Patents Amendment Regulations 1998 (No. 8) 1998 No. 319
EXPLANATORY STATEMENT
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.
Overview
The Patents Amendment Regulations 1998 (No. 8) were introduced to facilitate the implementation of amendments to the Patents Act 1990 through Schedule 1 of the Intellectual Property Laws Amendment Act 1998. These regulations were issued by the authority of the Minister for Industry, Science and Resources, ensuring that the amendments would be properly integrated into the existing legal framework. The primary objective of these regulations was to streamline the procedures and requirements associated with patent opposition, extensions of term, and associated fees, thus enhancing the efficiency and clarity of the patent system in Australia.
These amendments aimed to bring various aspects of the patent process under the appropriate regulatory provisions, such as aligning opposition proceedings with the relevant sections of the Patents Regulations 1991. Furthermore, they introduced specific requirements for applications for extensions of term, including the necessity for certain information to be provided and the establishment of specific timelines and fees. The regulations were designed to ensure that the amendments to the Act would be effectively operationalised without creating inconsistencies or gaps in the regulatory process.
Scope and Application
The Patents Amendment Regulations 1998 (No. 8) amend the Patents Regulations 1991 to implement certain changes to the Patents Act 1990 made by the Intellectual Property Laws Amendment Act 1998. The Regulations apply to persons and entities involved in patent processes, particularly those seeking to extend the term of a patent, and they are intended to align the administrative processes with the legislative amendments. The regulations affect the conduct of opposition proceedings, the submission of applications for patent term extensions, and the payment of associated fees. These amendments are designed to streamline the patent process by clarifying the procedural requirements and timelines, such as the necessity for opposition notices to be filed within three months of the publication of a notice of acceptance of an application for an extension of term. The regulations also specify the form and information required for applications and the timing for fee payments during the extended term of a patent. The changes are to be applied nationally, impacting all entities under the Commonwealth jurisdiction. The regulations do not specify exclusions or thresholds, but they do set out clear guidelines for the operation of the amended provisions. The operation of these Regulations may be further extended or restricted through subordinate instruments as deemed necessary by the relevant authorities.
Key Provisions
The main operative sections of these regulations are those that amend the Patents Regulations 1991 to incorporate changes made by the Intellectual Property Laws Amendment Act 1998. Specifically, Regulation 3 of the Patents Amendment Regulations 1998 (No. 8) amends the Patents Regulations 1991 to align with the amendments to the Patents Act 1990. These amendments primarily concern the process for opposition proceedings and the requirements for applications for the extension of patent terms. For example, Item 1 of Schedule 1 to the Statutory Rules brings the conduct of opposition proceedings under section 75 of the Act under the operation of Chapter 5 of the Regulations. Item 2 specifies that a notice of opposition must be filed within 3 months of the publication of a notice of acceptance of an application for an extension of term and must be in the approved form. Additionally, Items 3 through 6 of Schedule 1 introduce new provisions related to applications for the extension of patent terms, such as the requirement that the application be accompanied by information showing that the pharmaceutical substance is included in the Australian Register of Therapeutic Goods and identifying the substance, as well as information on the first regulatory approval date.
The obligations and requirements imposed by the Patents Amendment Regulations 1998 (No. 8) on parties and entities governed by the Act include specific procedural and substantive requirements for opposition proceedings and applications for patent term extensions. For opposition proceedings, parties must file notices of opposition within three months of the publication of a notice of acceptance of an application for an extension of term, and the notice must be in the approved form. For applications for patent term extensions, applicants must include specific information about the pharmaceutical substance, such as its inclusion in the Australian Register of Therapeutic Goods and the date of first regulatory approval. Furthermore, applicants must ensure that the application is accompanied by all required documents and information, or be prepared to provide additional information upon request from the Commissioner.
The amendments also introduce several civil and criminal consequences for breaches of the new requirements. Firstly, if a notice of opposition is not filed within the stipulated timeframe or in the approved form, it may be deemed invalid, potentially allowing the patent to remain unchallenged. Secondly, failure to include the required information in an application for patent term extension could result in the application being rejected. Additionally, any party found to have provided false or misleading information in an application could face legal consequences, including potential fines or other penalties. The precise penalties are not detailed in the regulations but would be determined according to the provisions of the Patents Act 1990.