Australia has relatively recently implemented support laws that require a specification to provide sufficient information to enable the skilled person to perform an invention over the entire scope of the claims without undue burden or the need for further invention. These new support laws have been stringently applied by the Patent Office, in particular in relation to claims defining chemical compounds where, in many cases, the only claims considered to be enabled are ones directed to exemplified embodiments.
In Evolva SA  APO 57 (14 November 2017) the Australian Patent Office considered the enablement of claims directed to polypeptides covered by at least 90% sequence identity to defined polypeptide sequences.
In determining whether the claims were enabled, the Delegate of the Patent Office considered the Explanatory Memorandum to the relevant support legislation as well as European and UK case law. Based on this, the Delegate settled on a two-step enquiry consistent with that taken under UK law.
The first stage involved determining whether the disclosure of the patent, read in the light of the common general knowledge of the skilled person, makes it plausible that the invention will work across the scope of the claim. If so, the second stage required consideration of whether the invention can be performed across the scope of the claim without undue burden.
The Delegate considered whether it was plausible that polypeptides which have as low as 90% identity would exhibit functional activity. In coming to a conclusion regarding the plausibility of the claims, the Delegate referred to a discussion in the specification regarding the manner in which functional polypeptide homologues may be generated. He also referred to the fact that conservative substitution of amino acids in polypeptides is widely practiced, and that the properties of the resulting variants can be predicted with some certainty, particularly where the active binding regions of the proteins are known. For these reasons, the Delegate found it plausible that the invention could be worked across the full scope of the claims.
In reaching a conclusion on the undue burden part of the enablement test, the Delegate found that the specification provided adequate guidance as to the manner in which polypeptide variants may be generated and tested; and that this did not present any apparent difficulties that would require the skilled person to undertake any prolonged research or experimentation that would be considered an undue effort. While the work to produce polypeptide variants could involve a reasonable degree of experimentation or trial and error, and even be time-consuming, the Delegate found that the nature of the work did not appear to constitute a research programme. Accordingly, the specification was found to meet the relevant enablement requirements.
This decision provides much-needed clarity regarding the test for determining enablement of chemical/protein and polypeptide claims and permits Examiners greater latitude for allowing claims directed to subject matter that goes beyond embodiments exemplified in the specification.
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