Figure 1: Typical regulatory review timeline with standard patent litigation overlay in Australia
3. Beware of preliminary discovery in Australia
Preliminary discovery as a precursor to patent litigation has emerged as an effective tool to prevent generic/biosimilar market entry. When considering the strategic options available in response to such an application, applicants must be mindful of the lessons learned from the recent five-year (and counting) etanercept (Enbrel) Federal court preliminary discovery dispute (Pfizer Ireland Pharmaceuticals and Ors v Samsung Bioepis AU Pty, NSD2149/2016). Using a “typical” timeline, an application for preliminary discovery, followed by patent litigation, could result in judgment six to eight years after Therapeutic Goods Administration approval of the biosimilar/generic application, as shown in Figure 2.
Figure 2: Typical regulatory review timeline with preliminary discovery and standard patent litigation overlay in Australia
4. Beware of reforms regarding early disclosure
Further reforms are anticipated in Australia which will result in the originator receiving notification of the generic/biosimilar application shortly after the dossier is filed. This will alter the dynamics of patent litigation in Australia.
For applicants who have not taken steps to “clear the way”, the result will be the induced commencement of patent litigation by the patentee to shortly after filing the application, rather than on approval.
CEO, Executive Lawyer, Patent & Trade Mark Attorney
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is market leading in the field of pharma/biopharma, biotechnology and animal health.
Underpinning Naomi’s legal work is a deep understanding of pharma/biopharma industries, resulting from 25+ years' experience, including as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm and as the Founding Principal of Pearce IP.