IP Australia should avoid 'over reach' on gene patent decision

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AusBiotech CEO Dr Anna Lavelle says the High Court's decision to overturn Federal Court decisions on gene patents should not have a major impact assuming IP Australia adopts an appropriately narrow interpretation of the decision.

Dr Lavelle was speaking to ABC Radio after the High Court announced its decision to invalidate a patent covering isolated DNA sequences relating to the BRCA 1 gene.

The BRCA 1 gene is linked to increased susceptibility to breast and ovarian cancer in some women.

According to Dr Lavelle, the "surprising decision" should not undermine research into genes and potential new therapies, assuming IP Australia avoids "over-reach" and applies a narrow interpretation of the decision.

The High Court ruled unanimously in favour of cancer survivor Yvonne D’Arcy, who brought the action against US company Myriad Genetics after it was granted a patent over the BRCA 1 and BRCA 2 genes.

"The High Court held that an isolated nucleic acid, coding for a BRCA1 protein, with specific variations from the norm that are indicative of susceptibility to breast cancer and ovarian cancer, was not a 'patentable invention' within the meaning of s 18(1)(a) of the Patents Act 1990 (Cth) ("the Act")," it said in a statement.

It added that, while the invention claimed might be 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 a statement, Myriad said it was “disappointed with the decision”.

“The High Court’s decision comes at a critical time when we’re entering the golden era of personalised medicine.

“In order for personalised medicine to become a reality, strong patent protection is essential because it provides the research-based companies like Myriad with an incentive to continue to invest in R&D.

“Myriad invested more than $1 billion over 25 years to develop its world-class hereditary cancer testing business and the company has tested more than 2 million patients to date. We remain committed to what we do best, developing innovative and high-quality molecular diagnostic tests that save and improve the lives of patients.”

The decision was welcomed by shadow innovation minister, Senator Kim Carr, and the Consumers Health Forum.

“Gene patents presented an indefensible barrier to both research and ultimately patient treatment by making naturally-occurring genes susceptible to exclusive ownership provisions,” said CHF communications director, Mark Metherell.

During a recent address to the National Press Club in Canberra, Trade Minister Andrew Robb used the existence of gene patents as an argument against Australia accepting longer data exclusivity periods for biologics in the recently finalised Trans Pacific Partnership Agreement.