Patents Amendment Act 1989
No. 96 of 1989
An Act to amend the Patents Act 1952, and for related purposes
[Assented to 30 June 1989]
BE IT ENACTED by the Queen, and the Senate and the House of Representatives of the Commonwealth of Australia, as follows:
PART I—PRELIMINARY
Short title etc.
1. (1) This Act may be cited as the Patents Amendment Act 1989.
(2) In this Act, “Principal Act” means the Patents Act 19521.
Commencement
2. This Act commences on a day to be fixed by Proclamation.
PART II—AMENDMENTS OF THE PATENTS ACT 1952
Interpretation
3. Section 6 of the Principal Act is amended by inserting the following definitions:
“ ‘marketing approval certificate’, in relation to a pharmaceutical substance, means a certificate given by the Secretary to the Department of Community Services and Health certifying that he or she has approved the marketing of the substance, or a product containing the substance, in Australia;
‘pharmaceutical substance’ means a substance (including a mixture or compound of substances) for therapeutic use the application, or one of the applications, of which involves a chemical interaction, or physico-chemical interaction, with a human physiological system, or involves action on an infectious agent, or on a toxin or other poison, within a human body, but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing;
‘therapeutic use’ means use for the purpose of:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons;
(b) influencing, inhibiting or modifying a physiological process in persons; or
(c) testing the susceptibility of persons to a disease or ailment;”.
Duration of patent of addition
4. Section 75 of the Principal Act is amended:
(a) by omitting subsection (1) and substituting the following subsections:
“(1) Subject to subsection (1a), a patent of addition remains in force for so long as the patent for the main invention remains in force.
“(1a) The term of a patent of addition may be extended under Part IX even though the term of the patent for the main invention is not so extended.
“(1b) An extension of the term of a patent of addition shall commence at the end of the term of the patent for the main invention.”; and
(b) by inserting after subsection (2) the following subsection:
“(2a) If the term of a patent of addition is extended under Part IX and the patent for the main invention is not so extended, the patent of addition becomes an independent patent and the fees payable after the patent becomes an independent patent, and the dates when they become payable, shall be determined by its date.”.
Validity of patent of addition
5. Section 76 of the Principal Act is amended by adding at the end the following subsection:
“(2)…
Overview
The Patents Amendment Act 1989 was enacted to address the need for extending the duration of patents, particularly for pharmaceutical substances, in recognition of the time required to gain marketing approval from regulatory authorities. This Act amends the Patents Act 1952 by introducing provisions for extending the term of patents, particularly for pharmaceutical substances, under specific conditions. The Act was passed by the Queen, with the assent of both the Senate and the House of Representatives of the Commonwealth of Australia on 30 June 1989. The policy objective of this amendment is to ensure that inventors and patentees in the pharmaceutical sector can adequately protect their inventions, which often require lengthy regulatory processes before they can be marketed.
Scope and Application
The Patents Amendment Act 1989 applies to the Patents Act 1952, amending it to extend the duration of patents of addition and introduce provisions for the extension of the term of certain patents, particularly those relating to pharmaceutical substances. This Act is applicable to patents held by individuals and entities within Australia, and it governs the process for extending the term of patents that disclose pharmaceutical substances. The Act's provisions allow for the extension of patent terms to compensate for delays in obtaining marketing approval for pharmaceutical substances. The Act applies nationally across Australia, as it is a Commonwealth Act. Exclusions include patents that solely relate to in vitro diagnostic or testing substances. The application and scope of this Act can be further defined or modified through subordinate instruments, such as regulations that may detail the specific processes and requirements for extending patent terms.
Key Provisions
- The Patents Amendment Act 1989 makes significant changes to the Patents Act 1952, particularly in relation to the duration and extension of patents for pharmaceutical substances. Section 4 of the Act amends the duration of patents of addition, stating that they remain in force as long as the patent for the main invention is in force. It also allows for the term of a patent of addition to be extended even if the patent for the main invention is not extended, and clarifies that if such an extension is granted and the main patent expires, the patent of addition becomes an independent patent (Sections 4(1) and 4(2a)). Additionally, Section 5 adds a new definition for "patent of addition" to ensure clarity in the context of the Act.
- The Act imposes several obligations on patentees and the Commissioner of Patents. For instance, Section 90 mandates that a patentee who wishes to extend the term of a patent relating to a pharmaceutical substance must apply to the Commissioner within 12 months before the patent term ends and provide a copy of the application to the Secretary to the Department of Community Services and Health. The Commissioner is required to publish the application in the Official Journal and must not consider an application if it is objected to and the objection is not withdrawn within the prescribed period (Sections 90(2)-(5)). Furthermore, Section 92 outlines the process for obtaining a marketing approval certificate, which is a prerequisite for the extension application.
- Breaches of the provisions in this Act can lead to various consequences. While the Act does not explicitly state penalties for non-compliance, the failure to adhere to the timelines and requirements for extensions could result in the loss of the right to extend the patent term. Additionally, any actions or proceedings for infringement of a patent that has had its term extended cannot be instituted more than two years after the original term expired, except in specific circumstances (Section 96(1)). The Act also provides for appeals to the Federal Court for decisions related to the grant or refusal of an extension (Section 96b). These provisions underscore the importance of strict compliance with the Act’s requirements to ensure the proper administration of patent extensions.
- Area of Law
- Intellectual Property Law
- Instrument
- Act
- Concepts
- Definitions & Interpretation
- Commencement Provisions
- Repeal & Amendment
- Reporting & Disclosure Obligations
- Regulatory Standards
- Offence Provisions
