Federal Court decision resets expectations for patent term extensions

The Federal Court of Australia (Federal Court) overturned a decision of the Australian Patent Office (APO)¹, in Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643. The Court ruled that an application for an extension of term must be based on the first regulatory approval date of a patentee's own (and not a third party's) product falling within the scope of the patent claims.

The decision clarifies that pharmaceutical patent extensions of term must be based on the patentee's earliest registered product. Importantly, even if a competitor product falls within the scope of the patent, and is registered first, the competitor's product cannot form the basis for a patent term extension or deprive the patentee of an extension based on their own product.