Banki Haddock Fiora v Glaxo Group Limited - [2024] APO 20

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Banki Haddock Fiora v Glaxo Group Limited [2024] APO 20
Patent:2018282427

Title:COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST

Patentee:Glaxo Group Limited

Opponent:Banki Haddock Fiora

Delegate:Dr S. J. Smith

Decision Date: 28 May 2024

Hearing Date: 28 February 2024, by videoconference

Catchwords: PATENTS – section 75 – opposition to grant of an extension of term – section 71 – approved form for application for an extension of term – pharmaceutical substance per se an admixture – relevant earliest first regulatory approval date – nature of goods included on the ARTG – opposition unsuccessful – costs awarded

Representation: Counsel for the patentee: David Shavin KC
Patent attorney for the patentee: Annabella Newton of Phillips Ormonde Fitzpatrick
Counsel for the opponent: David Larish
Solicitor for the opponent: Banki Haddock Fiora

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE

Patent:2018282427

Title:COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST

Patentee:Glaxo Group Limited
Date of Decision: 28 May 2024
DECISION

The opposition to grant of an extension of term of patent 2018282427 is unsuccessful. Subject to appeal, I grant the extension of term.
I award costs according to Schedule 8 against Banki Haddock Fiora.
REASONS FOR DECISION

Background

This matter concerns an opposition to an extension of term of patent number 2018282427 (the patent) in the name of Glaxo Group Limited (the patentee). The patent was granted on 15 July 2021 and the patentee filed an application for an extension of term (the application) of the patent under section 70 of the Patents Act 1990 (the Act) on 3 November 2021.
The application is based on the product TRELEGY ELLIPTA, which was first listed on the Australian Register of Therapeutic Goods (ARTG) on 16 January 2018. Prior to consideration of the application, the patent was re-examined pursuant to section 97 of the Act and the patentee made section 104 amendments to the claims and description which were allowed unopposed on 16 June 2022. The application was advertised accepted on 7 July 2022.
Banki Haddock Fiora (the opponent) filed a notice of opposition on 7 October 2022 and a statement of grounds and particulars on 23 December 2022. The statement of grounds and particulars identifies the ground as follows: “The Application incorrectly treated the earliest first regulatory approval date as the inclusion of Trelegy Ellipta on the ARTG when the actual earliest first regulatory approval date was the inclusion of Anoro Ellipta on the ARTG.” At the hearing I confirmed with the opponent that this reflected an opposition on the basis that the requirements of section 71 were not satisfied.[1]
[1] I note that the opponent also observed that the combined effect of sections 76 and 77 is that an extension of zero term could be granted following the opposition.
On 3 January 2023 a delegate of the Commissioner directed that the documents that accompanied the statement of grounds and particulars (various documents concerning the TRELEGY ELLIPTA and ANORO ELLIPTA products and the associated listings on the ARTG) were to be treated as evidence in support of the opposition. Declaratory evidence in this matter consists of declarations (and associated exhibits) by Julie Robb filed as evidence in support (Robb #1) and reply (Robb #2) and a declaration (and associated exhibits) by Gavin Fowler filed as evidence in answer (Fowler). Ms Robb is a partner of the opponent and Mr Fowler is an assistant General Counsel of GSK of Medicines Research Centre and responsible for the extension of term request for the patent.
The statutory framework
Part 3 of Chapter 6 of the Act provides a statutory framework for the extension of the term of standard patents relating to pharmaceutical substances. Section 70 relevantly provides:
(1)The patentee of a standard patent may apply to the Commissioner for an extension of the term of the patent if the requirements set out in subsections (2), (3) and (4) are satisfied.
(2)Either or both of the following conditions must be satisfied:
(a)   one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;
(b)   one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.
(3)Both of the following conditions must be satisfied in relation to at least one of those pharmaceutical substances:
(a)   goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods;
(b)   the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years.
Note: Section 65 sets out the date of a patent.
(4)     The term of the patent must not have been previously extended under this Part.
The expression “pharmaceutical substance” is defined in Schedule 1 of the Act as:
“a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:
(a) a chemical interaction, or physico-chemical interaction, with a human physiological system; or
(b) action on an infectious agent, or on a toxin or other poison, in a human body;
but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing.”
Section 71 sets requirements for the form and timing of an extension of term application. With respect to form, section 71(1) provides:
(1) An application for an extension of the term of a standard patent must:
(a) be in the approved form; and
(b) be accompanied by such documents (if any) as are ascertained in accordance with the regulations; and
(c) be accompanied by such information (if any) as is ascertained in accordance with the regulations.
For this purpose, document includes a copy of a document.
With respect to timing, section 71(2) provides:
(2) An application for an extension of the term of a standard patent must be made during the term of the patent and within 6 months after the latest of the following dates:
(a) the date the patent was granted;
(b) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, any of the pharmaceutical substances referred to in subsection 70(3);
(c) the date of commencement of this section.
Section 75(1) provides that the Minister or any other person may oppose the grant of an extension of term only on the ground that one or more of the requirements of sections 70 and 71 are not satisfied in relation to the application for the extension.
Section 77 provides for the term of an extension if granted:
(1)If the Commissioner grants an extension of the term of a standard patent, the term of the extension is equal to:
(a) the period beginning on the date of the patent and ending on the earliest first regulatory approval date (as defined by section 70) in relation to any of the pharmaceutical substances referred to in subsection 70(2);
reduced (but not below zero) by:
(b) 5 years.
Note: Section 65 sets out the date of a patent.
(2)However, the term of the extension cannot be longer than 5 years.
The patent
At the outset, it is necessary to determine the version of the specification relevant to the opposition. As noted above, the specification was amended after the application for extension of term was filed, but before it was considered by a delegate. The amendments were made in response to grounds of invalidity raised during re-examination. The Commissioner’s longstanding practice has been to assess an application for extension of term in view of the claims as they stand at the time of the assessment.[2]
[2] See, e.g. Boehringer Ingelheim International GmbH [2000] APO 18, Ono Pharmaceutical Co., Ltd [2020] APO 43 at [4]-[5].
The opponent’s contention is that the relevant specification for the section 70 analysis is that prior to amendment. My understanding is that the central reason for this is that the application refers to the specification prior to amendment, and “the scheme of the relevant part of the Patents Act (Ch 6 Pt 3) requires the Commissioner to determine whether the requirements for an assessment are met based on the content of ‘the application’”[3] (that is, sections 74 and 75 require that the Commissioner be satisfied, or not, in relation to the application). The opponent submitted that:
“the Patents Act does not allow for the possibility that a version of the patent other than that the subject of (and which existed at the time of) the application can be considered for the purposes of deciding whether to accept the application or determine an opposition thereto.”[4]
[3] Opponent’s submissions at [27].
[4] Opponent’s submissions at [29].
In other words, the opponent’s submission is that the application is made at a fixed point in time, and the assessment of whether the section 70 requirements are satisfied is made in the context of the application, and therefore the patent at the time of the application, rather than in the abstract. The opponent noted that other provisions of the Act clearly direct attention to the specification at the time of the proceeding – referring specifically to section 138.
The patentee, in contrast, submitted that the current version of the specification is the only relevant version for consideration. In this regard the patentee submitted that under section 43 the priority date of an amended claim is taken to be that of the patent (unless the provisions of section 114 apply), such that amended claims have effect as if they had been included in the specification on its filing date,[5] and, once the amendment is made, that is the form of the specification upon which the extension of term application must be assessed. The patentee noted that if this were not so, re-examination of patents the subject of extension of term applications would be futile. Further, to look at anything other than the specification as it exists at the time of the decision of whether or not to extend the term of the patent would not make sense from a policy perspective given that is the form of the patent that will be extended.
[5] Patentee’s submissions at [31]-[34].
In addition, the patentee pointed to the situation in Alphapharm Pty Ltd v H Lundbeck A/S,[6] where a (second) extension of term application was filed while an incorrectly allowed extension was still recorded on the Register. The application was considered after the Register had been corrected to remove the original extension, and, while section 70(4) precludes the grant of an extension of term in circumstances where the patent term has previously been extended, the delegate in that case concluded that “the critical date for assessing compliance with section 70(4) is the day on which I make my decision” and that “[l]ooking at the Register today, there is no previous extension of term of the patent.”[7]
[6] [2014] APO 41.
[7] Ibid at [56].
At the hearing I suggested that an approach of assessing the application against a superseded form of the specification could lead to problematic outcomes. For example, the Commissioner’s practice of conducting re-examination prior to assessing an extension of term application protects the public interest in not extending the term of invalid patents. The re-examination may well, as in this case, lead to amendments. If amendments were made, either as a result of a re-examination or for any other reason, such that all claims were directed to methods of treatment and a pharmaceutical substance per se no longer in substance fell within the scope of any claims, it would seem perverse for the Commissioner to be obliged to grant an extension of term of the patent on the basis of claims that no longer subsisted. The opponent responded that the alternative of allowing an extension of term in relation to a patent which at the time of the extension application did not meet the requirements for an extension would also lead to perverse outcomes – for example, allowing a patentee to continuously amend the patent around any reasoning, or even decision, preventing the extension based on the original form of the patent from being allowed. The patentee responded that overcoming defects is precisely the reason for amendments.
Having considered the parties’ submissions, for the reasons that follow I consider that the relevant specification to consider is that subsisting at the time of making the decision of compliance with the requirements.
I recognise that section 70(1) provides that an application may be made if the requirements of sections 70(2)-(4) are satisfied, that the approved form for making an application for an extension of term requires that the patentee indicate how the pharmaceutical substance per se is in substance disclosed in the specification and falls within the scope of the claims, and that section 74 refers to acceptance or refusal of the application. However, a patentee is able to seek an amendment under section 104 at any time, subject to the allowability requirements of section 102, and, once an amendment is made, the patent no longer subsists in its unamended form. I cannot see that the words or context of the Act dictate that the reference to the claims and specification in section 70(2) should be understood as departing from their plain meaning, that being the extant amended form upon allowance of the amendment. Similar to the conclusion of the delegate with respect to section 70(4) discussed above, I think it is reasonable to assess compliance with sections 70(2) and 70(3) on the day on which I make my decision. I note that a decision to grant or refuse the application is, subject to appeal, final, such that I am not persuaded that the opponent’s spectre of a patentee’s repeated amendments to defeat a decision to refuse arises. And while clearly not directly analogous, this also seems to me to be consistent with the approach of the Full Court in Commissioner of Patents v Ono Pharmaceutical Co., Ltd in referring to the “objective determination” of compliance with section 70(2) by reference to the specification and claims of the patent in question.[8]
[8] [2022] FCAFC 39 at [119] (‘Ono’).
Moreover, I agree with the patentee that it would be quite an extraordinary result for the Commissioner to be compelled to make an assessment of compliance with section 70 of a patent specification in one form with a view to granting an extension of the term of a patent in another. Indeed, this would seem to defeat the purpose of the extension of term scheme, explained in the Explanatory Memorandum to the Intellectual Property Laws Amendment Bill 1997 as to provide a patentee with an “effective patent life” after marketing approval is obtained which is more in line with that available to inventions in other technologies. Further references to the specification in this decision relate to the specification as amended.
The description
The specification explains that the invention is particularly concerned with:
“novel pharmaceutical combination products comprising 4-{(1 R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl) phenol triphenylacetate and 4- [hydroxy(diphenyl)methyl]-1-{2-[(phenylmethyl) oxy]ethyl}-1- azoniabicyclo[2.2.2]octane bromide and the use of said combination products in medicine, particularly in treating diseases mediated via the M₃ muscarinic acetylcholine receptor and/or the beta-2 adrenoreceptor, for example in the prophylaxis and treatment of inflammatory or respiratory tract diseases.”[9]
[9] Specification, page 1, lines 15-21.
Throughout the specification 4-[hydroxy(diphenyl)methyl]-1-{2-[(phenylmethyl)oxy]ethyl}-1- azoniabicyclo[2.2.2]octane is referred to as Compound (I) and 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol is referred to as Compound (II). Compound (I) is said to be “a long acting high-affinity pan-active muscarinic receptor antagonist which has potential for once-daily administration”[10] and the specification states that Compound (II) “has been found to demonstrate sustained bronchodilation over a 24 hour period in conjunction with a favourable safety profile and thus has the potential for once-daily administration.”[11] I note that Compound (I) is also known as umeclidinium and Compound (II) is also known as vilanterol.
[10] Specification, page 7, lines 14-15.
[11] Specification, page 7, lines 18-20.
The specification states that:
“The individual compounds of the pharmaceutical composition as described herein may be administered either sequentially or simultaneously in separate or combined pharmaceutical formulations/compositions. Thus Compound (I) and Compound (II) may for example, be formulated separately and presented in separate packs or devices, or said individually formulated components may be presented in a single pack or device. Where appropriate, the individual compounds may be admixed within the same formulation and presented as a fixed pharmaceutical composition. … In one embodiment, the individual compounds of the pharmaceutical composition product may be administered simultaneously in a combined pharmaceutical admixed composition.”[12]
[12] Specification, page 9, line 31 – page 10, line 7.
The specification goes on to describe various details concerning suitable formulations and administration of the compositions of the invention and clinical studies regarding both Compound (I) and Compound (II). Relevant to the matter at hand, various dry powder inhaler devices containing two blister strips are described wherein:
·the first blister strip contains Compound (I) and excipients and the second blister strip contains Compound (II) and excipients; or
·the first blister strip contains both Compound (I) and Compound (II) and excipients and the second blister strip contains fluticasone furoate and excipients.[13]
The claims
[13] Specification, page 26, line 11 – page 28, line 2.
The specification ends with 20 claims. Claim 1 is the only independent claim. Some claims of relevance are reproduced below:
1. An admixture composition comprising:
a) compound of the formula:
Compound (I)
wherein
X- is a pharmaceutically acceptable anion; and
b) a compound of the formula:
or a pharmaceutically acceptable salt thereof (Compound (II)).
15. A composition according to any one of Claims 1 to 14 further comprising [fluticasone furoate] as a separate component where the fluticasone furoate is administered simultaneously with the composition of claims 1 to 14.
18. A composition according to any one of Claims 15 to 17 wherein the composition is in the form of a dry powder and included with an inhaler, the inhaler is selected from a reservoir dry powder inhaler, a unit-dose dry powder inhaler, or a pre-metered multidose dry powder inhaler, wherein the composition of claims 1 to14 and the fluticasone furoate are housed within the dry powder inhaler and the inhaler is able to administer the composition and fluticasone furoate simultaneously.
19. A composition according to Claim 18 wherein the composition of Compound (I) and Compound (II) are formulated in one blister strip and the [fluticasone furoate] is formulated in a second blister strip.
Notably, claim 1 defines an “admixture composition”.[14] Admixture is relevantly defined in the Macquarie Dictionary Online[15] as “the state of being mixed” and it is apparent from the specification that the claim refers to a single composition within which the two components are mixed as opposed to collocated independent formulations. For example, the specification indicates that the compounds “may be formulated independently or in admixture.”[16]
[14] I note that the reference to an “admixture composition” was introduced in the amendments allowed on 16 June 2022. Claim 1 as accepted referred to “[a] composition”, which the delegate who re-examined the patent construed, based on the specification, as including components not in admixture.
[15] Macquarie Dictionary Publishers, an imprint of Pan Macmillan Australia Pty Ltd, accessed 29 February 2024.
[16] Specification, page 12, line 27 (with my emphasis).

Appended claims 15, 18 and 19 reproduced above define combinations of the admixture composition of claims 1-14 with a separate fluticasone furoate component. In particular, claim 19 defines an arrangement whereby the admixture composition is formulated in one blister strip and fluticasone furoate is formulated in a second blister strip.
Section 71 requirements
As set out above, section 71(1)(a) requires that an application for an extension of term be in the approved form. Relevantly, the approved form requires, among other things, an indication of, to the best of the patentee’s knowledge, the earliest first regulatory approval date in relation to goods containing, or consisting of, any pharmaceutical substance that is, in substance, disclosed in the specification and falls within the scope of the claims. Here the opponent has asserted that the earliest first regulatory approval date is not correctly identified in the application on the basis that ANORO ELLIPTA contains a pharmaceutical substance that is in substance disclosed in the specification and falls within the scope of the claims and was listed on the ARTG earlier than the goods relied on by the patentee.
The inclusion of erroneous information regarding the first regulatory approval date within the application for extension of term has been taken to be a failure to comply with the requirements of section 71.[17]
[17] Re AbbVie Biotechnology Ltd v Commissioner of Patents [2016] AATA 682 at [91].
For completeness, I note that while it is not unusual in cases such as this for questions of compliance with the timing requirements of section 71(2) to arise, no issue arises in this case. The relevant date from which the period for applying for an extension of term is to be calculated in this case is the date the patent was granted (section 71(2)(a)), and the application was made within six months of that date.
In order to determine the earliest first regulatory approval date I will first consider the nature of the ANORO ELLIPTA and TRELEGY ELLIPTA goods included on the ARTG, then identify the relevant pharmaceutical substance or substances per se disclosed and claimed in the patent, and then ascertain which of the goods contain or consist of a pharmaceutical substance per se disclosed and claimed in the patent.
The goods
As noted previously, the opponent has asserted that the goods identified in the application, TRELEGY ELLIPTA, are not the earliest relevant ARTG-listed goods, and instead identified ANORO ELLIPTA as the relevant goods. GlaxoSmithKline Australia Pty Ltd is the sponsor of both goods. Both parties provided evidence regarding these goods, both of which are powders for inhalation comprising umeclidinium bromide and vilanterol trifenatate contained within the Ellipta inhaler – that is, the goods are not powders alone, but packaged in an inhaler.
The inhaler comprises two separate blister strips containing the powder for inhalation. A helpful figure of the inhaler is provided on a GSK webpage for US Healthcare Professionals “DOSING AND DELIVERY FOR THE ANORO ELLIPTA INHALER”[18] and reproduced below.
[18] Exhibit JR-4.
The activation of the inhaler is explained as follows:
“Single-step dose activation:
·When the inhaler is opened fully, the contents of both blisters are combined in the manifold and ready for inhalation by the patient. Each time patients open the cover, they will hear a clicking sound and the dose counter will decrease in number
·If patients open and close the cover without inhaling the medicine, they will lose the dose. Any lost dose is securely held in the holding chambers and is no longer available to be inhaled
·It is not possible to accidentally take a double dose or an extra dose in one inhalation”[19]
[19] Exhibit JR-4.
At the hearing there was some discussion as to whether the contents of the inhaler are combined within the inhaler upon activation, or only when the patient inhales. In view of the above discussion of the activation of the inhaler, the opponent’s position was that an admixture, or single powder comprising the contents of both blister strips, is created within the device prior to inhalation. Consistent with this, the GSK webpage “HOW TO USE YOUR INHALER” for ANORO ELLIPTA states: “When you open the inhaler (and hear the click), the contents of 1 blister from each strip combine to form 1 dose of ANORO.”[20] In contrast, the patentee submitted that “there is no pre-release of the contents of each blister strip into the manifold to create an admixture”,[21] referring to the US FDA Product Information for ANORO ELLIPTA which states: “After the inhaler is activated, the powder within both blisters is exposed and ready for dispersion into the airstream created by the patient inhaling through the mouthpiece.”[22] The patentee also observed that if the contents did enter the manifold, it was unclear how the loss of an unused dose to the holding chamber, which prevents accidental overdosing, could be effected.
[20] Exhibit JR-5.
[21] Patentee’s submissions at [58].
[22] Exhibit GF-4.
Given the dispute between the parties it is unfortunate that there is no evidence specific to the operation of the inhaler as opposed to its use by a patient, but it seems to me to be consistent with the totality of the evidence that upon activation the contents of both blisters are exposed within the manifold – that is, there is a combination at least in some sense at that point – prior to the dispersion that occurs upon inhalation. In any event, I understand the relevant point for the opponent’s argument to be that a mixture occurs within the device rather than only within a patient. Given that the airstream into which the dispersion of the powder occurs appears to necessarily transit through the manifold, I am prepared to proceed on the basis that this is the case. I also note that it appeared to be accepted by both parties that combination of the powders in an airstream is a relevant admixture composition and I have also proceeded on that basis.
TRELEGY ELLIPTA
TRELEGY ELLIPTA was first listed on the ARTG on 16 January 2018. The TRELEGY ELLIPTA Product Information indicates that:
“Each foil strip contains regularly distributed blisters with one strip containing either 100 micrograms or 200 micrograms of fluticasone furoate and the other strip containing 62.5 micrograms of umeclidinium (equivalent to 74.2 micrograms umeclidinium [as bromide]) and 25 micrograms of vilanterol (as trifenatate).”[23]
[23] Exhibit GF-1.
That is, the product includes one strip wherein the blisters contain a combination of umeclidinium and vilanterol and a second strip wherein the blisters contain fluticasone furoate. As noted above, the inhaler releases the contents of the two blister strips together, and the Product Information states that the delivered dose contains all three actives.[24]
ANORO ELLIPTA
[24] Exhibit GF-1.
ANORO ELLIPTA was first listed on the ARTG on 4 July 2014. The ANORO ELLIPTA Product Information refers to the product as:
“Moulded plastic device containing two foil strips of either 7 or 30 regularly distributed blisters, each containing a white powder formulation of 74.2 micrograms of umeclidinium bromide (equivalent to 62.5 micrograms of umeclidinium) and 25 micrograms of vilanterol (as trifenatate). Each delivered dose (the dose leaving the mouthpiece of the inhaler) contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms vilanterol (as trifenatate).”
To my mind this phrasing is somewhat ambiguous as to the distribution of the two actives within the strips. However, according to Mr Fowler “the active ingredients are in separate dry powder formulations in separate blister strips”[25] and the Product Information from the US FDA for ANORO ELLIPTA states that:
“Each blister on one strip contains a white powder blend of micronized umeclidinium bromide (74.2 mcg equivalent to 62.5 mcg of umeclidinium), magnesium stearate (75 mcg), and lactose monohydrate (to 12.5 mg), and each blister on the other strip contains a white powder blend of micronized vilanterol trifenatate (40 mcg equivalent to 25 mcg of vilanterol)), magnesium stearate (125 mcg), and lactose monohydrate (to 12.5 mg).” [26]
[25] Fowler at [12].
[26] Exhibit GF-4.
I note that the opponent accepts that ANORO ELLIPTA contains two strips of blisters with one containing umeclidinium and the other containing vilanterol,[27] but emphasised that the two blisters are combined in the inhaler before administration and cannot be separately inhaled.[28]
[27] Opponent’s submissions at [18].
[28] Opponent’s submissions at [19].
The pharmaceutical substance per se
Dispute as to the relevant pharmaceutical substance per se is essentially resolved by determination of the relevant form of the specification.[29]
[29] I understand the opponent’s case, on the view that the relevant claims are those prior to amendment, to include that the defined composition encompasses active ingredients in separate blisters, as in the ANORO ELLIPTA product, and that this is a relevant pharmaceutical substance per se: opponent’s submissions at [46], [62].
Having regard to the specification in its current form, the claims require an admixture composition of substances such that it is clear that the relevant pharmaceutical substance per se which is in substance disclosed in the specification as filed and falls within the scope of the claims is an admixture of a pharmaceutically acceptable salt of umeclidinium and vilanterol (or a pharmaceutically acceptable salt thereof). To my mind this is broadly consistent with the pharmaceutical substance identified in the application, which includes reference both to a composition comprising umeclidinium and vilanterol and to the three-part composition that makes up the TRELEGY ELLIPTA product, and as such I do not agree with the opponent’s view that the patentee pursued the extension on a basis inconsistent with the case it now puts.
For completeness, I note that, as submitted by the patentee, decisions of the Patent Office and the Court make it clear that a pharmaceutical substance per se within the meaning of section 70(2)(a) should be a pharmaceutical substance alone.[30] It is uncontroversial, however, that a mixture of substances (as opposed to a kit or combination[31]) is a pharmaceutical substance per se.[32]
[30] See, e.g., The Children’s Medical Center Corporation [2011] APO 80 at [23]-[25] (‘Children’s Medical Center’), Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647 at [38]-[39].
[31] See, e.g., Children’s Medical Center at [24].
[32] See definition of “pharmaceutical substance” at Schedule 1 of the Act, also, e.g., Spirit Pharmaceuticals Pty Ltd v Mundipharma Pty Ltd [2013] FCA 658 at [64]-[67], Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2022] FCAFC 40 at [83] (‘Merck’).
The earliest first regulatory approval date
TRELEGY ELLIPTA clearly contains an admixture of umeclidinium bromide and vilanterol trifenatate – the two components are combined within single blisters. The question is whether ANORO ELLIPTA also contains or consists of an admixture of a pharmaceutically acceptable salt of umeclidinium and vilanterol (or a pharmaceutically acceptable salt thereof) such that the relevant earliest first regulatory approval date is 4 July 2014, rather than the 16 January 2018 approval date of TRELEGY ELLIPTA which is indicated on the application. In answering this question, the key issue is whether the goods included in the ARTG referred to in section 70(3) are limited to the form of the goods as identified in the ARTG – essentially as presented for sale or supply – or whether they extend to the form of the goods subsequent to supply, for example, at or around the point of administration.
To contextualise the parties’ submissions on this point, it is useful to first set out some of the most relevant cases.
In H Lundbeck A/S v Alphapharm Pty Ltd Bennett J (with whom Middleton J agreed) explained that:
“The level of enquiry required by s 70(3) does not look to the therapeutic effect of the pharmaceutical substance. Rather, it is a simple comparison of the pharmaceutical substance with the ‘ingredients’ of the goods on the ARTG.”[33]
[33] [2009] FCAFC 70 at [239] (‘Lundbeck’).
The delegate in Celgene Corporation, when considering whether an indication for a therapeutic use formed part of the consideration of the goods included on the ARTG, observed that:
“The goods that are included in the ARTG are limited to therapeutic goods (section 9A of the Therapeutic Goods Act 1989), which are goods intended for therapeutic use (section 3 of the Therapeutic Goods Act). Goods included in the ARTG have an indication, which is defined as the therapeutic use of the goods (section 3 of the Therapeutic Goods Act). The Therapeutic Goods Act draws a clear distinction between the goods and their indications. …
… in identifying the goods that are included in the ARTG I should not import elements of the indications of the goods. The ‘goods’ for the purposes of the Patents Act is equivalent to the product that appears in the ARTG certificate, and does not extend to the indications.”[34]
He went on to identify the goods as the product the patentee has approval to supply.[35]
[34] [2011] APO 37 at [22]-[23] (‘Celgene’).
[35] Ibid at [24].
In Children’s Medical Center a delegate considered a submission by a patentee that the whole of the ARTG entry should be taken into account when determining the goods included on the ARTG.[36] Specifically, the submission was that where the product included on the ARTG contained a single drug, drug combinations were also goods included on the ARTG in circumstances where the Product Specific Indications referenced the use of the drug in particular combinations. The delegate, following the reasoning in Celgene, found that a reference to the use of the drug in combinations did not constitute inclusion in the ARTG of such combinations.[37] He also observed that “the separate components cannot be considered a single pharmaceutical substance per se because of the interaction they have in the human body following their separate administration to the patient.”[38]
[36] Children’s Medical Center at [13].
[37] Ibid at [15]. I note that this decision and Celgene were affirmed by the AAT: Celgene Corporation and Commissioner of Patents and Children’s Medical Center Corporation [2013] AATA 55.
[38] Ibid at [29].
In The Regents of the University of California & Regeneron, Inc., again in circumstances where the product included on the ARTG included a single active and the relevant pharmaceutical substance per se was a combination of two actives, the delegate similarly rejected a submission that “the product-specific indications for a pharmaceutical substance registered in the ARTG, or similar information in other documents relevant to the registration process, identify goods included in the ARTG for the purposes of paragraph 70(3)(a).”[39]
[39] [2016] APO 33 at [22].
In Pharma Mar S.A. it was essentially put by the patentee that where a product in the form of a two-part mixture of a powder and reconstitution solution was included on the ARTG with an indication that it must be reconstituted for use, the reconstituted formulation was also included on the ARTG.[40] Having considered the above cases, I came to the view that there is a distinction between the goods included on the ARTG and their use:
“Section 3 of the [Therapeutic Goods Act 1989] identifies ‘appropriate doses of the goods’ and ‘the method of administration or use of the goods’ as ‘directions for use, in relation to therapeutic goods’. Accordingly, there seems to be, analogous to the circumstances previously considered in relation to indications, a distinction between therapeutic goods (the product listed on the ARTG) and their use.”[41]
Accordingly, I concluded that the goods included on the ARTG were limited to the two-part product (that is, as supplied) and not the product reconstituted in accordance with the directions for use.[42]
Patentee’s submissions
[40] [2020] APO 8 at [20] (‘Pharma Mar’).
[41] Ibid at [24].
[42] Ibid at [25].
The patentee submitted that the product associated with the ANORO ELLIPTA ARTG registration comprises a two-part combination of separate dry powder formulations which are only mixed at the point of administration[43] and characterised the product as a kit, comprising the device and two blister strips. The patentee said that the goods included in the ARTG do not extend beyond the two-part mixture and that the use of the inhaler, at which point an admixture is produced, is a method of delivery and part of the directions for use. In the patentee’s submission it does not matter where in the airstream the ingredients are mixed, because they are not mixed in the product as included on the ARTG, and mixtures produced at the point of administration have been found not to be pharmaceutical substances per se.
[43] Patentee’s submissions at [57].
Following from this, the patentee submitted that the ANORO ELLIPTA product is not a composition falling within the scope of any claim in the patent – the selling of the ANORO ELLIPTA product which does not, as packaged, contain the claimed admixture, would not be an act of infringement. This is consistent with Mr Fowler’s statement that:
“…the umeclidinium and vilanterol of TRELEGY ELLIPTA form a composition for use in the inhaler while these two actives are presented as separate components when ANORO ELLIPTA is used. It follows that ANORO ELLIPTA is not claimed in the claims of The Patent as the claims of The Patent require these two actives to be presented as ‘An admixture composition’ as set out in claim 1.”[44]
Opponent’s submissions
[44] Fowler at [17].
The opponent submitted that the plain language of section 70 does not provide any temporal restriction on the assessment of whether the goods included on the ARTG contain or consist of the pharmaceutical substance per se. That is, it does not matter when the pharmaceutical substance is contained in the goods, simply that it is. The relevant goods for the purpose of the opponent’s case is the ANORO ELLIPTA device which, the opponent pointed out, is described in the ARTG Public Summary and Product Information as “powder [singular] for inhalation”. The delivered dose contains a combination and the components cannot be inhaled separately[45] – the Product Information recites that “[e]ach delivered dose (the dose leaving the mouthpiece of the inhaler) contains [umeclidinium and vilanterol].” That is, the ANORO ELLIPTA product itself contains an admixture of umeclidinium and vilanterol, albeit in operation and at a point subsequent to supply.[46]
[45] Opponent’s submissions at [19].
[46] Opponent’s submissions at [63].
The opponent submitted that this is not inconsistent with the cases referenced above, as there is no reliance upon indications, therapeutic uses, or directions for use. The inclusion of the admixture in the inhaler follows from what the good physically is, and in this regard the present facts are distinguished from those in Pharma Mar where the product on the ARTG was in two parts and required reconstitution to produce the medication to be administered. Nor does the mixture occur only in the body after administration as referenced in Children’s Medical Center; the admixture is included within the goods. The opponent also observed that there is a limit to how far decisions which relate to two separate drugs where only one is included in the goods included on the ARTG can be extrapolated.
The opponent submitted that the patentee’s approach of considering the goods only in the form supplied is inconsistent with the policy behind the extension of term provisions (that is, the balancing of competing interests[47]):
“The policy behind Ch 6 Pt 3 would be subverted if, as here, a patentee could obtain an extension of term based on the ARTG listing date of a product containing two active ingredients in the same blister, in circumstances where the patentee had previously had a product listed with the same two active ingredients in separate blisters. This would be to put form over substance, and to encourage stratagems aimed at extending the period of exploitation of the monopoly in circumstances where there had not been any delay in its exploitation. This would be contrary to the public interest and the purpose of the extension of term provisions.”[48]
The opponent submitted that I should be slow to find that a manoeuvre of this kind could result an extension of term.
[47] See Ono at [139], Merck at [79], Alphapharm Pty Ltd v H Lundbeck A/S [2014] HCA 42; 254 CLR 247 at [60] (‘Alphapharm’).
[48] Opponent’s submissions at [66].

Finally, while submitting that the proper question is not whether ANORO ELLIPTA would infringe the claims, but simply whether it contains or consists of the pharmaceutical substance per se,[49] the opponent’s position was that ANORO ELLIPTA would infringe the present claims, as I understand it for the same reasons as it contains or consists of the admixture.
Consideration
[49] Opponent’s submissions at [57]-[58].
It is clear that ANORO ELLIPTA is a single self-contained product which, at point of supply, contains the separate components of an admixture as disclosed and defined in the patent. The product does not include an admixture until it is activated at the point of use. That it is described on various documents as powder (singular) for inhalation cannot transcend this reality. However, it is not a combination of separate parts, and it is not to be combined with a component extraneous to the listing prior to administration. The present facts are therefore not directly analogous to those of any of the cases referenced above.
While there is no express statement of a temporal restriction on when the contents of goods included on the ARTG are to be considered, for the reasons discussed below I think it is most consistent with the line of reasoning in the decisions I have referred to above, and with the extension of term provisions as a whole, that the assessment be made with respect to the goods in the form the patentee has approval to supply them.
Inclusion on the ARTG provides for lawful supply[50] of a therapeutic good in Australia; ARTG Certificates relevantly state that they are issued “for approval to supply” the goods included in the Register.[51] That is, the inclusion of goods in the ARTG is intrinsically connected with the supply of therapeutic goods. Despite the differences between the present facts and the aforementioned cases, the supply of goods is distinct from the subsequent use of the goods, and that is a common theme consistent with the reasoning in Celgene and the subsequent decisions expanding therefrom, none of which were criticised by either party. Moreover, while I appreciate the opponent’s point that there is no reconstitution or combination with any integers external to the inhaler in this case, it is nevertheless the case that until the inhaler is in use, the admixture is not present.
[50] Or, as the case may be, export, e.g. Merck at [94]-[114].
[51] For example, Celgene at [18], ARTG Certificates for TRELEGY ELLIPTA filed on 8 November 2021.
Similarly, as noted above, Bennett J observed that what is required is “a simple comparison of the pharmaceutical substance with the ‘ingredients’ of the goods on the ARTG”[52] – this simplicity would seem to be served by reference to the goods in their form of supply, rather than in use. It follows that on a simple assessment, the ingredients of ANORO ELLIPTA are separate formulations of umeclidinium and vilanterol, rather than a mixture which is transiently present in the goods in use.
[52] Lundbeck at [239].
I do not find the opponent’s submission that a view that the TRELEGY ELLIPTA goods were the first relevant inclusion on the ARTG would be inconsistent with the policy behind the extension of term provisions particularly helpful. The claims as they stand define an admixture composition and merit is “assumed for a pharmaceutical substance suitable for human use.”[53] The question is simply which goods contain or consist of that pharmaceutical substance. It seems inevitable that this will sometimes lead to outcomes that some parties find unsatisfactory, but “[i]t can be taken that the legislature saw the correct balance as being achieved by the very words it chose in order to implement the extension of term regime.”[54] Moreover, as noted in Merck, the narrower the scope of the claims, the more likely a patentee is to benefit from an extension;[55] here the patentee has expressly disclaimed non-admixture compositions.
[53] Alphapharm at [48].
[54] Ono at [139].
[55] Merck at [83].
Ultimately, the extension of term provisions refer to the regulatory or marketing approval of a pharmaceutical substance. This aligns with inclusion on the ARTG representing approval to supply goods containing or consisting of such a substance. The ANORO ELLIPTA goods, as supplied, do not contain or consist of the pharmaceutical substance per se defined and disclosed in the patent, being an admixture composition; this is not the pharmaceutical substance for which approval to supply has been given. It follows that I am not satisfied that the opponent has established that the application incorrectly identifies the earliest first regulatory approval date or, correspondingly, fails to comply with the requirements of section 71.
Conclusion
The opposition to the grant of an extension of term is unsuccessful.
Costs
It is usual in matters before the Commissioner that costs should follow the event and I see no reason to depart from this approach. The patentee has been successful in this matter, and therefore I will award costs according to Schedule 8 against the opponent.
Dr S. J. Smith
Delegate of the Commissioner of Patents