Landmark High Court ruling - human genetic material cannot be patented
7 October 2015
A leading intellectual property (IP) lawyer has noted the significance for the biotechnology industry of today’s landmark decision by the High Court, essentially prohibiting patent protection for human genetic material and genetic sequences.
The decision reverses the 15 February 2013 Full Federal Court ruling, which found that United States company Myriad Genetics Inc’s (Myriad) patent on the isolated BRCA1 gene, associated mutations and utilisation of the sequence for diagnostic purposes was valid.
Malcolm McBratney, a Partner at independent Australian law firm McCullough Robertson, said that following the 2013 decision, concerns were raised in the wider community about the implications of a precedent being created allowing for human genetic material and genetic sequences to qualify for patent protection.
“On the one hand, some have suggested that if the High Court, in this appeal of the 2013 decision, had found in favour of Myriad it could have restricted patient access to diagnostic genetic tests,” Mr McBratney said.
“On the other hand, there is the potential for this decision to have an impact on commercialisation and the ability of biotechnology companies to protect their research.”
The BRCA1 gene is commonly referred to as the “breast cancer gene” and has been used as a diagnostic tool to determine an individual’s genetic predisposition to developing breast and ovarian cancers. The BRCA1 gene is associated with approximately 45% of hereditary cases of breast cancer and at least 80% of hereditary cancers involving both breast and ovarian cancers.
Cancer Voices Australia, an independent national organisation committed to improving the lives of those affected by cancer, and Yvonne D’Arcy, a Brisbane cancer patient brought legal action against Myriad over the ownership of the gene.
The case centred around concerns that ownership of the gene patent could limit research and development of treatments for genetic diseases.
The Court unanimously allowed the appeal, holding that the invention claimed did not fall within the concept of a “manner of manufacture” within the Patents Act 1990 (Cth). The Court held that, having regard to the relevant factors, an isolated nucleic acid, coding for the BRCA1 protein, with specified variations, is not a manner of manufacture. While the invention claimed might be, in a formal sense, a product of human action, it was the existence of the information stored in the relevant sequences that was an essential element of the invention as claimed.
In 2013, the United States Supreme Court also ruled against the patent, ruling that naturally-occurring DNA was a product of nature and not patentable.
“The concept underlying the decision is that genes exist in nature and therefore were discovered rather than invented and can’t be patented,” Mr McBratney said.
“It’s a very important decision for both patients and the life sciences industry and brings Australia in line with the United States.”
Mr McBratney said that while it was important to recognise the argument that a potential monopoly in Australia by way of the grant of an exclusive licence over BRCA1 testing could have resulted in higher prices being payable for diagnostic genetic tests, it’s also important to draw attention to Myriad’s unsuccessful argument that patents ensured innovation could be commercialised for everyone's benefit.
“It will be important for biotechnology companies to understand how this decision impacts their research and commercialisation going forward,” Mr McBratney said.
Malcolm McBratney is listed in the Best Lawyers’ publication as a leading Australian intellectual property lawyer. He is also acknowledged by Managing Intellectual Property Handbook, is a recommended lawyer in the 2015 Asia IP Profiles and is ranked in the Chambers Global and Asia Pacific editions of leading IP lawyers. McCullough Robertson has one of the largest IP practices of any law firm in Australia and acts for clients across the country.
About McCullough Robertson
McCullough Robertson is a leading Australian independent law firm with industry experts combining legal expertise with deep industry knowledge and foresight. The firm provides innovative, relevant and commercial legal solutions to major corporate, government and high net worth individuals across Australia and internationally. Established in 1926, the firm’s major focus areas are the resources (mining and energy), food and agribusiness, technology, telecommunications, health, life sciences, real estate and financial services sector.