In Australia, eligible subject matter for a patent must define a “manner of manufacture within the meaning of section 6 of the Statute of Monopolies“.
Recently, the High Court of Australia (our Supreme Court equivalent) issued its decision in D’Arcy v Myriad Genetics [2015] HCA 35. That decision was the most significant judicial consideration of manner of manufacture since the 1959 decision of NRDC[1]. The decision significantly changed our understanding of the manner of manufacture requirement.
In Myriad, the Court rejected a blanket ruling as to what constitutes a manner of manufacture in preference to a case by case analysis. That analysis entails asking whether the invention falls into a category previously accepted as a manner of manufacture. If not, then patentability considerations turn to the “Myriad factors” to determine whether the scope of “manner of manufacture” ought to be extended to encompass the invention. Those factors are discussed separately.
IP Australia responded to Myriad by releasing guidelines [viewed here] for the assessment of manner of manufacture (Patentability) during patent examination (Guidelines).
- The Guidelines
Examiners have been directed to follow the Guidelines when considering manner of manufacture requirements. This approach applies to all pending applications and has immediate effect.
A.1. Biological Materials
In short, the Guidelines state that, in light of Myriad, all forms of isolated naturally occurring nucleic acid molecules, such as DNA and RNA (whether human, non-human, coding or non-coding) are not a manner of manufacture because, in substance, they are not considered to have been “made”. Further, claims to:
- cDNA and synthetic nucleic acids;
- probes and primers; and
- isolated interfering/inhibitory nucleic acids;
insofar as they merely replicate the genetic information of a naturally occurring organism, are also excluded. This position does not apply to the use of those materials or claims directed to diagnostic or other applications to which such sequences may be deployed.
Nucleic acid sequences may be claimed where the utility of the invention attracts to genetic information that has been “made” (e.g., non-naturally occurring nucleic acids). In practice, this means that if a nucleic acid sequence is to be claimed, a claim to that sequence will need to focus on the manipulated part of the sequence.
A.2 Established Categories for Manner of Manufacture
In assessing the manner of manufacture requirement, the Guidelines require examiners to take the following approach:
Firstly, examiners must consider the extent to which the claimed invention in substance falls within established categories of eligible subject matter. Importantly, the “established categories” are only those that have previously been approved by a court (identified below). Patents previously granted by IP Australia in respect of such subject matter are not considered determinative.
Examiners must then consider the substance, rather than the form, of the claims by referring to the specification, taking into particular account:
- the form of the words and breadth of the claim;
- the emphasis of the claim; and
- the subject matter of the invention (particularly whether a claimed product is a step along the way to a process or method that is the real invention).
Where the invention relates to a chemical compound or genetic material, examiners must also consider the size of the class of compounds and whether the compound embodies or conveys genetic information that is of importance to the utility of the claimed invention, respectively.
A.2.1. Invention within an Established Category
The Guidelines note that courts have already established the following categories as acceptable patentable subject matter:
- recombinant or isolated proteins;
- pharmaceuticals and other chemical substances;
- methods of treatment;
- methods of applying herbicides; and
- applications of computer technology.
Inventions falling within an established category are assessed according to the following two requirements outlined in NRDC:
- The invention must be a “product” in the sense that it is “made”, or represents an “artificially created state of affairs”.
- The invention must be “vendible” in the sense that it has economic utility.
Provided a claimed invention displays these requirements, that will “ordinarily be sufficient” to establish that the claim defines a manner of manufacture.
The Guidelines state that the determination of whether the substance of a claim is “made” or “artificial” involves a comparison between the state of affairs before the invention, and the state of affairs as a result of the invention. Relevant factors in this comparison include:
- whether the substance of the claim was ‘”made”, i.e., created or modified by human action (it is not enough that the subject matter of the claim is artificial);
- the physical differences between the claim and the natural state; and
- the labour required to produce the product.
The Guidelines also note that:
- “made” includes created or modified, but not merely through replication; and
- isolation or purification can represent making or modification when the substance of a claim is properly directed to a chemical product.
Economic utility principles in the Guidelines simply refer to NRDC.
A.2.2. No Established Category
Inventions falling outside an established category will be subject to a manner of manufacture objection, resolvable only by a formal hearing or in an appeal to the Federal Court.
The Guidelines do not clarify if applicants may overcome a manner of manufacture objection by persuading the examiner that the invention does fall within an existing category. We certainly would argue that, where the examiner is so persuaded, the basis for the objection is removed and the objection ought to be withdrawn.
If an invention does not fall within an established category, Myriad states that a new category may be created provided it is consistent with the overarching purposes of the Patents Act, and considers all relevant interests and legal principles.
Summary
By declaring that naturally occurring nucleic acids are no longer patentable subject matter, Myriad has altered the course for biological inventions in Australia.
All is not doom and gloom for inventors in this field as methods, processes and uses of such biological materials remain eligible patentable subject matter under Myriad.
If you would like further information on any of the material discussed in this article, please contact Gary Cox (Principal), Craig Humphris (Principal) or Donna Meredith (Patent Attorney).
[1] National Research Development Corp v Commissioner of Patents (1959) 102 CLR 252.