Grant Fisher v ToolGen Incorporated - [2018] APO 65

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Grant Fisher v ToolGen Incorporated [2018] APO 65

Patent Application: 2013335451

Title:Composition for cleaving a target DNA comprising a guide RNA specific for the target DNA and Cas protein-encoding nucleic acid or Cas protein, and use thereof.

Patent Applicant: ToolGen Incorporated

Opponent: Grant Fisher

Delegate: Dr Leslie F. McCaffery, Deputy Commissioner

Decision Date: 18 September 2018

Hearing Date: 21 May 2018, in Canberra (Supplementary submissions finalised 21 June 2018)

Catchwords: PATENTS – opposition to the grant of a patent under section 59 – Section 40(2)(a) and whether the specification is clear enough and complete enough for the skilled person to work the invention across the full scope of the claims – Section 40(3), clarity and support – Section 43 and priority – novelty – inventive step – opposition successful – opportunity to amend – costs awarded.

Representation: Counsel for the applicant: Patrick W. Flynn

Patent attorney for the applicant: Jones Day
Counsel for the opponent: Christian Dimitriadis SC and Clare Cunliffe
Solicitor for the opponent: Ashurst Australia

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application: 2013335451

Title:Composition for cleaving a target DNA comprising a guide RNA specific for the target DNA and Cas protein-encoding nucleic acid or Cas protein, and use thereof.

Patent Applicant: ToolGen Incorporated

Date of Decision: 18 September 2018

DECISION

The opposition under Section 59 is successful.

Claim 19 lacks clarity.

Claims 1 to 8 and 10 to 18 lack novelty.

Claims 1 to 8, 10 to 18 and 21 lack inventive step.

The Applicant has 2 months from the date of this decision to propose amendments to overcome the issues.

As the opposition is successful, costs according to Schedule 8 are awarded against the Applicant Toolgen Incorporated.

REASONS FOR DECISION

1. Patent application 2013335451 was filed by ToolGen Incorporated (the Applicant) on 23 October 2013. The application claims earlier priority from several US provisional applications: 61/717324 which was filed on 23 October 2012 (hereinafter P1), 61/803599 which was filed on 20 March 2013 (hereinafter P2) and 61/837481 which was filed on 20 June 2013 (hereinafter P3).

2. Examination was requested on 21 August 2015. Following two adverse examination reports, the application was advertised as accepted on 15 September 2016. A notice of opposition was filed by Grant Fisher (the Opponent) on 15 December 2016.

3. The statement of grounds and particulars was filed on 15 March 2017 and set out the following grounds of opposition: novelty, inventive step, utility, and sections 40(2)(a) (sufficiency), 40(2)(aa) (best method), 40(2)(b) (definition) and 40(3) (clarity and support). A request to amend the statement to reflect the evidence in support provided by the opponents was filed on 13 July 2017, and allowed on 24 August 2017.

4. The matter was heard on 21 May 2018. The grounds of novelty, inventive step, sufficiency, clarity and support were pressed at hearing. The Applicant was represented by Mr Patrick Flynn and the Opponent by Mr Christian Dimitriadis and Ms Clare Cunliffe.

Standard of…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

Case: [2018] APO 65
Decision Date: 18 September 2018

CaseChat Overview and Summary

In the case of Grant Fisher v ToolGen Incorporated, the applicant, ToolGen Incorporated, had filed a patent application for CRISPR-based gene editing technology. The applicant's patent application claimed priority from three earlier provisional patent applications filed in the United States. The opponent, Grant Fisher, filed an opposition to the grant of the patent under section 59 of the Patents Act 1990, arguing that the patent application lacked clarity, sufficiency, and inventive step. The opposition was heard on 21 May 2018 and the decision was handed down on 18 September 2018.

The court found that the opposition was successful, and that the patent application lacked clarity, sufficiency, and inventive step. Claim 19 lacked clarity as it referred to guide RNA that is in vitro transcribed and introduced into the cell, which was not supported by the specification. Claims 1 to 8 and 10 to 18 lacked novelty and inventive step in light of three prior art documents. Claims 9 and 20 were found to be inventive, but Claim 21 lacked inventive step.

The applicant was granted two months from the date of the decision to propose appropriate amendments to the specification. The court awarded costs to the opponent according to Schedule 8.

Orders