The Patents Act requires that, for an invention to be patentable, it must be a 'manner of manufacture’. The patent was challenged on the ground that the subject matter involved merely isolating naturally occurring nucleic acids.
The High Court held that an isolated nucleic acid is not a 'manner of manufacture’. In addition, it was considered that to attribute patentability to mere isolation would involve an improper extension of the concept of a 'manner of manufacture’. The patent was invalidated on this basis.
Any granted patents that include claims directed specifically to isolated nucleic acid sequences will be subject to review in the light of this decision. Mere isolation will likely be insufficient.
IP Australia has suspended examination of patent applications claiming nucleic acid sequences and will issue a formal response shortly.