ToolGen Incorporated v Fisher (No 2) [2023] FCA 794
Claims not entitled to priority from P1 because P1 does not disclose or enable the invention across the full scope of the claims—especially systems using Cas9 proteins from bacteria other than S. pyogenes—without undue burden; specification similarly fails to enable or support broad claims; claim 19 lacks clarity as it cannot sensibly be read with its parent claim; thus, all claims either lack novelty or do not involve an inventive step at the deferred priority date, and insufficient disclosure across claim breadth renders them invalid.
- Jurisdiction
- Australia
- Judgment Date
- 14 July 2023
- Procedural Posture
- Appeal (de Novo) From Opposition Decision – Patents / Judgment After Trial – Orders as to Amendment and Standing Over for Final Orders
- Outcome
- No final substantive orders—orders made for any amendment application; if none is filed, anticipated orders are to dismiss appeal, allow cross-appeal, and direct Commissioner to refuse patent application, with costs to respondents.
- Legal Topics
- ['patents' 'genome Editing' 'disclosure and Enablement' 'priority Date' 'novelty' 'inventive Step' 'support Requirement' 'clarity of Claims']
Case Brief
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Procedural Posture
Appeal (de Novo) From Opposition Decision – Patents / Judgment After Trial – Orders as to Amendment and Standing Over for Final Orders
Legal Issues
- 1 ['Who is the skilled addressee of P1 and the patent application?' "What construction should be given to claims regarding 'nucleic acid encoding a guide RNA'?" "Do the claims extend to 'paired Cas nickases'?" 'Does claim 19 lack clarity?' 'Does P1 provide an enabling disclosure as required for priority?' 'Do the claims lack novelty or inventive step at deferred priority date?' 'Does the complete specification enable the invention of the claims?' 'Are the claims supported by the specification?']
Ratio Decidendi
Claims not entitled to priority from P1 because P1 does not disclose or enable the invention across the full scope of the claims—especially systems using Cas9 proteins from bacteria other than S. pyogenes—without undue burden; specification similarly fails to enable or support broad claims; claim 19 lacks clarity as it cannot sensibly be read with its parent claim; thus, all claims either lack novelty or do not involve an inventive step at the deferred priority date, and insufficient disclosure across claim breadth renders them invalid.
Court Disposition
No final substantive orders—orders made for any amendment application; if none is filed, anticipated orders are to dismiss appeal, allow cross-appeal, and direct Commissioner to refuse patent application, with costs to respondents.
Orders
- ['Appellant to file any interlocutory amendment application and supporting affidavit by 4pm 11 August 2023.' 'Proceedings stood over to 9:30am on 17 August 2023 for final/further orders and costs.']
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