Today, the High Court of Australia unanimously held that Myriad's claims to isolated nucleic acids which encode a naturally occurring human protein were invalid as they were not patentable inventions.
Myriad's patent related to the use of mutations or polymorphisms in the BRCA1 gene to diagnose a subject's susceptibility to breast and ovarian cancer. The patent includes claims to products such as isolated nucleic acids, probes and vectors, as well as methods of diagnosis using those products.
Yvonne D'Arcy only challenged the validity of claims 1 to 3, which are directed to isolated nucleic acids coding for BRCA1 proteins with specific mutations or polymorphisms that Myriad has linked to cancer risk. The basis of Ms D'Arcy's challenge was that the disputed claims involved naturally occurring nucleic acids and therefore there was no 'manner of manufacture' as required by section 18(1)(a) of the Patents Act1990. In response, Myriad argued that isolated nucleic acids were analogous to chemical compounds.
Ms D'Arcy's challenge was previously dismissed by both the Federal Court and the Full Federal Court: see our previous analysis here.
The High Court unanimously allowed the appeal, although the Court's reasoning is presented in three separate judgments.
The majority rejected the argument that isolated nucleic acids were analogous to chemical compounds, indicating that such an argument elevates form over substance. Instead, they considered that it was the existence of the information stored in the relevant sequences that was the essential element of the invention as claimed. The majority held that, properly construed, the claims were not within the established boundaries of patentable subject matter since the sequence information which characterised the claims challenged by Ms D'Arcy is not something which was 'made' by human action.
Instead, the majority considered that to attribute patentability to the invention as claimed would extend the concept of 'manner of manufacture'. It said that the implications of allowing patentability for a new class of invention were such that the invention as claimed should not be treated as patentable by judicial decision. Rather, it was a decision that was only appropriate only for the legislature. Notwithstanding this, the majority sets forth some factors to be considered in establishing whether a new class of claim should be patentable including:
(a) whether allowing the class could give rise to a large new field of monopoly protection with potentially negative effects on innovation;
(b) whether such claims could have a chilling effect on activities beyond those formally the subject of the exclusive rights granted to the patentee (eg, stopping all genetic testing because one could never be certain a patent would not be infringed); and
(c) whether to accord patentability would involve a court assessing important and conflicting public and private interests and purposes.
The Court also expressly states that, for the purposes of patentability, there is no distinction between DNA and cDNA. This contrasts with the position taken by the US Supreme Court in its corresponding 2013 Myriad decision. In the US case, cDNA was held to be patentable because it was artificially created, ie, not a product of nature.
We will provide further analysis on the impact of this decision in due course.