Quality

Quality Management at IP Australia

Quality Policy

1.1 International Searching

1.1.3 Search Allocation and Preliminary Classification

1.1.4 Unity of Invention

1.1.5 Abstract and Title

1.1.7.1 Claim Interpretation According to the PCT Guidelines

1.1.7.2 Broad Claims

1.1.8 Search Strategy

1.1.12 Search Report and Notification Form Completion

1.1.19 Annexes

1.2 International Type Searching

1.3 International Examination

1.3.4 Top-up Search

1.3.5 First IPE action

1.3.6 Response to Opinion

1.3.9 General Considerations

1.3.10 Annexes

Annex A Sub-Annexes

1.4 Fiji Applications

1.5 Thai Applications

1.6 WIPO Searches

2. National

2.1 General Approach to Examination

2.1.7 Citations

2.1.9.4 FERs and Report Formulation

Annex A - Open Patent Services (OPS) FER Process

2.2 Other Examination Considerations

2.2.8 Summary of IP Reform Changes

2.3 Definitions

2.4 Novelty

2.4.4 Relevant Prior Art

2.4.5 Construing the Citation

2.4.6 Level of Disclosure Required

2.4.12 Novelty - Some Specific Examples

2.4.12.1 Chemical Compounds

2.4.12.2 Range of Variables

2.4.12.2.1 Examples Needed for Clear and Unmistakable Directions

2.5 Inventive Step

2.5.1 Overview

2.5.2 Identifying the Relevant Facts

2.5.2.1 Common General Knowledge

2.5.3 Tests for Inventive Step

2.5.3.4 Special Inducements, Obvious Selections

2.5.3.4.1 Examples of Special Inducement

2.5.3.10 Indicators of Inventive Step

2.5.4 Inventive Step - Some Specific Examples

2.5.4.1 Chemical Situations

2.6 Applicants and Nominated Persons, Patent Requests, Entitlement

2.6.1 Applicants and Nominated Persons

2.6.2 Patent Requests

2.6.3 Entitlement

2.6.4 Changing the Applicant or Nominated Person

2.7 Micro-Organisms and Other Life Forms

2.7.3 The Budapest Treaty

2.7.4 The Deposit Requirements

2.7.4.3 Deposit Receipt and Notice of Entitlement to Rely on Deposit

2.7.4.3.1 Contents of the Receipt

2.7.5 Amendments to Insert Section 6(c) Information and Extensions of Time Therefor

2.7.6 Release of a Sample of Deposit

2.7.7 Deposit Requirements Cease to be Satisfied

Annexes

2.8 Abstracts

2.9 Patentability Issues

2.9.2.17 New Uses

2.9.2.18 Ethics and Social Policy

2.9.3 Other Issues

2.9.3.4.1A Assessing the Claims for Lack of Usefulness

2.9.3.5 Human Beings and Biological Processes for Their Generation

2.9.3.5.1 Stem Cells

2.9 Annex A - History of Manner of Manufacture

2.10 Divisional Applications (Sections 79B and 79C)

2.10.9.1 Supervision of Divisional Applications with Great Grandparent or Earlier Ancestors

2.11 Section 40 - Specifications

2.11.2.1 The Addressee

2.11.2.2 Rules of Construction

2.11.2.3 Construction of Claims

2.11.2.4 What is the Invention?

2.11.2.4A What is the Invention?

2.11.3 Full Description, Best Method

2.11.3A Clear Enough and Complete Enough Disclosure

2.11.7A Support for the Claims

2.11.7.1A Principles for Examination

2.11.7.1.1A Contribution to the Art

2.11.9.1 Consistency of Title in the Documents

2.12 Priority Dates and Filing Dates

2.12.1 Priority Dates

2.12.2 Filing Dates

2.13 Examination

2.13.5 Stringency of Tests During Examination

2.13.15.5 Opinion

Annexes

2.18 Multiple Applications (Sections 64(2) and 101B)

2.19 Patents of Addition (Chapter 7)

2.19.1 Applications for Patents of Addition

2.19.2 Examination Procedure

2.20 National Phase Applications

2.20.1 Introduction

2.20.4 Complete Specification in a Foreign Language

2.20.5 Priority Considerations

2.20.10.1 Determining Whether Amendments Made Under Articles and Rules of the PCT are Considered During Examination

2.21 Convention Applications

2.21.3 Making Convention Applications

2.22 Re-Examination

2.22.4 Re-Examination Consideration

2.22.5 Re-Examination Report

2.22.6 Completion of Re-Examination Process

2.22.9 Revocation of Patent Following Re-examination

2.23 Amendments

2.23.3 Formalities

2.23.4 Fees

2.23.5 Granting Leave to Amend/Allowing the Amendments

2.23.8A Allowability Under Section 102(1)

2.23.9 Allowability Under Section 102(2) etc

2.23.10 "Clerical Error" and "Obvious Mistake"

2.23.11 Amendments After the Grant of a Patent

2.23.12 Other Allowability Issues Concerning Amendments to Complete Specifications

2.23.13 Amendment of a Patent Request or of Other Filed Documents

2.23.14 Amendments During Section 59 Opposition and Section 101M Opposition Proceedings

2.23.15 Opposition to Amendments

2.24 Requesting and Directing Examination, Withdrawal, Lapsing, Extension of Term

2.24.1 Requesting and Directing Examination

2.24.2 Withdrawal of Applications (Section 141, Regulation 13.1A)

2.24.2.2.1 Reversing Withdrawal of an Application

2.24.3 Lapsing of an Application

2.25 The Register of Patents (Chapter 19)

2.26 Employees, Delegations, Administration

2.26.1 Restrictions on Patent Office Staff (Sections 182-185)

2.26.4.1 Statutory Provisions

2.26.4.2 Types of Delegations Made by the Commissioner

2.26.5 Secret Cases

2.27 Payment of Fees (Section 227)

2.28 Transitional and Savings Provisions

2.29 Formalities and Forms

2.30 Patent Deed

2.30.1 Sealing of Duplicate Patent

2.31 Innovation Patents

2.31.1 Features of the System

2.31.2 Types of Innovation Patent Application

2.31.3 Formalities Check for Innovation Patents

2.31.4 Examination

2.31.4.5.4A Innovative Step

3. Oppositions, Disputes and Extensions

3.2.1 Section 59 - Opposition to Grant of a Standard Patent

3.2.2 Section 101M - Opposition to an Innovation Patent

3.2.3 Section 75(1) - Opposition to an Extension of Term of a Pharmaceutical Patent

3.2.4 Section 104(4) - Opposition to a Request to Amend a Filed Document

3.2.5 Section 223(6) - Opposition to an Extension of Time under Subsection 223(2) or 223(2A)

3.2.6 Reg 22.21(4) - Opposition to Grant of a Licence

3.2.7 Sections 17 & 32 - Disputes Between Applicants and Co-Owners

3.2.8 Entitlement - Sections 33, 34, 35, 36 and 191A

3.3 Directions

3.3.1 Directions in Opposition Proceedings

3.3.2 Directions that an Application Proceed in Different Name(s) - Section 113

3.4 Opposition Documents - Requirements and Amendments

3.5 Evidence

3.5.1 Presentation of Evidence

3.5.3.1 Further Evidence

3.6 Production of Documents, Summonsing Witnesses

3.7 Withdrawal and Dismissal of an Opposition

3.7.1 Withdrawal of an Opposition

3.7.2 Dismissal of an Opposition

3.7.3 Withdrawal of an Opposed Application

3.8 Hearings and Decisions

3.8.1 Setting Down Hearings

3.8.2 Hearings Procedure

3.8.3 Ex Parte Hearings

3.8.4 Natural Justice and Bias

3.8.5 Principles of Conduct

3.8.6 Decisions

3.8.9 Quality

3.8.10 Appointment of Hearing Officers and Assistant Hearing Officers, Hearing Officer Standards Panel, Hearing Officer Delegations

3.9 Costs

3.10 The Register of Patents

3.10.3 Amendment of the Register

3.11 Extensions of Time and Restoration of the Right of Priority

3.11.1 Extensions of Time - Section 223

3.11.1.3 Subsection 223(2) - Error or Omission and Circumstances Beyond Control

3.11.1.4 Subsection 223(2A) - Despite Due Care

3.11.1.4.1 Filing a Request under Subsection 223(2A)

3.11.2 Extensions of Time - Reg 5.9

3.11.2.2.1 Application of Regulation 5.9

3.11.3 Extensions of Time - Reg 5.10 (as in force immediately before 15 April 2013)

3.11.4 Restoration of the Right of Priority under the PCT

3.12 Extension of Term of Standard Patents Relating to Pharmaceutical Substances

3.12.1 Section 70 Considerations

3.12.2 Applying for an Extension of Term

3.12.3 Processing an Application for an Extension of Term

3.12.3.3.1 Renewal Fees

3.12.3.4 Refusal of Application for Extension of Term

3.13 Documents not OPI - Orders for Inspection

3.14 Appeals, AAT and Judicial Review, Other Court Actions Involving the Commissioner, Section 105 Amendments

3.15 Computerised Decisions

4.1 Searching

4.1.4 Development of the Search Strategy

4.1.4.3 Search Area

4.1.4.3.3 Non-Patent Literature

4.1.5 Conducting the Search

3.12.1.4 Meaning of "mixture or compound of substances"

Date Published 16 Dec 2020

The definition of a “pharmaceutical substance” provided in schedule 1 refers to:

"a substance (including a mixture or compound of substances) for therapeutic use …”.

Other than the passing remarks made by Burchett J that the expression “a mixture or compound of substances” was unusual in a scientific context (Virbac (Australia) Pty Limited and Ancare Distributors Limited v Merck Patent GmbH [1994] FCA 1255), this phrase has not been the subject of judicial consideration. However, it has been the subject of Office decisions including Sanofi-Aventis [2007] APO 35 and N. V. Organon [2009] APO 8.

In Sanofi (supra), the claims were to a biphasic composition presented in the product as a bi-layered tablet. In N. V. Organon (supra), the invention involved a steroidal mixture contained in a thermoplastic polymer core, over which was laid a permeable thermoplastic skin through which the steroidal mixture diffused and was delivered in use.

More specifically, in N. V. Organon (supra) it was stated:

“In this light it appears to me that a pharmaceutical substance (including a mixture or compound of substances) can include a compound with a controlled spatial configuration if, as a whole, it can still be considered a pharmaceutical “substance” but the combination of such a substance with what would reasonably be considered a separate physical device, layer or structure or, from Sanofi, “any purely physical integers” is excluded and indeed would not be a “pharmaceutical substance per se”.”

It was recognised that it may be difficult to determine whether a particular feature of a product is correctly considered part of a “substance” rather than a separate physical integer. However, in the circumstances of that case, it was found that the product as a whole exhibited a level of integration or interaction between the component parts that was considered more characteristic of a pharmaceutical substance itself, rather than a substance combined with another element or integer.

It therefore follows that other inventions which potentially involve a spatial configuration need to be considered on their merits.

There is also a need to consider whether a composition claim encompasses a single pharmaceutical substance or a mixture or compound of substances. Where the claim is directed to a mixture or compound of substances, the same must also be found in the goods.

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