D’Arcy v Myriad Genetics Inc [2015] HCA 35
The High Court of Australia has today handed down its decision in D’Arcy v Myriad Genetics Inc [2015] HCA 35, unanimously striking down the validity of the first three claims of Myriad Genetics Inc’s (Myriad) patent. Those claims related to isolated nucleic acid sequences of the BRAC1 gene, mutations of which have been implicated as a risk factor for breast cancer and ovarian cancer.
Myriad’s Patent
Myriad was responsible for locating the BRCA1 gene in the human genome and identifying certain mutations or polymorphisms in the BRCA1 gene that were indicative of a predisposition to breast cancer and ovarian cancer.
Myriad’s patent covered various aspects of this finding, including the isolated nucleic acid itself, probes, vectors, methods of producing mutant BRCA1 polypeptides, preparations and uses of polypeptides, and various methods of diagnosis.
Only the claims in respect of the isolated nucleic acid (claims 1 to 3) were in issue in the appeal – all other claims of the invention (claims 4 to 30) were not challenged. Indeed, the Court went to significant lengths to confine its decision only to isolated nucleotide sequences (claims 1 to 3), even holding in one instance that probes (the subject of claims 4) were patentable.
Claim 1 of the Myriad patent provided:
An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ.ID No.1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12 A and 14 and the polymorphisms set forth in Tables 18 and 19.
The High Court’s Decision
This decision was on appeal from the Full Federal Court of Australia decision handed down last year, where the Full Federal Court of Australia upheld the claims of the patent for the isolated nucleic acid.
The issue before the High Court was whether the isolated nucleic acid coding for the mutant BRCA1 polypeptide was a ‘manner of manufacture’ as required under section 18(1)(a) of the Patents Act 1990.
Questions of novelty, inventive step and usefulness were not in issue.
Manner of Manufacture
The leading case on what is patentable subject matter in Australia was and still is in many respects National Research Development Corporation v Commissioner of Patents[1] (NRDC) That case set out the framework for whether a claimed invention was a manner of manufacture. That decision was modified by today’s decision but not overturned. Instead the present decision seeks to add its gloss to NRDC.
In NRDC, the Court upheld the validity of a patent for the use of previously unknown properties of a known chemical to effect a new purpose. The Court stated that in order for an invention to be a “manner of manufacture”, the invention needs to create an ‘artificially created state of affairs’, which is of economic significance.
Consideration by the High Court
The High Court considered the NRDC case, and found that the statement of the test in NRDC was not intended as an exhaustive formula of the concept of manner of manufacture.
The majority judgment found that the satisfaction of the integers outlined in the NRDC case will ordinarily be sufficient to conclude that an invention falls within the existing concept of manner of manufacture, where the claim in question falls within existing boundaries of the “manner of manufacture”.
However, where the claim in question involves a significant new application or extension of the concept of “manner of manufacture”, other factors may assume importance, such as:
(a) whether patentability would be consistent with the purposes of the Patents Act, and in particular whether the invention, if patentable would give rise to a large new field of monopoly protection with potentially negative effects on innovation;
(b) whether to accord patentability to the invention as claimed would involve the court in assessing important and conflicting public and private interests and purposes;
(c) Australia’s obligations under international laws and the patent laws of other countries; and
(d) whether to accord patentability to the type of invention as claimed would involve law making of a kind which should be reserved for the legislature.
In applying this reasoning to the Myriad claims, the majority judgment characterised the claimed invention as “information” rather than a chemical product, because it was defined as a code for the BRAC1 gene, which can be stored in various products, such as the isolated DNA of a person or cDNA where the introns in the sequence have been excised. The product was merely the medium in which that information resides.
Accordingly, the High Court considered that the genetic information claimed in the patent was subject matter that lies at the boundaries of the concept of manner of manufacture, and the additional factors identified above were relevant to the question of patentability.
In determining that the relevant claims were not a manner of manufacture, the High Court considered the following points:
(a) the claims could be infringed without the infringer being aware of that fact – the invention only claimed certain mutations of the BRAC1 gene, but this state of affairs could not be identified unless the DNA was isolated from the human and tested for the mutation;
(b) the class of nucleic acids which all bear the requisite information was vast and unquantifiable. This therefore raised the risk of a chilling effect on legitimate innovative activity outside the formal boundaries of the monopoly, and created a penumbral de facto monopoly impeding the activities of legitimate improvers and inventors.
Conclusion
This unanimous decision of the High Court makes it clear that claims for isolated nucleic acid sequences may not pass the requirement “manner of manufacture”.
Other types of claims such as those relating to methods of diagnosis, and methods of preparing polypeptides are however not directly affected by this decision.
Further, the High Court clearly confirmed that the appeal was not concerned with “gene patenting” generally.
The decision leaves it open to consider factors other than whether the invention is an “artificially created state of affairs of economic significance” in determining whether the invention is a manner of manufacture.
However, as per the majority judgment of French CJ, Keifel, Bell and Keane JJ, these other considerations only come into play when the invention under consideration falls outside the boundaries of what is currently defined as a “manner of manufacture”.
[1] (1959) 102 CLR 252