High Court decision
In D'Arcy v Myriad Genetics Inc  HCA 35 (D'Arcy v Myriad), the High Court of Australia unanimously held that the impugned claims of Myriad's patent-in-suit to isolated nucleic acids coding for mutations or polymorphisms of the BRCA1 gene, do not meet the requirements of a `manner of manufacture' within the meaning of the Patents Act 1990 (Cth) (Act) and are therefore not a patentable invention in Australia. Claims to methods of diagnosing a predisposition to breast and ovarian cancer as well as claims to probes, cloning and expression vectors and host cells, were not in issue.
The majority held that, properly characterised in accordance with substance rather than form, the essential element of the invention as claimed was the `genetic information' of the nucleotide sequences which coded for mutated or polymorphic BRCA1 polypeptides, rather than to classes of chemical compounds. Based on this construction, their Honours held that the claims in issue were not within the established boundaries of the concept of a `manner of manufacture'.
The majority further held that where such a new class of claim involves a significant new application or extension of the concept of `manner of manufacture', the following factors may be relevant to determining whether that concept should be extended by judicial decision to include that class of claim:
- whether the invention as claimed is for a product made or a process producing an outcome as a result of human action.
- whether the claimed invention has economic utility.
- whether patentability would be consistent with the purposes of the Act.
- whether according patentability to the claimed invention would enhance or detract from coherence of the law relating to inherent patentability.
- factors relevant to Australia's place in the international community.
- whether according patentability would involve law-making of a kind which should be done by the legislature.
The majority held that the above wider considerations militated against characterising the claimed invention as a `manner of manufacture' within the meaning of the Act. The claimed invention was therefore deemed not to be a patentable invention in Australia.1
Australian Patent Office response
Following the High Court's decision in D'Arcy v Myriad, and after a period of public consultation, in December 2015, the Australian Patent Office published revised examination practice guidelines taking into account the High Court's decision (Guidelines).2 In January 2016, IP Australia's Manual of Practice and Procedure (Manual) was amended to incorporate the substance of the Guidelines.3
The Guidelines and Manual provide that, in accordance with the High Court's reasoning in D'Arcy v Myriad, in considering whether a claimed invention is patentable, examiners should consider the following questions:
- what is the substance of the claim?
- has the substance of the claim been "made" or changed by man?
- does the invention have economic utility?
- does the invention as claimed represent a new class of claim?
The Guidelines and Manual indicate that the Australian Patent Office considers that a claim to an isolated nucleic acid that replicates genetic information deriving from a naturally occurring organism will be excluded from patentability, even if it is a sequence that does not code for a polypeptide (i.e. a `non-coding' sequence), or is synthetically produced. Importantly, however, the Guidelines and Manual do not extend to exclude from patentability claims to methods of treatment, any other isolated biological materials (e.g. proteins), or non-naturally occurring nucleic acid sequences.
The Guidelines and amendments to the Manual provide prospective patentees with certainty in respect of how the Australian Patent Office will assess the patentability of inventions relating to biological materials in light of the High Court's decision in D'Arcy v Myriad. As they provide for a relatively confined interpretation of the High Court's decision, the Guidelines and Manual are likely to increase confidence in Australia as a jurisdiction which clearly recognises and reasonably affords patentability to inventive contributions in the life sciences sector.