Today the High Court of Australia in the Myriad Genetics appeal has held unanimously that an isolated nucleic acid sequence, coding for a BRCA1 protein, with specific variations from the norm that are indicative of susceptibility to breast cancer and ovarian cancer, is not a patentable invention within the meaning of the Australian Patents Act.

The conclusion is consistent with the US Supreme Court decision which recently held that a claim for an isolated DNA coding for a BRCA1 polypeptide was not patentable as it fell within a “law of nature” exception.

Myriad’s Australian patent in suit contains thirty claims, however the validity of only the first three claims were in issue in the appeal. Those claims each related to “an isolated nucleic acid”. The Court held that an essential integer of those claims requires that the isolated nucleic acid must code for all or part of a mutant or polymorphic BRCA1 polypeptide. Importantly, four of the High Court Justices held that “Despite the formulation of the claimed invention as a class of product, its substance is information embodied in arrangements of nucleotides.” That feature of the claims was said to raise a question about whether they fit within the concept of “manner of manufacture”.

Section 18(1)(a) of the Australian Patents Act requires that, for an invention to be patentable, it must be “a manner of manufacture” within the meaning of s6 of the Statute of Monopolies.

“Manner of manufacture” requirement

The sixty year old Australian High Court decision in NRDC established that the “manner of manufacture” requirement dictated an “artificially created state of affairs” i.e. something brought about by human action. Here, the majority of the Justices have held that the requirement of the claims in suit, that the nucleic acid sequence in the isolate bear specified mutations or polymorphisms, depends on a characteristic of the human being from which the nucleic acid is isolated. According to their Honours this has nothing to do with the person who isolates the nucleic acid bearing the mutant sequence and therefore does not satisfy the “artificially created state of affairs” requirement.

A majority of the Justices also considered that the claims in suit include products obtained by applying any process, known or unknown, to the cells of a human being which extracts or replicates from them nucleotides which code for mutant or polymorphic BRCA1 in the sequence as specified in the patent. The Justices considered that this potentially included a very large class of products with a consequence that there was a risk that granting a patent monopoly in respect of them would have a chilling effect which would lead to the creation of “an exorbitant and unwarranted de facto monopoly on all methods of isolating nucleic acids containing the sequences coding for the BRCA1 protein”.

Implications

The decision handed down today has fundamental and potentially far reaching implications for the whole of Australian patent law, not just in respect of biotechnology inventions. It also remains to be seen how IP Australia will give practical application to the decision and if this will have ramifications for patent drafting and prosecution practice.

A further, detailed consideration of the decision and its implications will follow shortly.

Our Experts Project Team

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