- Home
- 2. About this Manual
- 2.1 Purpose of the Manual
- 2.2 Navigating the Manual
- 2.3 Determining Changes to the Manual
- 2.4 Governance for Editing the Manual
- 2.5 Periodic Review and Maintenance
- 3. Quality and Customer Engagement
- 3.1 Quality
- 3.2 Customer Service Charter (Timeliness Guidelines)
- 3.3 Efficient Examination
- 3.3.1 Use of FERs (Earlier Search and Examination Reports)
- 3.3.2 General Approach to Examination
- 3.3.3 Reserving Opinion and Restricting the Search
- 3.3.4 Communicating with the Applicant and Third Parties
- 3.4 Assisting Unrepresented Applicants
- 3.5 Staff Delegations, and Restrictions on Providing Customer Assistance
- 4. Classification and Searching
- 4.1 Search Theory
- 4.2 Patent Classifications
- 4.2.1 Patent Classification Systems
- 4.2.1.1 International Patent Classification (IPC)
- 4.2.1.1.1 Structure of the IPC
- 4.2.1.1.2 Headings and Titles
- 4.2.1.1.3 Definitions, Warnings and Notes
- 4.2.1.1.4 Function-Oriented and Application-Oriented Places
- 4.2.1.1.5 References
- 4.2.1.1.6 Indexing Codes
- 4.2.1.2 Cooperative Patent Classification (CPC)
- 4.2.2 Principles of Classification
- 4.2.2.1 Invention Information and Additional Information
- 4.2.2.1.1 Application of Indexing Codes/2000 Series
- 4.2.2.1.2 Classifying in Residual Places
- 4.2.2.1.3 Places that cannot be the First Symbol
- 4.2.2.2 Classification Priority Rules
- 4.2.2.2.1 Common Rule
- 4.2.2.2.2 First Place Priority Rule
- 4.2.2.2.3 Last Place Priority Rule
- 4.2.2.2.4 Special Rules
- 4.2.2.2.5 Classifying a Combination of Technical Subjects
- 4.2.2.3 Classifying in Function-Oriented and Application-Oriented Places
- 4.2.2.4 Classifying Chemical Compounds
- 4.2.2.5 CPC Classification Rules
- 4.2.2.6 Classification using C-sets
- 4.2.3 Other Classification Information
- 4.2.3.1 Sub-Codes - Discontinued
- 4.2.3.2 The Australian Classification System - Discontinued
- 4.2.3.3 Indexing According to IPC Edition (2006) - Discontinued
- 4.2.3.4 Master Classification Database (MDC)
- 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
- 4.3 Initial Search Considerations
- 4.3.1 Construction and the Inventive Concept
- 4.3.2 Earlier Search Results
- 4.3.3 Additional Searching
- 4.3.4 Top-Up Searching
- 4.3.5 Preliminary Search
- 4.3.6 Applicant and/or Inventor Name Searching
- 4.4 Development of the Search Strategy
- 4.4.1 Three Person Team (3PT)
- 4.4.2 Search Strategy Considerations
- 4.4.2.1 Independent Claims
- 4.4.2.2 Dependent Claims
- 4.4.2.3 Broad Claims
- 4.4.2.4 Reserving the Search
- 4.4.2.5 Controlled Language
- 4.4.3 Search Area
- 4.5 Conducting the Search
- 4.6 Recording the Search Details
- 4.7 Annexures
- Annex D - Search Information Statement
- Annex E - Examples and Instructions for completing the SIS for Sequence and Chemical Structure Searches
- Annex F - When to Complete the Search Information Statement (SIS)
- Annex N - Guidelines for Searching Indian TKDL
- Annex P - The Role of the Three Person Team (3PT) in Searching
- 4.8 User Guides
- 5. National
- 5.1 Procedures
- 5.2 Understanding Legislation
- 5.2.1 Modern Australian Law
- 5.2.2 Working with case law
- 5.2.3 Working with statute
- 5.2.4 Practical guide to interpreting legislation
- 5.3 Formalities and Forms
- 5.3.1 Formalities Checking
- 5.3.1.1 Formalities Required and Assessed at Filing
- 5.3.1.2 Credible Address for Service
- 5.3.1.3 Formalities Required and Assessed During Examination
- 5.3.2 Formal requirements of the Specification
- 5.3.2.1 Title of the Application
- 5.3.2.2 Abstracts
- 5.3.2.3 Requirements for Text, Pagination, Formulas, Equations, Drawings, Graphics, and Photographs
- 5.3.2.4 Substitute Pages to comply with formalities
- 5.3.2.5 Requirements for Amino Acid and Nucleotide Sequences
- 5.3.2.6 Scandalous Matter
- 5.3.3 Approved Forms (including patent request)
- 5.3.4 Signature Requirements for Forms and Other Documents
- 5.3.5 Return or Deletion of Documents
- 5.4 Entitlement
- 5.4.1 Who can file and who can be granted a patent
- 5.4.2 Statement of entitlement
- 5.4.3 Artificial Intelligence - Inventorship and Entitlement
- 5.4.4 Annex A - Examples of Legal Persons
- 5.4.5 Annex B - Examples of Organisations of Uncertain Status as Legal Persons
- 5.5 Construction of Specifications, Claims, and Claim Types
- 5.5.1 Purpose of Construction
- 5.5.2 Considerations Relevant to Construction of the Specification
- 5.5.2.1 Initial Considerations
- 5.5.2.2 The Addressee
- 5.5.2.3 The Role of Common General Knowledge
- 5.5.2.4 The Invention Described
- 5.5.3 Rules of Construction for a Specification
- 5.5.3.1 Words are Given Plain Meaning
- 5.5.3.2 Specification Read as a Whole
- 5.5.3.3 Purposive Construction
- 5.5.3.4 Dictionary Principle
- 5.5.3.5 Reject the Absurd
- 5.5.3.6 Description Construed as a Technical Document
- 5.5.3.7 Errors, Mistakes, Omissions
- 5.5.4 Claim Construction and Claim Types
- 5.5.4.1 Claims are Construed as a Legal Document
- 5.5.4.2 Presumption Against Redundancy
- 5.5.4.3 Omnibus Claims
- 5.5.4.4 Swiss Claims
- 5.5.4.5 Product by Process Claims
- 5.5.4.6 Parametric Claims
- 5.5.4.7 ‘For Use’, ‘When Used’ and Similar Wording in Claims
- 5.5.4.8 ‘Comprises‘, ‘Includes‘, ‘Consists of‘ and ‘Contains‘ and Similar Wording in Claims
- 5.5.4.9 Reference Numerals in Claims
- 5.5.4.10 Relative Terms
- 5.5.4.11 ‘Substantially‘, ‘About‘, ‘Generally’
- 5.5.4.12 Appended Claims
- 5.6 Examination
- 5.6.1 Relevant Dates, Definitions, Legal Standards and Other Prescribed Matters (e.g Publication)
- 5.6.1.1 Priority dates and Filing Dates
- 5.6.1.2 Effect of Publication
- 5.6.1.3 Definitions (Invention, Alleged Invention, Meaning of a Document etc.)
- 5.6.1.4 Balance of Probabilities Standard
- 5.6.1.5 Application of the Balance of Probabilities in Examination
- 5.6.2 Factors to consider before commencing examination
- 5.6.2.1 Request for Examination
- 5.6.2.2 Application in a State of Lapse?
- 5.6.2.3 Extension of Time Requested (s223 actions)
- 5.6.2.4 Payment of Fees
- 5.6.2.5 Translations of Specifications, Article 19 and Article 34 Amendments (Requirements for Certification, Poor Translations)
- 5.6.2.6 Obtaining Priority Documents
- 5.6.2.7 Excess Claims Fees and Invitation to Pay
- 5.6.2.8 Report Dispatch, Correction of Report etc.
- 5.6.2.9 Further Report Considerations
- 5.6.2.10 Convention applications
- 5.6.3 The Specification and Claims to Examine
- 5.6.3.1 Consideration of Amendments Made prior to examination
- 5.6.3.2 Claims are directed to a Single Invention (Unity)
- 5.6.3.3 Omnibus claims – References to the Descriptions or Drawings
- 5.6.3.4 Provisional specifications - Examination
- 5.6.4 Citations: Prior Art Base and Construction of Prior Art
- 5.6.4.1 Prior Art - What is Included (Definition From the Act, Publicly Available, Exclusions, Grace Period)
- 5.6.4.2 Construing a Citation
- 5.6.4.3 Level of Disclosure Required (Enabling Disclosure, Clear and Unmistakable Directions etc)
- 5.6.4.4 Single Source of Information, Combination of Documents
- 5.6.4.5 Third Party Notifications
- 5.6.4.6 Identifying and Raising Citations
- 5.6.5 Novelty, Whole of Contents, Grace Periods, Secret Use
- 5.6.5.1 Determining Novelty
- 5.6.5.2 Whole of Contents
- 5.6.5.3 Prior Use, Secret Use and Confidential Information
- 5.6.5.4 Novelty - Specific Examples
- 5.6.5.5 Selections
- 5.6.5.6 Issues Specific to Chemical Compositions
- 5.6.6 Inventive Step
- 5.6.6.1 Inventive Step Requirements
- 5.6.6.2 Information for Assessing Inventive Step
- 5.6.6.3 Tests for Inventive Step
- 5.6.6.4 Assessing Inventive Step
- 5.6.6.5 Indicators of Inventive Step
- 5.6.6.6 Issues Specific to Chemical Compositions
- 5.6.7 Full Disclosure, Sufficiency, Clarity and Support (S40 considerations)
- 5.6.7.1 Claims are Clear and Succinct
- 5.6.7.2 Clear and Complete Disclosure s40(2)(a)
- 5.6.7.3 Support for the Claims s40(3)
- 5.6.7.4 Difference Between ‘Clear and Complete Disclosure’ and ‘Support’
- 5.6.7.5 Best Method
- 5.6.7.6 Complete Disclosure Micro-Organisms and Other Life Forms (Budapest Treaty, Deposit Requirements)
- 5.6.7.7 Claims define the Invention
- 5.6.7.8 Annex A - Examples: Subsections 40(2)(a) and 40(3)
- 5.6.8 Patent Eligible Subject Matter (Manner of Manufacture, Usefulness)
- 5.6.8.1 General Principles-Assessing Manner of Manufacture
- 5.6.8.2 Alleged Invention
- 5.6.8.3 Fine Arts
- 5.6.8.4 Discoveries, Ideas, Scientific Theories, Schemes and Plans
- 5.6.8.5 Printed Matter
- 5.6.8.6 Computer Implemented Inventions, Schemes and Business Methods
- 5.6.8.7 Games and Gaming Machines
- 5.6.8.8 Mathematical Algorithms
- 5.6.8.9 Methods of Testing, Observation and Measurement
- 5.6.8.10 Mere Working Directions
- 5.6.8.11 Nucleic Acids and Genetic Information
- 5.6.8.12 Micro-Organisms and Other Life Forms
- 5.6.8.13 Treatment of Human Beings
- 5.6.8.14 Human Beings and Biological Processes for Their Generation
- 5.6.8.15 Agriculture and Horticulture
- 5.6.8.16 Combinations, Collocations, Kits, Packages and Mere Admixtures
- 5.6.8.17 New Uses
- 5.6.8.18 Other Issues e.g. Contrary to Law, Mere Admixtures
- 5.6.8.19 Useful (Utility)
- 5.6.8.20 Annex A - History of Manner of Manufacture
- 5.6.9 Acceptance, Grant and Refusal of Applications
- 5.6.9.1 Conditions and Time for Acceptance
- 5.6.9.2 Postponement of Acceptance
- 5.6.9.3 Extension of Acceptance Period
- 5.6.9.4 Revocation of Acceptance
- 5.6.9.5 Refusal of Acceptance-Specific Circumstances
- 5.6.9.6 Refusal of an Application
- 5.6.9.7 Continued Examination-Result of a Decision
- 5.6.9.8 Lapsing of an Application
- 5.6.9.9 Withdrawal of an Application
- 5.6.9.10 Double Patenting - S64(2) and 101B(2)(h) - Multiple Applications
- 5.6.9.11 Parallel applications (applications for both innovation and standard)
- 5.6.9.12 Register of Patents
- 5.6.9.13 Annex A - Example Bar-to-Grant Letter (Accepted Despite Multiple Inventions)
- 5.6.9.14 Acceptance and QRS Issues
- 5.6.10 Divisional Applications
- 5.6.10.1 Requirements to Claim Divisional Status
- 5.6.10.2 Priority Entitlement
- 5.6.10.3 Time Limits for Filing
- 5.6.10.4 Status of the Parent
- 5.6.10.5 Examination of Divisional Applications
- 5.6.10.6 Innovation Divisional Applications
- 5.6.10.7 Annex A - Procedural Outline to Divisional Examination
- 5.6.11 Patents of Addition
- 5.6.11.1 Conditions for Filing
- 5.6.11.2 Improvement or Modification
- 5.6.11.3 Differentiation from the Parent
- 5.6.11.4 Examination of Additional Applications
- 5.6.11.5 Amendment of the Parent
- 5.6.11.6 Annex A - Procedural Outline to Patents of Addition Examination
- 5.6.12 Preliminary search and Opinion (PSO)
- 5.6.12.1 Requests for PSO
- 5.6.12.2 PSO - Search and Examination Procedure
- 5.6.12.3 PSO - Report Requirements
- 5.6.12.4 Response to the PSO
- 5.6.13 Re-Examination
- 5.6.13.1 Commencing Re-Examination
- 5.6.13.2 Re-Examination Process
- 5.6.13.3 Completion of Re-Examination
- 5.6.13.4 Refusal to Grant or Revocation Following Re-Examination
- 5.6.14 Prohibition Orders- Applications Concerning Defence of the Commonwealth and/or involving Associated Technology (e.g. enrichment of nuclear material)
- 5.6.14.1 Effect of Prohibition orders
- 5.6.14.2 Applications Concerning Defence of the Commonwealth
- 5.6.14.3 Applications Concerning ‘Associated Technology’ (Chapter 15 Applications)
- 5.6.15 Innovation Patents
- 5.6.15.1 The Innovation Patent System
- 5.6.15.2 Types of Innovation Patents
- 5.6.15.3 Formalities Check for Innovation Patents
- 5.6.15.4 Examination of Innovation Patents
- 5.6.15.5 Determining Innovative step
- 5.6.15.6 Certification, Opposition, Ceasing/Expiring of Innovation Patents
- 5.6.15.7 Annex - Innovation Patent Certification Form
- 5.6.16 Annex A - Procedural Outline for Full Examination of a Standard Patent Application
- 5.6.17 Annex B - Examination of National Phase Applications: Indicators of Special or Different Considerations
- 5.6.18 Annex C - Applicant and Inventor Details as Shown on PCT Pamphlet Front Page
- 5.6.19 Annex D - Example of PCT Pamphlet Front Page
- 5.7 Amendments
- 5.7.1 What can be Amended and When
- 5.7.1.1 What Documents can be Amended?
- 5.7.1.2 Who can Request Amendments (incl consent of licensees/mortgagees)?
- 5.7.1.3 When can Amendments be Requested?
- 5.7.1.4 Requirements to provide Reasons for Amendments
- 5.7.1.5 Withdrawal of Amendments
- 5.7.1.6 Circumstances where an amendment cannot be processed (i.e. pending court proceedings, Application has been Refused)
- 5.7.1.7 Granting Leave to Amend
- 5.7.1.8 Fees Associated with Amendments
- 5.7.1.9 Annex A - Guidelines for Completing the Voluntary Section 104 Allowance Form
- 5.7.2 Amendment of the Patent Request and Other Filed Documents
- 5.7.2.1 Form of the Request to Amend the Patent Request
- 5.7.2.2 Non-Allowable Amendments to Patent Request
- 5.7.2.3 Changing the Applicant or Nominated Person
- 5.7.2.4 Converting the Application
- 5.7.2.5 Amendments to the Notice of Entitlement and Other Documents
- 5.7.3 Amendments-Provisional Applications
- 5.7.4 Amendments to Complete Specifications
- 5.7.4.1 Form of proposed amendments (statement of proposed amendments)
- 5.7.4.2 Allowability of Amendments Prior to Acceptance
- 5.7.4.3 Allowability of Amendments After Acceptance
- 5.7.4.4 Allowability of Amendments After Grant
- 5.7.4.5 Amendments not Otherwise Allowable
- 5.7.4.6 Opposition to Amendments
- 5.7.4.7 Annex A - Amended Claims Format
- 5.7.5 Amendments to Correct a Clerical Error or Obvious Mistake
- 5.7.5.1 Definition of Clerical Error
- 5.7.5.2 Definition of Obvious Mistake
- 5.7.5.3 Evidence required to prove a Clerical Error or Obvious Mistake
- 5.7.6 Amendments Relating to Micro-Organisms and Sequence Listings
- 5.7.6.1 Insertion or Alteration of Sec 6(c) Information
- 5.7.6.2 Amendments or Corrections of Sequence Listings
- 5.7.7 Amendments during Opposition Proceedings
- 5.7.7.1 Initial Processing of the Request to Amend During Oppositions
- 5.7.7.2 Considering the Amendments and Comments from the Opponent
- 5.7.7.3 Considering Amendments as a Result of a Hearing Decision
- 5.7.7.4 Amendments where Decision of the Commissioner is Appealed
- 5.7.7.5 Annex A - Section 104 Amendments During Opposition Proceedings: Check Sheet
- 6. International
- 6.1 International Searching
- 6.1.1 Procedural Outline - PCT International Search
- 6.1.2 Introduction- International Searching
- 6.1.2.1 Overview- International Searching
- 6.1.2.2 Overview-International Search Opinion (ISO)
- 6.1.2.3 General Procedures
- 6.1.2.4 Extent of Search
- 6.1.2.5 Minimum Documentation
- 6.1.2.6 Examination Section Procedures
- 6.1.2.7 Searching Examiner
- 6.1.2.8 Other Considerations
- 6.1.2.9 Copending Applications
- 6.1.3 Search Allocation and Preliminary Classification
- 6.1.4 Unity of Invention
- 6.1.4.1 Unity of Invention Background
- 6.1.4.2 Determining Lack of Unity
- 6.1.4.3 Combinations of Different Categories of Claims
- 6.1.4.4 Markush Practice
- 6.1.4.5 Intermediate and Final Products in Chemical Applications
- 6.1.4.6 Biotechnological Inventions
- 6.1.4.7 Single General Inventive Concept
- 6.1.4.8 A Priori and A Posteriori Lack of Unity
- 6.1.4.9 Issuing the Invitation to Pay Additional Search Fees
- 6.1.4.10 Unsupported, Unclear, Long and/or Complex Claim Sets with Clear Lack of Unity
- 6.1.4.11 Payment of Additional Search Fees Under Protest
- 6.1.4.12 Completing the Search Report
- 6.1.4.13 Time for Completing the Search Report
- 6.1.4.14 Reported Decisions
- 6.1.4.15 Other Decisions from the EPO
- 6.1.5 Abstract and Title
- 6.1.6 Subjects to be Excluded from the Search
- 6.1.7 Claim Interpretation, Broad Claims, PCT Articles 5 and 6
- 6.1.7.1 Claim Interpretation According to the PCT Guidelines
- 6.1.7.1.1 PCT Guideline References and Flow Chart
- 6.1.7.1.2 Overview of the Hierarchy
- 6.1.7.1.3 Special Meaning, Ordinary Meaning, Everyday Meaning
- 6.1.7.1.4 Closed and Open Definitions and Implications for Interpretation
- 6.1.7.1.5 Implications of the Hierarchy on Searching
- 6.1.7.1.6 Practices for the Interpretation of Claims
- 6.1.7.1.7 Interpretation of Citations - Inherency
- 6.1.7.2 Broad Claims
- 6.1.7.3 PCT Articles 5 and 6
- 6.1.7.4 Claims Lacking Clarity and Excessive/Multitudinous Claims
- 6.1.7.5 Procedure for Informal Communication with the Applicant
- 6.1.8 Search Strategy
- 6.1.8.1 Introduction
- 6.1.8.2 The Three Person Team (3PT)
- 6.1.8.3 Area of Search
- 6.1.8.4 Search Considerations
- 6.1.9 Basis of the Search
- 6.1.10 Non-Patent Literature
- 6.1.11 Search Procedure
- 6.1.11.1 Overview - Novelty / Inventive Step
- 6.1.11.2 Inventive Step
- 6.1.11.3 Searching Product by Process Claims
- 6.1.11.4 Dates Searched
- 6.1.11.5 Conducting the Search
- 6.1.11.6 Useful Techniques ("piggy back/forward" searching)
- 6.1.11.7 Obtaining Full Copies
- 6.1.11.8 Considering and Culling the Documents
- 6.1.11.9 Ending the Search
- 6.1.11.10 Categorising the Citations
- 6.1.11.11 Grouping the Claims
- 6.1.12 Search Report and Notification Form Completion
- 6.1.12.1 Background Search Report and Notification Form Completion
- 6.1.12.2 Applicant Details
- 6.1.12.3 General Details
- 6.1.12.4 Fields Searched
- 6.1.12.5 Documents Considered to be Relevant
- 6.1.12.5.1 Selection of Documents Considered to be Relevant
- 6.1.12.5.2 Citation Category
- 6.1.12.5.3 Citation of Prior Art Documents
- 6.1.12.5.4 Citation of URLs
- 6.1.12.5.5 Citation Examples
- 6.1.12.5.6 Citing Patent Documents Retrieved from EPOQUE
- 6.1.12.5.7 Relevant Claim Numbers
- 6.1.12.6 Family Member Identification
- 6.1.12.7 Date of Actual Completion of the Search
- 6.1.12.8 Refund Due
- 6.1.12.9 Contents of Case File at Completion
- 6.1.13 Reissued, Amended or Corrected ISRs and ISOs
- 6.1.14 Priority Document
- 6.1.15 Foreign Patent Search Aids and Documentation
- 6.1.16 Assistance with Foreign Languages
- 6.1.17 Rule 91 Obvious Mistakes in Documents
- 6.1.18 Nucleotide and/or Amino Acid Sequence Listings
- 6.1.18.1 Background Nucleotide and/or Amino Acid Sequence Listings
- 6.1.18.2 Office Practice
- 6.1.18.3 Summary
- 6.1.19 Annexes
- Annex A - Blank ISR
- Annex B - Completed ISR
- Annex C - Completed ISR
- Annex D - Declaration of Non-Establishment of ISR
- Annex E - Completed Invitation to pay additional fees
- Annex F - Completed ISR with unity observations
- Annex H - Searching Broad Claims
- Annex I - Completed notification of change of abstract
- Annex J - Completed notification of decision concerning request for rectification
- Annex K - The role of the 3 Person Team in Searching
- Annex S - Refund of Search Fees
- Annex U - ISR Quality Checklist
- Annex V - Internet Searching
- Annex W - Obtaining full text from internet
- Annex Z - USPTO kind codes
- Annex AA - Markush Claims
- Annex BB - Article 5/6 Comparisons
- 6.2 International Type Searching
- 6.2.1 Procedural Outline International Type Search Report
- 6.2.2 Introduction - International Type Searching
- 6.2.3 Classification and Search Indication
- 6.2.4 Unity of Invention
- 6.2.5 Subjects to be Excluded from the Search
- 6.2.6 Obscurities, Inconsistencies or Contradictions
- 6.2.7 Abstract and Title
- 6.2.8 Search Report
- 6.2.9 Completing Search Report and Opinion Form
- 6.2.10 Annexes
- 6.3 International Examination
- 6.3.1 Procedural Outline Written Opinion
- 6.3.2 Introduction International Examination
- 6.3.3 The Demand and IPRPII
- 6.3.4 Top-up Search
- 6.3.5 First IPE action
- 6.3.5.1 Introduction - First IPE Action
- 6.3.5.2 Supplementary International Search Report
- 6.3.5.3 PCT Third Party Observations
- 6.3.6 Response to Opinion
- 6.3.7 IPRPII and Notification
- 6.3.8 Completing ISO, IPEO and IPRPII Forms
- 6.3.8.1 Front Page and Notification Application Details
- 6.3.8.2 Box I Basis of Opinion/Report for ISOs, IPEOs and IPRPs
- 6.3.8.3 Box II Priority
- 6.3.8.4 Box III Non-establishment of Opinion
- 6.3.8.5 Box IV Unity of Invention
- 6.3.8.6 Box V Reasoned Statement Regarding Novelty, Inventive Step & Industrial Applicability
- 6.3.8.7 Box VI Certain Documents Cited
- 6.3.8.8 Box VII Certain Defects
- 6.3.8.9 Box VIII Certain Observations
- 6.3.9 General Considerations
- 6.3.9.1 Article 19 or Article 34(2)(b) Amendments
- 6.3.9.2 Formalities
- 6.3.9.3 General Notes on Form Completion
- 6.3.9.4 Rule 91 Obvious Mistakes in Documents
- 6.3.9.5 Processing withdrawals of PCTs
- 6.3.10 Annexes
- Annex A - Written Opinion-ISA
- Annex B - Written Opinion-IPEO
- Annex C - Notification of Transmittal of IPERII
- Annex D - IPRPII
- Annex E - IPRPII Clear Novel and Inventive Box V Only
- Annex F - Invitation to Restrict/Pay Additional Fees - Unity
- Annex G - Extension of Time Limit
- Annex H - IPE Quality Checklist
- Annex I - Examples of Inventive Step Objections
- Annex J - Examples of Objections under PCT Articles 5 and 6
- Annex K - Example of PCT Third Party Observations
- Annex L - Blank Written Opinion - ISA
- Annex M - Blank Written Opinion - IPEO
- Annex N - Blank IPRPII
- Annex O - ISO/ISR with Omnibus Claims
- Annex P - PCT Timeline
- Annex Z - Best Practice Examples
- 6.4 Fiji Applications
- 6.4.1 Introduction
- 6.4.2 Completion Time and Priority
- 6.4.3 Initial Processing
- 6.4.4 Search Procedure
- 6.4.5 Search Report and Advisory Opinion
- 6.4.6 Further Advisory Opinion
- 6.4.7 Final Processing
- 6.4.8 Annexes
- 6.5 Thai Applications
- 6.5.1 Introduction to Thai Applications
- 6.5.2 Completion Time and Priority
- 6.5.3 Initial Processing
- 6.5.4 Search Procedure
- 6.5.5 Search Report
- 6.5.6 Final Processing
- 6.5.7 Annex A - Thai Search Report
- 6.6 WIPO Searches
- 6.6.1 Introduction
- 6.6.2 Completion Time and Priority
- 6.6.3 Initial Processing
- 6.6.4 Search Procedure
- 6.6.5 Search Report
- 6.6.6 Final Processing
- 6.6.7 Annexes
- 6.7 Other Countries
- 6.8 PCT Articles, Regulations and Guidelines et al
- 6.9 Miscellaneous
- 7. Oppositions, Disputes and Extensions
- 7.1 Role and Powers of the Commissioner in Hearings
- 7.2 Oppositions, Disputes and other proceedings-Procedural summaries
- 7.2.1 Oppositions to grant of a standard patent-Section 59 oppositions
- 7.2.1.1 Commencing the Opposition - Filing a Notice of Opposition
- 7.2.1.2 Filing the Statement of Grounds and Particulars
- 7.2.1.3 Evidence and Evidentiary Periods
- 7.2.1.4 Finalising the Opposition
- 7.2.2 Opposition to Innovation Patents-Section 101M Oppositions
- 7.2.2.1 Commencing the Opposition - Filing the Opposition Documents
- 7.2.2.2 Evidence and Evidentiary Periods
- 7.2.2.3 Finalising the Opposition
- 7.2.3 Oppositions to an Extension of Term of a Pharmaceutical Patent (Section 75(1) Oppositions)
- 7.2.3.1 Commencing the Opposition - Filing a Notice of Opposition
- 7.2.3.2 Filing the Statement of Grounds and Particulars
- 7.2.3.3 Evidence and Evidentiary Periods
- 7.2.3.4 Finalising the Opposition
- 7.2.4 Oppositions to Request to Amend an Application or Other Filed Document (Section 104(4) Oppositions)
- 7.2.4.1 Commencing the Opposition - Filing a Notice of Opposition
- 7.2.4.2 Filing the Statement of Grounds and Particulars
- 7.2.4.3 Evidence and Evidentiary Periods
- 7.2.4.4 Finalising the Opposition
- 7.2.5 Oppositions to Extensions of Time Under Section 223 (Section 223(6) Oppositions
- 7.2.5.1 Commencing the Opposition - Filing a Notice of Opposition
- 7.2.5.2 Filing the Statement of Grounds and Particulars
- 7.2.5.3 Evidence and Evidentiary Periods
- 7.2.5.4 Finalising the Opposition
- 7.2.6 Oppositions to Grant of a Licence (Regulation 22.21(4) Oppositions)
- 7.2.6.1 Commencing the Opposition - Filing a Notice of Opposition
- 7.2.6.2 Filing the Statement of Grounds and Particulars
- 7.2.6.3 Evidence and Evidentiary Periods
- 7.2.6.4 Finalising the Opposition
- 7.2.7 Disputes Between Applicants and Co-Owners (Directions Under Section17 and Determinations Under Section 32)
- 7.2.8 Entitlement Disputes (Applications Under Sections 33-36 and 191A)
- 7.3 Directions
- 7.3.1 Directions in Opposition Proceedings
- 7.3.1.1 Direction to Stay an Opposition Pending Another Action
- 7.3.1.2 Further and Better Particulars
- 7.3.1.3 Time for Filing Evidence in a Substantive Opposition
- 7.3.1.4 Time for Filing Evidence in a Procedural Opposition
- 7.3.1.5 General Conduct of Proceedings
- 7.3.1.6 Further Directions
- 7.3.2 Directions that an Application Proceed in Different Name(s) - Section 113
- 7.4 Opposition Documents, Requirements and Amendments
- 7.4.1 Notice of Opposition
- 7.4.2 Statement of Grounds and Particulars
- 7.4.3 Amending Opposition Documents
- 7.4.4 Filing of Opposition Documents
- 7.5 Evidence
- 7.5.1 Presentation of Evidence
- 7.5.1.1 Written Evidence and Declarations
- 7.5.1.2 Oral Evidence
- 7.5.1.3 Physical Evidence - Special Considerations
- 7.5.2 Admissibility of Evidence
- 7.5.3 Evidence Filed Out of Time
- 7.6 Production of Documents, Summonsing Witnesses
- 7.6.1 Requests for Commissioner to Exercises Powers Under Section 210(1)(a) & 210(1)(c)
- 7.6.2 Basis for Issuing a Summons
- 7.6.3 Basis for Requiring Production of Documents or Articles
- 7.6.4 Reasonable Expenses
- 7.6.5 Complying with the Summons or Notice to Produce, Reasonable Excuses
- 7.6.6 Sanctions for Non-Compliance
- 7.6.7 Schedule to Requests for Summons or Notice to Produce
- 7.7 Withdrawal and Dismissal of Oppositions
- 7.7.1 Withdrawal of an Opposition
- 7.7.2 Dismissal of an Opposition
- 7.7.2.1 Requests for Dismissal
- 7.7.2.2 Dismissal on the Initiative of the Commissioner
- 7.7.2.3 Reasons for Dismissal
- 7.7.3 Withdrawal of an Opposed Application
- 7.8 Hearings and Decisions
- 7.8.1 Setting Down Hearings
- 7.8.1.1 Setting of Hearing
- 7.8.1.2 Location and Options for Appearing
- 7.8.1.3 Hours of a Hearing
- 7.8.1.4 Hearing Fee
- 7.8.1.5 Who May Appear at a Hearing?
- 7.8.1.6 Relevant Court Actions Pending
- 7.8.2 Hearings Procedure
- 7.8.2.1 Overview of Proceedings
- 7.8.2.2 Adjournment of Hearings
- 7.8.2.3 Contact with Parties Outside of Hearing
- 7.8.2.4 Hearings Involving Confidential Material
- 7.8.2.5 Consultation with Other Hearing Officers
- 7.8.2.6 Hearings and the Police
- 7.8.3 Ex Parte Hearings
- 7.8.4 Natural Justice and Bias
- 7.8.4.1 Rules
- 7.8.4.2 Waiving of Objection of Bias by Standing by until Decision Issued
- 7.8.4.3 Bias as a Result of Contact with Parties Outside of Hearing
- 7.8.4.4 Bias as a Result of Other Proceedings Involving the Same Parties
- 7.8.5 Principles of Conduct
- 7.8.5.1 Lawfulness
- 7.8.5.2 Fairness
- 7.8.5.3 Rationality
- 7.8.5.4 Openness
- 7.8.5.5 Diligence and Efficiency
- 7.8.5.6 Courtesy and Integrity
- 7.8.6 Decisions
- 7.8.6.1 Written Decisions
- 7.8.6.2 Time for Issuing a Decision
- 7.8.6.3 Publication of Decisions
- 7.8.6.4 Rectification of Errors or Omissions in Decisions
- 7.8.6.5 Revocation of Decisions
- 7.8.7 Further Hearings
- 7.8.8 Final Determinations
- 7.8.8.1 Overview of Proceedings
- 7.8.8.2 Applicant Does Not Propose Amendments
- 7.8.8.3 Opponent Withdraws the Opposition
- 7.8.9 Quality
- 7.8.10 Appointment of Hearing Officers and Assistant Hearing Officers, Hearing Officer Standards Panel, Hearing Officer Delegations
- 7.9 Costs
- 7.9.1 Principles in Awarding Costs
- 7.9.2 Scale of Costs, Variation of the Scale
- 7.9.3 Awarding Costs, Taxation
- 7.9.4 Security for Costs
- 7.9.5 Exemplary Situations in Awarding Costs
- 7.10 The Register of Patents
- 7.10.1 What is the Register
- 7.10.2 Recording Particulars in the Register
- 7.10.2.1 Recording New Particulars in the Register
- 7.10.2.2 Change of Ownership
- 7.10.2.2.1 Assignment
- 7.10.2.2.2 Change of Name
- 7.10.2.2.3 Bankruptcy
- 7.10.2.2.4 Winding Up of Companies
- 7.10.2.2.5 Death of Patentee
- 7.10.2.3 Security Interests
- 7.10.2.4 Licences
- 7.10.2.5 Court Orders
- 7.10.2.6 Equitable Interests
- 7.10.2.7 Effect of Registration or Non-Registration
- 7.10.2.8 Trusts
- 7.10.2.9 False Entries in the Register
- 7.10.3 Amendment of the Register
- 7.11 Extensions of Time and Restoration of Priority
- 7.11.1 Extensions of Time - Section 223
- 7.11.1.1 Relevant Act
- 7.11.1.2 Subsection 223(1) - Office Error
- 7.11.1.2.1 Extensions under Subsection 223(1) to Gain Acceptance
- Annex A - Section 223(1) Extension of Time for Acceptance File Note
- 7.11.1.3 Subsection 223(2) - Error or Omission and Circumstances Beyond Control
- 7.11.1.3.1 The Law
- 7.11.1.3.2 Subsection 223(2)(a) - Error or Omission
- 7.11.1.3.3 Section 223(2)(b) - Circumstances Beyond Control
- 7.11.1.3.4 Filing a Request under Subsection 223(2)
- 7.11.1.3.5 The Commissioner's Discretion
- 7.11.1.4 Subsection 223(2A) - Despite Due Care
- 7.11.1.5 Common Deficiencies in Requests under Section 223(2) or (2A)
- 7.11.1.6 Advertising an Extension - Subsection 223(4)
- 7.11.1.7 Extension of Time for an Extension of Term
- 7.11.1.8 Grace Period Extensions
- 7.11.1.9 Extension of Time to Gain Acceptance
- 7.11.1.10 Examination Report Delayed or Not Received
- 7.11.1.11 Co-pending Section 104 Application - Budapest Treaty Details
- 7.11.1.12 Payment of Continuation or Renewal Fees Pending a Section 223 Applicaiton
- 7.11.1.13 Person Concerned: Change of Ownership
- 7.11.1.14 Date of a Patent Where an Extension of Time is Granted to Claim Priority
- 7.11.2 Extensions of Time - Reg 5.9
- 7.11.2.1 Requesting an Extension of Time
- 7.11.2.2 Application of the Law
- 7.11.2.3 Justification for the Extension
- 7.11.2.4 Discretionary Matters
- 7.11.2.5 Period of an Extension
- 7.11.2.6 A Hearing in Relation to an Extension
- 7.11.2.7 Parties Involved in Negotiations
- 7.11.2.8 Review of a Decision to Grant or Refuse an Extension
- 7.11.2.9 "Out of Time" Evidence
- 7.11.3 Restoration of the Right of Priority Under the PCT
- 7.12 Extensions of Term of Standard Patents Relating to Pharmaceutical Substances
- 7.12.1 Section 70 Considerations
- 7.12.1.1 Pharmaceutical Substance per se
- 7.12.1.2 Meaning of Pharmaceutical Substance
- 7.12.1.3 Meaning of "when produced by a process that involves the use of recombinant DNA technology"
- 7.12.1.4 Meaning of "mixture or compound of substances"
- 7.12.1.5 Meaning of "in substance disclosed"
- 7.12.1.6 Meaning of "in substance fall within the scope of the claim"
- 7.12.1.7 Included in the Goods
- 7.12.1.8 First Regulatory Approval Date
- 7.12.2 Applying for an Extension of Term
- 7.12.2.1 Documentation Required
- 7.12.2.2 Time for Applying
- 7.12.2.3 Extension of Time to Apply for an Extension of Term
- 7.12.3 Processing an Application for an Extension of Term
- 7.12.3.1 Initial Processing
- 7.12.3.2 Consideration of the Application
- 7.12.3.3 Grant of Application for Extension of Term
- 7.12.3.4 Refusal of Application for Extension of Term
- 7.12.4 Calculating the Length of the Extension of Term
- 7.12.5 Patents of Addition
- 7.12.6 Divisional Applications
- 7.12.7 Oppositions to an Extension of Term
- 7.12.8 Relevant Court Proceedings Pending
- 7.12.9 Rectification of the Register
- 7.13 Orders for Inspection of non OPI Documents
- 7.13.1 Documents not-OPI by direction of the Commissioner - Regulation 4.3(2)(b)
- 7.13.2 Inspection of non-OPI Documents
- 7.14 Appeals ART, ADJR, The Courts
- 7.14.1 Appeals to the Federal Court
- 7.14.2 Administrative Review Tribunal (ART) Review
- 7.14.3 Judicial Review (ADJR)
- 7.14.4 Other Court Actions Involving the Commissioner
- 7.14.5 Section 105 Amendments
- 7.15 Computerised Decisions
- 8. Superseded Legislation and Practice
- 8.1 Summary of Relevant Legislative Changes
- 8.2 General Approach to Examination
- 8.2.1 Restriction of the Report
- 8.2.2 Not All Claims Previously Searched and/or Examined
- 8.2.3 Law and Practice Differences
- 8.3 Amendments
- 8.3.1 Allowability of Amendments to Complete Specifications
- 8.3.2 Allowability Under Section 102(1)
- 8.3.3 Allowability Under Section 102(2) - General Comments
- 8.3.4 Amendments to a Provisional Specification
- 8.3.5 Opposition to Amendments - Standard Patents
- 8.4 Novelty
- 8.4.1 Introduction
- 8.4.2 Prior Art Information
- 8.4.3 Exclusions
- 8.4.4 Doctrine of Mechanical Equivalents
- 8.4.5 Basis of the "Whole of Contents" Objection
- 8.5 Inventive Step
- 8.5.1 The Statutory Basis for Inventive Step
- 8.5.2 Prior Art Base
- 8.5.3 Assessing Inventive Step in Examination
- 8.5.4 Common General Knowledge
- 8.5.5 Determining the Problem
- 8.5.6 Identifying the Person Skilled in the Art
- 8.5.7 Could the PSA have Ascertained, Understood, Regard as Relevant and Combined the Prior Art Information
- 8.5.7.1 Ascertained
- 8.5.7.2 Understood
- 8.5.7.3 Regarded as Relevant
- 8.5.7.3.1 Document Discloses the Same, or a Similar, Problem
- 8.5.7.3.2 Document Discloses a Different Problem
- 8.5.7.3.3 Age of the Document
- 8.5.7.3.4 Would the Person Skilled in the Art Have Used the Document to Solve the Problem
- 8.5.7.4 Does the Document Constitute a Single Source of Information
- 8.5.7.5 Could the PSA be Reasonably Expected to Have Combined the Documents to Solve the Problem
- 8.6 Innovative Step
- 8.7 Section 40 Specifications
- 8.7.1 Overview
- 8.7.2 What is the Invention?
- 8.7.2.1 General Considerations
- 8.7.2.2 Approach in Lockwood v Doric
- 8.7.2.3 Consistory Clause
- 8.7.2.4 Requirement for Critical Analysis
- 8.7.2.5 "Essential Features" of the Invention
- 8.7.3 Full Description - Best Method
- 8.7.3.1 Date for Determining Full Description
- 8.7.3.2 Can the Nature of the Invention be Ascertained?
- 8.7.3.3 Compliance with Subsection 40(2) is a Question of Fact
- 8.7.3.4 Enabling Disclosures
- 8.7.3.5 Effort Required to Perform the Invention
- 8.7.3.6 Different Aspects Claimed in Different Claims
- 8.7.3.7 Inclusion of References
- 8.7.3.8 Trade Marks in Specifications
- 8.7.3.9 Colour Drawings and Photographs
- 8.7.4 Claims Define the Invention
- 8.7.5 Claims are Fairly Based
- 8.7.5.1 General Principles
- 8.7.5.2 Sub-Tests for Fair Basis
- 8.7.5.3 Relation Between the Invention Described and the Invention Claimed
- 8.7.5.4 Only Disclosure is in a Claim
- 8.7.5.5 Alternatives in a Claim
- 8.7.5.6 Claiming by Results
- 8.7.5.7 Reach-Through Claims
- 8.7.5.8 Claims to Alloys
- 8.7.6 Provisional Specifications
- 8.7.7 Complete Applications Associated with Provisional Applications
- 8.8 Patentability Issues
- 8.9 Abstracts
- 8.10 Divisional Applications
- 8.10.1 Application
- 8.10.2 Priority Entitlement
- 8.10.3 Time Limits for Filing Applications
- 8.10.4 Subject Matter
- 8.10.5 Amendment of Patent Request - Conversion of Application to a Divisional
- 8.10.6 Case Management of Divisional Applications
- 8.11 Priority Dates and Filing Dates
- 8.11.1 Priority Date of Claims
- 8.11.2 Priority Date Specific to Associated Applications (Priority Dociment is a Provisional)
- 8.11.3 Priority Date Issues Specific to Convention Applications
- 8.11.4 Priority Date Issues Relating to Amended Claims
- 8.12 Examination
- 8.13 Modified Examination
- 8.14 Petty Patents
- 8.15 National Phase Applications
- 8.15.1 Key Features of the Legislation
- 8.15.2 National Phase Preliminaries
- 8.15.3 Formality Requirements
- 8.15.4 Priority Sources
- 8.15.5 Determining Whether Amendments Made Under Articles and Rules of the PCT are Considered During Examination
- 8.15.6 Amendments During Examination
- 8.16 Convention Applications
- 8.16.1 Convention Country Listing
- 8.16.2 Convention Country Status Change
- 8.16.3 Basic Application Outside 12 Month Convention Period
- 8.16.4 Convention Priority Dates
- 8.17 Patent Deed
7.12.1.4 Meaning of "mixture or compound of substances"
Date Published
Also in this Chapter:
- 7.12.1.1 Pharmaceutical Substance per se
- 7.12.1.2 Meaning of Pharmaceutical Substance
- 7.12.1.3 Meaning of “when produced by a process that involves the use of recombinant DNA technology”
- 7.12.1.5 Meaning of “in substance disclosed”
- 7.12.1.6 Meaning of “in substance fall within the scope of the claim”
- 7.12.1.7 Included in the Goods
- 7.12.1.8 First Regulatory Approval Date
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.
A pharmaceutical substance was defined as the pharmaceutical active ingredient in Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd [2025] FCAFC 161. Consequently, a mixture or compound of substances would be a mixture or compound of pharmaceutical active ingredients. The term does not include formulations or compositions of pharmaceutical active ingredients with excipients and/or carriers.
Where the claim is directed to a mixture or compound of substances, the same must also be found in the relevant ARTG goods.
Amended Reasons
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Updating content in view of Otsuka decision ([2025] FCAFC 161) |
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Adding note banner about the page being under review. |
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