Australian CRISPR update: Federal Court doubles down on unpatentable ToolGen gene editing claims

The Australian Federal Court yesterday confirmed that the accepted patent application owned by ToolGen Inc. and directed to CRISPR/Cas9 systems and methods of genome editing in eukaryotic cells contains no patentable claims.¹

The Court found that all claims of ToolGen’s application² lacked entitlement to the earliest priority date,³ lacked novelty or inventive step, and were not supported by the specification. The Court also found that the specification did not provide an enabling disclosure of the invention. This decision doubles down on the findings of the Patent Office during earlier opposition proceedings⁴ in which all but two claims of the patent application were found to lack novelty or inventive step and entitlement to the earliest priority date – and therefore offered ToolGen a now much diminished prospect of securing some patentable claims and a stronger foothold in the Australian CRISPR patent landscape.

This decision is interesting because it gives us an Australian perspective on developments that occurred in the critical and intense foundational CRISPR research period between June 2012 and February 2013. At this time, several groups internationally (including ToolGen) were filing key provisional patent applications and publishing groundbreaking papers exploring the tantalizing and ever-expanding potential applications for the CRISPR/Cas9 gene editing technology.

CRISPR, which stands for “Clustered Regularly Interspaced Short Palindromic Repeats”, and Cas9, which is an endonuclease protein that cuts DNA, are both components of certain bacterial adaptive immune systems that can be modified and targeted to certain cells and DNA sequences (including in human cells) to perform a variety of gene editing functions.

Our full analysis on the decision will follow, but in the meantime, the Court has given ToolGen 28 days to file an application to amend the patent application (which the anonymous respondents in this proceeding are primed to oppose). We will be keeping a close eye on developments.

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1. ToolGen Incorporated v Fisher (No 2) [2023] FCA 794 (fedcourt.gov.au)
2. AU 2013335451
3. The earliest priority date claimed was 23 October 2012
4. Fisher v ToolGen Inc (2018) 144 IPR 315, [2018] APO 65

Dr Danielle Burns, Principal

BSc(Hons) Phd MIPLaw

Danielle has extensive experience as a patent attorney with expertise in patent strategy, protection and enforcement in the Biotech sector.  She has a strong understanding of global patent and regulatory exclusivities (including data and market exclusivities) and has facilitated entry of several biopharmaceuticals (including antibodies and antisense molecules), diagnostics, cellular therapeutics, and agricultural products (including transgenic plants) to market.

Malcolm Bell, Principal

BSc(Hons) LLB LLM FIPTA MRACI

Malcolm is a Principal of Phillips Ormonde Fitzpatrick and Phillips Ormonde Fitzpatrick Lawyers. His practice is split between litigious matters and his work as a patent attorney.