ToolGen Incorporated v Fisher (No 2)

ToolGen Incorporated appealed against a decision of the delegate of the Commissioner of Patents, who upheld an opposition to their patent application for compositions and methods using the CRISPR/Cas9 system for genome editing in eukaryotic cells. The respondent, Fisher, opposed the patent on various grounds, including the identity of the person skilled in the art, the clarity of certain claims, and the sufficiency of the disclosure in the patent application and priority document. The court had to determine whether the person skilled in the art would include a microbiologist with expertise in CRISPR/Cas systems in prokaryotes, the meaning of certain phrases in the claims, and whether the claims were clear, enabled, and novel.

The court found that the dependent claim lacked clarity due to an inconsistency between it and the independent claim. The court also found that the invention was not disclosed by the priority document and that the disclosure was not enabling. The court held that the work required of the person skilled in the art would be an undue burden. The court further found that the claims were not entitled to the priority date based on the priority document claims and that the claims lacked novelty and/or did not involve an inventive step. The court also found that the patent application did not provide an enabling disclosure of the invention of the claims and that the claims were not supported by matter disclosed in the specification. The court held that any application to amend the specification should be heard and determined by the Court.

The court ordered that the appellant file and serve any interlocutory application seeking an order directing that the complete specification be amended pursuant to s 105(1A) of the Patents Act 1990 (Cth) together with any affidavit in support of such application by 4.00pm, 11 August 2023. The proceeding was stood over to 9.30am on 17 August 2023 for the making of final orders in the event no application was filed pursuant to the first order, for the making of further orders in relation to any application filed pursuant to the first order, and other orders as may be considered appropriate.