Juno Pharmaceuticals Pty Ltd v Janssen Pharmaceutica NV - [2024] APO 48

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Juno Pharmaceuticals Pty Ltd v Janssen Pharmaceutica NV [2024] APO 48
Patent:2008340101

Title:Dosing regimen associated with long acting injectable paliperidone esters

Patentee:Janssen Pharmaceutica NV

Opponent:Juno Pharmaceuticals Pty Ltd

Delegate:Dr S. J. Smith

Decision Date: 4 December 2024

Hearing Date: 14 August 2024, by videoconference

Catchwords: PATENTS – section 104 – opposition to amendments – allowability under section 102 – sections 102(1), 102(2)(a), 102(2)(b) – what arises as a result of the amendment – amendments allowed – costs awarded against the opponent

Representation: Counsel for the patentee: Cynthia Cochrane SC
Patent attorney for the patentee: Katrina Crooks of Spruson & Ferguson Lawyers
Counsel for the opponent: Marcus Fleming
Patent attorney for the opponent: Paul Jones, Sarah Couper, Rosemary Manhire-Heath and Ellen Reid of Jones Tulloch

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE

Patent:2008340101

Title:Dosing regimen associated with long acting injectable paliperidone esters

Patentee:Janssen Pharmaceutica NV
Date of Decision: 4 December 2024
DECISION
The opposition is unsuccessful. Subject to appeal, I allow the amendments.
I award costs according to Schedule 8 against the opponent, Juno Pharmaceuticals Pty Ltd.
REASONS FOR DECISION

Background

Patent 2008340101 (the patent) was filed by Janssen Pharmaceutical NV (the patentee) on 17 December 2008 under the provisions of the Patent Cooperation Treaty as international application PCT/EP2008/067738 and claiming an earliest priority date of 19 December 2007. The patent was granted on 3 December 2015.
On 22 February 2023 the patentee sought leave to amend the specification, which amendments were subsequently superseded by further amendments filed on 17 May 2023. Leave to amend was granted and the amendments were advertised for opposition purposes on 15 June 2023.
Juno Pharmaceuticals Pty Ltd (the opponent) filed a notice of opposition to the allowance of the amendments on 15 August 2023 and a statement of grounds and particulars on 15 September 2023. The statement of grounds and particulars identifies as grounds of opposition to the amendments failure to comply with ss 102(3), 102(2)(a), 102(2)(b) and 102(1). At the hearing grounds of ss 102(2)(a), 102(2)(b) and 102(1) were pressed.
Evidence in support consists of a declaration by Professor Nicholas Keks dated 10 January 2024 (Keks) together with annexures NK-1 to NK-10 and a declaration by George Moksdi dated 10 January 2024 (Moksdi). Professor Keks was, as at the priority date, a clinical psychiatrist diagnosing and treating patients for schizophrenia or schizoaffective disorders.[1] He was also involved in clinical research projects and lectured to psychiatry students.[2] Mr Moksdi gives evidence as a patent and literature searcher of the publication date of various documents[3] but his evidence is not relied on by the opponent. Evidence in answer consists of a declaration by Professor Bruce Sugriv Singh dated 4 April 2024 (Singh) together with exhibits BSS-1 to BSS-5. Professor Singh has many years of experience as a medical practitioner specialising in psychiatry.[4] No evidence in reply was filed. I am satisfied that both Professor Keks and Professor Singh have backgrounds that enable them to give evidence as to how a skilled person would have understood the specification, and where necessary I will decide which evidence should be given greater weight.
[1] Keks at [12].
[2] Keks at [13].
[3] Moksdi at [1], [4].
[4] Singh at [7].
On 11 April 2024 the patentee advised that it would not press proposed new claims 45-54 and sought a direction that the opposition proceed only insofar as the opponent’s grounds and particulars relate to amendments other than proposed new claims 45-54. On 19 April 2024 a delegate of the Commissioner declined to make such a direction:
“It is not necessary nor appropriate for the Commissioner to make the requested direction. … The current opposition has been raised in respect of the amendments proposed on 17 May 2023 for which the Commissioner granted leave to amend on 26 May 2023. It is these amendments, as they stand in their entirety, which are the subject of the opposition… The choice of which grounds or particulars to defend before the hearing officer is entirely the Patentee’s prerogative. Similarly, it will remain open to the Patentee to propose further amendments regardless of the outcome of the Opposition.”
Subsequently, the patentee confirmed on 19 July 2024 that it would press the entirety of the proposed amendments, including the proposed new claims 45-54.
The specification
The patent relates to dosage regimens for administration of long acting injectable paliperidone palmitate formulations. Paliperidone is an atypical antipsychotic agent. The background part of the specification concludes:
“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 (sic) this goal in patients in need of treatment.”[5]
[5] Specification, page 2, lines 9-20.
Against this background it is said:
“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.”[6]
[6] Specification, page 7, lines 8-20.
The specification goes on to explain the recommended regimen in view of these discoveries:
“…the recommended dosing regimen for patients to attain a therapeutic plasma level of paliperidone is for patients to receive the first dose of paliperidone palmitate on day 1 of treatment, followed by a second dose between days 6 to 10 of treatment, then a third dose between days 34 to 38 of treatment or monthly ±7days after the second dose. … The first two doses will preferably be injected in the deltoid muscle. Thereafter paliperidone palmitate will be administered by injection approximately once a month (e.g. monthly ±7 days or approximately once every four weeks) thereafter. To assure that a potential therapeutic plasma level of paliperidone is attained at least a first loading dose of 150 mg-eq of paliperidone as a paliperidone palmitate ester should be administered on day one of treatment. Preferably the first two doses will be loading dose of between from about 100 mg-eq. to about 150 mg-eq. of paliperidone as a paliperidone palmitate ester to assure that a potential therapeutic plasma level of paliperidone is attained by the patient. The subsequent doses thereafter will drop to a therapeutic maintenance dose of from about 25 mg-eq. to 150 mg-eq. per month (±7 days). … Those of ordinary skill in the art will understand that the maintenance dose may be titrated up or down in view of the patient[’]s condition (response to the medication and renal function).
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 it would [be] desirable to adjust the loading doses to account for the increased exposure levels of patients with renal impairment.” [7]
[7] Specification, page 7, line 22 - page 8, line 18.
The specification concludes with eight examples. Example 1 relates to preparation of the paliperidone palmitate formulations. Example 2 describes a study to compare the pharmacokinetic profile of paliperidone palmitate in the deltoid and gluteal muscles, concluding that injection into the deltoid muscle results in an increased AUC, higher C_max and increased FI relative to injection into the gluteal muscle. Example 3 describes a study evaluating dose proportionality of paliperidone injections into the deltoid and gluteal muscles. Example 4 is a comparison of the plasma concentration-time profile of paliperidone after a single i.m. injection into the deltoid or gluteal muscle. Example 5 relates to the effect of multiple administration of paliperidone palmitate to the gluteal muscle, stating that:
“The dosing regimen consisting of two initial i.m. injections separated by one week followed by subsequent doses at monthly intervals resulted in faster attainment of apparent steady state compared with a dosing regimen of one initial injection of twice the monthly dose followed by subsequent doses at monthly intervals.”[8]
Example 6 is a description of the target exposure range for paliperidone following injection of the paliperidone palmitate formulation.
[8] Specification, page 31, lines 7-10.
Example 7 is titled “Optimal way of dosing” with the optimised loading dose regimen summarised as follows:
-     150 deltoid (day 1), 100 mg deltoid (day 8), then every 4 weeks maintenance (gluteal or deltoid)
-     100 deltoid (day 1), 100 mg deltoid (day 8), then every 4 weeks maintenance (gluteal or deltoid)
-     150 mg deltoid (day 1), maintenance dose day 8 and then every 4 weeks (gluteal or deltoid)
Example 8 describes a study titled “A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia”. This study entailed administration of an initial i.m. injection of 150 mg eq. of paliperidone palmitate (in the deltoid muscle) followed by 3 fixed i.m. doses of paliperidone palmitate of either 25, 100, or 150 mg eq. (in either deltoid or gluteal muscle). All three doses tested were effective, with symptoms improved relative to the placebo group. Significantly greater improvements in personal and social functioning were seen in the 100 mg eq. and 150 mg eq. doses compared with placebo.
The law
The examination request was filed before 15 April 2013 and therefore substantive amendments to the Patents Act 1990 (the Act) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the patent.
Subsection 104(5) provides that the Commissioner must not allow an amendment that is not allowable under s 102. Subsections 102(1) and 102(2) of the Act as they apply to the present application are as follows:
(1)An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.
(2) An amendment of a complete specification is not allowable after the relevant time if, as a result of the amendment:
(a) a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment; or
(b) the specification would not comply with subsection 40(2) or (3).
The “relevant time” for the purpose of s 102(2) is after the specification has been accepted (s 102(2A)). The requirements of s 102(2) therefore apply to the present amendments. However, pursuant to s 102(3), amendments made for the purposes of correcting a clerical error or obvious mistake made in, or in relation to, a complete specification are not subject to s 102 requirements.[9]
[9] I note that at the hearing that the opponent indicated that failure to comply with s 102(2)(a) was no longer pressed in relation to the amendment to which the obvious mistake ground related – the substitution of maintenance dose with second loading dose in claims 9 and 10 as proposed to be amended – and as such, it is not necessary to consider any further whether any amendment was for the purpose of correcting an obvious mistake.
Relevant to the present case, s 40(3) of the Act as it applies to the present application reads:
The claim or claims must be clear and succinct and fairly based on the matter described in the specification.
Central to the s 102 consideration is the requirement to consider what arises “as a result of the amendment”:
“There may be deficiencies in the (existing) complete specification or lack of compliance with s 40 which do not fall for consideration at this time. The question is whether, as a result of the introduction of the proposed new claims, the amendments are not allowable because of the requirements of s 102.”[10]
[10] Apotex Pty Ltd v Les Laboratoires Servier (No 2) [2009] FCA 1019 at [28] (‘Apotex’).
I also note that it is “a well settled approach that the requirements of s 102 should generally be given a liberal construction.”[11]
Section 102(1)
[11] Gambro Pty Ltd v Fresenius Medical Care South East Asia Pty Ltd [1999] FCA 1848 at [25].
It is well established that the test for whether matter is in substance disclosed is very similar to that used to assess fair basis.[12] The High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd[13] approved the approach to fair basis set out by Gummow J in Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd:

“the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification.” [14]

[12] ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc [2000] FCA 1349 at [118], United States Gypsum Company v CSR Building Products Ltd [2017] FCA 595 at [37], Meat and Livestock Australia Limited v Branhaven LLC [2020] FCAFC 171 at [97].
[13] [2004] HCA 58; (2004) 217 CLR 274 (‘Lockwood’).
[14] (1988) 81 ALR 79 at 95.

At a practical level, in United States Gypsum Company v CSR Building Products Ltd Moshinsky J said:
“where amendments would merely narrow the scope of the invention claimed, they are likely to have been in substance disclosed and fairly based … a claim that is more limited in scope than the invention as described can be, and perhaps usually will be, fairly based on the description given.”[15]
[15] [2017] FCA 595 at [44] (with references omitted).
However, in AstraZeneca AB v Apotex Pty Ltd[16] a narrowing amendment the effect of which was that the claims defined an invention “fundamentally inconsistent” with the specification was found by the Full Court to have been not allowable, there being no real and reasonably clear disclosure of what was claimed in the specification prior to the amendment.
[16] [2014] FCAFC 99 at [244], [247] (‘AstraZeneca’).
Accordingly, for an amendment to be allowable under s 102(1) there must be a real and reasonably clear disclosure of the claims as proposed to be amended in the specification as originally filed. This requires that the amended claims must not, as a result of the amendment, be inconsistent with what the specification as originally filed describes as the invention.
Section 102(2)(a)
The requirement of s 102(2)(a) can be practically assessed by asking whether the amendment would have the effect of making something an infringement that would not have been an infringement before the amendment.[17] This directs attention to the scope of exploitation of the invention claimed before and after amendment. The Act sets out the following definition:
exploit, in relation to an invention, includes:
(a)where the invention is a product––make, hire, sell or otherwise dispose of the product, offer to make, sell, or otherwise dispose of it, use or import it, or keep it for the purpose of doing any of those things; or
(b)where the invention is a method or process––use the method or process or do any act mentioned in paragraph (a) in respect of a product resulting from such use.
Section 102(2)(b)
[17] Bristol-Myers Squibb Company v Apotex Pty Ltd [2010] FCA 814 at [40].
The opponent’s case with respect to s 102(2)(b) relates only to fair basis. The test for fair basis is set out above in relation to s 102(1) and I will not repeat it here. I note, however, the observation of the Full Court in Meat and Livestock Australia Limited v Branhaven LLC[18] that “a claim may be fairly based on the matter described in the specification even though it defines the invention in terms that are narrower than those used to describe the invention in the body of the specification.” It is also relevant to note that for the analysis under s 102(1) the specification as filed includes the claims[19] whereas the fair basis assessment is made with regard to the description only.[20]
[18] [2020] FCAFC 171 at [100].
[19] Apotex at [29].
[20] Lockwood at [49].
The opponent advanced this ground for substantially the same reasons as given in relation s 102(1).[21]
[21] Opponent’s submissions at [76].
The amendments
The amendments objected to by the opponent fall into two broad categories: (i) amendments to the loading dose range and (ii) the introduction of method of treatment claims. For the purpose of this decision, these categories are sufficiently illustrated by reference to proposed claims 1, 5, 6, 7 and 45 reproduced with mark-ups below.
1. 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 ~~from about 100mg-eq. to~~ 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 ~~from~~ about 100mg-eq. ~~to about 150 mgeq.~~ 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 monthly ± 7 days after the second dose; and
wherein the sustained release formulation is an aqueous nanoparticle suspension.
5. A dosage regimen for administering paliperidone palmitate to a renally impaired psychiatric patient in need of treatment comprising:
(a)     administering intramuscularly in the deltoid of a renally impaired psychiatric patient in need of treatment a first loading dose of ~~from~~ about 75 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment;
(b)     administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of ~~from~~ about 75 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the 6th to about 10th day of treatment; and
(c)     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 75 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.
6. A dosage regimen for administering paliperidone palmitate to a renally impaired psychiatric patient in need of treatment comprising:~~according to claim 5 wherein said dosage regimen comprises~~
(a)     administering intramuscularly in the deltoid of a renally impaired psychiatric patient in need of treatment a first loading dose of about 100 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment;
(b)     administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of about 75 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the 6th to about 10th day of treatment; and
(c)     administering intramuscularly in the gluteal muscle of the patient in need of treatment a maintenance dose of about 25 mg-eq. to about 75 mg-eq. of paliperidone as paliperidone palmitate in a sustained release formulation approximately monthly from the date of the second loading dose; and
wherein the sustained release formulation is an aqueous nanoparticle suspension.
7. A dosage regimen for administering paliperidone palmitate to a renally impaired psychiatric patient in need of treatment comprising:
(a)     administering intramuscularly in the deltoid of a renally impaired psychiatric patient in need of treatment a first loading dose of about 100 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the first day of treatment;
(b)     administering intramuscularly in the deltoid muscle of the patient in need of treatment a second loading dose of about 75 mg-eq. of paliperidone as paliperidone palmitate formulated in a sustained release formulation on the 6th to about 10th day of treatment; and
(c)     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 75 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.
45. A method of treating a psychiatric patient in need of treatment for psychosis 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.
The opposition
Loading dose amendments

There are three discrete issues put by the opponent in relation to the amendments to the loading doses:
(i) lack of compliance with s 102(2)(a) due to the amendment extending the range of the loading doses;
(ii) lack of compliance with ss 102(1) and 102(2)(b) due to the selection of specific values within the ranges of first and second loading doses; and
(iii) lack of compliance with ss 102(1) and 102(2)(b) due to the inclusion of a first loading dose of 100 mg eq. for administration to a renally impaired patient in proposed claims 6 and 7.
I will consider each of these in turn.
With respect to the first of these issues, it is sufficient to consider the amendments to the first and second loading doses in claim 1: “a first loading dose of ~~from about 100mg-eq. to~~ about 150 mg-eq. of paliperidone” and “a second loading dose of ~~from~~ about 100mg-eq. ~~to about 150 mgeq.~~ of paliperidone”.
In the opponent’s submission, the skilled person would understand that the claims prior to amendment include administration of a first and second loading dose of at least 100 mg eq. (but not less than that) up to no more than 150 mg eq. Following amendment, however, the claims define doses of about 150 mg eq. and about 100 mg eq., which would be understood to include doses above and below 150 and 100 mg eq., respectively.[22] As the opponent contends that none of the claims prior to amendment define a dosing regimen comprising administering: a first loading dose of greater than 150 mg eq.; and a second loading dose of less than 100 mg eq.; and a monthly maintenance dose of about 25 mg eq. to about 150 mg eq., the opponent submits that the amendment has the effect of broadening the claim scope.
[22] Opponent’s submissions at [35]-[37].
The patentee submitted that the claim prior to amendment defines a ranges of doses extending from a lower limit of “about 100 mg eq” to an upper limit of “about 150 mg eq”, wherein “about” means “approximately” and encompasses doses somewhat greater and somewhat less than the specified quantum.[23] The patentee observed that if it were the case that 100 mg eq. and 150 mg eq. were hard lower and upper limits on the loading dose ranges, the “about” qualifiers in the claim would be redundant.[24]
[23] Patentee’s submissions at [77]-[78].
[24] Patentee’s submissions at [79].
The experts disagree as to the construction of the dose ranges in the claims prior to amendment. Professor Keks observed with respect to the loading dose range in claim 1 prior to amendment that he considered the parameters to be “imprecise and lack clarity”, but, consistent with the opponent’s submission, “would interpret this recommendation to mean that the loading dose is in the range of at least 100 mg-eq (i.e., equal to or more than 100 mg-eq) but no more than 150 mg-eq. (i.e., equal to or less than 150 mg-eq).”[25] While not discussed at the hearing, I note that it appears that it is the use of the term “from” that underpins Professor Keks’ views with respect to the values providing a hard border on the dose range. For example, he says with respect to a maintenance dose of about 25 mg eq. to about 150 mg eq: “I note that ‘from’ is not included, so the dose can be about 25 mg -eq, i.e., less than, equal to or more than 25 mg eq.”[26]
[25] Keks at [50].
[26] Keks at [53]. I note this evidence is reflected in the opponent’s written submissions at [36].
In contrast, Professor Singh’s evidence aligns with the patentee’s submissions:
“Unamended Claim 1 specifies first and second loading doses of ‘from about 100 mg eq to about 150 mg eq’. In the context of the Specification, including in the Unamended Claims and in the Amended Claims, I understand the word ‘about’ to mean ‘approximately’.
As used in Unamended Claim 1, I understand the phrase ‘about 100 mg eq’ to mean approximately 100 mg eq, and to encompass doses slightly less than 100 mg eq and doses slightly greater than 100 mg eq (in addition to a dose of precisely 100 mg eq).”[27]
“Nothing in the Specification indicates to me that, when the authors refer to a loading dose of ‘from about 100 mg eq to about 150 mg eq’, they intended to convey that the administered dose should not be even marginally less than 100 mg eq, or that the administered dose should be not even marginally more than 150 mg eq. On the contrary, by employing the terms ‘about 100 mg eq’ and ‘about 150 mg eq’ (emphasis mine), I understand that the authors of the AU 101 Patent intended to convey that the stated limits of this dose range are approximate and include (for example) doses slightly less than 100 mg eq and doses slightly greater than 150 mg eq.”[28]
[27] Singh at [51]-[52].
[28] Singh at [82].
Ultimately, determination of this ground is a question of construction. It is for the court (or Commissioner) to construe the specification, and the correct approach to construction is well understood.[29] While expert evidence may assist in understanding the position of the relevant skilled addressee, where the language in contention is ordinary English language which would not be ascribed a specific technical meaning, the utility of expert evidence may be limited,[30] and it is not apparent to me that any specific technical meaning of “about” arises in the context of the specification.
[29] See, e.g., H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70 at [118]-[120].
[30] See, e.g., Jupiters Ltd v Neurizon Pty Ltd [2005] FCAFC 90 at [67], Airco Fasteners Pty Ltd v Illinois Tool Works Inc [2023] FCAFC 7 at [59], MMD Australia Pty Ltd v Camco Engineering Pty Ltd [2024] FCAFC 38 at [20].
I agree with the patentee’s construction of the claims. As the patentee submitted, the opponent’s approach deprives the word “about” of any meaning in the context of the claims defining ranges. I can see no reason why “about” should mean something different when used in a range (or prefaced by “from”) than when used to qualify a specific integer. Indeed, in Pharmacia LLC v Juno Pharmaceuticals Pty Ltd the Full Court noted, albeit not, as the opponent noted, in the context of an amendment, an unchallenged finding by the primary judge that “the word ‘about’ must be understood to extend the ranges set out in the various claims”[31] and went on to observe that “it is axiomatic that a claim term should be construed consistently throughout the claim set of a patent”.[32] To my mind, for “about” to be given different meanings as advanced by the opponent, such that in some contexts it is completely redundant, would be a tortured and unnatural construction. I can see no support in the specification for such an approach.
[31] [2022] FCAFC 167 at [54].
[32] Ibid at [80].
Given that I consider “about” to have the same meaning throughout the claim set, the amendment to define specifically the upper or lower limit of a range as it existed in a claim prior to amendment cannot have the effect of broadening the scope of the claims in the manner alleged by the opponent.
To understand the second issue set out above regarding the loading dose amendments, it is again sufficient to have regard to claim 1, in which the first loading dose is amended to the upper limit of the range present prior to amendment and the second loading dose is amended to the lower limit of the range present prior to amendment, and the maintenance dose range is unchanged.
In the opponent’s submission, the specification only relevantly discloses ranges for the first and second loading doses; there is no disclosure regarding the selection of the two specific doses to which the amendments are directed.[33] While the opponent accepts that, as set out above, Example 7 discloses a dosing regimen with 150 mg eq. and 100 mg eq. first and second loading doses, respectively, followed by maintenance doses, it contends that this disclosure is insufficient as the range for the maintenance dose is not disclosed.[34] In this regard, at the hearing the opponent submitted that given the nature of the invention, being a dosing regimen involving defined doses in particular ranges, when considering the amendments it is necessary to consider the extent of the disclosure with respect to the dosing regimen as a whole rather than specific disclosures of particular dosing values.
[33] Opponent’s submissions at [68].
[34] Opponent’s submissions at [69].
Moreover, the opponent highlighted that the contemplated range for the maintenance dose in the claim as proposed to be amended is such that the claim encompasses a dosing regimen wherein a loading dose (the second loading dose of about 100 mg eq. of paliperidone) may be less than the maintenance dose (which is from about 25 mg eq. to about 150 mg eq. of paliperidone). In the opponent’s submission there is no disclosure of such a regimen in the specification. To the contrary, the specification states that “[t]he subsequent doses thereafter will drop to a therapeutic maintenance dose”.[35] In the opponent’s submission “[t]he requirement that the ‘loading dose(s)’ be greater than the ‘maintenance dose’ is also inherent in the use of those terms.”[36] Relatedly, the opponent referenced the definition of “loading dose” in the Macquarie Dictionary Online: “an initial dose of a drug which is higher than subsequent doses, intended to rapidly achieve a therapeutic concentration in the body”.[37]
[35] Specification, page 8, lines 4-5.
[36] Opponent’s submissions at [70].
[37] Macquarie Dictionary Publishers, an imprint of Pan Macmillan Australia Pty Ltd, accessed 19 August 2024.
In the patentee’s submission, the specification as filed, by way of the ranges disclosed, clearly encompasses regimens as defined in the claim as proposed to be amended. With respect to the opponent’s contention regarding the passage in the specification referring to subsequent doses dropping to a therapeutic maintenance dose, the patentee submits that this is in the context of a passage which commences “[p]referably” and is not limiting on the scope of the invention. As to the meaning of “loading dose”, the patentee referred to Professor Keks’ evidence:
“…the loading dose is a known strategy for administering a drug in quick succession and/or higher concentration (compared to maintenance dose) to bring the level of the drug to the desired concentration in the blood up quickly as possible. … In some respects, the concept of ‘loading dose’ could be regarded as a semantic construction. There could be considerable debate as to what exactly is a loading dose as there may be substantial variation in what is done in order to balance benefits versus adverse effect. For instance, an acceptable alternative to the concept of loading dose would be ‘recommendations for accelerated drug initiation’.”[38]
[38] Keks at [46].
Notwithstanding that the invention described relates to a dosing regimen, if the claim simply narrows to specific values within the pre-existing ranges which the skilled person would have understood to form part of the scope of the claim, then it would seem that no issue could arise as a result of the amendment (unless there is a fundamental inconsistency with the specification[39]) – that is, the claims prior to amendment would have encompassed what is claimed. I think it is clear that the first and second loading doses of about 150 mg eq. and about 100 mg eq., respectively, are within the scope of the pre-existing ranges (i.e. they are narrowing amendments) and are consistent with the disclosure (for example, Example 7). As to the combination of these loading doses with the claimed maintenance dose, and in particular the clear contemplation of a maintenance dose which is higher than the second loading dose, I do not consider that the opponent has made out a case that this is inconsistent with the disclosure of the specification as filed, or as it currently stands. There is no clear indication in the specification that a maintenance dose must be lower than a loading dose, and despite the dictionary definition referred to by the opponent, the evidence of Professor Keks seems clear enough that to the extent that “loading dose” has a meaning in the art, it includes both higher doses and more rapid administration than the maintenance dose. Indeed, in the context of the specification the second of these aspects of the definition seems apposite given the timing of the dosing regimen and the absence of a clear disclosure of necessarily lower maintenance doses (for instance, maintenance doses which are the same as the loading doses but delivered less frequently are clearly contemplated in Example 8). I also note that the specification contemplates a greater degree of variability in the maintenance dose than the loading doses: “[t]hose of ordinary skill in the art will understand that the maintenance dose may be titrated up or down in view of the patient[’]s condition (response to the medication and renal function).”[40] Given this, and set against Professor Keks’ evidence, I do not think that the passage of the specification referred to by the opponent and referencing dropping to a therapeutic maintenance dose, can support a conclusion that a plain reading of the claim as proposed to be amended is inconsistent with the specification. Moreover, the parties did not refer me to, and I have not identified, any concern on the part of the expert declarants regarding this aspect of the amendment.[41] In the context of a question concerning the meaning of what seems, based on Professor Keks’ evidence, to be a technical term, I attach some relevance to this.
[39] See AstraZeneca.
[40] Specification, page 8, lines 11-13.
[41] Professor Keks did observe that prior to amendment claim 1 allows for a maintenance dose that is the same or lower than the initial loading dose at [70], but made no comment with respect to claim 1 as proposed to be amended.
As such, I consider that the amendment simply narrows the claim to a particular embodiment which is not inconsistent with the specification. It follows that I do not consider that, as a result of the amendment, there is a claim to matter not in substance disclosed in the specification as filed, or a lack of fair basis.
The final issue relates to proposed claims 6 and 7, with the opponent submitting that there is no disclosure of a first loading dose of about 100 mg eq. for administration to a renally impaired patient in the specification, such that these claims offend ss 102(1) and 102(2)(b).
Specifically, the opponent observed that the specification describes that for renally impaired patients “the loading doses should be reduced to 75mg-eq. for the first two loading doses”[42] and as such there is no in substance, or real and reasonably clear, disclosure of a dosing regimen for renally impaired patients in which the first loading dose is about 100 mg eq. The opponent submitted that mere coincidence in language with a consistory clause is not sufficient disclosure in circumstances where the body of the specification as a whole is inconsistent with that consistory clause.
[42] Specification, page 8, lines 18-19.
In response, the patentee referenced consistory clauses including a first loading dose of “about 100 mg-eq” to renally impaired patients and the inclusion in the specification as filed of claims directed to a dosing regimen for administering paliperidone palmitate to a renally impaired psychiatric patient comprising a first loading dose “of from about 75 mg-eq.”; that is, encompassing a first loading dose of about 100 mg eq. as defined in claims 6 and 7 as proposed to be amended.
Here the question of what arises as a result of the amendment is key. As set out above, claim 6 prior to amendment was appended to claim 5, which defines a dosage regimen for administering paliperidone palmitate to a renally impaired psychiatric patient comprising “a first loading dose of from about 75 mg-eq. of paliperidone”. Unamended claim 6 defines “[a] dosage regimen according to claim 5” comprising “a first loading dose of about 100 mg-eq. of paliperidone”. While there are some differences with respect to the timing of the maintenance dose between claims 5 and 6 both before and after amendment, these do not appear material to the point of whether the claims prior to amendment contemplated administration of a first loading dose of about 100 mg eq. of paliperidone to a renally impaired patient. While I understand the opponent’s position to be that claim 6 is a new independent claim as a result of the amendment, it is not apparent to me that the construction of claim 6 has relevantly changed as a result of the amendment to make it independent; the amendment is limited to the replacement of the statement of dependency with the preamble of the claim to which it was appended. That is, the administration of a first loading dose of about 100 mg eq. of paliperidone to a renally impaired patient is not introduced by the amendment.
For completeness, I note that the maintenance dose schedule defined in proposed claim 7 is different to that in claim 6 prior to amendment, and proposed claim 7 has no directly corresponding claim in the claim set prior to amendment. However, the maintenance dose schedule defined in proposed claim 7 is in the same terms as claim 5 prior to amendment. As noted above, claim 5 prior to amendment defined a first loading dose of from about 75 mg eq.; that is, about 75 mg eq. was defined as a lower limit and no upper limit was defined. Given this, and that claim 6, defining a first loading dose of about 100 mg eq., was appended to claim 5, I consider that the skilled addressee would, in the context of the claim set, have understood a first loading dose of about 100 mg eq. to be within the scope of the first loading dose defined in claim 5 prior to amendment.
It follows that I cannot see any basis to conclude that the claims prior to amendment did not encompass, and indeed clearly define, a dosage regimen for administering paliperidone to a renally impaired psychiatric patient including a first loading dose of about 100 mg eq. of paliperidone. This subject matter is not claimed as a result of the amendment. As such, the question of whether there is any deficiency with respect to the extent of the disclosure in the description or the specification as filed does not fall for consideration at this time.
I find the opposition unsuccessful with respect to the amendments to the loading doses.
Method of treatment claims
The proposed amendments include the introduction of new method of treatment claims 45 to 54. Taking claim 45 as an example, the claim defines a method of treating a psychiatric patient in need of treatment for psychosis comprising administering paliperidone palmitate in a dosing regimen according to selected preceding claims. In the opponent’s submission these new claims are not allowable pursuant to s 102(2)(a) as they do not fall within the scope of either the dosing regimen claims discussed in the decision to this point, or claim 25 prior to amendment, which reads:
Use of paliperidone palmitate in a dosage regimen according to any one of claims 1 to 23 for treating a psychiatric patient, or a renally impaired psychiatric patient.[43]
[43] I note that some of claims 1-23 refer to a dosing regimen rather than a dosage regimen. I do not understand this inconsistency in terminology to reflect a difference in meaning.
As set out previously, a practical test for s 102(2)(a) is to ask whether the amendment has the effect of making something an infringement that would not previously have been an infringement.
In written submissions the opponent put the nature of a dosing regimen as follows:
“A ‘dosing regimen’ is not a method of treatment. It is a list of recommended instructions from the manufacturer for administering a drug. A method of treatment might involve administration of a drug according to a schedule, but the schedule does not treat the patient. … The nature of the method of treatment claims expands the range of infringing acts.”[44]
[44] Opponent’s submissions at [60].

At the hearing the opponent characterised the dosing regimen claims as directed to information. Posing the question of how a person then infringes a dosing regimen, the opponent submitted that to use a dosing regimen in a method of treatment, a person must be provided with that regimen (that is, the information regarding the schedule to follow). The opponent submitted that the method of treatment claims, expressed as “in a dosage regimen according to”, contemplate the treatment of the patient wherein the treating physician does not have the dosing regimen of the preceding claims (i.e. such that they are using that regimen), but is simply administering the paliperidone in a regimen that corresponds with the dosing regimen of the preceding claims (i.e. without having been provided with that regimen). While in the opponent’s submission the ordinary meaning of “according to” would suggest following instructions, it submitted that there is ambiguity in the claims as proposed to be amended (based on the reference to the indefinite “a dosing regimen”) and that to the extent that they include methods of treatment where there is mere correspondence with the steps of the regimen defined, rather than use of the regimen as such, the claims are broadened – something is made an infringement which would not have been previously.
The opponent also submitted that the dosing regimen claims are directed to a dosing regimen for (that is, suitable for) administering paliperidone palmitate, and what follows is a description of the regimen, rather than treatment steps as would be found in method of treatment claims.
As to the question of whether the new method of treatment claims fall within the scope of claim 25 prior to amendment, the opponent submitted that this claim would be construed as use of the paliperidone palmitate in a dosing regimen which is suitable for treating the patient but does not include an administration step (the opponent elaborated at the hearing that if the dosing regimen is construed as a list of instructions, the use of paliperidone could take the form of writing paliperidone on a list), as opposed to a method of treatment which comprises the act of administering the drug to a patient.
I note that in written submissions the opponent made a further submission regarding the scope of claim 25 prior to amendment:
“…the scope of claim 25 as accepted (the ‘use’ claim) is not identical to the scope of proposed amended claims 45 to 54. Claim 25 as accepted is limited to ‘use of paliperidone palmitate in a dosage regimen…’. The skilled addressee would understand that claim to be directed to the exclusive use of paliperidone in a dosing regimen. Proposed amended claims 45 to 54 are not so limited. …each of the claims is directed to a method of treatment comprising the administration of paliperidone palmitate in accordance with one or more claimed dosage regimen.”[45]
[45] Opponent’s submissions at [62] (emphasis in original).
In response, the patentee noted that use is an act of exploitation, and in its submission both alternative constructions of the method of treatment claims contemplated by the opponent would be acts of infringement of claim 1 prior to amendment. Moreover, in the patentee’s submission the dosing regimen claims are, properly construed, method of treatment claims, and there is no basis for the opponent’s restrictive construction of these claims. This is because, as said by the delegate in Northern Rivers Pty Ltd v Janssen Oncology, Inc., “[m]ethods are characterised by the steps of the method”[46]; here the dosage regimen claims define (in the present tense) steps of administering paliperidone palmitate to a patient.
[46] [2015] APO 53 at [69] (‘Northern Rivers’).
The patentee also submitted that the opponent’s contention in written submissions that the scope of claim 25 prior to amendment is not identical in scope to the method of treatment claims was misconceived for two reasons; the first being that the relevant comparison is between each amended claim and the unamended claims as a whole, and the second that, as observed by Jacobs J in AMP Incorporated v Commissioner of Patents, “it is not necessary before an amendment is allowed to find that the amended claim would actually fall within the scope of one or all of the other claims. It need only fall in substance within that scope.”[47] The patentee contended that there was no basis in the specification or the evidence to understand claim 25 prior to amendment to require the exclusive use of the defined dosage regiment for treating a psychiatric patient.[48]
[47] (1974) 3 ALR 283 at 290.
[48] Patentee’s submissions at [120]-[121].
I consider that the claims considered by the delegate in Northern Rivers differ from the present claims to such an extent that this decision is not of particular assistance with respect to construction of the present dosage regimen claims. However, I find it unnecessary to turn to the dosage regimen per se claims to decide this issue. Irrespective of the precise bounds of these claims, I consider that in the context of the specification and as a matter of common sense, the use defined by claim 25 prior to amendment must encompass the administration of paliperidone palmitate. That is, this claim defines the “[u]se of paliperidone palmitate in a dosage regimen according to [the preceding claims] for treating a [patient]”, with the regimen according to the preceding claims being “for administering paliperidone palmitate” and setting out steps of administering paliperidone palmitate to a patient. I do not consider that use being for the treating of a patient in the context of this claim can fairly be considered merely a suitability limitation. While it may also encompass other uses, I cannot see that a sensible construction of claim 25 prior to amendment does not include the use (for treating a [patient]) being use in the form of the administration which is expressly defined within the regimen. That being the case, I consider that the claims prior to amendment encompass the steps of administration of paliperidone palmitate to appropriate patients in the defined dosing regimens – that is, a use (or method) for treating a patient by administering paliperidone palmitate.
To the extent that anything turns on the construction of “in a dosing regimen” with respect to intentional use of the regimen I understand this to apply equally to claim 25 prior to amendment; it does not arise as a result of the amendment. Insofar as it is necessary to draw a conclusion, I do not consider that the mental state of the person carrying out the administering is relevant to the scope of a method “comprising administering paliperidone palmitate in a dosing regimen” or to a use of a drug “in a dosage regimen”. Whether a medication is administered in a specified regimen or schedule is to my mind a question that can be objectively determined. It follows that in my view, the state of mind of the person administering paliperidone palmitate is irrelevant both to the new method of treatment claims and to claim 25 prior to amendment. Finally, with respect to the written submissions regarding whether claim 25 requires the exclusive use of paliperidone palmitate as compared with the method of treatment claims which “comprise” administration of paliperidone palmitate, I agree with the patentee; I can see no reason to construe claim 25 as excluding the concomitant use of any other therapeutic intervention, provided that paliperidone palmitate is used in the relevant dosage regimen. As such, I consider the method of treatment claims in substance fall within the scope of the claims prior to amendment – they do not make anything an infringement that would not have been prior to amendment.
It follows that the opponent has not established that the introduction of the new method of treatment claims leads to any claim of the specification not in substance falling within the scope of the claims before amendment, and it has not been established that there is a lack of compliance with s 102(2)(a).
Conclusion
The opposition is unsuccessful; the opponent has not established that the amendments do not comply with ss 102(1), 102(2)(a) or 102(2)(b).
Costs
It is usual in matters before the Commissioner that costs follow the event and I see no reason to depart from this approach. I will award costs against the opponent.
Dr S. J. Smith
Delegate of the Commissioner of Patents