$10 Billion Deal, page-8639

PATENT TERM EXTENSION

In Australia, as in most jurisdictions, the standard patent term is 20 years from the filing date. In many major developed countries, however, the holder of a pharmaceutical patent can apply for this term to be extended for an additional period (e.g. up to five years in Australia, the US and Europe).

Such regimes recognise that, in reality, the commercial protection afforded to pharmaceutical patent holders typically fall far short of the full 20 years, as much of that period will be lost to developing the product, establishing its safety and efficacy, and obtaining essential marketing authorisations from health regulators. Accordingly, extending the patent protection period aims to compensate patentees for at least part of the time spent on product development and to recognise the significant investment required for the development of novel therapeutics.

Typically, there is a limited timeframe within which patent holders can apply for a PTE once marketing approval has been granted. In Australia, applicants have six months from the date of first inclusion on the Australian Register of Therapeutic Goods (ARTG). The issue in the present matter is whether the clock starts running as soon as any product falling within the scope of the patent’s claims appears on the ARTG, rather than the patentee’s own product.