ToolGen’s CRISPR/Cas9 patent application rejected –

Nicholas J has ruled that ToolGen’s application for a patent, AU 2013335451, for “what is now a well-known gene editing system known as the CRISPR/Cas9 system” for editing target DNZ sequences in eukaryotic cells. His Honor has allowed ToolGen until 11 August 2023 to bring any application to leave to amend pursuant to s 105(1A).

As the complete specification was filed after 15 April 2013, the Patents Act in the form amended by the Raising the Bars Act applied.

The matter came before his Honor on ToolGen’s “appeal” from an opposition in which the Commissioner’s delegate found that all but one of the claims should be refused but allowed ToolGen 2 months to amend.

At [13]Nicholas J summarised his Honor’s findings:

For the reasons that follow I have concluded:

(a) None of the claims are entitled to priority based on P1 (s 43(2A)).

(b) All of the claims lack novelty or do not involve an inventive step (s 18(1)(b)).

(c) The complete specification does not provide an enabling disclosure of the invention (s 40(2)(a)).

(d) The claims are not supported by matter disclosed in the specification (s 40(3)).

(e) Claim 19 lacks clarity (s 40(3)).

More detailed consideration will have to wait for another day.

ToolGen Incorporated v Fisher (No 2) [2023] FCA 794

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