IP SPOTLIGHT 17 August 2020

The Full Court’s decision suggests that it will be more difficult to establish inventiveness based on a lack of expectation of success. Instead, a patentee defending an obviousness case may be better served by providing reasons for why the PSA would not be directly led to try the invention, or that the path from the prior art to the invention would require inventive work as opposed to routine trial and error. FA I R BAS I S The Dissolution Patent included a claim to a fenofibrate composition with a specified dissolution profile. The Full Court, applying well-established principles, found this claim lacked fair basis because, although the specification included references to compositions with the specified dissolution profile, those compositions also contained micronized fenofibrate. There was thus no “real and reasonably clear” description of compositions with the specified dissolution profile per se . The Full Court’s decision is a further reminder of the importance, when claiming an invention by reference only to the results that it achieves (as opposed to the means of achieving those results), of drafting the specification carefully to ensure that it is clear that the invention disclosed in the patent includes achieving that result by any means.

“In the context of s 7(2) of the Act, the legal standard, expressed by the word ‘obvious’, is a flexible and indeterminate standard which poses a question of fact to which there is often, perhaps usually, no single, right answer.” Thus in answering the question whether an invention is obvious, an evaluative judgment is called for and, in order to answer the question affirmatively, the Court must be persuaded that the invention, as it is claimed, is indeed obvious. As a general proposition, reasoning to such a conclusion is not assisted by a percentage-based analysis.” The Treatment Patent was held obvious in light of second prior art publication that disclosed the results of a clinical trial suggesting that a reduction of elevated serum lipid levels may help prevent vision loss associated with diabetic retinopathy. The publication did not specifically test whether the use of a lipid-lowering agent (like fenofibrate) would be useful for treating diabetic retinopathy. Further, the scientific method employed by the publication was imperfect, leading to some minor doubts as to the significance of its observations. However, the Full Court adopted a practical approach when interpreting the publication and considered that these imperfections did not raise enough doubt as to the likelihood of success to render the Treatment Patent inventive. Similarly, in relation to the Nanoparticulate Patent, doubts expressed by witnesses as to the likelihood of the claimed formulations being useful (one witness described trying the invention as a “gamble”, and that he could not be sure that it would work) were not enough to support a finding that its claims were inventive. The Full Court was also unperturbed by the need to conduct some experimentation in order to implement the invention, characterising that work as routine optimisation and trial and error. As a result, the line between a sufficient expectation of success and “worth a try” remains elusive.

ANDREW MULLANE Special Counsel

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