Patent law in Australia: 2022 in review
In Australia, 2022 was an exciting year in patent litigation, with key patent law developments relating to patent terms extensions, unjustified threats, experimental use exception, and AI. In this update we provide a summary of key 2022 Australian patent law “hot topics”, and highlight the same for 2023.
Patent term extensions
Several decisions in 2022 resulted in both new opportunities to challenge patent term extensions (PTEs) in Australia and new patent prosecution practices.
The Full Court of the Federal Court in Merck Sharp & Dohme & Anor v Sandoz Pty [2022] FCAFC 40 affirmed a decision of a single judge holding that a PTE application must be based on the first approval date of any product claimed in the subject patent, irrespective of whether that first approved product results in PTE eligibility. In this case, two Merck products fell within the scope of the claims of the patent in suit—‘Januvia’ which was approved first, and ‘Janumet’. As the ‘Januvia’ approval was within five years of the relevant patent date, the patent was ineligible for PTE.
This decision likely leaves a number of PTEs vulnerable to attack, potentially shortening the effective patent period for significant commercial products. The practical implications for prosecution are clear—patentees are very mindful of PTEs and are adopting strategies to ensure that at least one patent in the family covers only the patentee’s commercial embodiment, so as to avoid running the risk of compromising the length of the PTE because the claims read onto a competitor’s product.
On the same day as the decision was handed down in Merck Sharp & Dohme & Anor v Sandoz Pty, in Commissioner of Patents v Ono Pharmaceutical Co & Anor [2022] FCAFC 39, the Full Court also held that the relevant approval date for PTE purposes is the approval date of any product falling within the scope of the claims, whether or not that product is the patentee’s product. The Australian Patent Office initially refused Ono’s PTE application based on ‘Opdivo’ because its patent also covered Merck’s ‘Keytruda’, which had an earlier regulatory approval date. The application for PTE was therefore out of time. Following several appeals, this decision was ultimately affirmed by the Full Court. This decision means that patentees must be aware of competitor products registered on the Australian Register of Therapeutic Goods which may fall within the scope of their patents and seek PTEs based on the earliest of their approval, and their competitors’ (within the defined time frame).
Diagram: PTE decisions “score card” for 2022
