SoftKemo Pharma Corp - [2022] APO 81

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

SoftKemo Pharma Corp [2022] APO 81

Patent Application: 2019219792

Title:Bendamustine anionic-cationic cyclopolysaccharide compositions

Patent Applicant: SoftKemo Pharma Corp

Delegate:Dr Scott D. Makin

Decision Date: 13 December 2022

Hearing Date: Written submissions filed on 25 August 2021

Catchwords: PATENTS – examiner’s objections – novelty -
grace period provisions apply – information is disclosed in original application – information in currently cited prior art must be disregarded – section 40 – support – support objection cannot be maintained – usefulness – utility – the claimed invention is useful – the claimed invention has utility

Representation: Patent attorney for the applicant: Halfords IP

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE

Patent Application: 2019219792

Title:Bendamustine anionic-cationic cyclopolysaccharide compositions

Patent Applicant: SoftKemo Pharma Corp
Date of Decision: 13 December 2022
DECISION

The information in D1 (WO 2010/097700 A1) and D2 (WO 2011/103150 A2) must be disregarded in deciding whether the present claims are novel.

The present claims are supported under subsection 40(3).

The present claims meet the usefulness requirement under subsection 18(1)(c).

The current outstanding objections cannot be maintained. The application will be referred back to examination to consider whether further prior art searching is required. The period to gain acceptance is extended to three (3) months from the date of this decision.

REASONS FOR DECISION
Background

Patent application 2019219792 (the application or the present application) was filed by SoftKemo Pharma Corp (the applicant) on 21 August 2019. It is a divisional application of 2017216568 (the parent application) which lapsed on 21 August 2019. The parent application is in turn a divisional application of now granted patent 2011363446 which was a national phase application of PCT/IB2011/003367 (the grandparent application or the grandparent patent). The present application has an earliest claimed priority date of 19 July 2010.
The parent application was the subject of a single examination report issued on 21 August 2018 which raised objections on the grounds that the claims lacked support under subsection 40(3) and that the claims lacked novelty. There was no response to that examination report and the parent application duly lapsed for failure to gain acceptance by 21 August 2019.
Prior to lapsing of the parent application, the applicant filed for a divisional application which forms the basis of the application under consideration here. The present application and the parent application are almost identical except for some minor differences in the description. Two examination reports have been issued on the present application. A first examination report for the present application was issued on 15 June 2020 raising identical grounds of objection to that of the single examination report issued against the parent application. The applicant responded to the first report on 7 June 2021 without proposed amendments. A second examination report was issued on 11 June 2021 maintaining the previous grounds of objection and raising an additional objection that the claimed invention also lacked utility under subsection 18(1)(c).
On 15 June 2021 (the final date for acceptance of the…

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: [2022] APO 81
Decision Date: 13 December 2022

CaseChat Overview and Summary

SoftKemo Pharma Corp is the applicant of patent application 2019219792, which is a divisional application of 2017216568, which in turn is a divisional application of now granted patent 2011363446. The present application is directed to a composition comprising bendamustine and a first charge cyclopolysaccharide comprising at least one charged group, and optionally a stabilizing agent which is a second charged cyclopolysaccharide having at least one charged group having a charge opposite to that of the first polysaccharide. The applicant alleged to have found that compositions of bendamustine with certain combinations of charged cyclopolysaccharides lead to increased stability of the active compound and potentially increased anticancer activity. The claims of the present application are of broader scope than the grandparent patent’s claims. As I also stated earlier, the compositions of the present claims are not limited to include only these two components, but the scope is such that the composition may contain any other ingredient. There is no requirement in the present claims that the bendamustine composition additionally comprises a cyclopolysaccharide stabilising agent of opposite charge as per the claims of the granted grandparent application. The present claims are supported under subsection 40(3). The present claims meet the usefulness requirement under subsection 18(1)(c). The current outstanding objections cannot be maintained. The information in D1 and D2 must be disregarded in deciding whether the present claims are novel. The application will be referred back to examination to consider whether further prior art searching is required. The period to gain acceptance is extended to three (3) months from the date of this decision.

Orders