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.
Naomi Pearce
Executive Lawyer, Patent Attorney & Trade Mark Attorney
Naomi is recognised as one of Australia’s leading patent lawyers in virtually every notable legal guide and directory. Naomi is also Lawyers Weekly Women in Law Partner of the Year (SME Law) for 2021, and the Founding Principal of Pearce IP, which was recognised as the IP Team of the Year in the Australian Law Awards in December 2021.
Underpinning Naomi’s legal work is a deep understanding of the pharma/biopharma industries, resulting from 25 years’ experience including as VP of IP in-house at global pharma giants, Partner of a top-tier international law firm, and as the founding Principal of Pearce IP.
Alex May
Senior Associate, Foreign Qualified Lawyer
Alex is an intellectual property disputes lawyer with twelve years’ experience and a track record of obtaining successful outcomes for clients. He specialises in advising pharmaceutical companies on patent litigation and related matters and has a technical background in genetics.