Introduction

Procedures for updating this manual

Using this Manual

Quality

Quality Management at IP Australia

1. International

1.1 International Searching

1.1.2 Introduction

1.1.3 Search Allocation and Preliminary Classification

1.1.4 Unity of Invention

1.1.5 Abstract and Title

1.1.7 Claim Interpretation, Broad Claims, PCT Article 5 and 6

1.1.7.1 Claim Interpretation According to the PCT Guidelines

1.1.7.2 Broad Claims

1.1.8 Search Strategy

1.1.11 Search Procedure

1.1.12 Search Report and Notification Form Completion

1.1.12.5 Documents Considered to be Relevant

1.1.15 Foreign Patent Search Aids and Documentation

1.1.18. Nucleotide and/or Amino Acid Sequence Listings

1.1.19 Annexes

Annex V - Internet Searching

1.2 International Type Searching

1.2.10 Annexes

1.3 International Examination

1.3.3 The Demand and IPRPII

1.3.4 Top-up Search

1.3.5 First IPE action

1.3.6 Response to Opinion

1.3.8 Completing ISO, IPEO and IPRPII Forms

1.3.9 General Considerations

1.3.10 Annexes

Annex A Sub-Annexes

1.4 Fiji Applications

1.4.8 Annexes

1.5 Thai Applications

1.6 WIPO Searches

1.6.7 Annexes

1.10 Miscellaneous

2. National

2.2 Other Examination Considerations

2.2.4 Communication of Report

2.2.7 Communication with Applicants and Attorneys Outside the Reporting Process and Recording of Case Notes

2.3 Definitions

2.4 Novelty

2.4.3 Applying the Test for Novelty

2.4.4 Relevant Prior Art

2.4.5 Construing the Citation

2.4.5.2 Principles for Construing the Citation

2.4.5.1 Introduction

2.4.6 Level of Disclosure Required

2.4.8 Not All Features of Claim Disclosed in Citation

2.4.11 "Whole of Contents"

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

2.5.1.4 Comparison between Novelty and Inventive Step

2.5.2 Identifying the Relevant Facts

2.5.2.1 Common General Knowledge

2.5.2.3 Determining the Problem

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

2.7 Micro-Organisms and Other Life Forms

2.7.2 Full Written Description of a Life Form

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

2.7.7 Deposit Requirements Cease to be Satisfied

Annexes

2.8 Abstracts

2.9 Patentability Issues

2.9.2 Patentable Subject Matter (Manner of Manufacture)

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

2.10 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

2.11.2.3 Construction of Claims

2.11.2.1 The Addressee

2.11.2.2 Rules of Construction

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

2.15 Acceptance of Standard Patent Applications

2.15.7 Exending the Time for Acceptance

2.17 Publications

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

2.18.3 Examination Reports

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

2.20.3 Patent Request and Entitlement

2.20.4 Complete Specification in a Foreign Language

2.20.5 Priority Considerations

Annexes

2.20.1 Introduction

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

2.21 Convention Applications

2.21.2 Convention Countries

2.21.3 Making Convention Applications

2.21.1 Introduction

2.22 Re-Examination

2.22.3 When Re-Examination Applies

2.22.4 Re-Examination Consideration

2.22.5 Re-Examination Report

2.22.6 Completion of Re-Examination Process

2.22.8 Refusal to Grant a Patent Following Re-examination

2.22.9 Revocation of Patent Following Re-examination

2.23 Amendments

2.23.2 General Provisions - Section 104 Amendments

2.23.3 Formalities

2.23.4 Fees

2.23.5 Granting Leave to Amend/Allowing the Amendments

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

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

2.23.14.4 Considering the Amendments

2.23.15 Opposition to Amendments

Annexes

2.23.8A Allowability Under Section 102(1)

2.23.13 Amendment of a Patent Request or of Other Filed Documents

2.23.16 Amendment of Refused Application

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

2.30 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 Ground (2): Subsection 18(1A)

2.31.4.5.4A Innovative Step

2.1 General Approach to Examination

2.1.6 Examination and Report Requirements

2.1.6.2 Examination and Level of Report Detail

2.1.6.1 Overview

2.1.7 Citations

2.1.9 Guidelines for Using IPRPI/IPRPIIs and Other Foreign Examination Reports (FERs) in Examination

2.1.9.4 FERs and Report Formulation

2.6 Applicants and Nominated Persons, Patent Requests, Entitlement

2.6.2 Patent Requests

2.6.3 Entitlement

2.6.4 Changing the Applicant or Nominated Person

2.6.1 Applicants and Nominated Persons

2.13 Examination

2.13.2 Applications in a State of Lapse, or Lapsed

2.13.4 Request for Examination

2.13.5 Stringency of Tests During Examination

2.13.7 Amendments

2.13.11 Notices Under Section 27

2.13.13 Examining Cases Subject to a Prohibition Order

2.13.15 Preliminary Search and Opinion (PSO)

2.13.15.5 Opinion

Annexes

Printable Version

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

3.8.2 Hearings Procedure

3.8.3 Ex Parte Hearings

3.8.4 Natural Justice and Bias

3.8.6 Decisions

3.8.8 Final Determinations

3.8.9 Quality

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

3.8.1 Setting Down Hearings

3.8.5 Principles of Conduct

3.8.7 Further Hearings

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

3.12.3 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

3.12.1 Section 70 Considerations

3.12.2 Applying for an 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

Printable Version

4. Classification, Searching and Information Technology

4.1 Searching

Annexes

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

4.1.6 Recording the Search Details

4.3 IPC Distribution

4.6 Patent Family Member Searching

4.7 PATADMIN

4.7.4 Senior Examination and Supervising Examiner Menu

4.8 STN

4.9 INTESS User Guide

4.9.3 INTESS Basics: Getting started, Workflow Diagram, Checklists and Searches

4.9.3.1 Workflow Diagrams

4.9.3.2 Getting Started

4.9.3.2.5 Objects

4.9.3.3 Checklists

4.9.3.4 Searches in INTESS

4.9.4 International Work Distribution

4.9.5 Examiner Actions in INTESS

4.9.5.1 Basic Actions when Assigned a New or Further eCase

4.9.5.2 Document Storage

4.9.5.2.1 What documents are to be stored on INTESS?

4.9.6 Further Actions, New Material and Additional Correspondence (e.g. Invitation to Pay)

4.9.7 FAQs

4.9.8 Tech Sort

4.9.8.3 Assessing US PCT Applications

4.9.8.1 Overview of the Technology Sort Process

4.9.8.1.1 Tech Sort Process Checklist

4.9.8.2 Assessing Non-US PCT Applications

4.10 ISYS Database and Hearing Database

4.11 Using DocGen

4.11.3 First Further

4.11.3.5.1 Creating a Cover Letter for Examiner's Adverse Report to 3rd Party

4.11.3.6 Creating a new First or Further Report - Re-examination

4.11.3.6.1 Non-Adverse Re-examination Report

4.11.3.7 Editing an Existing First or Further Report

4.11.4 Article 15(5) Searches

4.11.5 PCT/ISA

4.11.6 PCT/IPEA

4.11.7 WIPO/Fiji/Thai/PNG

4.11.8 Preliminary Search and Opinion (PSO)

4.11.8.1 Preparing a Preliminary Search and Opinion (PSO)

4.11.2.8 Doc Gen Workflow User Guides

4.11.2.6.1 Opening a Saved Report

4.12 EPOQUE User Reference Guide

4.12.2 EPOQUE What's New

4.12.3 Accessing EPOQUE

4.12.3.1 Starting EPOQUE

4.12.3.1.1 EPOQUE Password

4.12.9 Miscellaneous

4.12.9.7.1 Other Known Issues

4.12.9.8 Printing

4.12.9.10 Slow Computer Response during File Save/Loading

4.12.9.11 EPOQUE Usage Costs

4.12.9.12 EPOXY

4.12.9.12.1 Useful Topics

4.12.6.1 Searching using INTERNAL

4.12.6.2 Searching using X-Full Module

4.12.7 VIEWER

4.12.7.4 Navigation

4.12.7.6 Drawers

4.12.7.9 VIEWER Preferences

4.12.7.10 Closing the VIEWER

4.12.8 Preparations

4.12.8.1 Private Preparations

4.2 Classification

4.2.3 Other Classification Information

4.2.3.5 Recording Classification Symbols on Machine-Readable Records

4.2.3.6 Presentation of Classification Symbols and Indexing Codes on Patent Documents

4.2.1 Patent Classification Systems

4.2.1.1 International Patent Classification (IPC)

4.2.1.2 Cooperative Patent Classification (CPC)

4.2.2 Principles of Classification

4.2.2.1 Invention Information and Additional Information

4.2.2.2 Classification Priority Rules

4.2.2.3 Classifying in Function-Oriented and Application-Oriented Places

4.2.2.3.1 Selection of Classification Places

4.4 COMPASS and Citation Storage

5. PAMS Examiner's Reference

5.2 PAMS Overview

5.3 Getting Started

5.3.5 Navigating PAMS

5.3.5.6 Tree View

5.3.6 Shortcut Keys

5.3.9 In-Trays

5.3.9.2 Examination In-Trays

5.3.10 PAMS Tables

5.3.10.1 Working with Tables

5.4 Tasks

5.4.8.1 Transferring Tasks between Sections

5.4.12 The Exam Request and Exam Response Verification Screen

5.4.12.1 Alerts and Warnings

5.4.13 Pending Exam Task

5.4.13.1 Pending Exam Routing Rules

5.4.14 Indicators in PAMS for Tasks to be Considered under 2012 Provisions

5.5 Bibliographic Information Screens

5.5.3 Examination Details

5.6 Documents/Correspondence

5.6.7 Document Manipulation

5.6.1 Creating Correspondence

5.6.2 Adding a Document

5.6.2.1 Add an Email to the Ecase

5.8 Enquiries

5.8.9 Non-OPI Search Enquiry (NOSE)

5.8.9.3.3.1 Generating a Search Report

5.8.2.1 Searching IPC Marks using AusPat

5.9 Indexing

5.9.2 Preliminary Sorting Processes

5.9.2.2 Processing Tasks of Non-Indexed Applications

5.9.2.1 Tech Sort Task Processing

5.9.3 Examiner Indexing

5.10 Standard Examination

5.10.12 Response to Examiner's Report

5.10.12.3.1 Removing Postponement of Acceptance

5.10.15 National Phase Issues

5.10.19 Acceptance

5.10.19.3 Acceptance Screens

5.10.10.1 Exam Corro

5.10.10.1.3 Dispatch of Exam Report

5.10.10.1.3.1 Dispatch Management

5.10.10.2 Bibliographic Information Screens

5.10.10.3 Assembly

5.10.11 Examination Results in Clear Report

5.11 Innovation Examination

5.11.6 Response to Examiner's Report

5.11.4.1 Exam Corro

5.11.4.2 Bibliographic Information Screens

5.11.4.3 Completing Exam Request Task

5.11.5 Examination Results in Clear Report

5.11.5.3 Certification

5.11.5.3.1 Apology Letter for Certified Innovation

5.12 International Type Searching

5.13 Voluntary Amendments

5.13.4 Allowing Voluntary s104 Amendments

5.14 Deferment of Grant

5.15 Re-Examination

5.16 Troubleshooting

5.16.4 FAQs

5.16.4.1 Indexing

5.16.4.2 Examination

5.16.4.3 Documents/Correspondence

5.16.4.4 General

5.16.4.5 Standard Comments - Reassigning Tasks to COG

5.17 Oppositions, Courts, Extensions and Disputes

5.17.1 Publications

5.18 Preliminary Search and Opinion (PSO)

Printable Version

6. PERP Manual

6.3A - Introduction Paragraphs

6.4B - Patent Request, Entitlement

6.5C - Convention Application/Basic Document

6.6D - Lack of Unity

6.7E - Specification - Omnibus Claims, Fair Basis, Disclosure, Support, Clear and Succint, Micro-Organisms

6.8F - Novelty, Inventive Step

6.8.3 Novelty

6.8.4 Inventive Step

6.9G - Amendments - Not Allowable, Rebuttals, Not In Order, Amendments Under Opposition, Amendments After Acceptance

6.10H - Divisionals

6.12K - National Phase

6.13L - Additionals

6.14M - Patentable Subject Matter

6.14.1 Manner of Manufacture

6.14.2 Usefulness

6.15P - Miscellaneous - Title, Subsection (51(1), Subsection 64(2), Other

6.16R - Applicant Cases - No Possibility of Grant, Possibility of Grant, Search Reserved, Drafting & Formalities, Amendments, Guide, State Offices

6.17 T/S - International

6.17.17 Certain Documents Cited

6.17.17.1 International

6.1 Introduction

7.12 Extension of Term of Standard Patents Relating to Pharmaceutical Substances

Date Published 09 Oct 2023

Also in this Chapter:

Sub-chapters:

Key Legislation:

Patents Act:

s70 Applications for extension of patent
s71 Form and timing of an application
s74 Acceptance or refusal of application
s75 Opposition to grant of extension
s76 Grant of extension
s77 Calculation of term of extension
s78 Exclusive rights of patentee are limited if extension granted
Schedule 1 Dictionary

Patents Regulations:

reg 6.8 Information to accompany application

In this topic:

Relevant Legislation

The Act

The Regulations

Overview

Requirements for Obtaining an Extension of Term

Rights of Patentee During the Extended Term

Relevant Legislation

The Act

Section 70	Applications for extension of patent
Section 71	Form and timing of an application
Section 74	Acceptance or refusal of application
Section 75	Opposition to grant of extension
Section 76	Grant of extension
Section 77	Calculation of term of extension
Schedule 1	Dictionary

The Regulations

Information to accompany application

Overview

The Intellectual Property Laws Amendment Act 1998 amended the Patents Act 1990 to provide for an extension of term for pharmaceutical patents. The scheme allows patentees to apply for an extension of term of up to 5 years for a standard patent that claims a pharmaceutical substance.

Requirements for Obtaining an Extension of Term

In order to obtain an extension of term for a patent, the following requirements must be met:

the patent must, in substance, disclose and claim a pharmaceutical substance per se, or a pharmaceutical substance when produced by recombinant DNA technology;
goods containing or consisting of that pharmaceutical substance must be included in the Australian Register of Therapeutic Goods (ARTG); and
the first regulatory approval for that pharmaceutical substance must have occurred more than 5 years after the date of the patent.

Provided the requirements of the Act are satisfied, the term of the patent (in its entirety) may be extended.

Rights of Patentee During the Extended Term

The rights of a patentee during the extended term of a patent are however limited over the normal rights in a patent. Although the term of the patent as a whole is extended, exploitation of any form of the invention that is not a pharmaceutical substance and exploitation of pharmaceutical substances for nontherapeutic uses do not constitute infringement of the patent during the extended term (s78).