Following the High Court of Australia’s decision in D’Arcy v Myriad Genetics Inc. (see our report), IP Australia sought public consultation on how it intended to modify its examination practice to align with the primary finding of the Court that “a claim to an isolated nucleic acid that merely represents information coding for a polypeptide is not patent eligible”.
Initially, IP Australia proposed a relatively narrow interpretation of the decision, limiting excluded subject matter to naturally occurring DNA and RNA nucleic acid sequences and cDNA. A broad range of other genetic subject-matter, including naturally occurring isolated regulatory DNA, non-coding RNA, naturally occurring isolated bacteria or virus, isolated polypeptides, probes, primers and vectors, were proposed to remain patent eligible. This moderate approach to the Court’s decision was widely welcomed by industry. However, during the consultation period, IP Australia received submissions which sought to impose a broader interpretation of the decision to exclude all biological materials and their uses from patentability.
Examination Practice Post-D’Arcy
In a statement published on 15 December 2015, IP Australia set out its examination practice in the wake of D’Arcy, which can be viewed here. Given the range of comments submitted during the consultancy period, the interpretation of the decision has been broadened to exclude probes and primers, isolated interfering/inhibitory nucleic acids and synthetic nucleic acids that merely replicate the genetic information of a naturally occurring organism, in addition to isolated naturally occurring DNA or RNA (coding and non-coding). However, it would appear that most other isolated biological materials, including proteins and isolated small molecules, will be considered to be inherently patentable by IP Australia. A comparison of patent eligible subject matter in both the proposed and finalised examination practice is presented in the table below.
Click here to view table.
Importantly, IP Australia has also set out a four-step test to be applied in a determination of patent eligible subject matter in accordance with the approach of the Court, as follows:
- 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?
Central to the operation of this test is a determination of whether the substance of a claim has been “made”. The Court held that naturally occurring nucleotide sequences cannot be “made” by human action, as the information contained within the molecule exists in nature. Both the Court and IP Australia appear to consider that polypeptides and chemical compounds are “made” if isolated.
Although the range of genetic subject-matter considered to be patent eligible has been narrowed by the approach adopted by IP Australia, the examination guidelines still appear to leave open avenues for pursuing protection for most inventions relating to isolated biological materials, since novel and inventive methods, processes and uses of isolated biological materials will remain patentable. Furthermore, the four-step test provides guidance to enable applicants to determine if their invention, insofar as it relates to biological material, is directed to patentable subject matter. This examination approach will be generally welcomed by industry as it provides certainty around patent protection with regard to biological inventions, at least from the perspective of examination and oppositions before IP Australia. Ultimately, however, it will be up to the courts to determine how the decision in D’Arcy is to be interpreted, and it will take some time for the courts to consider this issue.
In the immediate aftermath of the adoption of this new examination practice IP Australia has advised that applications in relation to which examination was in abeyance pending adoption of the new practice will be considered under the new approach over the next few days.