The Intellectual Property Laws Amendment Bill 2006 recently passed, unamended, through Australia’s Federal Parliament. The Bill offers potential benefits to Australia’s generic pharmaceutical sector by permitting enhanced springboarding activities in relation to drug patents.
Springboarding allows activities that would otherwise be an infringement of a patent to be carried out for the purpose of obtaining regulatory approval. Generic manufacturers may thereby obtain marketing approval prior to patent expiry for immediate entry onto the market at the end of the patent term. Springboarding is justified on the basis that obtaining regulatory approval is often a protracted process and it is argued that restricting such activities until after the patent expires provides an unjustified de facto extension of patent term.
Previously, springboarding was only permitted when an eligible pharmaceutical product patent had been granted an extension of term. The present amendments allow springboarding on any pharmaceutical patent at any time for purposes in connection with gaining regulatory approval, domestically or internationally.
Specifically, springboarding is now allowed on patents covering a pharmaceutical substance per se; a method of producing the substance; a product relating to the substance, such as a prodrug or metabolite; and any patent covering the use of the pharmaceutical substance. Manufacturing the patented product or using the patented process for any other purpose remains prohibited.
The amendments arguably serve to simplify the development of generic drugs in Australia, while remaining consistent with our international obligations under TRIPs and the Australia-US Free Trade Agreement. Such amendments are also consistent with existing provisions in competitor countries, thereby providing increased certainty and opportunity for those conducting research and development in Australia. This may, in turn, make Australia’s generic pharmaceutical industry more internationally competitive.
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