Expedition on Steroids – Federal Court Speeds to PI Decision in AstraZeneca’s AU Forxiga® Patent War

PI decision to be handed down 6 days after PI hearing. 

Justice Downes of the Federal Court of Australia is setting new records for expedition in a patent dispute between AstraZeneca and Pharmacor, relating to the latter’s generic dapagliflozin.  Following the hearing last Friday (6 February 2026) on the first week of the Court sitting in 2026, judgment on AstraZeneca’s PI application will be handed down next Monday (16 February), the 6^th working day after the hearing.  The hearing was 7 weeks from AstraZeneca’s application and the decision will be delivered 2 months from commencement despite the Court’s 6-week summer recess.  The substantive trial is likely to be scheduled to begin on 31 August 2026, 8 and a half months from commencement.

These timelines are unprecedented.  Justice Downes is demonstrating the Court’s sensitivity to commercial drivers where circumstances require it.

Assuming the matter proceeds to hearing in August, Justice Downes will be setting a new record for a substantive hearing in the Federal Court.  This will be faster even than Juno and Natco’s expedited hearing against Celgene before Justice Beach in 2021 regarding validity (and infringement) of a patent relating to blockbuster lenalidomide (in which Pearce IP acted for Juno and Natco).  That case went to hearing in 10 months (but without an interlocutory dispute) with his Honour promising judgement within 6 weeks (although the matter settled following the hearing).

The dispute between AstraZeneca and Pharmacor relates to infringement and validity of AU2003237886, AstraZeneca’s Australian patent to dapagliflozin, the active ingredient of its FORXIGA® type II diabetes treatment.  Pharmacor obtained ARTG registration of generic dapagliflozin products on 14 November 2025.

AstraZeneca filed infringement proceedings on 16 December 2025, with an application for a preliminary injunction restraining the launch of Pharmacor’s products.  Timetable orders were made by consent on the last sitting day of the year (19 December 2025), and the application for interlocutory injunction was heard on the first sitting week of the year.

At the beginning of the 6 February PI hearing, counsel for AstraZeneca informed the Court that the Department of Health’s position was if Pharmacor’s PBS listing application was to be withdrawn, it would need to do so by 18 February 2026.  AstraZeneca therefore sought a decision by this date.  The Court has met AstraZeneca’s request and will deliver a decision on 16 February, a record breaking 6 business days from the hearing, and 62 days from commencement, 44 of which were during the Court recess!

During the hearing, the parties discussed the possibility of a substantive trial, of five to seven days’ duration, commencing on 31 August 2026, i.e. only 258 days from commencement (including holidays).  The trial date is yet to be confirmed by Court orders.

Pearce IP maintains a close watch on all Australian patent proceedings and there has not been any first instance trial in a pharmaceutical patent dispute in less time than is proposed here in the last 30 years.

AstraZeneca has asserted four claims of one patent, which expires in 20 months.  Pharmacor is contesting validity of the asserted claims and is relying on one prior art publication, PCT/US0027187.  Pharmacor has also raised defences to infringement of a composition claim and a method of treatment claim under the term extension provisions of the Patents Act.

Generic pharmaceutical manufacturers setting strategies to enter the Australian market will already be aware of the current trend of the Courts to refuse PI.  It remains to be seen whether this proceeding will continue or buck this trend.  They should also take account of the potential for rapid resolution of both PI applications and substantive patent infringement/invalidity matters.

We will report further on Monday, once the interlocutory decision is issued.

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries.  Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.