The Australian Patent Office Once Again Allows Claims Directed to Nucleic Acids

In Commonwealth Scientific and Industrial Research Organisation v BASF Plant Sciences GmbH [2016] APO 83, the Australian Patent Office has once again confirmed that nucleic acids are patentable in Australia.[1]

The opposed application relates to methods of producing polyunsaturated fatty acids in the seeds of transgenic plants. The application included claims directed to a recombinant nucleic acid molecule comprising nucleic acid sequences coding for a polypeptide with Δ6-desaturase activity, a polypeptide with Δ5-desaturase activity, a polypeptide with Δ6-elongase activity and a polypeptide with Δ5-elongase activity, as well as one or more copies of a promoter and a terminator.

The Delegate found that the substance of those claims was the genetic information embodied in the recombinant nucleic acid molecule. However, because the combination of enzyme-encoding nucleic acids and associated regulatory sequences specified in the claims would not exist naturally as a single nucleic acid in any one organism, the Delegate found that the genetic information had been “made” by human action.  The Delegate also noted that the information conveyed by the claimed nucleic acid molecule had direct economic utility. The claims were therefore found to define a manner of manufacture.

The opposed application also included a claim directed to an isolated, codon-optimised nucleic acid sequence encoding a polypeptide having Δ5-elongase activity.  Consistent with an earlier Patent Office decision concerning a codon-optimised nucleic acid, the Delegate found that the substance of the claim was not merely naturally occurring information, but information that had been altered such that the nucleic acid sequence could be expressed in oil crop plants.  This alteration was found to provide economic utility and render the nucleic acid a manner of manufacture.

This decision adds to a growing list of Patent Office decisions in which claims directed to nucleic acids have been found to constitute patentable subject matter.

By: Michael Christie 

[1] We recently reported on a Patent Office decision in which claims directed to interfering RNA compositions with therapeutic utility were found to constitute patentable subject matter. The decision was made following the High Court’s ruling in D’Arcy v Myriad Genetics Inc [2015] HCA 35 against claims directed to isolated, naturally occurring nucleic acids.