The speed of getting a case to trial is a key metric of any litigation system. Pharmaceutical patent litigation often plays out on the cusp of patent expiry when a new market entrant seeks to clear the way to get a generic or biosimilar product on the market earlier and ahead of its competitors.
Faced with the prospect of early launch and a statutory price reduction triggered by the first competitor’s listing on the Pharmaceutical Benefits Scheme, an urgent interlocutory application is typically sought by the brand originator, which is often granted until the matter can be heard in full at trial . And historically, that is when things can slow down.
Faced with this prospect, an expedited trial which avoids the need for interim injunctive protection altogether is becoming a much more attractive proposition. In the Federal Court of Australia (FCA) parties may seek ‘expedition’ to obtain a shorter timetable to hearing. Expedition is at the judge’s discretion having regard to relevant commercial considerations amongst other factors. Australian judges within the IP practice area of the FCA have recently shown a willingness to expedite proceedings where appropriate, particularly in the pharmaceutical patent sphere. This may be due in part to the fate of several interlocutory injunctions granted in circumstances where the patents have ultimately been found invalid at trial, resulting in hugely complicated damage assessments involving hypothetical counterfactual market scenarios .
We discuss four recent cases that have shown that it is feasible to get a case to trial in Australia within or close to 12 months.
In Teva Pharma Australia Pty Ltd v Boehringer Ingelheim Pharma GmbH & Co. KG , Teva filed proceedings in the FCA in December 2018 seeking to invalidate three patents relating to tiotropium. The ‘powder patent’ was set to expire in September 2021, the other two patents expiring later. In March 2019, Justice Moshinsky set the matter down for trial in October 2019 with evidence in chief on invalidity to be filed by early April. The orders also included provision for discovery and remarkably, experiments on infringement, which traditionally would likely have dispelled any thought of expedition. In early May, discovery was ordered to be made in early August. The case settled and was discontinued in June 2019 at which point the expedited timetabling still appeared be on track for the October hearing date.
Earlier this year in Juno Pharmaceuticals Pty Ltd & Anr v Celgene Corporation , Beach J also agreed to an expedited timetable to reach a trial in August 2021 in proceedings that were instituted in November 2020. In that case, Juno originally sought to revoke claims of a patent to the compound of interest due to expire in July 2022. Celgene counterclaimed for infringement of various later expiring method of treatment patents in respect of the compound. Beach J accepted the need for expedition noting that the applicants would otherwise lose the opportunity to test the validity of the compound patent sufficiently in advance of its expiry date. The trial took place in August 2021, 10 months after commencement.
Similarly in Merck Sharp & Dohme Corp v Sandoz Pty Ltd , Merck brought proceedings in February 2021 against Sandoz for infringement of its patent relating to sitagliptin and treatment for diabetes. Sandoz accepted that the product it intended to market fell within the scope of the relevant patent claims and undertook not to exploit its product up to the original 20 year patent term expiry date of 5 July 2022. However, it challenged the validity of the patent term extension (PTE) and refused to give an undertaking in relation to the extended period of the patent. The outcome of the case depended entirely on Sandoz’s argument that the PTE was invalid, a question of law. At the first directions hearing, the matter was listed for a two-day hearing in July 2021. The judgment was handed down by Justice Jagot in August 2021 in favour of Sandoz. The decision has been appealed and will be heard by the Full Court on 5 November 2021, only 9 months from the issue of the proceedings. In this case there appears to be every prospect that a judgment may be issued on appeal only slightly more than 12 months after issue of the proceedings.
The readiness of judges to engage with forms of case management to appropriately limit the size of the case to be heard is also a key factor in speed to trial. Recently we observed that Justice Burley made orders to effectively ‘cap the evidence’ by limiting the length of the evidence in the case to 45 pages (excluding annexures) per expert in Novartis AG v Pharmacor Pty Ltd . This case was filed in March 2021 and has been set down for a hearing in June 2022.
In sum, we observe a willingness by the Australian judges within the IP practice area of the FCA to expedite proceedings where appropriate, particularly in the pharmaceutical patent sphere. We consider this good news for litigants in general, and a positive sign of improvement to Australia’s reputation for patent litigation. Of course, the quid pro quo for expedition is compressed timeframes, particularly in the evidentiary stages. So strategic planning, well before litigation is commenced, can be essential in making the most of the expedited timeframe and meeting the expectations of the Court.
 A recent exception is Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd  FCA 2060
 For example, Sigma v Wyeth  FCA 1556 and Lundbeck v Sandoz  FCA 1797
 Teva Pharma Australia Pty Ltd v Boehringer Ingelheim Pharma GMBH & Co. KG  FCA 625
 Juno Pharmaceuticals Pty Ltd v Celgene Corporation  FCA 236
 Merck Sharp & Dohme Corp. v Sandoz Pty Ltd  FCA 947
 Novartis AG & Anor v Pharmacor Pty Ltd (NSD183/2021)
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 the pharma/biopharma industries, resulting from 25 years' experience including as VP of IP in-house global pharma giants, Partner of a top-tier international law firm, and as the founding Principal of Pearce IP.
Special Counsel, Lawyer
Kate is an experienced IP and patent lawyer, providing IP leadership for pharmaceutical product development and commercialisation in global markets – from initial scoping through to post-launch.
She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.