Innovation is a major driver of commercial and economic growth, and of prosperity in the pharmaceuticals industry. Intellectual property (IP) protection is an essential requirement for innovative pharmaceutical companies to continue to be able to fund their huge investments in the research and development (R&D) of new medicines.
Australia has one of the most effective IP rights protection systems in the world. It is ranked fifteenth in the world and second in the region for its enforcement (The Global Competitiveness report 2013-14, World Economic Forum).
IP Australia is the Commonwealth agency responsible for granting rights in patents, trade marks, designs and plant breeder's rights. This agency also offers a wide range of other services such as assisting creators and users of these rights to understand and use the relevant parts of the IP system. IP Australia is a prescribed agency within the Department of Industry, Innovation and Science but operates independently and reports directly to the Minister.
Australia’s Patent Scheme
The Patents Act 1990 and Patents Regulations 1991 underpin Australia’s patent scheme. Under the Patents Act and its Regulations, holders of a standard patent are granted exclusive rights to make, hire, sell or otherwise dispose of their invention for up to twenty years. It grants an exclusive right to manufacture a potential product in Australia for sale in Australia or for export.
Another form of patent available is the innovation patent. The innovation patent system is designed to provide protection for those inventions which have a lower inventive threshold than that required for a standard patent. Although inexpensive and simple to obtain, an innovation patent cannot be enforced until after examination to determine if it meets the requirements of the Patents Act and its Regulations, and the patent is certified.
Under the Patents Act, a patent extension of up to five years is available for certain human use pharmaceutical substance patents. This is in large part to compensate for the lengthy and expensive R&D involved in producing marketable medicines, which can leave limited patent life in which to recoup the investment. This measure puts Australian pharmaceutical companies on an equal footing with their competitors in the United States, Japan and Europe with respect to effective patent life.
Patents that are eligible for extension are existing and new standard 20 year patents in relation to a pharmaceutical substance that is the subject of the first regulatory approval or registration as a therapeutic good on the Australian Register of Therapeutic Goods (ARTG) under the Therapeutic Goods Act 1989 (the TG Act). Extensions are permitted in relation to product claims for substances and for product by process claims for such substances when produced by recombinant DNA technology.
The length of the extension is determined by the period between the date of the patent and the day on which first registration on the ARTG commenced. The maximum period of extension will be five years to give a maximum effective patent life (from first inclusion on the ARTG) of 15 years.
An extension must be applied for - it is not granted automatically.
Springboarding refers to the ability for non-patent owners to undertake otherwise infringing activities, including collection of data, for the purposes of obtaining regulatory approval of a generic version of a product to which a patent relates, during the life of the patent.
Springboarding is allowed on all pharmaceutical patents at any time but only for purposes related to gaining regulatory approval in Australia for a product.
Data may be collected for regulatory approval by overseas regulatory agencies, but the export of a product is not permitted unless the product consists of or contains a substance claimed in a patent that has had its term extended.
The TG Act requires that therapeutic goods must be entered in the ARTG before they can be lawfully imported into, exported from, manufactured or supplied in Australia, unless the goods are the subject of an exemption, approval or authority under the TG Act. Pharmaceutical products containing a new chemical entity are normally considered as high risk medicines and require stringent assessment in relation to safety, quality and efficacy. Applicants for the entry of these goods in the ARTG are required to provide substantial information to the Therapeutic Goods Administration (TGA), an agency of the Department of Health, including information relating to pre-clinical studies, clinical or toxicological information, chemistry, quality control and manufacturing information.
Under section 25A of the TG Act the Secretary is prevented from relying upon, or using information previously submitted by an originator sponsor in relation to the registration of a new therapeutic good containing a new active component (commonly referred to as 'new chemical entity') that was never before entered in the ARTG, for the purposes of facilitating the registration of a generic product containing that same active component. This prohibition placed upon the Secretary lasts for five years from the date the therapeutic good containing the new active component became registered in relation to the originator sponsor. Section 25A of the TG Act; however, does not prevent the sponsor of the generic product obtaining its own independent data and lodging the full information required under the TG Act in order to register that product. Another way a company may register a generic product of the new active component within the five year protection period is by seeking agreement to use the data from the originator sponsor of the therapeutic good containing the new active component.
Harmonisation of IP Laws and International Obligations
There is increased pressure for greater harmonisation and mutual recognition of IP laws and administrative practices in IP systems. Australia’s IP laws are consistent with our obligations under various international treaties and agreements that are generally designed to standardise IP laws and systems around the world.
Australia has been a member of the World Intellectual Property Organization (WIPO) since 1972. There is substantial ongoing international dialogue within WIPO that aims to address issues arising from the internationalisation of the IP system. The WIPO administers a number of agreements and one such agreement is the Patent Cooperation Treaty (PCT), which makes it possible to seek patent protection in a number of countries by filing a single international patent application. Australia acceded to the PCT in 1980.
IP laws and systems are generally country or region specific. Businesses wanting worldwide registrable IP protection must apply for protection in each national or regional IP office. This is facilitated by the PCT application process which can be accessed through IP Australia.
Trade-Related Aspects of Intellectual Property Rights (TRIPS)
The TRIPS Agreement is part of international moves to standardise IP laws and systems. It sets minimum standards on IP protection and requires members of the World Trade Organization (WTO) to comply with the requirements of aspects of particular WIPO Conventions. As a Member of the WTO, Australia is required to ensure its IP regime meets the requirements of the TRIPS Agreement. Australia’s legislation is consistent with this framework and the IP regime for pharmaceutical patents is in line with those operating in other developed markets. For further information about TRIPS or a copy of the Agreement go to the WTO website.
For enquiries regarding this website or further information on the pharmaceuticals industry pleases contact:
Health Technologies Section
Advanced Technologies Branch
Department of Industry, Innovation and Science
GPO Box 9839
Canberra ACT 2601