Myriad’s gene patents declared valid by Australia’s Federal Court
The question as to whether the BRCA1 and BRCA2 genes claimed by Myriad are patent eligible has traveled outside the U.S. and landed within the scientific and legal communities across the ocean, in Australia and the E.U., forcing them to tackle the problem.
In Europe, the E.P.O. granted patents on the BRCA1 and BRCA2 genes and on a method for the diagnosis of breast and ovarian cancer. The patents can be challenged only at national level under the current EU patent system.
In Australia, Myriad received patents on the BRCA1 gene and subsequently granted an exclusive license to Genetic Technologies Ltd to perform the diagnostic testing of BRCA1 in Australia and New Zealand. Cancer Voices Australia filed a suit against Myriad and Genetic Technologies in 2010.
The question here was whether a naturally occurring but isolated nucleic acid is a "matter of manufacture" within the meaning of section 6 of the Statute of Monopolies (Article 18 (1)(a) of the Patent Act). According to Australian case law (in particular National Research Development Corporation v Commissioner of Patents (NRDC)) a matter of manufacture is an invention which is useful (thus it cannot belong to the fine arts category), provides a material advantage and has an economic significance for the country".
The Court referred to previous case law and briefly analysed the position of the European and U.S. jurisdictions on the patenting of genetic material. It made a special mention of the Myriad litigation in the U.S. and of the decision of the court of Appeals of the Federal Circuit which upheld the validity of the disputed patents. However, it stated that such a decision "does not provide direct assistance to either side in the present case" because the Australian law is different to the U.S. law and because the evidence in the two cases is different.
The Court concluded that, although naturally occurring DNA and RNA cannot be the subject of valid patents, the disputed claims do not cover naturally occurring DNA and RNA and therefore concern a "matter of manufacture".
The present decision is a great victory for Myriad genetics. It might, however, still be appealed before the High Court of Australia.