By Rebekah Gay, Emma Iles, Shaun McVicar and Bryce Robinson
Last week, a Full Court of the Federal Court of Australia handed down two unanimous decisions on appeal, clearing up some key uncertainties in the application of Australia’s patent term extension (PTE) regime.
Key takeaways
- A three-judge bench was convened to consider two important appeals relating to patent term extensions, comprising the Chief Justice and two respected intellectual property judges. Both decisions were handed down on 18 March 2022.
- In Commissioner of Patents v Ono Pharmaceutical Co. Ltd [2022] FCAFC 39 (Ono), the Full Court unanimously overturned the primary judge’s decision, finding that pharmaceutical patentees must apply for a PTE within six months of the first inclusion on the Australian Register of Therapeutics Goods (ARTG) of any product containing a pharmaceutical substance falling within the claims of the patent, regardless of whether it is the patentee’s own product.
- In Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2022] FCAFC 40 (Merck), the Full Court unanimously upheld the primary judge’s decision, thereby affirming that a PTE for a patent claiming more than one pharmaceutical substance must be calculated from the earliest regulatory approval date of any pharmaceutical substance disclosed in, and claimed by, the patent, even if that substance was not the basis of the PTE application.
- Pharmaceutical patentees should keep PTEs front-of-mind when filing patent applications, and will need to keep a close eye on regulatory listings that may impact PTE applications (including those by competitors).
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Disclaimer
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