There appears to be a softening by the Patent Office of the extension of patent term provisions in Australia. Traditionally, an extension of patent term was only available for pharmaceuticals. Indeed, the Act contained a specific limitation to "pharmaceutical substances per se".
However, the Patent Office has recently allowed an extension of term for an invention that looks increasingly like a medical device. In NV Organon [2009] APO 8 an extension of term application was made for a vaginal ring constructed with a thermoplastic polymer core and a permeable thermoplastic skin for the slow release of steroidal mixtures for the purpose of contraception or hormone replacement therapy.
The Patent Office took account of the intent of the extension legislation, which is to compensate patentees that have a delay going to market because of regulatory approval requirements. It was held that the product as a whole exhibited a level of interaction between components consistent with that of a pharmaceutical substance. Accordingly, the Office allowed the extension.
The net result of the decision is that, where there is a degree of interaction between component parts of a drug delivery device, the extension of term provisions may be available. This would, for example, apply for implantable devices and transdermal patches. This is a substantial broadening of the interpretation of the boundary of the extension provisions.
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| Peter Treloar |
Shelston IP
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