David Longmuir of Phillips Ormonde Fitzpatrick Lawyers and Mark Wickham of Phillips Ormonde Fitzpatrick recently acted for Rozenberg & Co in successfully opposing the grant of Australian Patent Application 2010294197 for a “method for the preparation of micro-RNA and its therapeutic application” in the name of Velin-Pharma A/S – see Rozenberg & Co Pty Ltd v Velin-Pharma A/S [2017].

While the opposition was successful on the grounds of novelty and inventive step, the decision is notable for its discussion of parametritis.

The Delegate cited and followed the recent judgment of Justice Beach in the Full Court decision in Otsuka which provided long awaited guidance on the concept of parametrits – see Otsuka at [176].

Relevantly, the claims of the opposed application were to “a method for the preparation of a composition comprising a therapeutically effective amount of one or more miRNA molecule(s), said miRNA being upregulated in a blood serum preparation derived from a body fluid after activation of said body fluid, the method comprising the steps [a, b and c]”.

In construing the claim, the Delegate found that the methods steps a to c define the limiting features of the claim and that since following the method would inevitably result in the preparation of a composition comprising a therapeutically effective amount of any or more miRNA molecules, the words in the preamble to the claim were purely descriptive and non-limiting.

As a consequence of this construction, the Delegate found that it was not necessary for a prior art to explicitly disclose a therapeutically effective amount of one or more (upregulated) miRNA molecules. The opponent was able to successfully argue that the claim was anticipated where in circumstances where the working of the prior art methods would carry out the method steps a, b and c of the claim.

While opponents often raise the issue of parametritis in opposition proceedings, the decision suggests that in light of the guidance provided by Otsuka, the Office is likely to be far more receptive to future submissions in appropriate circumstances.