2.9.2.14 Micro-Organisms and Other Life Forms

Date Published

In considering whether a claimed micro-organism is patentable, examiners should determine the substance of the claim and whether that substance is “made”, following the principles outlined in 2.9.2.6 Nucleic Acids and Genetic Information.  In general, where the substance of a claim is the organism, and not genetic information, the organism may be patentable if the technical intervention of man has resulted in an artificial state of affairs which does not occur in nature (i.e. the substance is “made”).

Office practice is that the isolation and cultivation of naturally occurring micro-organisms satisfy the requirements for technical intervention.  A claim to a biologically pure culture of the naturally occurring micro-organism is also acceptable.

In determining whether an organism is “made”, in Ranks Hovis McDougall Ltd's Application (1976) AOJP 3915 the hearing officer decided that:

  • any new variants claimed must have improved or altered useful properties and not merely have changed morphological characteristics which have no effect on the working of the organism;
  • naturally occurring micro-organisms per se are not patentable as they represent a discovery and not an invention; and
  • a claim to a pure culture of the micro-organism would satisfy the requirements for technical intervention.