Commonwealth Numbered Regulations - Explanatory Statements

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PATENTS AMENDMENT REGULATIONS 1998 (NO. 8) 1998 NO. 319

STATUTORY RULES 1998 NO. 319

Issued by the Authority of the Minister for Industry, Science and Resources

Patents Act 1990

Patents Amendment Regulations 1998 (No. 8)

The Statutory Rules amend the Patents Regulations 1991 (the Regulations) to enable the operation of amendments to be made to the Patents Act 1990 (the Act) by Schedule 1 to the Intellectual Property Laws Amendment Act 1998 (the 1998 Act). This Schedule will commence no later than 27 January 1999, if not proclaimed earlier.

Details of the amendments made by these Statutory Rules are as follows:

Regulation 1 identifies the Statutory Rules as the Patents Amendment Regulations 1998.

Regulation 2 provides the Statutory Rules are to commence when Schedule 1 to the 1998 Act commences.

Regulation 3 provides Schedule 1 to the Statutory Rules will amend the Patents Regulations 1991.

Item 1 of Schedule 1 to the Statutory Rules amends paragraph 5.1 (a) of the Regulations to bring the conduct of opposition proceedings under section 75 of the Act under the operation of Chapter 5 of the Regulations. Chapter 5 of the Regulations deals with opposition proceedings under the Act.

Item 2 of Schedule 1 to the Statutory Rules amends subregulation 5.3(1) of the Regulations to provide that a notice of opposition filed under section 75 of the Act must be filed within 3 months of publication of a notice of acceptance of an application for an extension of term. The notice of opposition must also be filed in the approved form.

Items 3 and 4 of Schedule 1 to the Statutory Rules divide Chapter 6 of the Regulations into two parts. The existing provisions of Chapter 6 are brought under Part 1. Part 2 will include the new provisions as follows:

a)       regulation 6.7 provides the term "pre-TGA marketing approval" has the same meaning as in section 70 of the Act;

b)       regulation 6.8 provides an application for extension of term under section 70 of the Act must be accompanied by information:

i)       showing that the pharmaceutical substance which the application is based upon is currently included in the Australian Register of Therapeutic Goods (ARTG); and

ii)       identifying the substance;

c)       regulations 6.9 and 6.10 provide that documents and/or information that indicate the first regulatory approval date for the pharmaceutical substance must accompany an application for extension of term. Regulation 6.9 applies where this date is based on the first inclusion of the substance in the ARTG, whereas regulation 6. 10 applies where pre-TGA marketing approval was given in relation to the substance; and

d)       regulation 6.11 allows the Commissioner to request further information to decide whether he or she is satisfied that the requirements for the grant of an extension of term are met.

Items 5 and 6 of Schedule 1 to the Statutory Rules amend regulation 13.6 of the Regulations to extend the period in which certain fees must be paid. During the extended term of a patent, annual renewal fees are payable by the patentee. The amendments made by items 5 and 6 provide for the payment of these fees up to six months after the grant of an extension of term. Without these amendments some renewal fees might fall due for payment before an application for extension of term is decided.

Item 7 of Schedule 1 to the Statutory Rules substitutes a new paragraph 22.11(3)(c) of the Regulations. This paragraph prescribes the action of filing an application for extension of term under section 70 of the Act during the term of the patent as being an action for which an extension of time under section 223 of the Act is not available.

Item 8 of Schedule 1 to the Statutory Rules inserts a paragraph into Schedule 7, Part 2, Item 7 of the Regulations. The paragraph specifies the fee of $790 as being the annual renewal fee payable during the extended term of a patent.

Item 9 of Schedule 1 to the Statutory Rules inserts new Item 31 into Schedule 7, Part 2 of the Regulations. This item prescribes the fee of $400 as being the fee payable for the filing of an application for extension of term under section 70(1) of the Act.