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Australia - Patent Extension for Pharmaceutical Patents

The Australian Parliament has passed legislation to provide for the possibility of extensions of patents relating to pharmaceutical products per se or to pharmaceutical products produced by use of recombinant DNA technology. The purpose of the extension is to compensate patentees for delays in securing approval to market pharmaceutical substances in Australia if the period between the filing of the Australian patent application and the grant of approval for sale under the Therapeutic Goods Act exceeds five years. The maximum term of extension is to be five years. Extensions are available only for those patents originally granted for a twenty-year term and those originally granted for a sixteen-year term but whose term was extended to twenty years when Australia implemented the TRIPS Agreement (see our April 1995 Newsletter (N.S. 185) as long as the original sixteen-year term for such patents expired on or after July 1, 1995. Applications for an extension must be filed within six months of the latest of the date of grant of the patent or the date of first regulatory approval.


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