The Australian Patent Office has released its new guidelines following the High Court of Australia’s decision in D’Arcy v Myriad Genetics Inc, in which it was decided that certain claims directed to “an isolated nucleic acid” do not relate to patent eligible subject matter. An attempt to summarise those findings follows.
The 4-step test
For claimed technical subject matter that does fall within well-established categories of patent eligible subject matter, it seems that the guidelines outlined below do not apply. For such cases, the usual tests for patentability will apply (e.g. utility, novelty and inventiveness).
For claimed technical subject matter that does not fall within well-established categories of patent eligible subject matter, the Patent Office has set out a 4-step test to be applied, generally in accordance with the approach of the High Court:
- What is the substance of the claim (not merely its form)?
- Has the substance of the claim been “made” or changed by man, or is it “artificial”?
- Does the invention have economic utility?
- Does the invention as claimed represent a new class of claim?
The steps of the test are quite abstract and are explained in more detail in the new guidelines. More concrete aspects of the new guidelines are briefly discussed below.
Patent ineligible subject matter
Where the substance of a claimed invention is genetic information that is not “made”, the claiming of an alleged invention as an isolated product does not confer patent eligibility. “Made” means that it was created or modified by human action, but not merely through replication. It is not enough that the subject matter of the claim is “artificial”.
Claims to the following are excluded since they apparently relate to genetic information that has not been “made”:
- Isolated naturally occurring nucleic acid molecules whether:
- DNA or RNA.
- Human or non-human.
- Coding or non-coding.
Claims to the following are excluded where they merely replicate the genetic information of a naturally occurring organism:
- cDNA and synthetic nucleic acids.
- Probes and primers.
- Isolated interfering/inhibitory nucleic acids.
Claims to the following may be excluded where they have not been “made”:
- Plants
- Microorganisms
Patent eligible subject matter
Subject to the above and other requirements of the Australian Patents Act, generally speaking, patents should remain available for products, methods of making and using products, and methods that otherwise result in a new and useful effect.
Examples of specifically mentioned patent-eligible subject matter include:
- Non-naturally occurring chimeric nucleic acids.
- Recombinant or isolated proteins.
- Pharmaceuticals and other chemical substances. (Apparently, isolation or purification equates to being “made”.)
- Methods of treatment.
- Methods of applying herbicides.
- Applications of computer technology.
- “Made” plants.
- “Made” microorganisms.
Patent Office practice
The Patent Office has indicated that examination will now proceed on applications previously held in abeyance. Examiners will raise a rejection where it is apparent that the claimed technical subject matter does not fall within well-established categories of patent eligible subject matter. If rejections of this nature cannot be resolved during examination, they can be resolved in the context of a Patent Office hearing or an appeal to the Federal Court. Normally a hearing would be requested after multiple responses to examination reports.
Our recommendation is that, for cases where claims to nucleic acid molecules are important, such rejections be argued in the first instance because the new guidelines are far from being clear and consistent with established precedent and practices. Failing that, novel and inventive methods and uses should remain patent eligible. If need be, a divisional application can be filed for any rejected claims, to “fight another day”.