AFT Pharmaceuticals Limited

Case [2024] APO 41


IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

AFT Pharmaceuticals Limited [2024] APO 41

Patent Applications:            2022201576 and 2023222825

Title:Medication

Patent Applicant:                AFT Pharmaceuticals Limited

Delegate:C.  Mitchell

Decision Date:  8 October 2024

Hearing Date:  Written submissions filed on 6 December 2023

Catchwords:  PATENTS – section 45 – Examiner’s objection – use of paracetamol, ibuprofen and xylometazoline to treat cold and flu during a day – inventive step – common general knowledge – claims lack an inventive step –  applications are refused

Representation:                   Patent attorney for the applicant: A J Pietras IP Ltd

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Applications:            2022201576 and 2023222825

Title:Medication

Patent Applicant:                AFT Pharmaceuticals Limited

Date of Decision:                8 October 2024

DECISION

Claims 1-22 of both applications are not inventive.

I refuse the parent application and divisional application. 

REASONS FOR DECISION

Background

  1. Patent application number 2022201576 (the parent application) was filed on 8 March 2022 by AFT Pharmaceuticals Limited (the applicant).  A further application 2023222825 (the divisional) was filed on 28 August 2023 and claims divisional status from the parent application.  The earliest priority date for both applications is 8 March 2022. 

  2. The request for examination of the parent application was also filed on 8 March 2022.  The first examination report was issued on 29 August 2022.  Subsequent reports were issued on 31 October 2022, 14 December 2022 and 10 March 2023 following responses from the applicant.  A fifth examination report was issued on 24 August 2023, maintaining an objection for a lack of inventive step.  The applicant requested a hearing on 28 August 2023.

  3. The request for examination of the divisional was also filed on 28 August 2023.  The first examination report was issued on 25 September 2023, raising an objection for a lack of inventive step.  Further, the examiner noted the divisional would also be referred to a Hearing Officer so that the hearing requested by the applicant can be in relation to both the parent application and the divisional.  On 7 December 2023 the applicant submitted that a hearing on the divisional should not be a part of the hearing proceeding.  On 11 December 2023 the Commissioner upheld that both the parent and divisional application will proceed to hearing together as previously indicated.  The claims of the divisional are identical to the claims as proposed to be amended in the parent.

    Applicable Law

  4. On 15 April 2013, the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (the Raising the Bar Act) commenced which resulted in significant amendments to the Patents Act 1990 (the Act) and Patents Regulations 1991 (the Regulations).  The amended provisions of the Act and Regulations apply to the examination of the instant applications and to these proceedings.

  5. This means that I must accept the instant applications if I am satisfied, on the balance of probabilities, that the instant applications comply with the Act. If I am not so satisfied, I may refuse the instant applications or remit it back to examination for further consideration.…

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AFT Pharmaceuticals Limited [2024] APO 41
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[2024] APO 41
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CaseChat Overview and Summary

AFT Pharmaceuticals Limited filed two patent applications with the Australian Patent Office: application 2022201576 (the parent application) and application 2023222825 (the divisional application). Both applications claimed a medication for treating cold and flu in humans by administering paracetamol, ibuprofen, and xylometazoline within a specified dosage regimen on the same day. The applications were objected to on the basis of a lack of inventive step over the prior art and common general knowledge. The applicant responded to the objections and requested a hearing, which was held on 11 December 2023. The Delegate of the Commissioner of Patents, C. Mitchell, decided that the claims in both applications lacked an inventive step and refused the applications. The Delegate found that the combination of the three actives in their known dosage formulations was obvious to a person skilled in the art, given the common general knowledge at the priority date. The Delegate also found that the additional feature of lowering the Cmax and increasing the Tmax for ibuprofen was an inevitable consequence of combining the known actives and did not contribute to inventiveness. The Delegate concluded that no allowable amendment could overcome the lack of inventive step and that the applications should be refused.

Orders

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Background

Background to the litigation

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Evidence

Evidence Before The Court

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Decision

Reasons for decision

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Ratio Decidendi

Legal Principle Established

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