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

Also in this Chapter: 

• 7.2.1 Oppositions to grant of a standard patent-Section 59 oppositions

• 7.2.2 Section 101M - Opposition to an Innovation Patent

• 7.2.3 Section 75(1) - Opposition to an Extension of Term of a Pharmaceutical Patent, 
• 7.2.4 Section 104(4) - Opposition to a Request to Amend a Filed Document, 
• 7.2.5 Section 223(6) - Opposition to an Extension of Time under Subsection 223(2) or 223(2A)
• 7.2.6 Reg 22.21(4) - Opposition to Grant of a Licence

Sub-chapters:

• 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

Key Legislation: 

Patents Act: 

• Chapter 6  Grant and term of patents s61-s68)​​​​​​​
• s70 Applications for extension of patent
• s71 Form and timing of an application
• s75 Opposition to grant of extension
• ​​​​​​​s223 Extensions of time

Patents Regulations:​​​​​​​

• Chapter 5 Patent Regulations 1991 Oppositions 
• reg 22.8 Costs
• reg 23.36(2) Amendments made by Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No. 1)
• Sch 7 Fees

Note: This information applies on and after 15 April 2013.

Overview

Under section 75 of the Patents Act 1990, the Minister or any other person may oppose the grant of an extension of the term of a standard patent. The opposition may only be on the ground that one or more of the requirements of sections 70 and 71 are not satisfied in relation to the application for an extension of term.

An opposition to an extension of term of the patent is generally filed by a person (the “opponent”) who would be in some way affected by the grant. The opposition process provides the opponent with the opportunity to make out a case to persuade the Commissioner that the term of the patent should not be extended.

Since the only grounds for opposition are that the application for extension of the patent (section 70) and the form and timing of the application (section 71) have not met the requirements of the Act, patentability issues such as novelty, inventive step, manner of manufacture and utility cannot be brought into the opposition.  

An opposition under section 75(1) commences when a person files a notice of opposition in the approved form within the period allowed by the regulations, and pays the appropriate fee.  Subsequently, the opponent files a statement of grounds and particulars, setting out the grounds upon which the extension of term is opposed, and the facts and circumstances supporting the grounds.  Both parties are provided with periods for filing evidence to establish their respective cases, after which the Commissioner will hear and decide the matter.  

The procedures involved in this process are explained more fully in the following sections.