In Australia potential parties to biosimilar patent litigation are relatively free to dance (or not) and in any which way they choose.
While our colleagues in the USA are currently attempting to come to grips with the Federal Circuit’s recent decisions in relation to the Biologics Price Competition and Innovation Act (BPCIA) and the “patent dance”, in Australia potential parties to biosimilar patent litigation are relatively free to dance (or not) and in any which way they choose.
The Therapeutic Goods Administration (TGA) regulatory approval process/mechanism in Australia is currently the same for all prescription medicines, including biosimilars and new biological entities as well as new chemical entities. The typical regulatory pathway for biosimilars (and other prescription medicines) to get on the market in Australia involves two steps.
The first step involves the sponsor submitting an application for registration in order to gain TGA approval and inclusion in the Australian Register of Therapeutic Goods (ARTG). Importantly, that an application for inclusion on the ARTG has been made is not made public until registration.
A sponsor seeking to rely on the safety or efficacy of other therapeutic goods that have already been approved, as in the case of an application for a biosimilar, must provide a certificate under section 26B of the Therapeutic Goods Act 1989 (Cth) in the application for registration. In essence, the certificate must state that, either the sponsor: believes that it would not infringe a valid claim of a granted patent; OR, that it has provided the patentee of any relevant patent(s) with notice of the application for inclusion on the ARTG.
This certificate requirement might be considered to start the music playing, but at this stage it is still up to the sponsor of the biosimilar as to whether or not they invite the innovator out onto the dance-floor.
The second step that most patented medicines undergo is for the sponsor to apply to the Pharmaceutical Benefits Advisory Committee (PBAC) for listing on the Pharmaceutical Benefits Scheme (PBS) Schedule. Through the PBS, the Commonwealth Government of Australia subsidises the cost to eligible patients of certain pharmaceutical products in Australia. The PBAC submission can be lodged during TGA evaluation of an application or after successful registration. However, that an application has been made to the PBAC for listing on the PBS Schedule is made public before a final decision is made. At that point, the innovator can choose to dance or commence proceedings.
Even though the regulatory landscape in connection with potential biosimilar patent litigation in Australia is less structured than in the USA, it is still prudent for both innovators and biosimilar companies to create a list of all possibly relevant Australian patents covering key biological products and to strategically review those patents ahead of time for the purposes of, respectively, enforcement and freedom to operate.