Patent term extensions are to be calculated using the patentees first in time ARTG listing | Federal Court narrows patentees’ use of Australian patent term extension regime
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Partner
Australia
I am a partner in our Intellectual Property Group, based in Sydney. My experience spans the breadth and depth of IP issues, but my specialty is complex IP litigation and disputes including contentious patent, trade mark, copyright, and confidential information and consumer protection/passing-off matters.
On 12 August, Jagot J handed down her decision in MSD v Sandoz1. It is a very important decision for both patentees seeking to navigate the extension of term provisions, and for generic companies trying to navigate complex patent landscapes as it clarifies the operation of the patent term extension regime in Australia.
While the term of a standard patent in Australia is 20 years, for “pharmaceutical substances per se” (new and inventive substances), the Patents Act 1990 (Cth) (the Act) provides a scheme whereby, in certain circumstances, the 20 year term can be extended once for further period of up to 5 years.
“Tethered to the statutory text and context”, Her Honour held that the calculation of any extension of term (under s 77(1)) of the Act) is to be by reference to the first inclusion in the Australian Register of Therapeutic Goods (ARTG) of goods containing or consisting of any of the pharmaceutical substances disclosed and claimed in the patent obtained by the patentee. So, where a patentee has a subsequent ARTG listing which goods include a pharmaceutical substance that is also disclosed and claimed by the patent, that ARTG listing cannot be the basis for the calculation of the extension.
For MSD, this meant that the extension of term of one in its suite of patents directed at the treatment and prevention of diabetes was wrongly calculated, and in fact, under the regime, no extension should have been granted.
Her Honour distinguished the case from the situation where an unrelated third party ARTG listing had been relied on to refuse an extension of time, as was the case in Ono (which we reported on here). In that case, Beach J held that the scheme operates only by reference to the patentee’s ARTG listings, and not those belonging to a third party.
The facts
The relevant patent was filed on filed on 5 July 2002, and would have normally expired on 5 July 2022.
A related body corporate to the patentee obtained ARTG listing for sitagliptin on 16 November…
