Federal Court of Australia Awards Janssen First Pharmaceutical Patent Preliminary Injunction in 7 Years

Janssen Pharmaceutica NV v Juno Pharmaceuticals Pty Ltd [2025] FCA 1538

Introduction

On 5 December 2025, Justice Burley of the Federal Court of Australia granted Janssen a preliminary injunction to restrain Juno Pharmaceuticals from launching generic versions of paliperidone palmitate long acting injectables (LAIs) used for the treatment of schizophrenia pending a final hearing of the matter.

Remarkably, the decision is the first preliminary injunction to be granted in a pharmaceutical patent infringement proceeding in Australia since mid-2018.  Since Justice Jagot’s landmark decision in Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth (2018) 136 IPR 8; [2018] FCA 1556, which highlighted the “many complexities involved in compensating a generic manufacturer for a wrongly granted preliminary injunction”, the Federal Court has consistently refused such applications.  Justice Rofe’s refusal just three months earlier in Regeneron Pharmaceuticals, Inc. v Sandoz Pty Ltd [2025] FCA 1067 (Regeneron v Sandoz), which we reported on here, appeared to confirm this trend.  Justice Burley’s decision, however, demonstrates that in the right circumstances, the Federal Court will grant preliminary injunctions in favour of pharmaceutical patentees.

Background

The dispute concerns Australian patent no. AU2008340101 (the Patent), entitled “Dosing regimen associated with long acting injectable paliperidone esters”.  The Patent outlines a dosing regimen for injectable paliperidone palmitate, based on research demonstrating that the drug exhibits “flip-flop kinetics” and achieves better results with injections into the deltoid muscles.  Claim 1 of the Patent claimed a regimen involving two initial deltoid injections on day one and between days 6-10 (loading doses of 150 mg-eq and then 100 mg-eq), followed by monthly maintenance doses of 25-150 mg-eq.

Janssen is the sponsor of pharmaceutical goods for the treatment of schizophrenia by paliperidone palmitate LAIs under the trade names INEVGA SUSTENNA (monthly), INVEGA TRINZA (three-monthly) and INVEGA HAFYERA (six-monthly) (collectively, the INVEGA Products).  Juno has been the sponsor on the ARTG since 28 February 2025 for two one-monthly generic paliperidone LAI products: PALJUNA MONTHLY and VALINO MONTHLY.

Consideration

The application for a preliminary injunction turned on two key questions: whether Janssen had established a prima facie case of infringement (including consideration of Juno’s invalidity arguments); and where the balance of convenience lay.

Strong Prima Facie Infringement

Janssen alleged that Juno would infringe the Patent pursuant to sections 117(2)(b)-(c) (infringement by supply) and section 13 of the Act (infringement by authorisation).

Janssen submitted that the infringement case was relatively straightforward for VALINO MONTHLY, as the product information (PI) was materially the same as the INVEGA SUSTENNA PI and as there were clear instructions to use VALINO MONTHLY for initiating and maintenance doses within the scope of claim 1. Accordingly,  Juno did not seek to defend the infringement case for this product on the basis that it did not authorise such use nor was a joint tortfeasor or infringer pursuant to s 117(2) of the Act. 

The more interesting question arose in relation to PALJUNA MONTHLY.  Its PI did not itself provide instructions for loading doses.  Instead, it directed practitioners that “patients needed to be initiated with another long-acting antipsychotic injection prior to progressing to maintenance dosing” and referred to INVEGA SYSTENNA being “available from another sponsor” for initiation dosing.

Juno argued that there would be no act of primary infringement because the initiating dose would be prescribed using INVEGA SUSTENNA, conduct authorised by Janssen.  Accordingly, Juno submitted it could not be said to ‘authorise’ any infringing conduct.  Juno accepted that there was novelty in this argument as no authority has dealt with the situation where elements of a method said to be infringed have been authorised by the patentee.

However, his Honour’s preliminary view was that by way of the instructions in the PALJUNA MONTHLY PI, “Juno is sanctioning, approving or countenancing the use of PALJUNA MONTHLY as part of a course of treatment that includes the provision of ongoing maintenance doses as part of a dosing regimen (or method) that includes the provision of initiating or maintenance doses”.

Janssen relied on various authorities which demonstrated that where a party supplies parts of a patented product together with instructions to supply a missing integer from another source, the claim will nevertheless be infringed.  Justice Burley also referred to the Full Court’s observations in Ramset[1], that:

[w]here a vendor sets out to make a profit by the supply of that which is patented, but omitting some link the customer can easily furnish, particularly if the customer is actually told how to furnish it and how to use the product in accordance with the patent, the court may find the vendor has ‘made himself a party to the [ultimate] act of infringement.

Juno also submitted that a proportion of patients would use the Juno products in a manner not falling within claim 1, including psychiatrists who do not prescribe in accordance with the PI; patients who fail to take their medicine as prescribed; patients with mild renal impairment who are prescribed doses outside the range claimed; patients switching from different LAI antipsychotics; and missed dose scenarios.  His Honour accepted that these represented “a small but non-trivial cohort” whose use would not amount to infringement, but noted that “the vast majority of uses of the Juno products would fall within the scope of the claims”.  Accordingly, his Honour’s preliminary view was that the prima facie case for infringement was strong.

Invalidity arguments

Juno relied on two grounds of invalidity; lack of inventive step and false suggestion.  Neither was determinative of the application.

Inventive step: Juno contended that the asserted claims lacked an inventive step having regard to the common general knowledge and the disclosure in Revill et al (2006) and three clinical trials referenced in that article.  His Honour found that Juno had “an arguable or prima facie case” that the asserted claims lacked an inventive step and that Janssen’s counterarguments, at least on a preliminary basis, did not demonstrate that the lack of inventive step case was “particularly weak”.  However, Justice Burley observed that a challenge based on lack of inventive step “involves a complex process of fact finding and legal analysis” and that “the ground of invalidity is ill suited to the objective that Juno seeks to attain, which is to demonstrate weakness in the prima facie case of infringement asserted against it”.

False Suggestion: Juno argued that the specification falsely represented that administering loading doses in the deltoid muscle leading to a faster rise of initial blood plasma concentrations was a “discovery” and that the identification of flip-flop kinetics was a “discovery”.  On the submissions available to him, his Honour found these grounds to be “arguable” but did not express a view on their strength, noting conflicts in the expert evidence and that materiality of the representations would turn on construction of the specification as a whole.

Justice Burley concluded that, while Juno had an arguable invalidity case, it did not “rise to the level that it diminishes the strength of the infringement arguments”.

Balance of Convenience

Turning to the balance of convenience analysis, Justice Burley considered a range of factors, including:

• the PBS price disclosure regime and likely price reductions;
• potential entry by other generic competitors;
• Juno’s first mover advantage; and
• difficulties associated with the calculation of the parties’ losses should an injunction be granted or denied.

PBS Price Reductions: Unlike cases involving the mandatory 25% price drop triggered by the first PBS listing of a generic product, the INVEGA products had already undergone automatic anniversary price cuts, including a 26.1% cut on 1 April 2023 in accordance with the 15^th anniversary of listing on the F1 formulary.  However, price disclosure obligations would still apply upon generic entry, resulting in the move of the INVEGA products to the F2 formulary, potentially triggering further reductions.

Justice Burley noted that any statutory price disclosure reduction would not come into effect until at least 12 months after generic entry, with the Patent expiring in December 2028.  His Honour expressed scepticism about Janssen’s claims that mandatory reductions would occur before expiry, finding there was “a real prospect that the first 12 months of competitive trade will not result in a difference between the [Approved Ex-Manufacturer Price] and [Weighted Average Disclosed Price] of greater than 10%”.

Other Generic Entrants:  Teva and Amdipharm had obtained ARTG listings for paliperidone LAIs but neither had applied for PBS listing.  In responses to letters written by Janssen, Teva indicated it had “no present intention” to launch before expiry of the Patent but would not provide the requested undertakings if Juno was not restrained.  Similarly, correspondence from Amdipharm indicated that it would take the outcome of the preliminary injunction application into account in deciding upon its launch plans, but undertook not to supply its products to the Australian market prior to 1 May 2026.  His Honour concluded that it was “a possibility” that additional generics would enter before patent expiry, but on the submissions before him, it could not be “regarded as a probability”.

First Mover Advantage: Justice Burley accepted that the first generic supplier “is likely to have competitive advantages over later generic entrants”, which was characterised by Juno’s witness as “enormous”.  However, the assessment of the value and duration of that advantage was “speculative”, which, in his Honour’s view, favoured Juno on the balance of convenience given the uncertainty of the assessment.  In his assessment of the balance of convenience, his Honour also considered it relevant that, to counter the effect on Juno losing its first mover advantage, Janssen offered an undertaking that if Juno is restrained, Janssen would notify and take steps to enjoin any other generic seeking to list the PBS, and would not itself launch an authorised generic.

Calculating Damages: His Honour rejected Janssen’s submission that calculating damages would be equally difficult in both scenarios.  In a non-restraint scenario where Janssen succeeds at trial, damages may be calculated against Janssen’s “lengthy period of exclusivity” which provides “a ready benchmark against which disruption of the market may be calculated”.  In contrast, calculating damages on the undertaking involved “many uncertainties”, including unknown countermeasures by Janssen in terms of pricing, whether other generics would enter the market, and the duration of Juno’s first mover advantage.  His Honour concluded that “the inherent difficulty in calculating a fair assessment of damages to Juno on the undertaking as to damages on the restraint scenario is greater than calculating damages to Janssen consequent of any finding of infringement in the non-restraint scenario”.

Outcome and implications

Justice Burley granted the interlocutory injunction, with the costs of the application to be costs in the proceeding.  His Honour was ultimately satisfied that a preliminary injunction was appropriate, taking into account both the strength of Janssen’s infringement case, which was not diminished by Juno’s invalidity arguments, and each of the balance of convenience considerations.

His Honour’s decision breaks the trend of Australian courts since mid-2018 refusing preliminary injunction applications in pharmaceutical patent cases.  The key distinguishing feature from recent unsuccessful applications is the strength of Janssen’s infringement case, which contrasts with Justice Rofe’s finding in Regeneron v Sandoz, where her Honour found a “real prospect” that use in accordance with the PI would not infringe due to the difference between “weeks” (as claimed) and “months” (as instructed in the PI).

[1] Ramset Fasteners (Aust) Pty Ltd v Advanced Building Systems Pty Ltd [1999] FCA 898; 164 ALR 239

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