In a landmark judgment, Australia’s highest court has declared that certain claims in a patent filed by a US company for a genetic product are not patentable inventions.
The decision is of great significance to the biotechnology industry and may have wider implications.
Myriad Genetics lodged a patent application for an isolated nucleic acid (DNA) coding for a particular (BRCA1) protein with specific variations from the norm that indicate susceptibility to breast cancer and ovarian cancer. The claims disallowed were product claims for the particular isolated nucleic acid. The decision did not involve considerations of “morality” but was based on the long-standing core question of whether the claims were a “manner of manufacture”.
Up till now the Australian Patent Office, its New Zealand equivalent, and the European Union have accepted the patentability of isolated nucleic acid sequences. The “invention” is said to lie in the fact of isolating the particular gene from the rest of the human DNA.
Such was also the case in the US – until 2013 when the Supreme Court forced a change in regulatory practice through its ruling in a case also involving Myriad Genetics.
Moreover, the Australian High Court has also recast the 1959 NRDC decision, which has been the benchmark for deciding what may be patentable and has been cited in numerous Australian and New Zealand cases. The Court has said, for instance, that amongst the things of primary importance to consider will be whether an invention as claimed “could give rise to a large new field of monopoly protection with potentially negative effects on innovation”.
The question now is not when but how soon, and with what effect, the precedent created by the Australian judgment will be considered in New Zealand and whether the New Zealand Courts will adopt what is, arguably, a revamped approach to a fundamental aspect of patentability?