope of the definiation of "manner of manufacture" which is essential for a patent in Australia. The statement noted that although there was some human action involved, the essential component of the invention came from the gene itself.

Key research implications

Ms D'arcy was determined to fight for the case, due to significance of the BRCA-1 gene. The National Breast Cancer Foundation (NBCF) has welcomed the decision, claiming that this will strengthen research in Australia. 

"This is great news for Australia. NBCF oppose any impediments to the timely and cost-effective diagnosis and treatment of breast cancer," says NBCF acting CEO Jackie Coles.

"Lifting the restrictions on BRCA-1 will allow researchers to translate fundamental knowledge about our genetic make-up into real advances in breast cancer detection and treatment."

This will be great outcome for businesses aiming to replicate and infringe existing patents targeting nucleic sequences. However, for researchers inventing new treatments in Australia using DNA or RNA – it will render their IP worthless in Australia.

It will be interesting to see the final outcomes of this decision as it may kill new and inventive research in Australia.

The future of intellectual property law

This decision has important implications for what can and cannot be patented in Australia. In response, IP Australia has suspended the examination of patent applications for nucleic acid sequences.

In light of the changing nature of law, it is best to consult professionals when seeking to protect your design. A patent attorney in Australia that is well versed and up to date with latest IP rulings can effectively guide you through the process.