RHONE-POULENC RORER S.A. - [1995] APO 50

official notice

decision of a delegate of the commissioner of patents

Application : No. 12264/92 in the name of RHONE-POULENC RORER S.A.

Title: Optically active 5H-pyrrolo[3,4-b]pyrazine derivative, its preparation and pharmaceutical compositions containing same

Action: Hearing in relation to objections during examination

Decision: Issued
Abstract: 1. The invention related to a single isomer isolated from a known racemic mixture. It was found that the claims which did not refer to the degree of purity of the isomer did not define the invention.

2. The problem-solution approach to inventive step is applicable if a problem can reasonably be inferred on the basis of the specification as a whole and the surrounding facts.

3. The invention was found to lack an inventive step by application of the problem-solution approach as it would have been considered worthwhile to separate the isomers to determine whether one isomer embodied the two desirable properties.

patents act 1990

decision of a delegate of the commissioner of patents

Re:Patent Application No. 12264/92 by Rhone-Poulenc Rorer S.A., and objections raised by the Commissioner during examination.

background

Patent application PCT/FR92/00031, which is entitled "Optically active 5H-pyrrolo[3,4-b]pyrazine derivative, its preparation and pharmaceutical compositions containing same" was filed (in the French language) as an international application on 16 January 1992. The application designated Australia, and the Australian application was accorded the number 12264/92. The applicant and nominated person is Rhone-Poulenc Rorer S.A. The application claims priority from a French application (number 91/00490) filed on 17 January 1991.

A first examination report was issued on 30 November 1993. This report raised only two issues: a notice of entitlement had not been filed, and an objection of lack of inventive step was taken against the claims. The objection of lack of inventive step was maintained through a further three reports in the light of argument from the patent attorney for the applicant.

On 7 August 1995 the applicant filed a facsimile correspondence requesting a hearing on the inventive step objection. The hearing was set down for 15 August. [This date was determined in consultation with the patent attorney for the applicant. The normal period of notice required under regulation 22.23 was not observed due to the imminence of the final date for acceptance of the application i.e. 30 August 1995]

The hearing was conducted by telephone. The applicant was represented by Mr J.Slattery (patent attorney of Davies Collision Cave, Melbourne).

THE SPECIFICATION

By virtue of section 89, the verified translation of the international application is taken to be the specification.

The specification relates to the known sedative compound zopiclone. The molecular structure of zopiclone is:

The molecular structure of zopiclone has an asymmetrical carbon atom (at position 5 of the pyrrolopyrazine ring), so the compound exists in different isomeric forms. The specification identifies the invention as the dextrorotatory isomer of zopiclone, which had not previously been separated from the racemic mixture. The dextrorotatory isomer is more active as a sedative, and less toxic, than the racemic mixture.

The specification contains…

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: [1995] APO 50
Decision Date: 25 August 1995

CaseChat Overview and Summary

The decision involved a patent application filed by Rhone-Poulenc Rorer S.A. for an optically active 5H-pyrrolo[3,4-b]pyrazine derivative, its preparation, and pharmaceutical compositions containing the same. The application was objected to by the Commissioner on the grounds that the invention lacked an inventive step. The applicant requested a hearing to address this objection. The court was required to determine whether the claims of the patent application adequately defined the invention and if the invention met the criteria for inventive step under the Patents Act 1990. The court applied the problem-solution approach to the question of inventive step and found that the claims did not define the invention because they did not limit the degree of purity of the dextrorotatory isomer. The court also concluded that the invention lacked inventive step because it would have been considered routine to separate the isomers to determine whether one isomer possessed both the desired properties of increased sedative activity and reduced toxicity. The court allowed the applicant time to propose amendments to overcome the objections.

Orders