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

1. The underlying brain changes that occur in people diagnosed with schizophrenia were not well understood as at the priority date and are not well understood today. While there are various neurotransmitter systems thought to potentially be abnormal in patients with schizophrenia, the system which received the most attention as at the priority date was the dopamine system. The most widely accepted hypothesis was that individuals who experience psychosis have an excess of the neurotransmitter dopamine in certain parts of the brain. Alterations to other neurotransmitter systems, such as the serotonin system were also thought to be linked to schizophrenia. As at 19 December 2007, antipsychotics broadly fell into two categories:

(a) first-generation antipsychotics, or typical antipsychotics, which are dopamine receptor antagonists that work by blocking dopamine receptors in the brain; and

(b) second-generation antipsychotics, or atypical antipsychotics, which are serotonin and dopamine receptor antagonists that block both serotonin and dopamine receptors in the brain, or dopamine receptor partial agonists.

1. Other psychotic disorders related to schizophrenia include schizophreniform disorder and schizoaffective disorder. Because of an overlap in symptoms and clinical features across these and schizophrenia, the three disorders were at the priority date, and are now often treated using the same medication.
2. Currently, when a person is first prescribed treatment for schizophrenia, they are typically introduced to oral medication, which is required to be taken on a daily basis. The introduction of oral medication as a first line of treatment is accepted best practice in the field of psychiatry, however a key issue in the effective treatment of schizophrenia is patient adherence. Often patients struggle to maintain adherence and will miss doses. If one or more doses of an antipsychotic is missed, there is an increased risk that a person with schizophrenia may relapse, which may lead to the onset of psychosis and other symptoms. Such patients may be considered for treatment using LAIs.
3. The evidence indicates that typically someone suffering from schizophrenia, following their first episode of psychosis, will be admitted on an involuntary basis to hospital. In this acute setting they are reviewed by a psychiatrist. They will often first be prescribed oral antipsychotic medication and then discharged when positive symptoms (as defined above) have settled. This will generally be between 10 to 14 days after medication has started, however it can be up to 28 days. Once discharged, they are likely to be prescribed a drug for continuing use to prevent further psychotic episodes. This will commence with an oral antipsychotic but after at least one relapse they are likely to be prescribed an LAI. Patients are also able to be prescribed an LAI upon request without having experienced a relapse. In Professor Singh's experience, PPLAIs are the preferred available LAI in Australia due to their efficacy and convenience. As stated above at [6], INVEGA SUSTENNA is currently the only one-monthly PPLAI on the Australian market.
4. The first initiation (or loading) dose will typically be administered to the patient while still in hospital. However, avoiding inpatient treatment is preferable as it reduces trauma to the patient and the burden on the hospital system. Accordingly, the patient may be stabilised on oral antipsychotics before discharge and then a PPLAI may be prescribed at a community mental health clinic (CMHC) once stabilised. Regardless of where first prescribed the PPLAI, evidence indicates that the psychiatrist is likely to issue a prescription for both of the initiation doses at the same time. Even where the first initiation dose is administered in a hospital setting, the second initiation dose and subsequent maintenance doses are generally administered in the CMHC setting. Usually, all doses are administered by a trained nurse, often a specialist psychiatric nurse.
5. The evidence discloses that about two-thirds of patients who are prescribed one-monthly PPLAIs are being treated with INVEGA SUSTENNA involuntarily and are subject to treatment orders, meaning that the patient is able to be treated involuntarily. Patient compliance within that population is high because the public health system has robust mechanisms in place to ensure that patients are followed up and "case managed". Psychiatrists who treat these patients are particularly aware of the risks of relapse within this population.
6. The evidence of Professor Singh is that when a patient who has commenced treatment with a one-monthly PPLAI is discharged from hospital, given that they will generally have higher needs (especially if they are subject to a treatment order) that patient will often be case managed by a member of a multidisciplinary team, such as a nurse or social worker. The case manager will often visit the patient while they are in the inpatient unit, prior to discharge, to ease the transition to treatment with a CMHC.
7. The one-third who are not subject to a treatment order, and therefore who received INVEGA SUSTENNA voluntarily, are also often subject to follow-up procedures through case management, including those managed by specialist teams in CMHCs.
8. Oral paliperidone was approved in the United States in about December 2006 and was released for use there in about January 2007, although it was not released in Australia until 2008 as INVEGA ORAL. PPLAIs were first made available in Australia in 2011. PPLAIs are injectable treatments which, once injected, will be released into the patient's bloodstream so as to achieve a steady rate of therapeutic exposure over a certain period of time - generally a fortnight, a month or longer. A treatment regimen involving PPLAIs minimises the risk of patient nonadherence and thereby minimises the risk of patient relapse.
9. PPLAIs contain paliperidone palmitate as the active pharmaceutical ingredient (API). Paliperidone is a second-generation antipsychotic. It is a major active metabolite of risperidone, which means that in the body, risperidone is broken down into several molecules, of which paliperidone is the active one.
10. The only PPLAIs currently available in Australia are the INVEGA range of products. They are available in dose amounts and formulations that allow for one-monthly injections (which has been available in Australia since 2011 as INVEGA SUSTENNA), three-monthly injections (which has been available in Australia since 2017 as INVEGA TRINZA), or six-monthly injections (which has been available in Australia since 2022 as INVEGA HAFYERA). The INVEGA products are the only PPLAIs currently available on the Australian market.

1. The patent is entitled "Dosing regimen associated with long acting injectable paliperidone esters".
2. The field of the invention is said to relate to a method of treating patients in need of treatment with long acting injectable paliperidone palmitate formulations (page 1 line 5).
3. The Background of the Invention states that antipsychotic medications are the mainstay in the treatment of schizophrenia, schizoaffective disorder and schizophreniform disorders. Conventional antipsychotics were introduced in the mid-1950s. These first-generation antipsychotics are usually effective in controlling the positive symptoms of schizophrenia, but are less effective in moderating the negative symptoms (see above at [41(b)]) or the cognitive impairment (see cognitive dysfunction symptoms above at ([41(c)]) associated with the disease.
4. Second-generation antipsychotics, typified by risperidone and olanzapine, were developed in the 1990s and are generally characterized by effectiveness against both the positive and negative symptoms associated with schizophrenia. Paliperidone palmitate is the palmitate ester of paliperidone, a monoaminergic antagonist that exhibits the characteristic dopamine D2 and serotonin antagonism of second-generation antipsychotics. The Background says that paliperidone is the major active metabolite of risperidone and that extended release osmotic controlled release oral paliperidone, as a tablet formulation, is marketed in the United States for the treatment of schizophrenia and maintenance of effect. It also says that paliperidone palmitate is being developed as a long-acting, intramuscular (i.m.) injectable aqueous nanosuspension for the treatment of schizophrenia and other diseases normally treated with antipsychotic mediations. Paliperidone esters such as paliperidone palmitate are said to dissolve slowly after i.m. injection before being hydrolysed to paliperidone and made available in the systemic circulation.
5. The Background continues (page 2 lines 3-25):

Many patients with these mental illnesses achieve symptom stability with available oral antipsychotic medications; however, it is estimated that up to 75% have difficulty adhering to a daily oral treatment regimen, i.e. compliance problems...

Paliperidone palmitate injection has been developed to provide sustained plasma concentrations of paliperidone when administered once monthly, which may greatly enhance compliance with dosing. Paliperidone palmitate was formulated as an aqueous nano suspension as is described in US Patents 6,577,545 and 6,555,544. However, after the data was analyzed from the clinical trials of this formulation it was discovered that the absorption of paliperidone from these injections was far more complex than was originally anticipated. Additionally, attaining a potential therapeutic plasma level of paliperidone in patients was discovered to be dependent on the site of injection until steady state concentration is reached. Due to the challenging nature of ensuring an optimum plasma concentration-time profile for treating patients with paliperidone it is desirable to develop a dosing regimen that fulfills this goal in patients in need of treatment...

It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative.

1. The specification then provides a section entitled "Summary of the Invention" which lists four separate aspects of the invention, broadly in accordance with the independent claims (to which I refer below) and describes a number of embodiments.
2. The section entitled "Detailed Description" commences with the following (page 7 lines 8-21):

We have discovered after extensive analysis of the clinical data that paliperidone palmitate due to its dissolution rate-limited absorption exhibits flip-flop kinetics, where the apparent half-life is controlled by the absorption rate constant. Additionally the volume of injected drug product also impacts the apparent rate constant. It was also discovered that deltoid injections result in a faster rise in initial plasma concentration, facilitating a rapid attainment of potential therapeutic concentrations. Consequently, to facilitate patients' attaining a rapid therapeutic concentration of paliperidone it is preferred to provide the initial loading dose of paliperidone palmitate in the deltoids. The loading dose should be from about 100 mg-eq to about 150 mg-eq of paliperidone provided in the form of paliperidone palmitate. After the first or more preferably after the second loading dose injection patients will be approaching a steady state concentration of paliperidone in their plasma and may be injected in either the deltoid or the gluteal muscle thereafter. However, it is preferred that the patients receive further injections in the gluteal muscle.

It may be noted that doses in the patent are expressed in milligrams equivalents (mg-eq) of paliperidone in the form of paliperidone palmitate.

1. The specification then says that in view of these discoveries, the recommended dosing regimen for patients to attain a therapeutic plasma level of paliperidone is for the patients to receive the first dose of paliperidone palmitate on day one of treatment, followed by a second dose between days six to 10 of treatment, then a third dose between days 34 to 38 of treatment or monthly ±7 days after the second dose. Further preferable treatment regimes are then described.
2. On page 8 at lines 14 to 18, the specification says that since paliperidone is mainly eliminated through the kidneys, patients with renal impairment will have a higher total exposure to paliperidone after i.m. injections of paliperidone palmitate. For patients with renal impairment, the specification says that "it would be desirable to adjust the loading doses to account for the increased exposure levels of patients with renal impairment". Altered regimes are then proposed.
3. The specification then provides further details of the dosing systems relevant to the invention as well as descriptions of various aspects of the manner in which the treatment may be administered and the formulation of paliperidone palmitate.
4. Eight examples are set out in the specification:

(1) Example 1 is entitled "Paliperidone Palmitate Formulations";

(2) Example 2 is entitled "Evaluation of the Pharmacokinetic Profile of Gluteal Versus Deltoid Intramuscular Injections of paliperidone palmitate 100 mg Equivalent in patients with Schizophrenia";

(3) Example 3 is entitled "Assessment of the Dose Proportionality of Paliperidone Palmitate 25, 50, 100, and 150 mg eq. following Administration in the Deltoid or Gluteal Muscles";

(4) Example 4 is entitled "Comparison of the PK profile in the deltoid to that in the gluteal";

(5) Example 5 is entitled "Description of the PK profile in the gluteal after multiple administrations";

(6) Example 6 is entitled "Description of the exposure range needed for efficacy using Invega data";

(7) Example 7 is entitled "Optimal way of dosing"; and

(8) Example 8 provides a summary of a phase 3 study of 3 fixed doses (25 mg-eq, 100 mg-eq and 150 mg-eq) of paliperidone palmitate in subjects with schizophrenia.

1. The applicants rely on the following claims of the Patent for the purpose of their application for interlocutory injunctive relief:

(a) claim 19 (as dependent on claim 13, as dependent on claim 1) (Regimen Claim);

(b) claim 46 (as dependent on claim 19, as dependent on claim 13, as dependent on claim 11, as dependent on claim 3) (defined below as a method of treatment (MoT Claim)); and

(c) claim 26 (as dependent on claim 19, as dependent on claim 13, as dependent on claim 1) (Swiss Claim).

A dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment comprising

(1) administering intramuscularly in the deltoid of a patient in need of treatment a first loading dose of about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation of the first day of treatment;

(2) administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of about 100mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the 6th to about 10th day of treatment; and

(3) administering intramuscularly in the deltoid of gluteal muscle of the patient in need of treatment a maintenance dose of about 25 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation monthly ± 7 days after the second dose; and

wherein the sustained release formulation is an aqueous nanoparticle suspension.

A dosage regimen according to claim 1 wherein said dosage regimen comprises

(1) administering intramuscularly in the deltoid of a patient in need of treatment a first loading dose of about 150 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment;

(2) administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of about 100 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the 6th to about 10th day of treatment; and

(3) administering intramuscularly in the deltoid or gluteal muscle of the patient in need of treatment a maintenance dose of about 25 mg-eq. to about 150 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation on about the 34th to about the 38th day of treatment; and

wherein the sustained release formulation is an aqueous nanoparticle suspension.

The dosage regimen according to claim 3 or claim 9 wherein the maintenance dose of a sustained release formulation of paliperidone palmitate is administered in the deltoid or gluteal muscle of the psychiatric patient approximately monthly from the date of the second loading dose.

The dosage regimen according to any of claims 1 to 11 wherein the psychiatric patient is in need of treatment for schizophrenia.

The dosage regimen according to any one of claims 1 to 18 wherein the aqueous nanoparticle suspension comprises nanoparticles, a surfactant, a suspending agent, and optionally one or more additional ingredients selected from the group consisting of preservatives, buffers and isotonizing agents.

Use of paliperidone palmitate for the manufacture of a medicament for treating a psychiatric patient in need of treatment for schizophrenia, wherein said medicament is to be administered in a dosage regimen according to any of claims 1 to 4 or any one of claims 9 to 24.

A method of treating a psychiatric patient in need of treatment for schizophrenia comprising administering paliperidone palmitate to the patient in a dosing regimen according to any one of claims 1 to 4 or any one of claims 9 to 24.

4. THERE IS A STRONG PRIMA FACIE CASE THAT THE JUNO PRODUCTS WILL INFRINGE

1. For the purposes of the present interlocutory application the infringement dispute is relatively confined. All of the asserted claims are ultimately dependent on claim 1.
2. Janssen submits that the infringement case is straightforward. The Regimen Claim and the MoT Claim provide for a method of treatment that involves the three integers identified in claim 1 above. It submits by providing instructions to prescribing mental health practitioners in the form of the PALJUNA MONTHLY product information (PI) and the VALINO MONTHLY PI, Juno is threatening either to authorise or participate as a joint tortfeasor in the infringement of the claim. Alternatively, it is threatening to engage in conduct in breach of s 117(2)(b) and (c) of the Patents Act 1990 (Cth). It relies on the reasoning in Damorgold Pty Ltd v JAI Products Pty Ltd [2014] FCA 150; 105 IPR 60 (Middleton J), Beadcrete Pty Ltd v Fei Yu (t/as Jewels 4 Pools) (No 3) [2013] FCA 187; 100 IPR 188 (Jagot J), Blue Gentian LLC v Product Management Group Pty Ltd [2014] FCA 1331; 110 IPR 453 (Middleton J) and Northern Territory v Collins [2008] HCA 49; 235 CLR 619 in support of its submissions. Separately, it contends that the Swiss Claim will be infringed by the threatened release of the Juno products by the production of the products for the therapeutic purpose evinced in the Juno product PIs.
3. Juno submits that there is not a strong prima facie case that PALJUNA MONTHLY or VALINO MONTHLY infringes. In the case of the PALJUNA MONTHLY product, it contends that no exploitation will infringe having regard to the terms of the PALJUNA MONTHLY PI and prescribing practices of health care professionals. It submits that there will be significant non-infringing use of the VALINO MONTHLY product, calling into doubt that the injunctive relief sought would be reflected in a final injunction. Juno's non-infringement case concerning the Regimen Claim and MoT Claim focusses on the integers of claim 1.
4. Before reviewing the apparent strength of the prima facie case for infringement it is necessary to set out aspects of the information contained in the PIs.

1. The INVEGA SUSTENNA PI identifies the active ingredient as paliperidone palmitate and notes that its pharmaceutical form is a modified release suspension for intramuscular injection. It lists five INVEGA SUSTENNA dosage amounts of paliperidone (as palmitate) containing respectively 25 mg, 50 mg, 75 mg, 100 mg and 150 mg modified release injection pre-filled syringes.
2. Section 4 on page 1 relevantly provides (paragraph numbers added for convenience):

[1] INVEGA SUSTENNA is indicated for the acute and maintenance treatment of schizophrenia in adults.

[2] For patients who have never taken oral paliperidone or oral injectable risperidone, it is recommended to establish tolerability with oral paliperidone or oral risperidone prior to initiating treatment with INVEGA SUSTENNA. Previous oral antipsychotics can be gradually discontinued at the time of initiation of treatment with INVEGA SUSTENNA. INVEGA SUSTENNA should be initiated as described under section 4.2 Dose and Method of Administration - Recommended Dosing.

Switching from Long-Acting Injectable Antipsychotics

[3] When switching patients currently at steady-state on long-acting injectable antipsychotic, initiate INVEGA SUSTENNA therapy in place of the next scheduled injection. INVEGA SUSTENNA should then be continued at monthly intervals. The one-week initiation dosing regimen as described under section 4.2 Dose and Method of Administration - Recommended Dosing is not required. ...

[4] For patients who have never taken oral paliperidone or oral or injectable risperidone, it is recommended to establish tolerability with oral paliperidone or oral risperidone prior to initiating treatment with INVEGA SUSTENNA.

[5] Recommended initiation of INVEGA SUSTENNA is with a dose of 150 mg on treatment day 1 and 100 mg one week later (day 8), both administered in the deltoid muscle. The recommended monthly maintenance dose is 75 mg; some patients may benefit from lower or higher doses within the recommended range of 25 to 150 mg based on patient tolerability and/or efficacy. Following the second initiation dose, monthly maintenance doses can be administered in either the deltoid or gluteal muscle.

[6] Adjustment of the maintenance dose may be made monthly. When making dose adjustments, the prolonged-release characteristics of INVEGA SUSTENNA should be considered (see section 5.2 Pharmacokinetic Properties) as the full effect of the dose adjustment may not be evident or several months.

[7] INVEGA SUSTENNA has not been systematically studied in patients with renal impairment (see section 5.2 Pharmacokinetic Properties). For patients with mild renal impairment (creatinine clearance ≥ 50 mL/min to 6 weeks to 6 months)

[11] If more than 6 seeks have elapsed since the last injection of INVEGA SUSTENNA, the recommendation is as follows:

[12] For patients stabilised with doses of 25 to 100 mg:

1. A deltoid injection as soon as possible at the same dose the patient was previously stabilised on.
2. Another deltoid injection (same dose) one week later (day 8).
3. Resumption of the normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy.

1. A deltoid injection as soon as possible at the 100 mg dose.
2. Another deltoid injection one week later (day 8) at the 100 mg dose.
3. Resumption of the normal monthly cycle of injections in either the deltoid or gluteal muscle of 25 mg to 150 mg based on individual patient tolerability and/or efficacy.

1. The VALINO MONTHLY PI is materially the same as the INVEGA SUSTENNA PI.

1. The PALJUNA MONTHLY PI provides that the active ingredient is paliperidone as palmitate and that it is a modified release suspension for intramuscular injection, supplied in a pre-filled syringe. It is available in 5 presentations in pre-filled syringes containing 25 mg, 50 mg, 75 mg, 100 mg and 150 mg of paliperidone as palmitate.
2. The PALJUNA MONTHLY PI provides that PALJUNA MONTHLY is indicated for the acute and maintenance treatment of schizophrenia in adults, the term "acute" referring to a cohort of patients actively experiencing the positive symptoms of schizophrenia.
3. Under the heading "4.2 Dosage and Administration" it relevantly provides (paragraph numbers added for convenience of reference):

[1] There are no systematically collected data to specifically address switching patients with schizophrenia from other antipsychotics to Paljuna Monthly or concerning concomitant administration with other antipsychotics.

[2] For patients who have never taken oral paliperidone or oral or injectable risperidone, it is recommended to establish tolerability with oral paliperidone or oral risperidone prior to initiating treatment with INVEGA SUSTENNA (available from another sponsor). Previous oral antipsychotics can be gradually discontinued at the time of initiation of treatment with INVEGA SUSTENNA. INVEGA SUSTENNA should be initiated as described under section 4.2 Does and Method of Administration of the INVEGA SUSTENNA Product Information.

Switching from Long-Acting Injectable Antipsychotics

[3] When switching patients currently at steady-state on a long-acting injectable antipsychotic, initiate Paljuna Monthly therapy in place of the next scheduled injection. Paljuna Monthly should then be continued at monthly intervals. For patients who have never taken oral or injectable paliperidone or risperidone, it is recommended to establish tolerability with oral paliperidone or oral risperidone prior to switching treatment from a long-acting injectable antipsychotic to Paljuna Monthly.

[4] For patients who have never taken oral paliperidone or oral or injectable risperidone, it is recommended to establish tolerability with oral paliperidone or oral risperidone prior to initiating treatment with INVEGA SUSTENNA (available from another sponsor).

[5] Patients need to be initiated with another long acting antipsychotic injection prior to progressing to maintenance dosing of Paljuna Monthly (see section 4.2 - Dose and method of administration - Switching from Long-Acting Injectable Antipsychotics).

[6] The recommended monthly maintenance dose is 75 mg; some patients may benefit from lower or higher doses within the recommended range of 25 to 150 mg based on individual patient tolerability and/or efficacy. Monthly maintenance doses can be administered in either the deltoid or gluteal muscle.

[7] Adjustment of the maintenance dose may be made monthly. When making dose adjustments, the prolonged-release characteristics of Paljuna Monthly should be considered...

[8] Paliperidone modified release injection has not been systematically studied in patients with renal impairment (see section 5.2 Pharmacokinetic Properties). For patients with mild renal impairment..., recommended maintenance dosing of Paljuna Monthly injections is with a dose of 50 mg in either the deltoid or gluteal muscle, adjusted within the range of 25 to 100 mg based on patient tolerability and/or efficacy.

[9] Paljuna Monthly is not recommended in patients with moderate or severe renal impairment...

[10] To avoid a missed monthly maintenance dose, patients may be given the injection up to 7 days before or after the monthly timepoint.

[11] If less than 6 weeks have elapsed since the last injection, then the missed monthly maintenance dose should be administered as soon as possible.

[12] If more than 6 weeks have elapsed since the last injection of Paljuna Monthly, the recommendation is to restart dosing with INVEGA SUSTENNA (available from another sponsor) as described in the INVEGA SUSTENNA Product Information. Patients can be switched from INVEGA SUSTENNA to Paljuna Monthly for maintenance dosing as described above - see section 4.2 Dose and Method of Administratoin - Recommended Dosing.

1. It will be noted that the PALJUNA MONTHLY PI makes several references to INVEGA SUSTENNA "available from another sponsor". The evidence indicates that a prescribing health care professional would regard this as an instruction to refer to the INVEGA SUSTENNA and its PI.

1. The VALINO MONTHLY PI is accepted to be relevantly the same as the INVEGA SUSTENNA PI. It provides clear instructions to use VALINO MONTHLY for initiating doses and maintenance doses within the scope of claim 1. Juno does not seek to defend the infringement case on the basis that it does not authorise such use or that it is not a joint tortfeasor or infringer within s 117(2) of the Patents Act. Whilst those arguments are made in relation to the PALJUNA MONTHLY product, they are not advanced for VALINO MONTHLY. Rather, Juno submits that its general defences to infringement based on exceptions within the PIs for both of the Juno products apply. I consider those after first considering the defences raised in relation to the PALJUNA MONTHLY product.
2. The PALJUNA MONTHLY PI is different to the INVEGA SUSTENNA PI in ways which Juno submits are material to the strength of the prima facie infringement case.
3. In this regard, in [2] of the PALJUNA MONTHLY PI, the reader is referred to the recommendation that patients who have never taken oral paliperidone or injectable risperidone should establish first their tolerability with oral paliperidone or oral risperidone prior to initiating treatment with INVEGA SUSTENNA. The paragraph refers the reader to "another sponsor" which of course can only be a reference to Janssen-Cilag. Prescribing practitioners would understand this to be so. The reader is invited to initiate doses of injectable INVEGA SUSTENNA in accordance with the INVEGA SUSTENNA PI and they are referred specifically to the part of the PI that describes the dose and method of administration. It will be seen above that this provides instructions for use of two initiating doses largely in accordance with integers (1) and (2) of claim 1, followed by a maintenance dose in accordance with integer (3). The exception is that the instruction at [10] of the INVEGA SUSTENNA PI is for the second dose to be four days before or four days after the one week (day 8) time point, whereas integer (2) of claim 1 requires the dose to be administered on the 6th to 10th day of treatment.
4. There is a dispute on the evidence as to the degree of adherence of health care professionals to the treatment regime recommended in a product information.
5. Professor Singh says that after testing for tolerability and efficacy with oral risperidone or oral paliperidone, he follows the recommended dosage regimen as set out in the PI (PI Dosage Regimen) for INVEGA SUSTENNA as do specialist psychiatric nurses who administer them, with a significant deviation from the 8th day of treatment for the administration of the second initiation dose being "rare". In his experience, he says that the proportion of patients that he prescribes with INVEGA SUSTENNA who miss a maintenance dose (i.e. outside the permitted seven day window after the monthly/four-weekly timepoint; see [77[9]] above) and later resume treatment with INVEGA SUSTENNA within six months would be approximately 7% to 9% of his patient population.
6. Professor Singh says that his aim is to adhere to that regime and that the "vast majority" of his patients are prescribed and administered in accordance with it. He so adheres because he understands that the INVEGA SUSTENNA PI Dosage Regimen is designed to deliver the most favourable patient outcome in terms of therapeutic efficacy: if the level of paliperidone maintained is too high the patient risks suffering from additional side effects, and if the level of paliperidone maintained is too low the patient may relapse. As the VALINO MONTHLY PI is substantially the same as the INVEGA SUSTENNA PI he would do the same for it.
7. Professor Siskind primarily treats patients who have TRS, being a patient who has ongoing psychotic symptoms and functional deficits despite two trials of different antipsychotic drugs, dosed at the equivalence of 600 mg of chlorpromazine, which have been adherent (in other words taken greater than or equal to 80%) to their prescribed doses. The recommended treatment for TRS is oral clozapine, but they may also be treated concurrently with an LAI. Within his estimated caseload of 80 patients, Professor Siskind estimates that he prescribes 20 with a PPLAI and "the majority" of those with either a three-monthly PPLAI or a six-monthly PPLAI, although all of these would have commenced their PPLAI treatment using one-monthly PPLAI. He considers that this has been the breakdown of his patients using PPLAIs since 2022, when INVEGA HAFYERA became available on the PBS.
8. Professor Siskind gives evidence that in determining what dosing requirements to follow he would refer to the PI and that he refers to the INVEGA SUSTENNA PI for instructions as to dosing regimens and periodically checks it to see if it has been updated. He does not often vary the timepoint for administration of second or maintenance doses from that set out in the PI, but when he does, he remains within day seven to day nine for the second loading dose or within the "7-day window" for the monthly maintenance dose (claim 1 integer (3)).
9. Mr Jackson, who has significant experience as a psychiatric nurse and is currently practising at a CMHC, gives evidence that he is responsible for administering PPLAIs to patients who have been prescribed by a psychiatrist to have them. He administers INVEGA SUSTENNA in accordance with the PI Dosage Regimen. Generally, the psychiatrist will write initial prescriptions for the two loading doses (prescribing by nurse practitioners is, in his view, rare) and once Mr Jackson has administered those, he will arrange for a further appointment for the patient to see the psychiatrist. Unless the loading doses cause undesirable side effects (such as restlessness, sedation, dizziness etc), the same psychiatrist may prescribe maintenance doses of up to five repeats.
10. Mr Jackson makes sure that the first two loading doses are administered into the patient's deltoid muscle and if it is a maintenance dose it will be administered to either the deltoid or the gluteal muscle. If Mr Jackson is their case manager, he will continue to administer the maintenance doses in accordance with the INVEGA SUSTENNA PI making sure that future appointments enable administration in accordance with the PI Dosage Regimen although sometimes for reasons often outside of his control there is some variation. He says that he administers the monthly maintenance dose as close as possible to the one-month period (approximated to 4 weeks). Where not possible to administer on the specific 28th day he "almost always" administers the dose one or two days on either side of that time point and it would be exceptional if he failed to do so. He gives evidence that the proportion of patients that are prescribed and treated with INVEGA SUSTENNA who miss a maintenance dose (by not having a monthly injection within seven days of the monthly timepoint) and resume treatment within six months is "very low". Mr Jackson was provided with the proposed PI for VALINO MONTHLY and noted that the instructions for use in section 4.2 "Dose and Method of Administration" are the same as those for INVEGA SUSTENNA PI. He would treat the two products as interchangeable and follow the same process as for INVEGA SUSTENNA PI for both initiation and maintenance doses and would expect other nurses to do so as well.
11. On the other hand, Professor Keks gives evidence that it is "not unusual" to vary and modify the PI Dosage Regimen, whether for INVEGA SUSTENNA or other antipsychotics. He considers that it is the role and responsibility of the treating clinician to consider each specific patient and vary the regimen as appropriate, it being a matter of professional judgment, with the PI Dosage Regimen being more akin to a "recipe" or general guideline for administering paliperidone palmitate rather than a "gold standard". He says this is because there is significant inter-patient variability with respect to the pharmacokinetics (the absorption, metabolism and clearance of a drug) and pharmacodynamics (the receptor activity and sensitivity to a drug) of antipsychotic agents.
12. He estimates that variation may be required for approximately 15 to 20% of patients being treated with INVEGA SUSTENNA and "can include" patients being administered doses below the range in the PI Dosage Regimen (i.e. below 25 mg-eq) and above the range (i.e. over 150 mg-eq) and may involve clinicians administering a portion of a pre-filled injection (e.g. in order to administer 12.5 mg-eq of paliperidone, a clinician may administer half of a 25 mg-eq pre-filled injection syringe). Further, Professor Keks takes issue with Professor Singh's estimate that of his patients those who miss a maintenance dose of INVEGA SUSTENNA by more than seven days and later resume treatment within six months represents only 7% to 9% of the patient population that he treats and considers it likely to be an underestimate. He notes that Professor Singh does not refer to sampling a patient population and that his estimate may not reflect the broader patient population in Australia.
13. Having regard to the current state of the evidence, my preliminary view is that a substantial proportion of those who prescribe and administer INVEGA SUSTENNA do so by closely following the instructions set out in the PI provided. In this regard, the evidence supports the view that the prescribing and administration practices of health care professionals will be to read and understand the PALJUNA MONTHLY PI as supplying an instruction to prescribe and administer initiation (or loading) doses in accordance with the instructions set out in the cross-referenced INVEGA SUSTENNA PI both when initiating PALJUNA MONTHLY as a PPLAI or when switching to PALJUNA MONTHLY from an oral antipsychotic.
14. Janssen's first infringement argument in relation to the Regimen Claim and the MoT Claim is that Juno, by the content of the PALJUNA MONTHLY PI, authorises the infringement of those claims. In response, Juno (which spent little time in argument on these points) submits that the present is an unusual case where there will be no act of primary infringement. It submits that in the case of the initiating doses of integers (1) and (2) of claim 1 the only direction given in the PALJUNA MONTHLY PI is for those doses to be used in accordance with the INVEGA SUSTENNA PI and for the use of the INVEGA SUSTENNA product. The act of the practitioner in prescribing INVEGA SUSTENNA as initiating doses cannot be an act of infringement, as that is an act that is authorised by Janssen. Accordingly, it cannot be said that Juno "authorises" any infringing conduct. Juno accepts that there is novelty in this argument as no authority deals with the situation where elements of a method said to be infringed (here, the prescription and administration of the loading doses) have been authorised by the patentee. However, it submits that its non-infringement case is strong.
15. In considering, at a threshold level, the prima facie strength of the infringement argument I bear in mind that the term "authorise" in s 13 of the Patents Act has been interpreted to mean "sanction, approve or countenance"; see Streetworx Pty Ltd v Artcraft Urban Group Pty Ltd [2014] FCA 1366; 110 IPR 82 at [390]-[391] (Beach J); Industrial Galvanizers Corporation Pty Ltd v Safe Direction Pty Ltd [2018] FCA 1192; 135 IPR 220 at [100] (Burley J) and the cases there cited. The question posed is whether by recommending only the monthly maintenance dose, but referring the prescribed practitioner to the INVEGA SUSTENNA PI for the initiation doses, Juno is not authorising infringement of the method steps in claim 1. As I understand it, the contention is that in such a situation integers (1) and (2) of claim 1 are authorised by Janssen and not by Juno.
16. Whilst the argument advanced by Juno may ultimately be found to be correct, my preliminary view is that the stronger argument is that by the instructions provided 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. The applicants rely upon the cases of Damorgold, Beadcrete and Blue Gentian in support of their submissions. Each of Damorgold and Beadcrete are different cases factually in that they concern the infringement of product claims. However, they demonstrate that where a party supplies parts of a product together with instructions to supply a missing integer from another source, nevertheless the claim will be infringed; Damorgold at [70], [84], [88]-[91]; Beadcrete at [128]; Blue Gentian at [215]. In Damorgold, Middleton J found authorisation in circumstances where the respondent supplied its customers, and through them ultimate consumers, with parts (spring assists) which could only reasonably be used to make roller blind mechanisms which infringed the patent and in so doing "granted, or purported to grant, its customers and ultimate consumers the right to make and use" the roller blind mechanisms of the claims (at [89]).
17. In Ramset Fasteners (Aust) Pty Ltd v Advanced Building Systems Pty Ltd [1999] FCA 898; 164 ALR 239 the Full Court (Burchett, Sackville and Lehane JJ) provide a survey of the cases then relevant, including those that show liability for infringement may be established against a respondent who has not performed the relevant operation. They observed at [41]:

These authorities show that liability for infringement may be established, in some circumstances, against a defendant who has not supplied a whole combination (in the case of a combination patent) or performed the relevant operation (in the case of a method patent). The necessary circumstances have been variously described: the defendant may "have made himself a party to the act of infringement"; or participated in it; or procured it; or persuaded another to infringe; or joined in a common design to do acts which in truth infringe. All these go beyond mere facilitation. They involve the taking of some step designed to produce the infringement, although further action by another or others is also required. Where 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". He has indeed procured it.

1. In the present case, Juno proposes to supply the PALJUNO MONTHLY PI together with the PPLAIs in the multiple dose forms set out in the PI. The instructions are that where initiating doses are required they must be administered according to the INVEGA SUSTENNA PI which means that (subject only to minor exceptions referred to below) the first loading dose is given in accordance with integer (1) of claim 1, the second initiation dose is given in accordance with integer (2) and then the PALJUNA MONTHLY maintenance dose (or doses) are given in accordance with integer (3). Whilst integers (1) and (2) are to be supplied by prescribing INVEGA SUSTENNA, my preliminary view is that this presents a strong case that by its PI, Juno is facilitating, procuring or persuading another to infringe the claim, notwithstanding that it does not itself supply the loading doses.
2. Juno makes the equivalent point in relation to its exposure to liability for infringement as a result of the PALJUNA MONTHLY product when provided together with its product information in relation to liability for joint tortfeasorship and also under s 117(2)(b) and (c) of the Patents Act, being that secondary liability of these types cannot be found where there is no primary act of infringement. It does not contend, for instance, that s 117(2) does not apply to a method claim. Nor does it dispute that Juno, as the supplier, had reason to believe that the person in s 117(1) would put PALJUNA MONTHLY to the use within the method of the claim in accordance with s 117(2)(b) or that the use within the product in accordance with any instructions for the use of the product would amount to use of the claimed method with s 117(2)(c). At the present level of enquiry my preliminary view is that these arguments have the same prima facie strength as the argument that I have set out above in relation to authorisation. The consequence is that in my preliminary view, the prima facie case for infringement is strong.
3. The Swiss Claim (claim 26, as dependent on claims 19, 13 and 1) is:

Use of paliperidone palmitate for the manufacture of a medicament for treating a psychiatric patient in need of treatment for schizophrenia, wherein said medicament is to be administered in a dosage regimen according to any one of claims 1 to 4 or any one of claims 9 to 24.

1. No indirect infringement argument is advanced in relation to the infringement of this claim. Janssen submits that manufacturing each medicament in 25 mg, 50 mg, 75 mg and 150 mg dosage amounts which are respectively included as part of the manufacturing process in the ready to use injection product that contains doses for the purposes of being administered in a dosage regimen as claimed, will amount to infringement.
2. However, each of these dosages is of a size suitable for maintenance dosing. The evidence indicates that each dose is separately prescribed. Juno does not supply multiple dose kits of injections. Whilst it is possible that at final hearing there will be a conclusion that the separate manufacture of each dosage amount could be understood as the manufacture of a medicament for administration of a dosing regimen in accordance with claim 1, my preliminary view is that this argument is weaker than the infringement case advanced in respect of the Regimen and MoT claims. I do not refer further to this claim.
3. I now turn to the additional points made by Juno in relation to infringement that are applicable both to VALINO MONTHLY and PALJUNA MONTHLY in relation to the MoT and its Regimen Claim. Juno submits by reference to several examples that a proportion of the population who will be prescribed the Juno products will use them in a manner that will not fall within the scope of claim 1.
4. The first is that psychiatrists do not always prescribe in accordance with the regime set out in the INVEGA SUSTENNA PI. Professor Keks gives evidence that for about 15% to 20% of his patients he varies the dosage amount or frequency and that this group "can include" those prescribed a regimen that falls outside the range specified in integers (1), (2) and (3) of claim 1. As I have outlined earlier, that evidence is contradicted by evidence adduced by Janssen. For instance, Professor Singh gives evidence that the "vast majority" of his patients are prescribed and administered INVEGA SUSTENNA in accordance with the dosing regimen set out in the PI. On the present evidence, it would appear that not all patients are prescribed in accordance with the INVEGA SUSTENNA PI dosing regimen, but it is not possible to quantify the cohort, although it would appear likely to be small.
5. The second is that a percentage of patients who take INVEGA SUSTENNA do not fall within the scope of integers (1), (2) and (3) of the Regimen claim and MoT claim because they fail to take their medicine as prescribed. There is a conflict in the evidence as to the size of this cohort, but Professor Singh gives evidence that it is in the range of 7% to 9% of his patients. The evidence of Professor Keks is that the cohort is "larger" without specifying how much larger. As having regard to the controlled manner in which these drugs are prescribed and administered in section 2 above, my preliminary view is that the non-compliant group of patients is also likely to be small.
6. The third is that the PIs for each of PALJUNA MONTHLY and VALINO MONTHLY (and also INVEGA SUSTENNA PI) allow for dosing in ranges that are not within the scope of integers (1), (2) and (3). Those are set out in the parts of the PALJUNA MONTHLY PI above (and are relevantly the same in the VALINO MONTHLY PI) in relation to:

(a) patients with mild renal impairment who are prescribed doses outside the range claimed. Professor Singh gives evidence that the sample size of this group is "miniscule". Professor Keks disagrees, saying that in his opinion this is not reflective of the patient population more broadly, noting that mild renal impairment is common in older patients, but does not put a figure on what he believes to be reflective of the patient population;

(b) patients switching from different LAI antipsychotics and who are at steady-state on that drug. Professor Keks considers that this practice is "common", often without commencing a fresh loading dose regimen. Professor Singh does not contest this evidence. Professor Siskind notes that this is something that he does but does not put forward evidence as to the frequency of this;

(c) where a patient has missed a maintenance dose and less than six weeks has passed since the last injection, in which case the monthly maintenance dose should be administered as soon as possible; and

(d) where the second loading dose may be administered under the VALINO MONTHLY PI and the INVEGA SUSTENNA PI four days before or four days after the one week (day 8) timepoint (see INVEGA SUSTENNA PI at [9]). The evidence noted above again suggests that this is rare.

1. I accept that each of these points provide examples of uses of both PALJUNA MONTHLY and VALINO MONTHLY that are not likely to amount to infringing uses of the method set out in steps (1), (2) and (3) of the method of claim 1 (and its dependent claims). On the basis of the available evidence at this stage of the proceedings, the most that can be said of them is that they indicate that there may well be a small but non-trivial cohort of patients whose use of PALJUNA MONTHLY or VALINO MONTHLY would not amount to an infringing use. I refer to this further below in considering the balance of convenience.

5. THERE IS A PRIMA FACIE CASE THAT THE ASSERTED CLAIMS MAY BE INVALID

1. Juno submits that there is a serious question to be tried that the asserted claims are invalid such that, in respect of the PALJUNA MONTHLY products, taking into account the strength of its non-infringement arguments, Janssen does not have a probability of success that it will establish infringement by supply of those products. It submits that in respect of the VALINO MONTHLY products, the Court should conclude that the issues of infringement and validity are evenly balanced such that the Court should proceed to consider adequacy of damages and the balance of convenience. For the purpose of the invalidity arguments, Juno relies on grounds based on lack of inventive step and false suggestion. Janssen submits that neither ground qualifies what it characterises as its strong prima facie case on the question of infringement.
2. I consider each ground below.

1. Juno contends that as at the priority date of the patent the asserted claims lack an inventive step within the meaning of s 18(1)(b)(ii) of the Patents Act, having regard to the common general knowledge and the disclosure in Revill P et al "Paliperidone - Antipsychotic agent, treatment of bipolar disorder, dual dopamine D2/5 HT2A receptor antagonist" (1 July 2006, Prous Science) 31(7) Drugs of the Future 579 and also three clinical trials referred to in Revill, which may be identified by their National Clinical Trial numbers as NCT00119756 (756 trial), NCT00210717 (717 trial) and NCT00210548 (548 trial also referred to as the NCT00147173 trial).
2. Having regard to the nature of the present application I do not summarise here the evidence, which (even on this application) is extensive. On the question of inventive step, Juno relies on the affidavits of Professor Goodwin, Professor Roberts and Rodney Cruise, each of whose experience is set out above in section 1.3.
3. In overview, the case advanced is as follows.
4. The person skilled in the art is a team including a clinician (a psychiatrist), formulator and clinical pharmacologist. Professor Goodwin, as the clinician in the notional team was asked to set out the general background knowledge on schizophrenia and related disorders, as well as the antipsychotic drugs used at the priority date for the treatment of schizophrenia and related disorders. He provided a 22 page summary of these matters. Professor Goodwin was then asked to explain what, if anything, was known and accepted by psychiatrists about paliperidone at the priority date, which he then explains by reference to a number of publications published before the priority date, one of which he co-authored. He notes that risperidone was well known at the priority date as being one of the leading, if not the leading, atypical antipsychotic agent. He furthers notes that paliperidone was known to be the primary metabolite of risperidone and that it is thought to be a major way through which risperidone has its therapeutic effect. He was aware before the priority date that paliperidone was being developed and that it had been approved in a tablet formulation. He had learned about this in September 2006 ahead of a United States launch of the tablet.
5. Professor Goodwin was asked what he would have recommended if, at the priority date, a drug company had asked him, as part of a drug development team, about the use of paliperidone to treat schizophrenia. He says that he would have been interested to pursue such a project and would have recommended the method for administering it to be via a depot injection, which was known to be generally more effective in preventing relapse when compared to an oral dosage form. He would have had "greater confidence" that it would be safe and effective because paliperidone is the active metabolite of risperidone, with risperidone being widely trialled, used and having generated a large volume of safety and efficacy data. To progress the prospective project, he says that the drug development team would need to ask the person in the team with expertise in formulation to prepare a depot injection and expressed a preference for four-weekly depot injections, as this required fewer visits to a clinician to administer the injection and would provide an improvement upon the existing two-weekly risperidone depot injections. After formulation, the development team would need to take it through the usual steps in drug development, including conducting phase III clinical trials upon a sufficiently large patient cohort.
6. Professor Roberts was given the hypothetical task as a member of the team to develop a method for administering paliperidone which would be a useful alternative to existing antipsychotic drug treatments. He would have begun by conducting literature searches, searching a number of pharmacology and pharmaceutical science journal databases using "paliperidone" as one of several keywords. He would have found Revill and, on the basis of information disclosed in it, noted that paliperidone is an active metabolite of risperidone, a widely prescribed antipsychotic agent used for the treatment of schizophrenia and bipolar disorder. He would have seen that Revill describes two methods of synthesis for preparing paliperidone and that an oral and depot formulation is described on page 579. He would have considered both worth pursuing. He notes that the disclosure refers to the use of Elan NanoCrystal technology in the formulation of the depot formulation, a technology which he knew about at the priority date. He considers it would have been straightforward to produce paliperidone palmitate and that Revill discloses that several phase III clinical trials were underway in relation to both the oral and depot formulations of paliperidone. He would have looked at the footnoted references to the clinical trials for the formulations disclosed in them and notes that six such trials are identified. He would have obtained the footnoted reports of each and summarises their contents.
7. Having regard to the content of Revill and the clinical trial information referenced within it, Professor Roberts would have considered that two potential dosage forms could be pursued, oral and depot formulations. He would have preferred a long-acting paliperidone palmitate intramuscular injection form as a useful starting point, noting that it had progressed to multiple phase III clinical trials, indicating that a nanoparticle suspension is a suitable formulation that had passed pre-clinical, phase I and phase II clinical trials. He would have accordingly focussed on this. He would have taken steps for the formulation and selection of excipients with confidence that he would succeed in doing so. He gives evidence that he would first adopt the doses referred to in the clinical trials and then confirm them in routine clinical testing ensuring that they provided appropriate blood plasma concentration levels, giving the desired therapeutic effect without causing adverse side effects. He would have adopted the loading dose regimen described in the 548 trial, which has doses on days one, eight, 36 and 64 using fixed doses of 50 mg-eq, 100 mg-eq and 150 mg-eq paliperidone. If testing indicated that there were inadequate blood plasma concentration levels, he would require patients to use higher loading doses, or, if there was a spike in blood plasma concentration, he would reduce one or more of the loading doses.
8. Janssen relies on the evidence of Professor Correll, a clinical professor of psychiatry and molecular medicine. He was asked by the solicitors for Janssen to assume that he was a member of a team seeking to develop a pharmacotherapy for the treatment of schizophrenia which would be an improvement, or useful alternative to the existing pharmacotherapies available at the priority date. He gives evidence that he would have pursued improving one of the existing second-generation antipsychotic oral treatments available on the market at the time, and explains his reasons for doing so. Amongst those reasons is a concern (that he explains) that LAIs had complications over oral medications, which risked magnifying exposure to serious side effects. He would not have recommended developing a second-generation antipsychotic LAI for risperidone or its metabolite because of the complications with the existing oral treatment, Risperdal Consta and because of the unknown relative contribution of paliperidone to the efficacy and safety of risperidone.
9. Janssen also relies on the evidence of Professor Taylor who supplies a lengthy affidavit responding to the hypothetical task that had also been asked of Professor Correll. He was provided with a copy of Revill. He was supplied with the published clinical trial information footnoted in Revell and reviewed six of these report summaries. He considers that without knowledge of the formulation used in the clinical trials he would have been unable to use them to assist in the hypothetical task. He was asked to assume that the nature of the formulations was known and was asked what he would do if the team found the loading dose regimens of the 548 trial resulted in inadequate blood plasma concentration levels or resulted in too much of a spike in blood concentration levels. He gives evidence that both would present a fundamental problem that would be characterised as a failure such that the team would have no expectation of success in being able to solve the problem.
10. Janssen submits that there are five reasons why, in this application, the Court should assess the case advanced by Juno are weak.
11. First, it submits that the common general knowledge supports the inventiveness of the claims. At the priority date the vast majority of patients were on oral treatments. The only second-generation antipsychotic LAI at that time was Risperdal Consta which required oral supplementation, administration at that time only being permitted in the gluteal muscle. They note that at the time serious side effects, which were a significant risk with first-generation antipsychotics, persisted with second-generation antipsychotics. They submit that the safety and efficacy of an oral formulation could not be used to predict the safety and efficacy of a LAI.
12. Secondly, it submits that Professor Goodwin was "led" to consider paliperidone as a treatment. Janssen accepts that paliperidone was known to those in the art, but disputes that the common general knowledge demonstrates the importance of paliperidone in the treatment of schizophrenia (as opposed to bipolar disorder).
13. Thirdly, Revill would not have been ascertained. They dispute the approaches to searches that would have been performed by the experts for the respondent, noting that a search of PubMed (an online biomedical database) would not have identified Revill as at the priority date.
14. Fourthly, the team would not have been directly led to the claimed invention with an expectation of success, assuming Revill to have been ascertained at the priority date. It relies on the evidence of Professor Taylor, where he explains that he would have considered trying the dosing regimen in the 548 trial. The applicants submit that this trial implemented a fixed dosing regimen different to that of the asserted claims and also involves gluteal, not deltoid injections for the loading doses. Unlike Professor Robertson, if the loading dose regimens of the trial resulted in inadequate or "spikes" in blood plasma levels, this would in his view be a fundamental problem that Janssen characterises as a "blind alley or dead end"; citing Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCA 92; 165 IPR 200 at [401] (Burley J).
15. Fifthly, Janssen relies on the evidence of one of the named co-inventors of the patent, Professor Vermeulen, given from proceedings in the Federal Court of Canada, as secondary evidence of inventiveness.
16. Considering a challenge based on lack of inventive step, especially in the discourse of patents concerning pharmaceutical products, involves a complex process of fact finding and legal analysis. See, for example; Novartis AG v Pharmacor Pty Ltd (No 3) [2024] FCA 1307; 186 IPR 24 at [300]-[494] (Yates J); Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477; 155 IPR 1 at [242]-[429], [711]-[871] (Burley J); Otsuka Pharmaceutical Co Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634; 113 IPR 191 at [371]-[479] (Yates J). It involves reading the patent and the claims in light of the common general knowledge in the eyes of the person skilled in the art as at the priority date to ascertain the nature of the invention and also the forensic task of considering the expert evidence with a view to determining whether the challenge meets the legal standard set out in the authorities; Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21; 235 CLR 173 at [50]-[56], [67]-[72] (Gummow, Hayne, Callinan, Heydon and Crennan JJ); Insta Image Pty Ltd v Kanopy Australasia Pty Ltd [2008] FCAFC 139; 239 FCR 117 at [80] (Lindgren, Bennett and Logan JJ); Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd ; at 270 (Aickin J, with whom Gibbs ACJ, Stephen, Mason and Wilson JJ agreed). The difficulties in resolving these questions prior to a final hearing have recently been recognised by Rofe J in at [205]-[207]. 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.
17. Having regard to the submissions advanced before me and the evidence to which they refer, it is my view that Juno has an arguable or prima facie case that the invention claimed in the asserted claims is invalid for want of inventive step. I do not consider, at this level of analysis, that the five points made by Janssen demonstrate that the case advanced is particularly weak. In this regard, there is no apparent contest that paliperidone was known to those skilled in the art, although there is a dispute as to its known benefits. I consider the argument that Professor Goodwin was "led" to paliperidone to be arguable, but do not consider it likely to be ruinous of the case theory advanced by Juno. I have doubts that Janssen will ultimately be successful in establishing that the person skilled in the art would not identify Revill and I consider, in relation to the fourth argument, that there may be a genuine contest between the experts as to the correct construction of the clinical trial results. Both parties call in aid the evidence of Professor Vermeulen to support their contentions concerning obviousness, but I was not sufficiently addressed on that affidavit, which is extensive and involves considerable technical detail, to form a conclusion as to its forensic utility in the context of the present dispute.
18. My preliminary view is that Juno has an arguable or prima facie case that the asserted claims lack an inventive step.

1. Juno relies on two arguments in support of a contention that it has a sufficiently strong case that the asserted claims are invalid for false suggestion pursuant to s 138(3)(d) of the Patents Act.
2. The first is that in the patent specification and also in a response to an examination report sent by the attorneys representing Janssen Pharmaceutica to the Commissioner of Patents on 5 February 2015, Janssen Pharmaceutica falsely represented that, to obtain a therapeutic dose, it is necessary to dose the patient in the deltoid muscle for the first two doses of paliperidone palmitate in the range of 100 mg-eq to 150 mg-eq of paliperidone (deltoid representation). The second is that the specification falsely contained suggestions or representations by Janssen Pharmaceutica to the Commissioner that it was not known that paliperidone palmitate in an aqueous depot formulation exhibited flip-flop kinetics (flip-flop representation). Professor Roberts gives evidence that flip-flop kinetics is where the absorption of paliperidone would take longer than its elimination. Both representations are said to be material to the grant of the patent or to have materially contributed to the decision of the Commissioner to grant the patent.
3. Both representations are said to have been made in the following passage on page 7, lines 8 to 21 of the specification:

We have discovered after extensive analysis of the clinical data that paliperidone palmitate due to its dissolution rate-limited absorption exhibits flip-flop kinetics, where the apparent half-life is controlled by the absorption rate constant. Additionally the volume of injected drug product also impacts the apparent rate constant. It was also discovered that deltoid injections result in a faster rise in initial plasma concentration, facilitating a rapid attainment of potential therapeutic concentrations. Consequently, to facilitate patients' attaining a rapid therapeutic concentration of paliperidone it is preferred to provide the initial loading dose of paliperidone palmitate in the deltoids. The loading dose should be from about 100 mg-eq to about 150 mg-eq of paliperidone provided in the form of paliperidone palmitate. After the first or more preferably after the second loading dose injection patients will be approaching a steady state concentration of paliperidone in their plasma and may be injected in either the deltoid or the gluteal muscle thereafter. However, it is preferred that the patients receive further injections in the gluteal muscle.

1. In addition, the deltoid representation is said to have been made on page 2 lines 15-18 of the specification (the complete paragraph in which it appears is set out in section 3 above):

Additionally, attaining a potential therapeutic plasma level of paliperidone in patients was discovered to be dependent on the site of injection until steady state is reached.

1. In relation to the deltoid representation, Juno submits that it was not a discovery that administering loading doses in the deltoid muscle rather than the gluteal muscle resulted in a faster rise of initial blood plasma concentrations. It submits that it was not correct that the dosage regimens described in the patent would only achieve adequate blood plasma concentrations if administered to the deltoid muscle.
2. Juno relies on the evidence of Professor Roberts, which is that he understands that the patent is asserting a discovery that administering loading doses in the deltoid muscle, rather than the gluteal muscle, resulted in a faster rise of initial blood plasma concentration and that potentially, based on the word "dependent", the dosage regimens described in the patent would only achieve adequate blood plasma concentrations if the loading doses are administered in the deltoid muscle, and would not achieve adequate blood plasma concentrations if the loading doses are administered in the gluteal muscle. He gives evidence that he would have expected a faster rate of release based on the different physiology of the deltoid and gluteal muscle groups and that he did not consider this to be a discovery or a surprising revelation. Professor Roberts further notes that whilst there may be a faster rise of initial blood plasma concentration in the deltoid muscle, statistically there is no significant difference between the two injection sites for peak blood plasma concentration.
3. Juno also relies on a representation to similar effect contained in correspondence with the Commissioner.
4. Janssen correctly submits that representations contained in the specification should be considered in view of the specification as a whole; Sequenom Inc v Ariosa Diagnostics Inc [2019] FCA 1011; 143 IPR 24 at [1117] (Beach J). I have in section 3 referred to the examples in the patent which include comparisons relating to the outcome of injections administered to the deltoid as against the gluteal muscles (such as examples 2, 4 and 7).
5. Professor Taylor gives evidence that, when read in the context of the specification as a whole, he understands that the patentee explains that the site of administration - the deltoid or the gluteal muscle - affects the rate at which a therapeutic concentration is reached and thus the deltoid is the preferred site of administration for the loading doses. There will no doubt be a debate at trial as to the meaning of "dependent".way. The materiality of the representation will no doubt turn on the construction of the specification as whole because the Commissioner will be assumed to have had a proper understanding of it. It is apparent that the specification says more about the "discovery" than that set out above, as a brief review of the examples indicates. It is to be assumed that the Commissioner has familiarity with the whole of the specification, not merely the part relied upon for the deltoid representation. At this stage of the proceedings, I do not consider that I have been put in a position to say further about the strength of this ground of invalidity other than that it appears to be arguable.
6. In relation to the flip-flop representation, the submission advanced by Juno is that the passage above misrepresents the position by characterising the identification of flip-flop kinetics as a "discovery". It submits that flip-flop kinetics are no more than the expected pharmacokinetic profile of the depot formulation, whereby paliperidone palmitate must dissolve from suspension into the muscle, hydrolysing into paliperidone in the muscle and throughout the body in order to exert the effects of its active drug paliperidone. Juno cites the evidence of Professor Roberts where he says that it is an inherent and intended feature of the prolonged release depot formulation that absorption will be a limiting factor for the half-life of the drug, saying that he would expect the flip-flop kinetics of an aqueous nanoparticle suspension of paliperidone palmitate, rather than saying that this gives rise to a discovery or surprising revelation. There is a conflict of evidence on this point in that Professor Taylor does not consider the statements to be misleading. Read as a whole, it may be that the "discovery" identified is not of flip-flop kinetics but that, as a result of those kinetics, the apparent half-life is controlled by the absorption rate constant. Other passages in the specification are likely to shed light on the issue.
7. Again, having regard to the submissions I do not consider that I have been put in a position to say further about this ground of invalidity, other than that it appears to be arguable.

1. Each party contends that the balance of convenience favours its position. Janssen submits that in the event that the launch of the Juno products is not restrained (non-restraint scenario) it will suffer significant and irreversible price reductions for its three paliperidone palmitate products, INVEGA SUSTENNA, INVEGA TRINZA and INVEGA HAFYERA. It submits that the entry of other generics into the market is likely to exacerbate price reductions. It also submits that it will lose market share and suffer very significant losses the magnitude of which will be difficult to quantify. The loss of sales will lead to other consequences including reductions in expenditure supporting the sales of the INVEGA products, the potential withdrawal of INVEGA TRINZA and INVEGA HAFYERA from the market and damage to its goodwill.
2. Juno submits that if the launch of the Juno products is restrained (restraint scenario) then it will suffer significant losses, particularly the loss of a first mover advantage in being the first generic product on the market. It points out that the patent is due to expire on 17 December 2028 and submits that the magnitude of potential loss to Janssen is not as great as Janssen contends particularly as the earliest PBS listing Juno can achieve is [REDACTED] [REDACTED] [REDACTED] and, if there is to be a mandated statutory price drop under the PBS, it would not take place upon listing but rather at least 12 months later and possibly later. It disputes that other generic competitors are likely to come on the market before the expiry of the patent and contends that, in any event, the difficulty of calculating damages on the undertaking is greater than the difficulty of calculating damages in the event that the patent infringement case is successful. Juno otherwise submits that there is no stable status quo and disputes the position adopted by Janssen.
3. Both parties relied on extensive evidence in support of their positions. Both also contended that the prima facie strength of their respective cases on infringement and validity aided their arguments on balance of convenience.
4. Arguments about price reductions cannot be considered separately from the operation of the PBS, to which I refer first below.

1. I provided an overview of the PBS in Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd (No 3) [2018] FCA 2060; 138 IPR 242 at [120]-[127], which the parties have referred to in their submissions. In Regeneron, those paragraphs were repeated and the key point, relevant to the present arguments, were emphasised at [230]-[232]:

1. Under the PBS, and pursuant to s 85AB of the National Health Act 1953 (Cth) (NH Act), for administrative and regulatory purposes, medicines (other than single brand combination drugs) are allocated to two different groupings or "formularies", namely:

(a) Formulary 1 (F1): which comprises single branded medicines that are generally not directly interchangeable with other branded medicines at the patient level; or > > (b) Formulary 2 (F2): which comprises multiple branded medicines with the same API that are interchangeable at the patient level due to their bioequivalence / therapeutic equivalence (or biosimilarity).

1. A drug can only be on F1 if there is only one listed brand of a pharmaceutical item containing that drug. When a second brand of a pharmaceutical item obtains PBS listing, provided that item is a bioequivalent or biosimilar to the pharmaceutical item, the pharmaceutical item originally on F1 will be re-allocated to F2. 2. The consequence of listing the first generic or biosimilar brand, on the PBS Schedule, and the re-allocation to F2, is a mandatory price drop of 25% for the original brand, being EYLEA® in this case.
2. However, in the present case the mandatory price drop will not be applied to any of the INVEGA products, because when a drug has been on the F1 formulary for more than five years, automatic anniversary price cuts are applied at five, 10 and 15 years, the last of which is a price cut of 26.1%. The 15th anniversary price cut occurred for the INVEGA products on 1 April 2023.
3. However, automatic price cuts may still be imposed under the PBS arising from the triggering of mandatory price disclosure obligations which come into effect upon the movement of the INVEGA products into the F2 formulary. Under those obligations, where there is more than a 10% difference between the PBS "Approved Ex-Manufacturer Price" (AEMP) and the "Weighted Average Disclosed Price" (WADP) then there will be a reduction applied to the AEMP.
4. The AEMP is the price negotiated between the pharmaceutical manufacturer and the Department as being the maximum price for the sale of the PBS reimbursed product to a wholesaler by the manufacturer. For example, at present, the AEMP for a 150 mg pre-filled syringe of INVEGA SUSTENNA is $244.62. When a patient is administered a dose of the 150 mg pre-filled syringe, it will have been purchased from a pharmacy supplied by Janssen-Cilag or its distributor, Aspen Pharmacare Australia Pty Ltd. The notional price that the pharmacy pays Janssen-Cilag or Aspen for the product will be the AEMP which the pharmacy will pay and then seek reimbursement from the Government for the difference between the payment received from the customer and the price paid to the manufacturer via the PBS. The maximum amount of reimbursement that the pharmacy is entitled to receive per dispense is known as the Dispensed Price for Maximum Quantity (DPMQ). It includes the AEMP and, in broad terms, a dispensing fee or other expenses for the pharmacist and other approved fees or markups charged by wholesalers. For all INVEGA PPLAIs, a pharmacist may only dispense one pre-filled syringe.
5. Mr Jones gives evidence that as a consequence of this arrangement, in his view it is commercially unrealistic for an originator such as Janssen-Cilag to sell a product at a greater price than the AEMP because it would cut into the reimbursement available to the pharmacist.
6. The mandatory price disclosure obligations require the sponsors of any brands that contain drugs allocated to the F2 formulary (here, Janssen-Cilag and Juno, in a non-restraint scenario) twice each year to disclose the volume of sales for all pack sizes of a brand of pharmaceutical item, the sales revenue and incentives given in relation to the brand in relation to products sold to wholesalers, retail pharmacies and private hospital pharmacies. That information is used to determine the price reduction of a pharmaceutical item in accordance with a specified method set out in the National Health (Pharmaceutical Benefits) Regulations 2017 (Cth). To determine the reduction, a "Weighted Average Percentage Difference" (WAPD, not to be confused with the Weighted Average Disclosed Price or WADP defined above) is calculated for each item using the F2 drug with the same manner of administration, relevantly here (on a non-restraint scenario) being the INVEGA products and the Juno products. The WAPD compares the AEMP of an item against the disclosed net revenue generated by each brand from sales to wholesalers, retail and private hospital pharmacies, divided by the total volume of those sales. This price difference is calculated for each brand and a weighted average is taken across all the brands of the relevant item, where each brand is weighted based on the total number of sales.
7. Mr Jones gives evidence that the two key variables that influence the WAPD calculation are the volume of sales and the level of incentives or discounts provided by the suppliers of the pharmaceutical item.
8. The WAPD calculated for each item is aggregated across "related brands" which contain the same listed drug and manner of administration as declared by the relevant Minister.
9. Mr Jones gives evidence that he expects that in a non-restraint scenario, the Juno products will almost certainly have the same listed drug and manner of administration as the INVEGA products. Mr Graham also gives evidence that the Juno products would be grouped together with the INVEGA products based on the drug and manner of administration. At the end of each price disclosure cycle, the AEMP of each pharmaceutical item is then reduced by the aggregated WAPD calculated across related brands, to obtain the WADP (weighted average disclosed price) of each brand of the item. Where there is more than a 10% difference between the AEMP and the WADP, then there will be a reduction applied to the AEMP. Mr Graham gives evidence that this reduction is calculable once market conditions such as the number of generic entrants and product prices are known.
10. As noted above, the price disclosure cycle is typically 12 months in length with two disclosures per cycle. Each cycle comprises a six month data collection period, followed by a six month processing period ending in a reduction day of either 1 April or 1 October on a particular year.
11. For new generic products, the initial month of data for the first month that the brand is listed on the PBS is removed from the WAPD calculations. For the first 42 months of a drug being subject to price disclosure obligations, data from the supply of the drug to public hospitals is excluded from the price data collected and not used to calculate any potential price reduction; however, any price reduction is applied to all sales of the products, including those in public hospitals.
12. Mr Graham gives uncontradicted evidence that the earliest any possible statutory price disclosure reduction may come into effect will be 12 months after the first generic enters the market, but may be longer depending on the time of the generic entry and the length of the first data collection cycle. This is also implied in Mr Jones' evidence, in which he observes that for a hypothetical generic entry date of 1 February 2026, any price cut calculated from the initial data collection period would be applied on 1 April 2027.
13. Mr Graham also gives evidence that in his experience, when a first generic product is launched into an established market, it often takes multiple price reduction cycles for there to be a substantial decrease in the AEMP as a result of the originator's high market share and relatively small market share of any generic, and due to the fact that the originator typically does not offer discounts on the price of the products it supplies even in the face of generic competition. Ms Hancock disagrees with this statement, and asserts that Janssen will be forced to discount the INVEGA products upon Juno's entry in order to remain competitive. However, she does not contradict Mr Graham's evidence that any statutory price drop (as opposed to one adopted by Janssen for competitive purposes) will not come into effect until 12 months after generic launch at the earliest, and appears to accept that any statutory price drop will occur at the start of [REDACTED] [REDACTED] at the earliest.
14. I have noted above that the patent expires on 17 December 2028. The expected listing date of the Juno products is [REDACTED] [REDACTED] [REDACTED]. This has the consequence that the first possible WADP price reduction is on [REDACTED] [REDACTED] [REDACTED], although depending on the variables to which I have referred above, it may be later and may not be before December 2028.

6.3 Price reductions for INVEGA products in non-restraint scenario

1. Janssen submits that it will suffer significant and irreversible price reductions for each of its INVEGA products caused by Juno's entry and discounting, which will require it to discount its own INVEGA products, and will also suffer from the discounting by other generics upon their entry into the market. Juno disputes that its entry into the market alone will result in a greater than 10% difference between the AEMP and the WADP and a subsequent mandatory price reduction, prior to the expiration of the patent. It disputes that the INVEGA TRINZA and INVEGA HAFYERA products will be affected by any launch. It also disputes that there will be other generic competitors in the market before the expiration of the patent.

6.3.1 Price reductions if Juno is the only generic competitor

1. Mr Graham expects that if the Juno products are launched and only used for maintenance treatment, it will achieve a market share in the region of [REDACTED] by the end of its first year from launch, and if the Juno products are used for maintenance treatment as well as loading or reinitiation doses (in the case of VALINO MONTHLY) it will achieve a market share of up to [REDACTED]. He expects that Juno will [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. He gives evidence that Juno intends to set the price of its products [REDACTED] [REDACTED] [REDACTED] [REDACTED] below the price to pharmacy (being the AEMP plus any wholesaler mark-up) of the INVEGA products.
2. Ms Hancock has direct oversight of the decision-making process that determines the steps Janssen-Cilag takes when a generic version of one of Janssen-Cilag's medicines enters the market. Ms Hancock gives evidence that upon Juno's entry, the price of all of the INVEGA PPLAI products will need to be immediately discounted, and in particular INVEGA SUSTENNA.
3. Ms Hancock is unable to forecast the level of discounting that Janssen-Cilag will apply in response to the entry of the Juno products, but in her evidence models projected discounts based the following assumptions as to the discounts applied by Juno to its products:

(a) [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]

(b) [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]

(c) [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]

(d) [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]

1. She postulates in a first scenario that Janssen-Cilag may respond by [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED].
2. Alternatively, in a second scenario, Ms Hancock hypothesises that Janssen-Cilag may respond by [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED].
3. However, in her evidence Ms Hancock also says that Janssen-Cilag may [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. Perhaps understandably, this leaves the impression that Janssen has no firm plan as to what it will do in response to the launch.
4. Mr Graham expresses scepticism that Janssen-Cilag will provide any discounts for either INVEGA SUSTENNA or INVEGA HAFYERA and INVEGA TRINZA. He gives evidence that he cannot recall any instance where a generic product was launched and Janssen, as the originator, applied any discount to match the entrant, and that he is aware of at least 10 Janssen products that have previously become open to generic competition where DBG Group is supplying a generic version and [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. Based on confidential market data, Mr Graham provides a list of 11 products he understands to fall within this category. Mr Graham says that discounting by Janssen would be commercially irrational as it could result in further price reductions and cause a spiral in reductions that would follow from the price disclosure obligations. In response, Ms Hancock supplies a non-exhaustive (confidential) list of six Janssen-Cilag products where, as the originator, Janssen-Cilag discounted its price upon entry of a generic to market, [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED].
5. I am unable to resolve the conflict of evidence concerning price reductions. The decision of whether to discount lies in the hands of Janssen and based on Ms Hancock's evidence I accept that it is likely that Janssen will reduce its price to make its product more attractive to dispensing pharmacists but note that this is by no means a foregone conclusion. Bearing in mind the manner in which the WADP system works it would seem likely that Janssen will be concerned to ensure that any discounting that it does is not responsible for a mandatory price disclosure discount.
6. It may be noted that in Ms Hancock's scenarios, [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. By way of example, Ms Hancock predicts that [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. Ms Hancock does state in her written evidence in answer that [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. I understand, however, that there were limitations on which documents Ms Hancock was permitted to see, given confidentiality undertakings, which may explain this.
7. If one accepts Mr Graham's evidence as to Juno's intentions, then a price reduction by Juno of [REDACTED] would be met by a price reduction of [REDACTED] [REDACTED] [REDACTED] [REDACTED] by Janssen and, similarly, if Juno discounted in the lower end of the range one might reasonably expect very little, if any, discount to be offered by Janssen. This is supported by examples given in Ms Hancock's evidence that should Juno and at least one other generic together obtain 25% market share and cause a [REDACTED] discount off the price to pharmacy, Janssen would respond by applying a discount of [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. Presumably, if Juno was the only market entrant and did not obtain that market share, the discounting applied by Janssen would be even less.
8. In a scenario where Janssen offers modest discounts and where Juno is the only market entrant, in my view there is a real prospect that the first 12 months of competitive trade will not result in a difference between the AEMP and WADP of greater than 10%, with the consequence that it may take some time before any mandatory price disclosure drops occurs.

6.3.2 No likely price reductions for INVEGA TRINZA and INVEGA HAFYERA

1. There is a dispute on the evidence about whether the introduction of the Juno products will lead to Janssen discounting the price of the INVEGA TRINZA or INVEGA HAFYERA products. Ms Hancock gives evidence that these products will likely have to be discounted to preserve their commercial viability because the Juno products will indirectly compete with them. She gives evidence on information and belief that doctors are able to switch patients from INVEGA TRINZA or INVEGA HAFYERA to a monthly PPLAI by substituting the monthly PPLAI for their next dose of INVEGA TRINZA or INVEGA HAFYERA. If those products are sold by Janssen-Cilag after Juno enters then it is possible that hospitals will try to switch patients to a monthly PPLAI for price reasons. She considers that retail pharmacies may also seek to do the same. She is also concerned that patients who are on monthly maintenance doses of INVEGA SUSTENNA will be less likely to switch to either INVEGA TRINZA or INVEGA HAFYERA if the prices are not discounted.
2. I consider, in the light of the evidence as a whole, that Ms Hancock's concerns are overstated. It is doctors who prescribe PPLAIs and the evidence of medical practitioners, including Prof Siskind whose professional focus is on TRS, is that the administration of monthly as against three- or six-monthly doses is carefully calibrated, taking into account the needs of the patient. The patient population is persons who suffer from schizophrenia who, I accept (on the basis of the present evidence), are likely to be hesitant to accept changes in their medication. Furthermore, as Mr Graham points out, more frequent dosing will likely require more patient copayments and inconveniencing patients by more frequent injections requiring more frequent visits to a health care clinic, if that is where they receive their injections.

6.3.3 Will additional generics enter the market?

1. Janssen submits that a downward spiral of prices is likely to be accelerated when additional generic competitors launch products following the launch of the Juno products, that will lead to further losses and an accelerated erosion of Janssen's market share. In this regard there is no real dispute that there will be a significant reduction in the product price. Mr Graham gives evidence that after the expiry of the patent relating to Bayer's rivaroxaban product, discounts provided by generic competitors range from 50% to 90% with each generic company attempting to provide the greatest incentive to pharmacist to encourage the purchase of their product. In her evidence in answer to Mr Graham's evidence, Ms Hancock says that if shortly after the launch of the Juno products other generics entered the market there will be even further discounting and that with the presence of competition in the market, pharmacists will be in a position to negotiate further reductions which will accelerate discounting both from the generics and also Janssen.
2. There is a contest between the parties as to whether other generics will enter the market before December 2028 when the patent expires. Each of Teva Pharma Australia Pty Ltd and Amdipharm Mercury Australia Pty Ltd are pharmaceutical companies that have obtained listings on the ARTG for PPLAIs, dating from 5 June 2024 (for Teva) and 4 July 2025 (for Amdipharm). The solicitors representing Janssen have written to each, apparently seeking undertakings that they will not, prior to 17 December 2028, exploit their products in Australia. The responses, but not the initial letters sent by Janssen, were tendered in evidence.
3. Teva on 28 June 2024, stated that it had no present intention to exploit its PPLAIs prior to 17 December 2028 and undertook to provide Janssen with three months' notice prior to any launch if that intention changes. Janssen responded by pointing out the fact of the present application and asking whether, if Juno is permitted to obtain a PBS listing and launch its generic products, Teva would undertake not to follow Juno into the market. Teva reiterated that it has no intention to launch prior to the expiry of the patent, but said that if Juno is not restrained, it would not provide Janssen with three months' notice of any change of intention.
4. I understand this correspondence to mean that Teva has no present intention to launch prior to the expiry of the patent, but that this position may change.
5. In a letter dated 4 September 2025, the solicitors representing Amdipharm confirmed that they would provide Janssen notice within seven days of filing an application for PBS listing of its products. Upon being prompted by the solicitors for Janssen with notice of the present application, Amdipharm said that it intended to take the outcome of the interlocutory application into account in deciding upon its next steps but undertook not to supply paliperidone palmitate products to the Australian market prior to 1 May 2026.
6. Having regard to this evidence, I consider that there is a possibility that one or maybe two generic PPLAIs, in addition to Juno, will apply for a PBS listing at some point prior to the expiry of the patent on 17 December 2028. In this regard I take it from the fact that Teva and Amdipharm have ARTG listings for PPLAIs that they may decide to launch competing products. That decision is not likely to crystallise until they seek PBS listing of those products. Neither has done so now and each has kept its options open in that regard. There is no evidence as to the state of preparedness of Teva or Amdipharm to launch. Whilst there is a possibility that they will be in a position to do so, in my view it cannot on the basis of the evidence be regarded as a probability.
7. I accept that the consequence of further generics entering the market is that there will be a downward spiral of prices caused by increased, competitive discounting such that there will, fairly quickly, be a greater than 10% difference between the AEMP and the WADP, and consequently a mandatory and irreversible price reduction.

6.3.4 Projected losses arising from launch of the Juno products

1. Ms Hancock and Mr Jones give evidence concerning projected losses to Janssen arising from the introduction of the Juno products. Ms Hancock forecasts, modelled upon observed erosion of market share following from [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] that Janssen-Cilag's market share will likely drop from 100% during market exclusivity, [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] upon Juno's entry in the market, to about [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED], and to [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. Mr Graham's less scientific estimate, to which I have referred above at [160], is that after the first [REDACTED] [REDACTED] Juno will achieve about [REDACTED] of market share if the Juno products are only used for maintenance treatment (meaning a corresponding [REDACTED] loss for Janssen), and about [REDACTED] if also used for loading or initiation doses (in the case of VALINO) (meaning a corresponding [REDACTED] loss for Janssen). Ms Hancock provides modelling as to projected loss of revenue as a result of Juno's entry into the market [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. For the reasons that I have given, in my view they are likely to be over-estimates having regard to Mr Graham's evidence of the range of the discount that Juno is likely to offer. However, for present purposes it is sufficient to note that on the modelling supplied, the loss of revenue estimated for a launch by Juno in June 2026 until the end of 2028 [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. This figure includes revenue lost in respect of INVEGA TRINZA and INVEGA HAFYERA, which suggests that it overstates the amount. Nevertheless, the modelling suggests that the loss of revenue to Janssen, whether or not additional generics come on the market and regardless of the impact on INVEGA TRINZA and INVEGA HAFYERA is likely to be very substantial.

1. Janssen submits that as a result of its loss of market share and revenue from the INVEGA products, it is likely to be obliged to implement cost reductions. Ms Hancock gives evidence that as a result of Janssen-Cilag's internal policies, operational expenditure [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. As a result, she contends that there will be [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] in the event that the patent is found to be valid and infringed. [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] that will not be recovered in the event that Janssen succeeds at trial. Janssen also submits that it will be forced to reduce its investment [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED].
2. Juno relies on evidence given by Mr Graham to the effect that the INVEGA SUSTENNA products represent [REDACTED] [REDACTED] [REDACTED] of Janssen-Cilag's Australian product portfolio for the 2025 financial year. It refers to Ms Hancock's evidence that the Johnson & Johnson group of companies (J&J Group), of which Janssen-Cilag is a part, employs over 138,000 people globally, of which there are over 350 staff in the Janssen-Cilag business employed in Australia and New Zealand. It contends that any decision [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] is a commercial decision of Janssen-Cilag that does not arise as a result of the conduct of Juno.
3. I accept that there is a real risk that a sudden reduction in revenue is likely to lead to a reduction in expenditure and that this may have follow-on effects for Janssen-Cilag's [REDACTED]. I note, however, that revenue losses are likely to start slowly and accelerate over time and that they will not all be experienced on the day of the launch of the Juno products. I also note that, regardless of the market share achieved by Juno or other generics, after December 2028 the expiry of the patent will mean that even in a restraint scenario Janssen will suffer a loss of exclusivity and the revenue consequences - with flow-on consequences [REDACTED] [REDACTED] and marketing - that will have the irreversible impacts to which Janssen refers.
4. Janssen next submits that with Juno's entry into the market and the consequential downward pressure on pricing, [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED].
5. [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. The harm that it is concerned about is a subset of the harm resulting from the loss of market share and revenue. [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED]. I accept that this may, depending on the extent of price reductions, be an impact upon Janssen in a non-restraint scenario.
6. Janssen submits that a further aspect of harm that it will suffer is loss of market share not only of INVEGA SUSTENNA but also for INVEGA TRINZA and INVEGA HAFYERA. I have addressed this question above in relation to likely price discounting. In my view, whilst it is possible that there may be some leakage of patients from these products to a Juno product, for the reasons given I consider that the evidence does not support the conclusion that it is probable or likely to be extensive.
7. Janssen next submits that in a non-restraint scenario there is a "significant possibility" that the commercial viability of INVEGA TRINZA and INVEGA HAFYERA will be sufficiently diminished such that those products will have to be permanently withdrawn from the market. For the reasons given, I regard the concerns expressed by Janssen as to the consequences to these products caused by the launch of the Juno products to be overstated. Furthermore, insofar as there is a risk that the withdrawal of INVEGA TRINZA or INVEGA HAYFERA might happen, with negative impacts upon psychiatric patients who depend on the extended maintenance dose regimes for quality of life, the Health Minister has the power to prevent a decrease in price from occurring in order to prevent the product from being withdrawn. Mr Graham gives evidence that Arrotex made such an application to the Department in respect of a PBS price reduction for its Anapen products proposed to occur in April 2023. In that instance a Ministerial discretion was exercised in favour of not reducing the price. While this would only be possible in respect of statutory price reductions, and does not address any voluntary discounting Janssen considers is required for competitiveness, I take the prospect of Ministerial intervention happening for the INVEGA TRINZA and INVEGA HAFYERA products into account in concluding that the risk of withdrawal of these products from the market is low.

1. The evidence of Mr Graham is that Juno, as a member of the DBG Group, is a large generic supplier in Australia. He says that the first generic product to obtain a PBS listing, if it is supplied by one of the large generic suppliers, often enjoys a considerable commercial advantage over any generic competitors. Mr Graham gives evidence that prior to any second or further generic entry, the first generic product enjoys the entire market for generic products of the relevant molecule. As a large supplier, Juno would be able permanently to secure a greater market share over later generic entrants, particularly smaller ones. The experience of Mr Graham of launching generic drugs in Australia is that the first generic version to market with a period of exclusivity rapidly acquires market share for that drug and retains most of that share, even when additional generic brands are subsequently launched. Mr Graham characterises that advantage as "enormous" in the short, medium and long-term, particularly in relation to the acquisition of market share for the product itself notwithstanding the later arrival of other generic suppliers. Further, his opinion is that the first mover is able to set the price of its generic product in the market as it sees fit, meaning that it can keep the price higher (by offering lower discounts off the price to pharmacists) than it might otherwise have to if it was a second or later generic.
2. Janssen submits that as a matter of reality, there will be no first mover advantage because Teva and potentially Amdipharm will also launch generic PPLAIs if Juno is not restrained.
3. As I have noted, the state of the evidence does not permit firm conclusions as to the likelihood that Teva and Amdipharm will enter the market. The correspondence to which I have referred in section 6.3.3 above suggests that Teva has no present intention to launch a generic and that Amdipharm is keeping its options open. My tentative view is that in a non-restraint scenario Juno will be the first to launch a generic PPLAI on the market, that there is a real possibility that it will be the sole generic on the market for the first 12 months, and a much lesser possibility that there will be no further generic entrant until after the expiry of the patent. If Teva or Amdipharm had a firm present intention to obtain a PBS listing then they may have indicated this to Janssen in order to more directly obtain the benefit of any undertaking as to damages. However, the evidence does not enable one to make any firm predictions in this regard.
4. I accept that the first generic supplier of an established pharmaceutical product is likely to have competitive advantages over later generic entrants. As Mr Graham's evidence indicates, the first mover is in a position to choose a price point and establish recognition in the market ahead of others. That advantage may extend for a considerable period of time.
5. However, the assessment of the value of that advantage in advance is speculative. So too is the likely duration of that advantage. The consequence is that issues of market share of the Juno products, price, duration of any position as first mover and duration of any advantage arising from it are matters of speculation. These issues, as I noted in F. Hoffman-La Roche AG v Sandoz Pty Ltd [2018] FCA 874; 134 IPR 172 at [204] and Sanofi-Aventis at [177], play (by analogy) to the advantage of Juno in considering the balance of convenience because of the uncertainty of assessment. While these cases concerned biosimilars rather than small molecules, as was pointed out in Janssen's submissions, I have accepted that there is still a first mover advantage in play in these proceedings subject to the speculative qualities noted above.
6. Janssen seeks to counter the effect on Juno of losing its first mover advantage by offering an undertaking that if Juno is restrained, Janssen will notify and take steps to enjoin any other generic if they seek to list on the PBS and not itself launch an authorised generic during that period. I note that this is relevant in the assessment of the balance of convenience.

6.6 Calculating damages on the undertaking in a restraint scenario is more challenging than a non-restraint scenario

1. One aspect of contest between the parties concerned the degree of difficulty of the calculation of damages in respect of a restraint scenario (being damages claimed on the undertaking offered by Janssen) and a non-restraint scenario (being damages or an account of profits claimed against Juno or other generic infringers). This was the subject of expert evidence given by two forensic accountants, Ms Conoulty and Mr Stone.
2. Janssen submits that calculating damages will be difficult in both scenarios and is at best a neutral factor in assessing irreparable harm. It submits that there will be considerable uncertainty in the calculation because of difficulties in creating a hypothetical market from the date of Juno's launch at least to the date of expiry of the patent (and beyond), the complexities caused by the entry of other generics into the market, the difficulties in calculating the effect to INVEGA TRINZA and INVEGA HAFYERA (including their potential withdrawal), the removal of Janssen's ability to rely on defensive strategies such as the launch of its own generic products, the loss of sales and market awareness and the extent to which pharmacy/hospital purchasing will be motivated by price and/or relationship with the specific generic entrants or other incentives.
3. Mr Stone gives evidence of some of these complications in reaching an opinion that supports the submission advanced by Janssen, being that one cannot conclude whether either scenario is more or less complex or uncertain. I do not accept that the calculation of damages (or an account of profits) is no less complex and difficult than calculating loss on the part of Juno in any claim by it on the undertaking as to damages. In a non-restraint scenario where Janssen succeeds on infringement at trial, damages may be calculated substantially against a background where Janssen has had a lengthy period of exclusivity in the PPLAIs which provides a ready benchmark against which disruption of the market may be calculated. If Juno is the only generic entrant, Janssen's losses may be calculated against that benchmark. It is true, as Mr Stone points out, that there will be complications and difficulties. However, the benchmark will be against known infringing conduct, commencing with the launch of one or both of the Juno products and whatever generic products are launched before the expiry of the patent. Furthermore, there is no suggestion that any generic competitor would not have the same exposure to infringement of the patent as Juno. In that circumstance, the question will not be whether Janssen is able to recover damages from the generic entrants, but the degree to which each will be held to account for the damage. I have earlier expressed my scepticism about the effect on INVEGA TRINZA and INVEGA HAFYERA of the launch of the Juno products. However, I do not consider that calculating the loss to those products will present substantial difficulties given that they too have stable market shares at the present against which the effects of generic products can be benchmarked. Otherwise, none of the voluminous affidavit evidence of Janssen personnel suggested that one of its defensive strategies would be to launch a competing generic product.
4. In this regard, I note that DBG Consolidated has provided an undertaking to meet any award of damages against Juno, following correspondence between the parties regarding Juno's asset position. There is no suggestion from Janssen, in the light of that undertaking, that Juno would not be able to meet a claim for damages, notwithstanding the very substantial assessment of damages to which Janssen has referred.
5. On the other hand, many uncertainties also arise in Juno's potential claim for damages under the restraint scenario. It is unknown what countermeasures Janssen will take in terms of pricing and whether and when a mandatory price drop would occur if the Juno products are the only competitors. It is unknown whether other generic products will enter the market, when that may occur and what the pricing effect of those entrants will be. It is also unknown for how long Juno would have the benefit of the first mover advantage that a launch in [REDACTED] [REDACTED] will give it and for how long it will last.
6. Weighing these matters in the light of the evidence of Ms Conoulty and also in light of a number of judgments in similar applications, including Regeneron at [312]; Sanofi-Aventis at [163]- [167]; and Abbey Laboratories Pty Ltd v Virbac (Australia) Pty Ltd [2024] FCA 1488 at [25] (Jackman J), in my view 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.

1. As I have noted, in considering the balance of convenience, it is necessary to assess the harm to the applicants if there is no injunction, and the prejudice or harm to the respondent if there is an injunction imposed. In this context whether or not one or the other will suffer "irreparable harm" is one of the matters that must ordinarily be factored into the Court's consideration of the balance of convenience and justice: Samsung Electronics Co Ltd v Apple Inc [2011] FCAFC 156; 217 FCR 238 at [61] (Dowsett, Foster and Yates JJ). Included in this is the consideration of whether or not damages are likely to be an adequate remedy for the applicants, in the event that its rights are vindicated in a final hearing but no injunction is granted; Samsung at [62]. On the other hand, given that a condition for the grant of interlocutory relief is the provision by Janssen of an undertaking as to damages, a countervailing consideration is whether or not a claim on the undertaking as to damages is likely to give adequate recompense to Juno and any affected third party in the event that Juno is successful in the substantive trial, and, in a related context, whether Juno is likely to suffer irreparable harm.
2. I have in this sections 6.1 to 6.6 above considered the respective arguments raised by the parties in relation to balance of convenience, including each of the considerations outlined in the paragraph immediately above. I have also considered the strength of Janssen's prima facie infringement case, and Juno's prima facie invalidity case. Drawing the threads together, and taking into account all of the matters to which I have referred (without repeating them), I am on balance satisfied that it is appropriate to grant the interlocutory orders sought.
3. The status quo is that Janssen enjoys the benefit of a monopoly in the supply of INVEGA SUSTENNA under the aegis of the patent. In considering the infringement arguments, my preliminary view is that Janssen has demonstrated a strong prima facie case of infringement in relation to the Juno products. On the other hand, whilst I accept that Juno has an arguable case that the asserted claims lack an inventive step, my preliminary view is that it does not rise to the level that it diminishes the strength of the infringement arguments. The same may be said of the false suggestion ground of invalidity.
4. Also relevant is the fact that, whilst there is a prima facie case that selling the Juno products together with the PALJUNA MONTHLY PI and VALINO MONTHLY PI is likely to infringe, in some instances it will not do so. These are identified in section 4.3 above and will arise, for instance, where paliperidone is prescribed as an injectable for the treatment of patients with mild renal impairment; where there are missed doses; where a psychiatrist prescribes different doses to that set out in the PI; and where patients switch from a different LAI antipsychotic and a fresh loading dose regimen is not required; and where the second loading dose is administered earlier than the 6th day of treatment. An injunction restraining the sale of the Juno products may include these non-infringing uses. However, the evidence indicates that this will apply to a very small cohort of patients. If Juno had wished to frame a PI to supply to that cohort or non-infringing doses, it could perhaps have done so separately. As it happens, I have little doubt that the vast majority of uses of the Juno products would fall with the scope of the claims.
5. I note that submissions were made by Juno that the case law indicates that it is not always necessary to consider the strength of the prima facie case and I could instead move directly on to the balance of convenience issues, referring to Abbey Laboratories at [2]. There was correspondence between the parties regarding whether it could be agreed that there was an arguable case for both infringement and invalidity, such that this hearing could be confined to the balance of convenience. However, this was ultimately not agreed and, as noted above, I have found that Juno's prima facie invalidity case does not diminish the strength of Janssen's infringement position. This finding as to the strength of the prima facie cases is relevant to assessing the balance of convenience. In this regard, I also note the Full Court's statement in Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd [2019] FCAFC 28; 139 IPR 409 at [8] (Jagot, Yates and Moshinsky JJ):

... The strength of the prima facie case is relevant to the balance of convenience, but the weighing process involved in evaluating where the balance of convenience lies does not affect the assessment of the existence or strength of the prima facie case. As was said in Samsung at [59] "[t]he critical integer in the test ...is the need for the Court to assess the strength of the probability of ultimate success on the part of the plaintiff. The strength of that probability will depend upon the nature of the rights asserted and the practical consequences likely to flow from the grant of the injunction which is sought".

1. Two time periods are relevant to consideration of the balance of convenience. The first is from the proposed launch date of the Juno products (likely to be [REDACTED] [REDACTED] [REDACTED]) until the expiry of the patent on 17 December 2028. It is from this date that Janssen will lose exclusivity in any event, regardless of the outcome of any trial. The second is the period starting with the restraint until the determination of the claim and cross-claim and any appeal. I was not directly addressed on this timing (except to the extent that Juno in oral submissions rejected any suggestion that the proceeding would not be resolved before the expiry of the patent, and hence it was not necessary to consider the strength of the prima facie case because the injunction would not be akin to final relief). There are a number of variables, including the time it takes for the parties to complete their evidence and the available time for the Court to hear and decide the case that cause uncertainty as to timing. I would expect the trial to be in the second quarter of 2027 and determination of it and any appeal to be during 2028. However, the vagaries of litigation are such that final determination of the case may be much easier, or alternatively the expiry of the patent may coincide, contrary to the submission made by senior counsel for Juno.
2. In a non-restraint scenario Janssen will suffer a very significant loss of exclusivity leading to a very substantial loss of sales and revenue. Despite scepticism towards Janssen's claims that mandatory price disclosure reductions will occur before the patent's expiry, and the extent of the price reductions Janssen claims it will be forced to apply, I accept that voluntary discounting of the Janssen products is likely to be required should Juno enter the market. Having regard to the likely time period involved, even voluntary price reductions, not required as a result of the mandatory price disclosure obligations under the PBS, are unlikely to be reversible. Janssen may well be obliged to [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED], leading to further decline in sales due to reduced marketing. Whilst I do not think that INVEGA HAFYERA and INVEGA TRINZA are likely to be removed from the market, it is a possibility. There is also a reasonable possibility that at some point during before the patent's expiry further generics, most likely Teva or Amdipharm, will come on the market, exacerbating price reductions during the last years of exclusivity available to Janssen from the patent protection available to it.
3. On the other hand, Juno seeks to gain a first mover advantage through conduct that, on the face of the evidence now available and the prima facie case put by Janssen, is likely to be infringing. There will be significant complexities in calculating any losses to Juno in the restraint scenario, which tend to tilt the scales a little, but difficulty in calculation does not necessarily equate to uncompensable loss. Relevant to both of these points is the undertaking offered by Janssen to not launch its own generic and to enjoin any other generic seeking to list on the PBS should Juno be so restrained.
4. Ultimately and as noted above, I am on balance satisfied that it is appropriate to grant the interlocutory orders sought. As was noted in Samsung at [67], the apparent strength of the parties' substantive prima facie cases will often be an important consideration to be weighed in the balance. Considering both the strength of Janssen's infringement case in the present circumstances, which is not diminished by Juno's invalidity arguments, and each of the balance of convenience considerations outlined in section 6 above, in my view the granting of an interlocutory injunction is appropriate.

1. I will direct that the parties confer and provide draft short minutes of order to my chambers reflecting this judgment by 10 December 2025. The costs of the interlocutory application will be costs in the proceedings.

I certify that the preceding two hundred and nine (209) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Burley.