IP Developments in Biotechnology Australia 2021

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The past year saw a number of important developments regarding intellectual property impacting on the biotechnology sector in Australia. Here, we provide a brief summary of a selection of the latest Court decisions and government initiatives in Australia that are likely to be of interest to the biotech sector going forward.

Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101.
On appeal, the Full Court of the Federal Court of Australia has re-confirmed that diagnostic methods are patentable in Australia. This aspect of the decision is largely conventional. More interesting, however, were the findings on infringement. The Full Court held that sending an Australian blood sample to the USA for performance of the claimed diagnostic method, before informing a subject in Australia of the results, does not constitute infringement. This reverses the decision of the lower court, and deviates from the previously understood position in Australia.

Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643.
The Federal Court overturned the first instance patent office decision, to clarify that pharmaceutical patent term extensions should be based on the earliest registered product from which the patentee derives benefit. Importantly, even if a competitor product falls within the scope of the patent, and is registered first, the competitor’s product should not form the basis for a patent term extension or deprive the patentee of an extension based on their own product at a later date. This decision has been appealed by the Commissioner of Patents.

Abolishment of the Australian innovation patent system.
Australia’s second-tier innovation patent system is no longer available for newly filed applications. The Australian government considered that the innovation patent system failed to meet its objective of promoting innovation. Rather, larger companies were allegedly using innovation patents as strategic tools, for example, as difficult to invalidate patents for litigation.

Australian Patent Box.
On the 11 May 2021, the Australian Government announced a new Patent Box regime for new patents in the medical and biotechnology sectors. The general concept is that profits derived from the commercialisation of patented technology developed in Australia will be subject to a reduced corporate tax rate of 17% (compared to the standard corporate tax rate of 30%).

Originally published as the Australian update in the AIPPI 2021 Annual Report for the Biotechnology Standing Committee.