There is no doubt that the Myriad High Court decision has impacts for patenting in Australia. Of particular concern is how this decision is received and interpreted by legal profession and IP Australia.
Summary D’Arcy v Myriad Genetics Inc  HCA 35
The decision only focused on three claims (Claims 1 to 3) and claim 1 was directed to:
“1. 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, 12A and 14 and the polymorphisms set forth in Tables 18 and 19[].“
Claims 2 and 3 are dependent Claims depending on Claim 1.
The High Court of Australia unanimously decided that all of these claims did not consist of a manner of manufacture and thus not patentable. Novelty, Inventive Step, Fair Base (descriptive support), and other grounds were not considered in the decision as they were not subject of the dispute.
All the judges found that the boundaries of the claimed invention were not defined by a limiting range of chemical formulae. … The infringement of the formal monopoly would not be ascertainable until the mutations and polymorphisms were detected.
The majority judges stated they were not concerned in the Myriad case with “gene patenting” generally, but with whether the invention as claimed in Claims 1 to 3 falls within established applications of the concept of manner of manufacture.
Hence, it could be interpreted that the Court did not rule out gene patenting generally. But it is certain that the Myriad style gene claim – a known isolation process with a gene code which could be found in nature, will definitely be rejected.
The long standing test on the manner of manufacture, the NRDC formula, has been reviewed and there were 3 different views coming out from this decision.
According to the NRDC case, for an invention to satisfy the manner of manufacture requirements, it is required ” a mode or manner of achieving an end result which is an artificially created state of affairs of utility in the field of economic endeavour.”
Gordon J indicted that NRDC was not apposite to product claims. The NRDC test is specific for process claims only.
GAGELER AND NETTLE JJ in a separated judgement also indicated that NRDC was not apposite to product claims. The NRDC test is specific for process claims only.
GAGELER AND NETTLE JJ reiterated that there is a threshold requirement of newness or inventiveness in the subject matter to be qualified as a manner of manufacture in pursuant to s6 of the Statute of Monopoly. The subject matter of Myriad Claims 1 to 3 did not possess this newness or inventiveness quality.
The Majority Judges there were additional factors to be considered when determining whether a new class of invention qualified as a patentable subject matter. The NRDC case only listed two of them.
- Whether the invention as claimed is for a product made, or a process producing an outcome as a result of human action.
- Whether the invention as claimed has economic utility.
It is necessary to further take into consideration of the following factors.
- Whether patentability would be consistent with the purposes of the Act and, in particular:
3.1. whether the invention as claimed, if patentable under s 18(1)(a), could give rise to a large new field of monopoly protection with potentially negative effects on innovation;
3.2. whether the invention as claimed, if patentable under s 18(1)(a), could, because of the content of the claims, have a chilling effect on activities beyond those formally the subject of the exclusive rights granted to the patentee;
3.3. whether to accord patentability to the invention as claimed would involve the court in assessing important and conflicting public and private interests and purposes.
- Whether to accord patentability to the invention as claimed would enhance or detract from the coherence of the law relating to inherent patentability.
- Relevantly to Australia’s place in the international community of nations:
5.1. Australia’s obligations under international law;
5.2. the patent laws of other countries.
- Whether to accord patentability to the class of invention as claimed would involve law-making of a kind which should be done by the legislature.
The implication of this case is that:
- The Myriad style gene claims will be rejected.
- NRDC and the current law will still be applicable to computer process, and other industrial process regarding to genetic technology. Thus the patentability of these subject matters will maintain.
- The High Court did not preclude all kinds of the gene patenting.
- Will Claim 1 consist a patentable subject matter if NRDC is codified in the Statute?
- Do all claims from now on has not pass the newly modified NRDC test prescribed in the majority decision?
- Is it the current law that, in running an invalidity case:
- according to the minority decision – NRDC are not applicable to all product claims
- even if it is all factors in the majority decision have to be considered
in determining the patentability of a claim
- Referring to GAGELER AND NETTLE JJ decision, what is the threshold for the newness to qualify as an invention? Is it a gut feeling or is it compared to all prior art? What is the definition of “new” in the threshold test?
- Is the majority decision constitution or in breach of the “Separation of Power”?