Extensions of term for patents covering multiple approved pharmaceutical substances clarified

In a significant pair of appeals handed down on the same day, with each cross referring to the other, the Full Federal Court has clarified extensions of term for patents covering more than one pharmaceutical substance with regulatory approval.

In Commissioner of Patents v Ono Pharmaceutical Co. Ltd  [2022] FCAFC 39 (Ono),sup>1 the first approved substance covered by the patent was a third party's. The Court overturned the trial judge and confirmed that the regulatory approval date of the third party's product, not the later approval date of the patentee's product, was to be used for the purpose of calculating regulatory delay - resulting in a shorter extension.

In Merck Sharp & Dohme Corp. v Sandoz Pty Ltd  [2022] FCAFC 40 (MSD v Sandoz),² both approved substances were the patentee's. MSD sought an extension based on the product with later regulatory approval, as that would have resulted in an enforceable extension of almost 18 months. The Court upheld