On 26 September 2022, Sanofi’s oppositions to five Amgen patent applications were held to be unsuccessful by the Australian Patent Office. The patent applications (AU2013203677, AU2013203685, AU2013203689, AU2013203748, AU2013203751) relate to antigen binding proteins to proprotein convertase subtilisin/kexin type 9 (PCSK9), including evolocumab, marketed by Amgen as Repatha®.
At the hearing, Sanofi challenged the applications including on grounds of manner of manufacture, fair basis, full description, definition, clarity and utility. Each of these grounds failed.
Sanofi filed an appeal to the Federal Court on 17 October 2022.