FEDERAL COURT OF AUSTRALIA

Regeneron Pharmaceuticals, Inc. v Sandoz Pty Ltd [2025] FCA 1067

ORDERS

THE COURT NOTES THAT:

A.    The Respondent / Cross-Claimant, by its Senior Counsel, has undertaken that:

(a)    Sandoz AG will submit to the jurisdiction of the Federal Court of Australia in proceeding no. VID 715 of 2025 and submit to an order that it be jointly liable with the Respondent / Cross-Claimant, to the extent that the Respondent / Cross-Claimant is unable to meet its obligations for any award of pecuniary relief in the proceeding, up to the sum of $100 million; and

(b)    to keep accounts and take all reasonable steps to procure that any distributor keeps accounts of all sales of the Sandoz Aflibercept products.

THE COURT ORDERS THAT:

1.    The Applicants’/ Cross Respondents’ claim for interlocutory relief in paragraphs 11 to 14 of its Amended Originating Application dated 8 August 2025 be dismissed.

2.    Until further order, the Court’s reasons for judgment not be disclosed to or published by any person, save for the parties’ legal representatives and Court staff.

3.    Within fourteen days, the parties confer, prepare and provide to the Chambers of Justice Rofe, proposed redactions to the reasons for judgment in relation to paragraphs that contain confidential information.

4.    If the parties are unable to agree on the proposed redactions referred to in order 3, each of the parties should file and serve on or before 29 September 2025:

(a)    a list of paragraphs of the agreed redactions; and

(b)    a list of paragraphs each of the parties consider ought to be redacted.

5.    Costs be reserved.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

REASONS FOR JUDGMENT

ROFE J:

1.    OVERVIEW

1.1    The Parties and the broad issues

1 The First Applicant, Regeneron Pharmaceuticals, Inc., is the patentee of Australian Patent No. 2012205599 entitled “Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders” (the 599 Patent). The Third Applicant, Bayer Consumer Care AG has been the exclusive licensee of the 599 Patent since 10 June 2025. The Second Applicant, Bayer Australia Limited was authorised by Regeneron (before 10 June 2025) and by Bayer Consumer Care (after 10 June 2025), via a sub-licence, to use any of its intellectual property rights (including the 599 Patent) in connection with the distribution, promotion and marketing of pharmaceutical products, comprising the active pharmaceutical ingredient (API) aflibercept under the trade name EYLEA® (EYLEA Aflibercept Products) in Australia. Unless otherwise stated, I refer to the three applicants together as the Applicants.

2 The Applicants seek final relief pursuant to the Patents Act 1990 (Cth) (Act) and the Australian Consumer Law (Schedule 2 to the Competition and Consumer Act 2010 (Cth)), broadly, to restrain the Respondent, Sandoz Pty Ltd, from launching its AFQLIR® and ENZEEVU® aflibercept products. These aflibercept products are bio-similar drugs to the EYLEA Aflibercept Products, which I refer to below as the Sandoz Aflibercept Products. In its response to the Applicants’ position statement on infringement filed on 26 June 2025, Sandoz accepts that the Sandoz Aflibercept Products and their corresponding Sandoz Product Information (Sandoz PI) are the same for the purposes of this proceeding. Given Sandoz’s indication that it does not intend to launch ENZEEVU® at this stage, any reference to Sandoz Aflibercept Products and Sandoz PI is reference to AFQLIR®.

3 For the present purposes, the Applicants seek urgent interlocutory orders to restrain Sandoz from marketing, importing and engaging in activities corollary to the launch of the Sandoz Aflibercept Products (Launching Activities). On 8 August 2025, the Applicants amended their Originating Application in which they sought an additional interlocutory relief in the form of an order that Sandoz immediately take reasonable steps to withdraw the application(s) for the Sandoz Aflibercept Products to be listed on the Pharmaceutical Benefits Scheme (PBS).  On 27 May 2025, Sandoz obtained listings for the Sandoz Aflibercept Products on the Australian Register of Therapeutic Goods (ARTG). As from 1 December 2025, Sandoz will receive approval for listing of the same on the Schedule of Pharmaceutical Benefits (PBS Schedule) pursuant to the PBS.

4 On 15 July 2025, the Applicants filed and served the evidence in support of their application for interlocutory relief in the form of orders:

(a)    restraining Sandoz, its directors, officers, servants, agents, related bodies corporate and associated entities, from importing, selling, supplying or otherwise disposing of the Sandoz Aflibercept Products;

(b)    that Sandoz take all reasonable steps to withdraw any Sandoz Aflibercept Products and prevent the use of any such products that have entered the market and serve on the Applicants an affidavit of Sandoz identifying any such steps taken; and

(c)    that Sandoz withdraw its application for Pharmaceutical Benefit Scheme (PBS) listing for the Sandoz Aflibercept Products.

5 The parties each expressed a desire that depending on the result, they wished to be heard as to the detail of the terms of any orders and undertakings.

1.2    Undertakings

6 In addition to the usual undertaking as to damages, the Applicants’ senior counsel, Mr Murray SC, indicated during the hearing that, in the event that an injunction was granted he had instructions that in order to preserve the status quo during the term of any injunction, his client would undertake to give notice to Sandoz of:

(a)    any decision by the Applicants to launch an EYLEA® 8mg pre-filled syringe (PFS) product in Australia;

(b)    any decision by the Applicants to launch an authorised biosimilar in Australia; and

(c)    any threatened launch of another biosimilar aflibercept product in Australia of which the Applicants become aware.

7 Mr Murray SC also indicated that the Applicants would be content with an injunction that included a rolling PBS application regime, whereby Sandoz could make a PBS application each cycle, but withdraw it each time before the requisite date, so that if Sandoz was successful at trial it could launch on the PBS as soon as possible thereafter.

8 During the hearing Sandoz’s Senior Counsel, Mr Cordiner KC, indicated that, in the event that an injunction was not granted he had instructions to give the following undertaking on behalf of Sandoz if required:

Sandoz AG would consent to submit to the jurisdiction and be jointly and severally liable with Sandoz for any damages award.

9 Sandoz also noted its willingness to undertake to keep detailed records and accounts of its AFQLIR® sales if it is not enjoined.

1.3    Expedited trial

10 The Applicants proposed that there could be an expedited or “speedy” trial for the final relief sought. They anticipated that, subject to the Court’s availability, the proceeding could be ready for a trial in December 2025. Sandoz did not embrace the proposal for a speedy trial.

11 Factoring in an appeal, Sandoz did not consider that there would be final determination of the proceeding in a timeframe that left it with any advantage (i.e., first mover advantage) over other potential biosimilar competitors.

1.4    Summary of conclusion

12 For the reasons I set out below, I consider that the balance of convenience does not lie in favour of the grant of interim relief sought by the Applicants. Accordingly, I dismiss the interlocutory application for injunctive relief.

1.5    The witnesses

13 The Applicants rely on evidence from seven witnesses:

Mark Davies Daniell is a senior consultant ophthalmologist at the Royal Victorian Eye and Ear Hospital (RVEEH) and Clinical Professor (Prof) of Ophthalmology at the Centre for Eye Research, University of Melbourne. Prof Daniell is the immediate past president of the Royal Australian and New Zealand College of Ophthalmologists (RANZCO) and has held numerous professional memberships and positions in societies, councils and authorities. Prof Daniell obtained a MBBS and Master of Surgery degrees from the University of Melbourne in 1986 and 1992, respectively. Prof Daniell gives evidence on the treatment of neovascular AMD and diabetic macular oedema (DME) using intravitreal injections of VEGF antagonist, and how the landscape for the treatment of those conditions will change if a biosimilar to one of the anti-VEGF reference drugs became available in Australia. The Applicants rely on one affidavit affirmed by Prof Daniell.

Robert Charles Andrew Symons is an Ophthalmologist, Vitreoretinal Surgeon and Clinician Scientist at the Centre for Eye Research Australia, the University of Melbourne and Monash University, with over 30 years’ experience working as a clinician in the field of ophthalmology and with particular expertise in the treatment of retinal disorders. Associate Professor (A/Prof) Symons has been appointed as an Investigator or Trial Committee Member of a number of ophthalmological Phase I, II and III clinical trials. The Applicants rely on one affidavit affirmed by A/Prof Symons.

Jan Gritzmann is the Senior Director, Finance and Administration of Regeneron Ireland Designated Activity Company, a wholly owned subsidiary of Regeneron. Mr Gritzmann provides evidence on the relationship between the Applicants, and potential losses, particularly to Regeneron, if the Sandoz Aflibercept Products were launched in Australia. The Applicants rely on one affidavit affirmed by Mr Gritzmann.

James Thomas Rock is the Marketing Strategic Lead of Ophthalmology and Oncology at Bayer Australia. Based on his experience as an employee of Bayer Australia and his oversight of the commercial operation of the EYLEA® brand, Mr Rock leads evidence on the existing market of anti-VEGF drugs, the contractual business relationships between the Applicants, the internal arrangements between Bayer Australia and Bayer Consumer Care, and the purported loss and damage which may arise should a biosimilar be launched into the Australian anti-VEGF drug market. The Applicants rely on one affidavit affirmed by Mr Rock.

Suyuan Zha is a Certified Practising Accountant and the Pricing & Reimbursement Manager of Bayer Australia. Ms Zha gives evidence to the regulatory history of EYLEA®, the operation of the PBS as it relates to EYLEA® and any biosimilar versions, and the impact on the pricing of EYLEA® and other anti-VEGF drugs should Sandoz obtain PBS listing for the Sandoz Aflibercept Products. The Applicants rely on one affidavit affirmed by Ms Zha.

Grant William Fisher is a Partner at Corrs Chambers Westgarth, the solicitors representing Regeneron. Mr Fisher gives evidence on the amino acid sequences in Australian Patents Nos 2006229930, 779303 and 2006213856 (the 856 Patent). Mr Fisher gives further evidence on the correspondence between the parties regarding the process whereby the 599 Patent and the 856 Patent were selected as patents asserted and to be asserted against Sandoz. The Applicants rely on three affidavits affirmed by Mr Fisher, one of them being relevant to the present interlocutory injunctive relief case.

Owain Rhys Stone is a Managing Director of Alvarez & Marsal’s disputes and investigations practice in Melbourne, with over 40 years’ experience as a forensic accountant. Mr Stone gives evidence on his approach to the quantification of loss sustained by the parties in both launch and restraint scenarios. The Applicants rely on one affidavit affirmed by Mr Stone.

14 The Applicants also tendered a tender bundle and a confidential tender bundle.

15 Sandoz relies on the evidence of five witnesses:

Sanjeewa Sudarshan Wickremasinghe is a consultant ophthalmologist in the Medical Retina Clinic at the RVEEH in Melbourne, a Medical Retina Specialist at Retina Specialists Victoria and a Clinical A/Prof in the Department of Ophthalmology at the University of Melbourne. A/Prof Wickremasinghe obtained his MBBS degree from the University of London in 1996 and a Doctor of Medical Science degree from the University of Melbourne in 2015. A/Prof Wickremasinghe gives evidence about the construction of the 599 Patent and the prior art documents relating to the lack of prima facie case. A/Prof Wickremasinghe gives further evidence on his current prescribing and treating practises in relation to Wet AMD, DME, Myopic CNV and RVO. Sandoz relies on two affidavits affirmed by A/Prof Wickremasinghe.

Robert Kelvin Cooper is a Partner at MinterEllison, the solicitors for Sandoz. Mr Cooper provides evidence on prior disclosures of the amino acid comprising SEQ ID NO:2 of the 599 Patent, which Sandoz relies on for its want of prima facie case. Mr Cooper also gives evidence regarding Sandoz’s launch plans for AFQLIR® and the Applicants’ promotional materials of EYLEA® 8mg. Sandoz relies on two affidavits affirmed by Mr Cooper.

Dr Louisa Maria King is a Patent and Design Searcher at KingSearch. Dr King obtained her Bachelor of Science degree and a Doctor of Philosophy in organic chemistry from the University of Sydney, in 1987 and 1992, respectively. Dr King provides evidence on how she would have located the amino acid sequence for aflibercept at the relevant priority date. Sandoz relies on one affidavit affirmed by Dr King.

Andrew Murray Ross is a Forensic Accountant and Partner at HKA. Mr Ross has more than 35 years’ experience in the preparation of expert reports and the provision of expert evidence as a forensic accountant. Mr Ross gives evidence responsive to Mr Stone. Sandoz relies on one affidavit sworn by Mr Ross.

Timothy Behrens is the Head of Growth at Sandoz. Mr Behrens has significant experience overseeing and forecasting the Australian biosimilar market for biosimilar products and is responsible for the proposed launch of the Sandoz Aflibercept Products. Mr Behrens gives evidence on the development of biosimilar drugs to reference biologics, the biologics market and more specifically the anti-VEGF market. Sandoz relies on one affidavit affirmed by Mr Behrens.

16 Sandoz tendered a confidential tender bundle.

1.6    The Applicants’ corporate relationship and structure

17 Bayer AG, which is not a party to the proceeding, is a global life sciences company with headquarters in Leverkusen, Germany. Mr Rock deposes that, as at December 2024, Bayer AG comprised 291 companies in 80 countries employing over 94,000 people. As at 1 May 2025, the Bayer Group has 563 employees in Australia, 250 of which are employed by Bayer Australia. Each of the Bayer Australia, Bayer Consumer Care and Bayer HealthCare LLC (also not a party) are 100% indirectly held by Bayer AG.

18 Regeneron and Bayer HealthCare collaborate on the development, manufacture and commercialisation of aflibercept products for use in the treatment and diagnosis of ocular diseases or disorders through local administration of any product to the eye, including, without limitation, by topical, intravitreal, periorbital, implants or other means of local administration to the eye (the Field).

19 Bayer HealthCare has the exclusive rights to sell and offer to sell aflibercept products in the Field in all countries other than the United States of America. [Redacted] Regeneron and Bayer AG affiliated companies, Regeneron and Bayer HealthCare share in the net profits from the global sales of EYLEA® outside of the United States.

1.7    Retinal and angiogenic eye disorders

20 Angiogenic eye disorders refer to eye diseases associated with angiogenesis, the growth of abnormal blood vessels under the retina. Angiogenesis arises from the overexpression of vascular endothelial growth factor (VEGF), which is the protein responsible for the development of new blood vessels. The growth of abnormal blood vessels under the retina, caused by the overexpression of VEGF, can cause eye impairments for two reasons. First, the abnormal blood vessels are more porous than healthy blood vessels and can leak fluid and blood into the photographic layers of the eye, causing vision loss. Secondly, these abnormal blood vessels can cause damage to otherwise healthy blood vessels, also leading to vision impairment.

21 Other related eye disorders pertaining to leakage of blood and/or fluid from ordinary blood vessels, as opposed to the abnormal blood vessels, are also categorizable under the umbrella of retinal and angiogenic eye disorders.

22 Together, the retinal and angiogenic eye disorders can be further classified as follows:

(a)    Wet macular degeneration (Wet AMD): due to abnormal blood vessels growing under the retina, blood and fluid leakage into the retina causes damage to the macula, a specialised area in the centre of the retina, which is responsible for sharp, central vision. Wet AMD is also referred to by certain experts as neovascular age-related macular degeneration AMD (nvAMD).

(b)    Choroidal neovascularisation secondary to pathologic myopia (Myopic CNV): caused by abnormal blood vessels growing from the choroid into the sub-retinal space, and into the retina, which can leak and damage the retina.

(c)    Diabetic macular oedema (DME): whilst not always caused by angiogenesis, DME occurs as a complication of diabetic retinopathy (DR), which may occur in two stages— non-proliferative or proliferative DR. Non-proliferative DR refers to the early stage of DR and is characterised by blood vessel leakage, whereby capillaries in the retina are damaged and rendered more permeable from microaneurysms, venous beading and intraretinal microvascular abnormalities. The damaged capillaries leak fluid into the macula causing its swelling and thickening. This process is otherwise known as an oedema, which contributes to the blurring of the central vision. Proliferative DR is considered more severe and occurs when the level of ischemia of the retina is such that angiogenesis occurs from increased levels of VEGF. Like Wet AMD, the new and fragile blood vessels can leak or cause haemorrhage or retinal detachment, leading to impairment or loss vision.

(d)    Retinal vein occlusion (RVO): refers to the blockage of retinal veins, which constricts blood leaving the eye. As in DME, anti-VEGF agents are used in RVO to reduce blood and fluid leakage in the eye, rather than to address angiogenesis. The visual impairment can be further divided into blockage in the main vein which takes blood out of the eye —central retinal vein occlusion (CRVO)—or blockage in one of the tributaries of the main vein limiting damage to a specific area—branch retinal vein occlusion (BRVO).

23 The treatment of retinal and angiogenic eye disorders relies on the use of VEGF-antagonists, which work by blocking the action of VEGF to prevent VEGF-driven angiogenesis, thereby treating the symptoms of the underlying disease.

24 Wet AMD and DME are the most prevalent of these diseases. The experts estimated that around 60% of their patients suffer from Wet AMD, around 25% from DME, and around 15% from other retinal vascular diseases including Myopic CNV and RVO.

1.8    VEGF antagonists for treating retinal and angiogenic eye disorders

25 Several VEGF antagonists, being proteins that block VEGF, exist in the form of intravitreal agents. The first VEGF-antagonist used to treat angiogenic eye diseases was ranibizumab, which has been marketed in Australia under the name of LUCENTIS® since 2007. Other VEGF-antagonists include the Applicants’ aflibercept, marketed under the name of EYLEA®; Roche’s faricimab, which is marketed in Australia under the name of VABYSMO®, and bevacizumab, which is marketed as AVASTIN®. AVASTIN® has only been approved for use in Australia for oncology indications.

26 VABYSMO® was initially approved for treating nvAMD only but has subsequently been approved to treat DME. VABYSMO® has very recently been made available in a pre-filled syringe (PFS) form.

27 As I indicated above, Wet AMD and DME are the most common retinal vascular eye diseases which are treated with anti-VEGF drugs. Other neovascular diseases that are also treatable with anti-VEGF drugs include: proliferative DR; RVO; Myopic CNV; multi-focal choroiditis; polypoidal choroidal vasculopathy; and central serous chorioretinopathy. All these conditions are less common than nvAMD or Wet AMD and DME.

28 Novartis launched its brolucizumab in Australia in January 2020 under the name BEOVU® for the treatment of Wet AMD and DME in adults. BEOVU® was made available in Australia in both vial and PFS forms. However, the uptake of BEOVU® has been extremely limited due to post-marketing safety-related concerns.

29 Each of EYLEA®, LUCENTIS® and VABYSMO® are listed on the PBS for a range of indications, including neovascular AMD, DME, RVO and Myopic CNV.

30 Amongst LUCENTIS®, EYLEA® and VABYSMO®, and their corresponding available dosages, EYLEA® 2mg is widely considered as the gold standard treatment by ophthalmologists at present. This is evidenced by the fact that 62% of PBS prescriptions for anti-VEGF drugs are attributable to EYLEA® 2mg prescriptions.

1.9    Aflibercept

31 The EYLEA Aflibercept Products are presently listed on the F1 formulary of the PBS Schedule. Aflibercept is a recombinant fusion protein consisting of extracellular domains of human VEGF receptor (VEGFR) 1 and 2 fused to the FC portion of human IgG1. The binding of VEGF to the VEGFR triggers a cascade of protein transcription and downstream protein-protein interactions giving rise to angiogenesis. Because aflibercept acts as a soluble decoy for the natural VEGFR, it competes against it for VEGF-VEGFR binding, thereby inhibiting the activation of certain genes that are responsible for angiogenesis.

32 Beyond angiogenesis, VEGFRs are a family of receptor tyrosine kinases that can play a critical role in haematopoiesis and lymphangiogenesis. As such, VEGFR decoys specific to angiogenesis such as aflibercept must be VEGF antagonist molecules comprising specific amino acids to ensure specificity to ocular angiogenesis. Specificity to ocular angiogenesis can also be ensured via the administration of VEGF antagonists intravitreally.

33 Aflibercept, the API compound, was claimed in an earlier Australian Patent No. 200050404 entitled “Modified chimeric polypeptides with improved pharmacokinetics properties” in the name of Regeneron, which expired on 23 May 2025.

1.10    The EYLEA® Aflibercept Products

34 The Second Applicant, Bayer Australia, is the sponsor of several products on the ARTG that contain aflibercept as an API in a vial or a PFS form.

35 EYLEA® was first approved for sale in Australia by the Therapeutic Goods Administration (TGA) on 7 March 2012. EYLEA® 2mg was first listed on the PBS on 1 December 2012 in the vial form for the treatment of Wet AMD. Over time, the EYLEA® 2mg vial has been PBS listed for further indications, including DME, CRVO, BRVO and Myopic CNV. For each PBS listing, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended listing on the basis of cost-minimisation compared to ranibizumab. EYLEA® is only eligible for reimbursement through the PBS for the PBS-listed indications.

36 EYLEA® 2mg in PFS form was listed on the PBS on 1 October 2020 for treatment of Wet AMD, DME, CRVO, BRVO and Myopic CNV.

37 The EYLEA® 8mg vial was approved by the TGA and entered on the ARTG for the treatment of Wet AMD and DME on 14 June 2024. In its May 2024 meeting, the PBAC recommended listing of EYLEA® 8mg vial on the PBS for the treatment of Wet AMD and DME, on the basis that it was cost-minimised to the lowest cost of PBS-listed anti-VEGF drugs for the same indications.

38 The EYLEA® 8mg PFS form with the OcuClick dosing system (a syringe design allowing for efficient and accurate dose delivery) was approved by the TGA and was entered on the ARTG for treatment of Wet AMD and DME on 8 October 2024. The PBAC also recommended the listing of the EYLEA® 8mg PFS with the OcuClick dosing system on the PBS for treatment of Wet AMD and DME during its November 2024 meeting. [Redacted].

1.11    The Sandoz Aflibercept Products

39 As I have indicated in paragraphs above, the Sandoz Aflibercept Products comprise AFQLIR® and ENZEEVU®, both of which were registered on the ARTG on the 27 May 2025 in vial and PFS forms. Both AFQLIR® and ENZEEVU® are biosimilars to the 2mg EYLEA Aflibercept Products, meaning that they are biologic drugs that have been granted regulatory approval by comparison with the reference biologic, EYLEA®. The Sandoz Aflibercept Products are registered for the treatment of Wet AMD, CRVO, BRVO, DME and Myopic CNV.

40 As I indicated at [2] above, Sandoz intends to supply AFQLIR® from October 2025 but does not intend to supply ENZEEVU® in 2025.

41 On 2 April 2025, the PBAC put forward the Sandoz Aflibercept Products for consideration at the July 2025 PBAC meeting. The consideration yielded a positive recommendation for the Sandoz Aflibercept Products to be listed on the PBS Schedule as from 1 December 2025.

42 It is not disputed that the Sandoz Aflibercept Products:

(a)    have the claimed amino acid sequence (SEQ ID NO:2);

(b)    are indicated for the treatment of angiogenic eye disorders; and

(c)    are administered via intravitreal injection.

1.12    Other aflibercept products

43 There is only one other ARTG-listed aflibercept biosimilar in Australia, being Celltrion’s EYDENZELT®, which is available in both vial and PFS forms. It is only indicated for Myopic CNV, which represents less than 1% of the PBS prescriptions for EYLEA® 2mg and for the total anti-VEGF market. It is possible that EYDENZELT® could enter the market from April 2026, as it was included in the PBAC Meeting Agenda for November 2025.

44 Mr Behrens gave his understanding of the potential competitor biosimilars of aflibercept, each of which he considered could launch in Australia:

(a)    Samsung Bioepis has developed a biosimilar to aflibercept (OPUVIZ®). Samsung Bioepis’ OPUVIZ® received regulatory approval in the United States in May 2024, in the EU in November 2024, and in South Korea in February 2024 for various indications including Wet AMD, DME, and Myopic CNV.

(b)    Biocon Ltd has developed a biosimilar aflibercept product, known as YESAFILI®, which has received regulatory approval in the EU in September 2023, in the United States in May 2024, and in Canada in June 2025, for various indications including Wet AMD, DME and Myopic CNV. Biocon Ltd settled litigation with Regeneron in the United States in April 2025.

(c)    Amgen received regulatory approval in April 2025 in the EU with respect to its own biosimilar aflibercept product known as PAVBLU®, for treatment of Wet AMD, macular oedema caused by CRVO or BRVO, DME and Myopic CNV. PAVBLU® launched in the United States in October 2024.

(d)    Formycon AG has also developed an aflibercept biosimilar product called AHZANTIVE, which was approved in the EU on 13 January 2025 for the treatment of Wet AMD, macular oedema caused by CRVO or BRVO, DME, and Myopic CNV.

(e)    Apotex Inc. (Apotex) announced on 2 July 2025 that it had obtained regulatory approval in Canada for its aflibercept biosimilar product, known as AFLIVU®, which is indicated for treatment of Wet AMD, macular oedema secondary to BRVO or CRVO, DME and Myopic CNV.

45 Whilst the typical course for pharmaceutical companies is to obtain an ARTG listing before applying to the PBAC, Mr Behrens’ evidence was that it is entirely possible to apply to the PBAC before obtaining an ARTG listing (as was the case for AFQLIR®).

1.13    Biologics v small molecules

46 Mr Behrens outlined the following differences between the market characteristics for biosimilar biologics and for a generic small molecule drug:

(a)    substantially more time and money must be invested in the development of the biosimilar than for a small molecule generic;

(b)    there are significant additional costs incurred in manufacturing a biosimilar drug due to the technology being more complex;

(c)    the inherent variability between biosimilars and their reference biologic means that more investment by biosimilar pharmaceutical companies is required to assure health care professionals (HCPs) and patients that the biosimilar has equivalent safety and efficacy to the reference biologic; and

(d)    there are typically fewer competitors for the same reference biologic because of the high costs of developing and manufacturing a biosimilar and the additional difficulty of convincing HCPs and patients to switch to a subsequent biosimilar in circumstances where the patient has already been switched from the reference biologic to a biosimilar.

47 The nature of aflibercept as a biosimilar to a reference biologic (cf generic small molecules) means that substitution or switching of the EYLEA®, the reference biologic, will be limited. This is due to concerns of immunogenicity and hypersensitivity, the “nocebo” effect, HCP and patient familiarity of aflibercept products already in the market and the availability of patient support programs.

48 A patient’s negative perception of a biosimilar may trigger a “nocebo” effect such that negative expectations unrelated to the drug’s pharmacological effects may lead to worsened symptoms, resulting in diminished perceived or actual therapeutic benefits, or adverse effects.

49 Adverse effects accompanied the introduction of brolucizumab in the United States. On 9 June 2020, the US Food and Drug Administration (FDA) approved a label change for BEOVU® which added warnings about retinal vasculitis and RVO. The TGA has approved an update of the BEOVU® Product Information to include details of reported adverse events. Consequently, there has been a very limited uptake of BEOVU® in Australia, and that experience has led ophthalmologists to be more wary of biologics.

50 Ophthalmologists are concerned by the prospect of “multiple switching’, whereby a patient is switched from a reference biologic to one biosimilar, and subsequently to another biosimilar. There is a concern that immunogenicity and hypersensitivity may be heightened by a switch, or multiple switches, with possible loss of efficacy and increased toxicity of a biologic drug as a result.

1.14    Idiosyncrasies of the VEGF antagonist market

51 The market for VEGF antagonist products for the treatment of retinal and angiogenic eye disorders is described, in broad agreement, by the Applicants’ and Sandoz’s experts. In all the experts’ evidence, the prescription and administration for the VEGF antagonist products are carried out concurrently by treating ophthalmologists.

52 Anti-VEGF drugs have transport, storage and administration requirements that make them different to small molecule drugs. For example, VEGF antagonists need to be refrigerated and kept at 4 degrees Celsius at all times, including during transport and storage. Anti-VEGF drugs are stored for use in the internal fridges of private clinics, or at a nearby pharmacy.

53 Unlike other products, the majority of patients who are prescribed a VEGF antagonist such as EYLEA® never handle the prescription of the drug. Instead, the usual practice in the context of an ophthalmologist administering EYLEA® to a PBS eligible patient is as follows:

(a)    a prescription is sent from the ophthalmologist’s clinic directly to a pharmacy which handles national distribution (cf retail pharmacy) to dispense the product. Examples of such pharmacies include wholesale pharmacies and vertically integrated business groups which manage the storage, supply, distribution and dispensation of specialist medicines. InServio is one of such business groups and comprises Seekwell Pty Ltd (Seekwell), iCare Pharma Distributors Pty Ltd (IPD), InServio Pty Ltd (IPL), and iCare Pharmacy (iCare Pharmacy).

(b)    the dispensed product arrives at the relevant clinic labelled with the corresponding patient’s name;

(c)    the patient arrives at the relevant clinic and receives their anti-VEGF injection;

(d)    the patient pays the required PBS co-payment fee for the anti-VEGF; and

(e)    the pharmacy claims the PBS reimbursement for the product that has been dispensed.

54 In some cases, a patient may collect the anti-VEGF injection from a chemist or pharmacy located nearby the ophthalmologist’s clinic. In such circumstances, the prescription is sent by the ophthalmologist to the dispensing pharmacy. However, these cases are very rare. Mr Behrens deposes that EYLEA®, for instance, is rarely collected by a patient from a retail pharmacy.

55 The mode of supply, dispensing and administration of VEGF antagonists differs from the ordinary meaning of “retail” supply which involves patients collecting their own prescriptions from retail pharmacies such as Chemist Warehouse or Terry White. The corollary of this important distinction is that, insofar as VEGF antagonists are concerned, pharmacists are unable to swap the Applicants’ EYLEA Aflibercept Products for the Sandoz Aflibercept Products. The election between VEGF products occurs almost exclusively at the prescription stage. In other words, only a prescribing ophthalmologist may decide whether to prescribe EYLEA® or the Sandoz Aflibercept Products.

56 A further unique feature of the aflibercept market is the fact that treatment rates for each of the indications is close to 100% of patients. This means that there is not a significant pool of patients who are undiagnosed, or diagnosed but not seeking treatment, or diagnosed and not complying with treatment requirements. Patients who notice their eyesight being compromised tend to seek treatment promptly.

57 Another idiosyncrasy of the VEGF antagonist market is that each of the intravitreal injections available in the market (i.e., aflibercept, ranibizumab, and faricimab) use slightly different devices for the administration of the drug. Each vial and/or PFS for each drug is slightly different. In the context of a PFS, ophthalmologists need to become familiar with using each type of syringe. For example, the EYLEA® PFS is substantially different from the PFS for LUCENTIS®, and from the PFS for administering VABYSMO®. Differences include the pressure required to be applied to the plunger, needle gauge, ease of use and familiarity.

58 In the context of an intravitreal injection, it is critical that the device used enables accurate, efficient and consistent application without introducing infection. Ophthalmologists administer VEGF antagonists to a high volume of patients daily. It is therefore imperative that the ophthalmologist is familiar and comfortable with the device to ensure safe and efficient treatment.

1.15    Sandoz proposed conduct

59 Once AFQLIR® stock arrives in Australia and can be distributed to clinics, Sandoz intends to publish press releases and send communications, such as emails, letters and promotional materials, to HCPs to announce the launch of AFQLIR® and promote its safety and efficacy. Sandoz also intends to issue additional communications in advance of the PBS listing of AFQLIR® on 1 December 2025, if it is permitted to launch.

60 [Redacted].

61 Sandoz does not intend to exploit its ENZEEVU® product in Australia during at least 2025.

2.    INTERLOCUTORY INJUNCTION PRINCIPLES

62 The principles concerning the grant of an interlocutory injunction are not controversial. An applicant for an interlocutory injunction must show that it has a prima facie case “in the sense that if the evidence remains as it is there is a probability that at the trial of the action” it will obtain the injunctive relief sought and that the balance of convenience favours such injunctive relief: see Samsung Electronics Co Ltd v Apple Inc (2011) 217 FCR 238 at [53]–[55], [60]–[67] (Dowsett, Foster and Yates JJ).

63 Regarding the first question, a prima facie case does not require that an applicant for interlocutory injunction show that it is more probable than not that it will succeed at trial. It is sufficient that the applicant shows a sufficient likelihood of success to justify in the circumstances the preservation of the status quo pending the trial: Beecham Group Ltd v Bristol Laboratories Pty Ltd (1968) 118 CLR 618 at 622–3, 625 (Kitto, Taylor, Menzies and Owen JJ), cited with approval in Australian Broadcasting Corporation v O’Neill (2006) 227 CLR 57 at [65] (Gummow and Hayne JJ). The threshold of sufficient likelihood of success recognises the serious consequences for the respondent where the interlocutory relief is granted: Samsung at [51] (Dowsett, Foster, Yates JJ).

64 The requisite likelihood of success for establishing a prima facie case is not to be considered in isolation and varies depending on the nature of the rights that are being asserted, and the harm likely to flow to the applicant unless the injunction sought is granted.

65 Where an interlocutory injunction is sought for threatened patent infringement and the alleged infringer alleges the patent is invalid, the applicable principles are found in the summary by the Full Court in Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd (2019) 139 IPR 409 at [8]–[10] (Jagot, Yates and Moshinsky JJ). At [10], their Honours explained that the apparent strength of the parties’ substantive cases will often be an important consideration to be weighed in the balance of convenience. Further, at [14], they explained that “a sufficiently strong case of invalidity may well qualify the conclusion that there is a prima facie case of infringement at all. […] What is relevant is the strength of the case that the claim or claims said to be infringed are invalid”.

66 Regarding the balance of convenience, the relevant considerations under the exercise of the discretion were summarised by the Full Court in Samsung at [66] as follows:

In exercising that discretion, the Court is required to assess and compare the prejudice and hardship likely to be suffered by the defendant, third persons and the public generally if an injunction is granted, with that which is likely to be suffered by the plaintiff if no injunction is granted. In determining this question, the court must make an assessment of the likelihood that the final relief (if granted) will adequately compensate the plaintiff for the continuing breaches which will have occurred between the date of the interlocutory hearing and the date when final relief might be expected to be granted.

3.    PRIMA FACIE CASE

3.1    The 599 Patent

67 The 599 Patent claims a priority date of 13 January 2011. The claims alleged to be infringed are 1, 3, 4, 5 and 12 (Asserted 599 Claims). The parties accept that the post-Raising the Bar form, being that amended by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth), of the Act applies.

68 The 599 Patent describes the field of invention as relating to the field of therapeutic treatments of eye disorders and, more specifically, the administration of VEGF antagonists to treat eye disorders caused by or associated with angiogenesis.

69 Various eye disorders associated with pathological angiogenesis are described at [0002], including Wet AMD, DME and CRVO. At [0003], the 599 Patent notes that FDA-approved treatments of angiogenic eye disorders such as AMD and CRVO include the administration of an anti-VEGF antibody called ranibizumab (LUCENTIS® Genentech, Inc.) on a monthly basis by intravitreal injection. Despite methods for treating eye disorders using VEGF antagonists being mentioned in prior patents, the 599 Patent notes that “there remains a need in the art for new administration regimens for angiogenic eye disorders especially those which allow for less frequent dosing while maintaining a high level of efficacy”.

70 The invention is summarised in [0005] as methods for treating angiogenic eye disorders comprising sequentially administering multiple doses of a VEGF antagonist to a patient over time. The sequential administration of a VEGF antagonist is specified as comprising a single initial dose of a VEGF antagonist, followed by one or more secondary doses of the VEGF antagonist, followed by one or more tertiary doses of the VEGF antagonists. In the same paragraph, the Specification notes that the “[…] inventors have surprisingly discovered that beneficial therapeutic effects can be achieved in patients suffering from angiogenic eye disorders by administering a VEGF antagonist to a patient at a frequency of once every 8 or more weeks, especially when such doses are preceded by about three doses administered to the patient at a frequency of about 2 to 4 weeks.”

71 In the same paragraph, the Specification states that “thus, according to the methods of the present invention, each secondary dose of VEGF antagonist is administered at least 8 weeks after the immediately preceding dose”. One advantage of such a dosing regimen is identified as allowing for less frequent dosing, as “for most of the course of treatment (i.e., the tertiary doses), it allows for less frequent dosing (e.g., once every 8 weeks) compared to prior administration regimens for angiogenic eye disorders which require monthly administrations throughout the entire course of treatment. See, e.g., prescribing information for LUCENTIS® [ranibizumab], Genentech, Inc.)”.

72 The wording of the Specification does not specify or limit the identity of the VEGF antagonist to which the method applies. Indeed, the Specification states at [0007] that:

The methods of the present invention comprise administering any VEGF antagonist to the patient. In one embodiment, the VEGF antagonist comprises one or more VEGF receptor-based chimeric molecule(s), (also referred to herein as a “VEGFTrap” or “VEGFT”). An exemplary VEGF antagonist that can be used in the context of the present invention is a multimeric VEGF-binding protein comprising two or more VEGF receptor-based chimeric molecules referred to herein as “VEGFR1 R2-FcC1 (a)” or “aflibercept”.

73 At [0009] the Specification notes that Aflibercept (EYLEATM) was approved by the FDA in November 2011, for the treatment of patients with Wet AMD with a recommended dose of 2 mg administered by intravitreal injection every 4 weeks for the first three months, followed by 2 mg administered by intravitreal injection once every 8 weeks.

74 The terms “initial dose”, “secondary doses” and “tertiary doses” are defined at [0016] as follows:

(a)    the “initial dose” is the dose which is administered at the beginning of the treatment regimen (also referred to as the “baseline dose”);

(b)    the “secondary doses” are the doses which are administered after the initial dose; and

(c)    the “tertiary doses” are the doses which are administered after the secondary doses.

75 The Specification then states that the “initial, secondary, and tertiary doses may all contain the same amount of VEGF antagonist but will generally differ from one another in terms of frequency of administration. In certain embodiments, however, the amount of VEGF antagonist contained in the initial, secondary and/or tertiary doses will vary from one another (e.g., adjusted up or down as appropriate) during the course of treatment”.

76 At [0017], one exemplary embodiment of the invention is said to be where:

Each secondary dose is administered 2 to 4 (e.g., 2, 2½, 3, 3½, or 4) weeks after the immediately preceding dose, and each tertiary dose is administered at least 8 (e.g., 8, 8½, 9, 9½, 10, 10½, 11, 11½, 12, 12 , 13, 13½, 14, 14½, or more) weeks after the immediately preceding dose. The phrase “the immediately preceding dose,” as used herein, means, in a sequence of multiple administrations, the dose of VEGF antagonist which is administered to a patient prior to the administration of the very next dose in the sequence with no intervening doses.

77 At [0019], the Specification notes that the methods of the invention may comprise administering to a patient any number of secondary and/or tertiary doses of a VEGF antagonist.

78 From [0021] to [0022], the term “VEGF antagonists” means “any molecule that blocks, reduces or interferes with the normal biological activity of VEGF” and is said to include “molecules which interfere with the interaction between VEGF and a natural VEGF receptor. Specific exemplary VEGF antagonists include anti-VEGF antibodies, anti-VEGF receptor antibodies, and VEGF receptor-based chimeric molecules (also referred to herein as “VEGF-Traps”).”

79 At [0030], the Specification describes each dose of the dosing regimen as a “therapeutically active amount”. A therapeutically active amount is defined as a “dose of VEGF antagonist that results in a detectable improvement in one or more symptoms or indicia of an angiogenic eye disorder, or a dose of VEGF antagonist that inhibits, prevents, lessens, or delays the progression of an eye disorder”. In the case of an anti-VEGF antibody or a VEGF receptor-based chimeric molecule such as VEGFR1R2-FcC1(a), a therapeutically effective amount can be from about 0.05 mg to about 5 mg.

80 At [0032], the Specification specifies, using the number of weeks as a parameter, when the claimed invention begins to demonstrate efficacy. More specifically, it discloses that the methods of the invention demonstrate efficacy within 104 weeks of the initiation of the treatment regimen. In the same paragraph, the Specification expressly notes that the measurement of the 104 weeks begins with the initial dose administered at week 0. Efficacy is then defined by reference to the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. For AMD, CRVO and DME, “efficacy” means where “the patient exhibits a loss of 15 or fewer letters on ETDRS visual acuity chart”. In certain embodiments, “efficacy” also means a gain of one or more letters on the ETDRS chart.

81 At [0034], the Specification discloses that the VEGF antagonist used in all Examples in the 599 Patent is “a dimeric molecule having two functional VEGF binding units” with each functional binding unit comprising an “Ig domain 2 from VEGFR1 fused to Ig domain 3 from VEGFR2, which in turn is fused to the hinge region of a human IgG1 Fc domain VEGFR1R2-FcC1(a); encoded by SEQ ID NO:1”. The paragraph further specifies that for the purposes of the Examples, the method of using the specific VEGF antagonist encoded by SEQ ID NO:1, referred to as “VEGFT”, the dosing regimen is to be measured by a parameter where “monthly” dosing is equivalent to dosing once every four weeks.

3.2    Person skilled in the art

82 It was common ground that the person skilled in the art is an ophthalmologist, being the medical practitioner responsible for treating angiogenic eye disorders.

83 The person skilled in the art would have experience in treating patients with angiogenic eye disorders, including Wet AMD and DME, an understanding of the pathology of those eye disorders and would be familiar with the existing treatments and treatment regimens for them.

84 Each of the ophthalmologist witnesses had such specialised knowledge and experience.

3.3    The issues

85 The present dispute concerns a challenge to the strength of the Applicants’ patent infringement case, which Sandoz advances on the bases of non-infringement and invalidity, and whether the balance of convenience and justice warrants the grant of the interlocutory relief sought.

86 Regarding the strength of the prima facie case, the following issues arise. First, whether the Applicants have established a sufficiently strong prima facie case of infringement of the Asserted 599 Claims. Secondly, whether considering the strength of the infringement case, the cross-claim for revocation of the Asserted Claims is such that the Applicants’ infringement case unlikely to succeed.

87 For the purposes of this interlocutory application Sandoz’s invalidity case raises three grounds:

(1)    lack of novelty;

(2)    lack of inventive step; and

(3)    lack of support limited to the question of disclosure and technical contribution, not enablement.

88 For the purpose of the interlocutory application, Sandoz confines its want of novelty case under s 7(1) of the Act to the following prior art documents:

(1)    Adis Data Information BV, “Aflibercept,” (2008): 9(4) Drugs R&D, page 261-269, published in 2008 (Adis); and

(2)    Dixon, J.A., et al, “VEGF Trap-Eye for the Treatment of Neovascular Age-related Macular Degeneration”, (2009): 18(1) Expert Opin. Investig. Drugs, 1573–1580, published in 2009 (Dixon).

3.4    Infringement

89 The Applicants’ case is that the Sandoz PI contains instructions or inducements to use the Sandoz Aflibercept Products in the manner claimed in the Asserted 599 Claims, and that by reason of that material, Sandoz has reason to believe that the products will be used in that way, giving rise to infringement under sections 117(1), (2)(b) and (c) of the Act. The Applicants also contend that this conduct will give rise to infringement by authorising persons other than the patentee to use the claimed method in contravention of the exclusive rights conferred by s 13 of the Act.

90 The Applicants allege infringement against Sandoz with respect to treatment of Wet AMD and DME.

91 Sandoz admits that the Sandoz PI contains instructions to use the Sandoz Aflibercept Products in a manner that would satisfy numerous integers of the methods claimed in the Asserted 599 Claims. However, Sandoz disputes that certain essential features of integers 1.3 and 1.4 are not taken by way of ss 117(2)(c) and 117(2)(b) and (c) of the Act, correspondingly. Sandoz further contends that the Sandoz PI is not “given” to ophthalmologists within the meaning of s 117(2)(c) of the Act.

92 Sandoz accepts that it has reason to believe that for the treatment of Wet AMD and DME some patients will be administered each Sandoz Aflibercept Product 4 weeks after the immediately preceding dose. However, Sandoz does not accept that it has a reason to believe that each tertiary dose will be administered 8 weeks after the immediately preceding dose, because:

(a)    the treat-and-extend regimen involves doses being administered at intervals other than 8 weeks; and

(b)    patient and ophthalmologist availability, preferences and logistics inevitably result in doses being administered at intervals other than 8 weeks even where there is an intention to administer at 8 weekly intervals (e.g. at 7.5 weeks, 8.5 weeks)

93 For the present purposes of the interlocutory injunction application, it suffices that the infringement case be considered by reference to claim 1 of the 599 Patent (integer numbers added):

(1.1) A method for treating an angiogenic eye disorder in a patient, comprising: (1.2) sequentially administering to the patient a single initial dose of a VEGF antagonist, followed by one or more secondary doses of the VEGF antagonist, followed by one or more tertiary doses of the VEGF antagonist;

(1.3) wherein each secondary dose is administered 2 to 4 weeks after the immediately preceding dose; and

(1.4) wherein each tertiary dose in administered 8 weeks after the immediately preceding dose

(1.5) wherein the VEGF antagonist is a VEGF receptor-based chimeric module comprising:

(1) a VEGFR1 component comprising amino acids 27 to 129 of SEQ ID NO:2;

(2) a VEGFR2 component comprising amino acids 130-231 of SEQ ID NO:2; and

(3) a multimerization component comprising amino acids 232-457 of SEQ ID NO:2.

94 This is because of the interrelationship between the claims of the Asserted 599 Claims, wherein claim 1 is the independent claim upon which the remaining dependent claims depend on. Claims 3 and 4 are method claims dependent on claim 1. Claim 5 is a dependent method claim of claim 4 and is therefore dependent on claim 1. Claim 12 is a method claim dependent on claim 7. Claim 7 is not asserted but is also dependent on claim 1.

95 Further, the focussed consideration of claim 1 aligns with Sandoz’s position as pleaded in its response to the Applicants’ position statement on infringement (PSI). The relevant PSI integers in claim 1, being the integers which are in contention, are 1.3 and 1.4. The primary dispute is therefore one of claim construction and concerns whether the Sandoz Aflibercept Products dosing regimen, as contained in the Sandoz PI, take integers 1.3 and 1.4 of claim 1 of the 599 Patent.

96 The dispute on infringement, is confined to:

(a)    a construction argument on whether an “instruction” to inject the relevant drug once a month amounts to an instruction to use it 4 weeks after the preceding dose;

(b)    a construction argument on whether an “instruction” to administer the product two months after the preceding dose amounts to an instruction to use it 8 weeks after the preceding dose; and

(c)    an argument on whether the “clear instructions” in the Sandoz PI in relation to Wet AMD that the product be administered “every two months” is overtaken by the introductory statement that when optimal visual acuity is achieved and/or there are no signs of disease activity, a treat-and-extend regimen may be used.

97 Sandoz also advances, as both a non-infringement argument and a reason why no injunction should be granted, a contention based on the evidence of A/Prof Wickremasinghe that he does not prescribe or administer aflibercept in accordance with the treatment regimen outlined in the EYLEA Aflibercept Products’ product information (which is in similar terms as the Sandoz Product Information). Neither A/Prof Daniell nor A/Prof Symons gave evidence as to their usual treatment regimens for EYLEA®. Sandoz submits that it is “rare” for any ophthalmologist to follow the regimen in the Sandoz PI. Thus, even if the Sandoz PI contains “instructions” for purportedly infringing use, most use of the Sandoz Aflibercept Products will not qualify as infringing use.

3.4.1    Sandoz PI

98 The Sandoz PI is Annexure B to the Amended Statement of Claim dated 18 June 2025.

99 Sandoz submits that it will not proactively distribute the Sandoz PI pertaining to AFQLIR® to ophthalmologists or patients. While Sandoz is not a member of Medicines Australia, the company refers to the Medicines Australia Code of Conduct (Code of Conduct) as a framework for best practice. In accordance with the Code of Conduct, as a sponsor of a medicine entered in the ARTG, Mr Behrens deposes that Sandoz will provide the Sandoz PI document to an HCP if they request it. The Code of Conduct also requires that promotional materials include a statement directing that HCPs are to review the product information of a medication before prescribing it. The Code of Conduct further stipulates that the foregoing statement must include the means for HCPs to access the product information immediately in electronic or other form, or the telephone number of the Company medical information service: see code 2.1 of the Code of Conduct.

100 According to Mr Behrens, the Sandoz PI will also be published on the TGA website in accordance with the Therapeutic Goods Act 1989 (Cth) (TG Act) requirements. Mr Behrens further deposes that the Sandoz website will include a hyperlink to the TGA website on which the product information is published.

101 The Sandoz PI provides the following in relation to Wet AMD and DME:

The interval between doses injected into the same eye should not be shorter than one month.

Advice on treatment initiation and maintenance of therapy specific to each patient population is described in the section below. Once optimal visual acuity is achieved and/or there are no signs of disease activity, treatment may then be continued with a treat-and-extend regimen with gradually increased treatment intervals to maintain stable visual and/or anatomic outcomes. If disease activity persists or recurs, the treatment interval may be shortened accordingly. Monitoring should be done at injection visits. The monitoring and treatment schedule should be determined by the treating ophthalmologist based on the individual patient’s response. If visual and anatomic outcomes indicate that the patient is not benefiting from continued treatment, AFQLIR should be discontinued.

* Treatment of neovascular (wet) age-related macular degeneration (wet AMD)

AFQLIR 2 mg treatment is initiated with one AFQLIR 2 mg injection per month for three consecutive months, followed by one injection every two months.

Based on the physician’s judgement of visual and/or anatomic outcomes, the treatment interval may be maintained at two months or further extended using a treat-and-extend dosing regimen, by increasing injection intervals in 2- or 4-weekly increments while maintaining stable visual and/or anatomic outcomes. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened to a minimum of four weeks based on anatomical and/or visual outcomes.

[…]

* Treatment of diabetic macular oedema (DME)

AFQLIR 2 mg treatment is initiated with one AFQLIR 2 mg injection per month for five consecutive months.

Following the initiation period and based on the physician’s judgement of visual and/or anatomic outcomes, the treatment interval may then be maintained at an injection every two months or further individualised, such as with a treat-and-extend dosing regimen, by increasing injection intervals in 2- or 4-weekly increments while maintaining stable visual and/or anatomic outcomes. If visual and/or anatomic outcomes deteriorate, the treatment interval should be shortened accordingly. Treatment intervals shorter than 4 weeks or longer than 4 months have not been studied (see Section 5.1 Pharmacodynamic properties, Clinical trials).

(Emphasis added in italics.) (Emphasis in original in bold.)

102 In addition to Wet AMD and DME, the Sandoz PI also discusses treatment using the Sandoz Aflibercept Products for CRVO, BRVO and CNV.

3.4.2    Ophthalmologist treatment regimens for EYLEA® 2mg

103 A/Prof Wickremasinghe currently uses EYLEA® 2mg as his standard treatment for both Wet AMD and DME. He uses what he describes as a “treat-and-extend” strategy which he considers to be the standard treatment strategy for Wet AMD in the Australian ophthalmology community. A/Prof Wickremasinghe notes that because the treatment of DME is less predictable, “a treat-and-extend strategy can be less useful in DME (although for some patients, it is appropriate)”.

104 A/Prof Symons gave evidence of the pre-priority date use of LUCENTIS® on a treat-and-extend basis. Prof Daniell gave evidence that he treated patients with EYLEA®, but gave no details of the treatment regimen he followed.

105 A/Prof Wickremasinghe described his “treat-and-extend” treatment strategy as follows:

48. In wet AMD, this consists of administering injections every 4 weeks until the patient has achieved their best vision and their retina is free from fluid. These doses are referred to as “loading doses”. Following achievement of that stability, I then extend the interval between each injection. I would most commonly extend the interval by 2 weeks at each visit. For example, if the patient's macula is dry after the last injection at a 4 week interval, I will administer the next injection at a 6 week interval, and then at 8 weeks, 10 weeks and 12 weeks, and so on, until the patient reaches a point where fluid returns or their vision decreases. Once that happens, I decrease the interval to the interval at which they were last stable. For example, if there was a recurrence at 14 weeks, I might try an interval of 10 weeks or 12 weeks and maintain that interval for a few doses before challenging the patient with a higher interval again, once their disease is stable and they are suitable to extend again.

49. The patient's suitability to extend a dosage interval (whether for the first time, or after decreasing an interval) is based on an assessment of the amount of fluid in the patient's macula, their level of vision, and how long their vision has remained that way. It also depends on my and the patient's willingness to extend out their injections and the risk of doing so. For example, if the patient's other eye has good vision, there is less at risk in challenging the eye I am treating. However, if their other eye has poor vision, I would take a more cautious approach to extending dosage intervals for the eye I am treating.

[…]

53. After the initial doses, and then a dose at typically 6 weeks, approximately:

(a)     40% of my wet AMD patients receive their doses between 8 and 10 weeks apart;

(b)    30% of my wet AMD patients are "stuck" at receiving a dose between 4 to 6 weeks apart, as their disease deteriorates when attempting to extend further than that interval; and

(c)     30% of my wet AMD patients can tolerate an interval of 12 to 16 weeks between doses.

54. Additionally, sometimes patients effectively extend their dosage themselves. For example, if their next dose is scheduled at an 8-weekly interval, but they reschedule that appointment for a week later, they have extended their dose to 9 weeks. If they tolerate that extension, I will likely extend again to 10 weeks for their next dose. However, if the 9-week interval prompts additional disease activity, then I will reduce the interval to 8 weeks again. I estimate that this unintentional extension occurs at least once for approximately 5% of the patients that I treat for wet AMD.

55. Further, notwithstanding the best intentions to treat patients at the precise interval intended (e.g. 2, 4, 6 or 8 weeks) often that is not possible due to practical realities such as patient inconvenience, doctor availability, illness and public holidays. Across any given patient's treatment course, there will invariably be at least some deviations from the intended treatment interval of at least several days.

(Emphasis added.)

106 A/Prof Wickremasinghe also gave the following evidence as to his use of “weeks” rather than months in his scheduling of patient appointments:

51. When I refer to extending by a number of weeks, both here [(being treatment of Wet AMD)] and in the context of DME, RVO and mCNV [(being Myopic CNV)], I mean that the patient returns on the same day of the week whether it be 1, 2, 3 or 4 etc weeks later. The software used by my practice enables such week-based appointments. Even where I am extending by 4 weeks, I do not book appointments in “monthly” because this results in some return dates being on weekends and variable intervals as some months do not have 31 days.

3.4.3    Construction principles

107 The principles of claim construction are well-established as set out in Jupiters Ltd v Neurizon Pty Ltd (2005) 65 IPR 86 at [67] (Hill, Finn and Gyles JJ); Décor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 at 400 (Sheppard J); and Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331 at [70]–[81] (Hely J). It suffices to note that the claims are to be construed “[…] from the perspective of a person skilled in the relevant art as to how such a person, who is neither particularly imaginative nor particularly inventive (or innovative), would have understood the patentee to be using the words of the claim in the context in which they appear […] in the light of the common general knowledge before the priority date”: Product Management Group Pty Ltd v Blue Gentian LLC (2015) 116 IPR 54 at [35] (Kenny and Beach JJ).

108 Claims are also to be construed in the context of the specification as a whole. However, it is not legitimate to narrow or expand the boundaries of the monopoly as delineated by the words of a claim via the addition to those words glosses drawn from other parts of the specification. Where terms are unclear, those terms may be defined by reference to the body of the specification, but the body of the specification cannot be used to change a clear claim for one subject matter into a claim for another and different subject matter.

109 It is well-established that a patent specification should be given a “purposive” construction, not a “purely literal”, “meticulous verbal analysis” or a “too technical or narrow” construction. A specification should be read in a practical and common-sense way: see Glass Hardware v TCT Group Pty Ltd (2024) 182 IPR 1 at [87] (Yates, Charlesworth and Rofe JJ), and cases cited therein.

110 To apply a “purposive” construction does not justify extending the patentee’s monopoly to the “ideas” disclosed in the specification: at [40] of Blue Gentian (per Kenny and Beach JJ). Instead, its application should be guided by considerations including those addressed by Hoffmann LJ when his Honour explained “purposive construction” in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd (2004) 64 IPR 444 at [33]–[34], a passage which has been endorsed by the Full Court including in Blue Gentian at [41] and Tramanco Pty Ltd v BPW Transpec Pty Ltd (2014) 105 IPR 18 at [174] (Nicholas J). The foregoing was fleshed out by the Full Court in Glass Hardware at [88]:

To apply a “purposive” construction does not justify extending the patentee’s monopoly to the “ideas” disclosed in the specification: at [40] of Blue Gentian (per Kenny and Beach JJ). Instead, its application should be guided by considerations including those addressed by Hoffmann LJ when his Honour explained “purposive construction” in Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] 1 All ER 667; (2004) 64 IPR 444; [2004] UKHL 46 at [33]–[34], a passage which has since been endorsed by the Full Court including in Blue Gentian at [41] (per Kenny and Beach JJ) and Tramanco at [174] (per Nicholas J). In particular at [34], Hoffmann LJ observed:

“Purposive construction” does not mean that one is extending or going beyond the definition of the technical matter for which the patentee seeks protection in the claims. The question is always what the person skilled in the art would have understood the patentee to be using the language of the claim to mean. And for this purpose, the language he has chosen is usually of critical importance. The conventions of word meaning and syntax enable us to express our meanings with great accuracy and subtlety and the skilled man will ordinarily assume that the patentee has chosen his language accordingly. As a number of judges have pointed out, the specification is a unilateral document in words of the patentee’s own choosing. Furthermore, the words will usually have been chosen upon skilled advice. The specification is not a document inter rusticos for which broad allowances must be made. On the other hand, it must be recognised that the patentee is trying to describe something which, at any rate in his opinion, is new; which has not existed before and of which there may be no generally accepted definition. There will be occasions upon which it will be obvious to the skilled man that the patentee must in some respect have departed from conventional use of language or included in his description of the invention some element which he did not mean to be essential. But one would not expect that to happen very often.

111 The only construction issues in the present application are whether “2 to 4 weeks” in the claims encompasses “monthly” dosing (as instructed by the Sandoz PI), and whether the claim integer of administering tertiary doses “8 weeks after the immediately preceding dose” encompasses tertiary dosing every two months (as the Sandoz PI instructs). It was not suggested that “2 to 4 weeks” and “8 weeks” were other than ordinary English words.

112 It is trite to say that the 599 Patent should be construed as if the alleged infringer had never been born. I will begin by construing the relevant integers without regard to the Sandoz PI, before considering whether the integer is present in the statements of the Sandoz PI.

3.4.4    Four weeks is not equivalent to a month

113 The relevant claim integer 1.3 is “wherein each secondary dose is administered 2 to 4 weeks after the immediately preceding dose […]”.

114 All discussion of periods of time between doses, as pertaining to the dosing regimen of the claimed invention, in the Specification is measured in terms of weeks, from 2 weeks to 104 weeks. Whilst there is description of time periods between administration by reference to months, these descriptions are strictly confined to the Examples.

115 At [0005], the Specification describes an advantage of the dosing regimen of the invention as being that for most of the course of treatment (i.e., the tertiary doses) it allows for “less frequent dosing (e.g., one every 8 weeks)” compared to prior regimens which required monthly administration.

116 At [0009], the Specification notes that aflibercept was approved by the FDA in November 2011, for the treatment of patients with Wet AMD, with a recommended dose of 2 mg administered by intravitreal injection every 4 weeks for the first three months, followed by 2 mg administered by intravitreal injection once every 8 weeks. The dosing regimen is again described via the parameter of “weeks” to measure the period between doses. It is apparent that the term “months” is used only as a descriptor of the duration of the dosing regimen, not the time periods between each dose within the dosing regimen itself.

117 Figure 1 shows an exemplary dosing regimen of the invention. In that dosing regimen, two secondary doses are administered at weeks 4 and 8 respectively, and at least six tertiary doses which are administered once every 8 weeks thereafter (i.e. at weeks 16, 24, 32, 40, 48, 56). The doses are depicted in Figure 1 as falling precisely on the week marker. There is no depiction of any margin for error, or +/- any days from the week mark.

118 At [0017], the Specification describes one exemplary embodiment of the invention wherein each secondary dose is administered 2 to 4 (e.g., 2, 2½, 3, 3½, or 4) weeks after the immediately preceding dose. The examples of what constitute “2 to 4 weeks” do not contemplate any period outside that range, including outside the upper limit of 4 weeks such as 4½ weeks. The discussion in [0018] of another embodiment speaks of the secondary doses being administered 4 weeks after the preceding dose “(i.e., at week 4 and at week 8)”. I have emphasised the use of “at” rather than “in”, which suggests a precision in dosing on the 4-week mark, rather than in or around the fourth week.

119 At first blush, the precision of the patentee’s reference to time periods in weeks sits slightly awkwardly with the evidence regarding ophthalmologist practice given by A/Prof Wickremasinghe. In the context of discussing the 8 weeks integer, his evidence was that in the case of patients being maintained on 8 weekly dosing, as a matter of practical reality, in his experience none of those patients would be administered aflibercept exactly every 8 weeks (i.e., every 56 days). Given the exigencies of life, illness and public holidays, patients will often receive a dose at a different interval such as after 7 weeks and 5 days, after 8 weeks and 4 days or after 9 weeks. Across any given patient's treatment course, A/Prof Wickramasinghe considered that there will invariably be at least some deviations from the intended treatment interval of at least a few days.

120 The Applicants contend for a purposive construction in which 4 weeks is equivalent to a month. In particular, they refer to [0034] which notes that “[f]or the purposes of the following Examples “monthly” dosing is equivalent to dosing once every four weeks”. Importantly, as I noted above, this comment is expressly restricted to the Examples rather than being inclusive of the description of the invention and its embodiments. Notwithstanding that comment, and a discussion of the prior art dosing regimen in terms of “monthly administrations”, the patentee deliberately chose to use weeks rather than months in the claims, and not to adopt qualifiers such as “at least” or “from” or “around” in relation to the specified number of weeks.

121 Adopting a commonsense construction, my provisional view is that the “2 to 4 weeks” integer requires the secondary dose to be administered in or within the time period range of 2 to 4 weeks after the immediately preceding dose. Claim 1 claims a range of time in which the secondary dose is administered after the immediately preceding dose, being within 2 to 4 weeks. The examples given or the “id est” specification (meaning, “that is”) of what is meant by that range are all within the range, capped at four weeks. There is no discussion of any secondary dose being given after 4 weeks. There is no reference to “at least 2 to 4 weeks” or other qualification to that range in the Specification. The two-week range of “2 to 4 weeks” provides sufficient flexibility to allow for illness, public holidays or other exigencies, so that the dose will be within that specified window, without the need for inferring any +/- days outside that window. The flexibility afforded by the range “2 to 4 weeks” resolves the apparent tension between the patentee’s choosing of the term “weeks” and A/Prof Wickremasinghe’s evidence on practical administrative realities. Indeed, what appeared to be overparticular diction with respect to the word “weeks” is ameliorated by the range of two weeks provided by “2 to 4 weeks”.

122 The Sandoz PI provides that for Wet AMD, secondary doses of AFQLIR® are one AFQLIR® 2 mg injection per month for three consecutive months, followed by one injection every two months.

123 The Applicants contend that the Sandoz PI itself treats 4 weeks as equivalent to one month. The Sandoz PI expressly refers to “[t]reatment intervals greater than four months (16 weeks) […] between injections” as not having been studied. Importantly, the reference of weeks pertains to hypothetical treatment intervals not falling within the guideline dosing regimen of AFQLIR®.  The Sandoz PI does, on the other hand, provide that the intervals between doses comprising the dosing regimen “should not be shorter than one month”. The reference to “a minimum of four weeks” is reserved for circumstances where “visual and/or anatomic outcomes deteriorate”, necessitating greater precision by reference to “weeks” rather than “months”. Rather than grounding a general implication that the Sandoz PI treats
a month as equivalent to 4 weeks as suggested by the Applicants, I consider that the use of the term “a minimum of four weeks” in the Sandoz PI arises from the necessity of greater precision and a closer proximity between doses where patients exhibit visual and/or anatomic deterioration. Relatedly, I further consider “a minimum of four weeks” as setting the lowest limitation of the suggested monthly dose. In this sense, “a minimum of” is akin to “at least”, which I discuss below on the dosing regimen of tertiary doses.

124 Lastly, whilst 4 weeks may be equivalent to a month in February, it will not be the case for the other eleven months of the year. At this stage, my provisional view is that “one month” or “each month” is not equivalent to “2 to 4 weeks”, and the language used by the Sandoz PI regarding the dosing regimen does not cause it to fall within claim 1.

3.4.5    Eight weeks is not equivalent to two months

125 The relevant claim integer 1.4 is “wherein each tertiary dose is administered 8 weeks after the immediately preceding dose […]”.

126 The Specification describes the administration of tertiary doses other than at precisely 8-week intervals. At [0017], the Specification speaks of a tertiary dose being administered “at least 8 (e.g. 8, 8½, 9, 9½, 10, 10½, 11, 11½, 12, 12½, 13, 13½, 14, 14½, or more) weeks after the immediately preceding dose”.

127 At [0020] of the Specification, a further embodiment of the invention is described wherein each subsequent tertiary dose is administered “from 8 to 12”. Examples from 8 to 12 weeks are again given (e.g. 8, 8½, 9, 9½, 10, 10½, 11, 11½, 12). The Specification also notes in the same paragraph that the frequency of administration may be adjusted during the course of treatment depending on the needs of the individual patient.

128 The Applicants refer to public literature and ophthalmologist practices to urge a purposive construction in which 8 weeks (or 56 days) is equivalent to two months. I note that two months will range from 59 days (February to March) to 62 days (July to August), both of which are in excess of 56 days and/or 8 weeks.

129 Adopting a commonsense construction, my provisional view is that the “8 weeks” integer requires the tertiary dose to be administered 8 weeks after the immediately preceding dose. I consider that “8 weeks” will encompass 8 weeks +/- one day on either side to accommodate for public holidays, the exigencies of life and other delays including those of administrative nature. The Specification contemplates periods between administration of tertiary doses of “at least” 8 weeks or “from” 8 weeks and expressly refers to the prior regimen for VEGF antagonist administration requiring “monthly” administration. However, the patentee deliberately chose to claim “8 weeks” without adding any qualification to that period.

130 Whilst the published literature and ophthalmologist practice may suggest a more flexible approach to periods of time in VEGF antagonist dosing regimens, the patentee has chosen to use the specific language of 8 weeks without qualification.

131 Relevantly, the Full Court in Glass Hardware observed at [96]:

Calling in aid a combination of purposive construction, together with the application of common sense, does not enable words deliberately chosen by the patentee to be broadened beyond their ordinary English meaning to expand the scope of the monopoly claimed (to what the patentee may have intended) in order to catch a creative alleged infringer, whilst maintaining priority from the earlier specification.

132 Purposive construction cannot be used to read in words of qualification used in the specification into the claim where the patentee has deliberately chosen not to include those words.

133 The Sandoz PI provides that for Wet AMD, the tertiary doses of AFQLIR® 2 mg injection is to be given every two months. For DME, the Sandoz PI provides:

Following the initiation period and based on the physician’s judgement of visual and/or anatomic outcomes, the treatment interval may then be maintained at an injection every two months or further individualised, such as with a treat-and-extend dosing regimen, by increasing injection intervals in 2- or 4-weekly increments while maintaining stable visual and/or anatomic outcomes.

(Emphasis added.)

134 Taken at its highest, the Sandoz PI provides guiding statements that the tertiary doses be administered “every two months”, which could be 59 to 62 days depending on the months. This is outside the claimed 8 weeks, which only accommodates for 8 weeks +/- a day. Whilst every two months might be considered as being “at least 8 weeks”, that is not what is claimed. Claim 1 requires exactly 8 weeks, with no qualification. On the current evidence I consider that the two months specified in the Sandoz PI falls outside the period claimed in claim 1.

3.4.6    Section 117

135 Sections 117(1) and (2) of the Act stipulate:

(1)    If the use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement of the patent by the supplier unless the supplier is the patentee or licensee of the patent.

(2)    A reference in subsection (1) to the use of a product by a person is a reference to:

(a)    if the product is capable of only one reasonable use, having regard to its nature or design—that use; or

(b)    if the product is not a staple commercial product—any use of the product, if the supplier had reason to believe that the person would put it to that use; or

(c)    in any case—the use of the product in accordance with any instructions for the use of the product, or any inducement to use the product, given to the person by the supplier or contained in an advertisement published by or with the authority of the supplier.

(Emphasis added.)

136 The Applicants submit that, the combined effect of s 117 as applied on the present facts is such that the threat of infringement is the supply of the Sandoz Aflibercept Products along with their corresponding Sandoz PI. The Applicants contend that in circumstances where the relevant product is one that may be used for both infringing and non-infringing uses, the operation of s 117(1) is to be read with s 117(2)(b) of the Act.

137 To enliven the infringement by supply provision under s 117(1), the Applicants refer to “use” under s 117(2)(b) and s 117(2)(c) of the Act. Regarding s 117(2)(b), the Applicants’ position is that the Sandoz PI demonstrates that Sandoz (the supplier) had reason to believe that ophthalmologist (the person) would put the Sandoz Aflibercept Products to use in a manner that infringes the Asserted 599 Claims. Similarly, the Applicants’ s 117(2)(c) claim is that the Sandoz PI are “instructions” or, in the alternative, an “inducement” to use the Sandoz Aflibercept Products in a manner that would infringe the method of the Asserted 599 Claims.

138 In response to the Applicants’ s 117(2)(c) infringement by supply case, Sandoz advances three arguments. First, it contends that the Sandoz PI does not constitute “instructions” within the meaning of s 117(2)(c). Sandoz refers to the permissive rather than instructive language of the Sandoz PI. For the treatment of Wet AMD, the Sandoz PI states that “the treatment interval may be maintained at two months”; similarly, for the treatment of DME, the Sandoz PI states that “the treatment interval may then be maintained at an injection every two months”. Sandoz relies on Allied Pumps Pty Ltd v LAA Industries Pty Ltd (2023) 179 IPR 1 at [709] (Downes J) to characterise the Sandoz PI as a document specifying a particular use, which it argues is to be distinguished from a document instructing a person to engage in that use. Sandoz also relies on the “overarching statement” of the Sandoz PI, which stipulates that “[t]he monitoring and treatment schedule should be determined by the treating ophthalmologist based on the individual’s response” (the Overarching Statement).

139 Secondly, Sandoz submits that even if the statements are an instruction, such statements do not instruct ophthalmologists to use the Sandoz Aflibercept Products on an infringing basis.  In so doing, Sandoz refers to the above Overarching Statement along with other statements in the Sandoz PI which account for the individualisation and adjustment of treatment protocols by ophthalmologists, as appropriate.

140 Thirdly, Sandoz submits that the Sandoz PI is not “given to” the ophthalmologist as required by s 117(2)(c) of the Act. Sandoz says that it will not proactively distribute the Sandoz PI to ophthalmologists or patients, and that any such distribution will be upon the request, which is rare. The only document which Sandoz says will be “given to the” ophthalmologist is the Consumer Medicine Information (CMI), which Sandoz says does not contain any of the Sandoz PI statements that are impugned by the Applicants.

141 Regarding s 117(2)(b) of the Act, Sandoz submits that the evidence does not establish a prima facie case that a reasonable person in Sandoz’s position would have reason to believe that ophthalmologists would engage in infringing use, by reason of the fact that most ophthalmologists adopt a treat-and-extend dosing regimen which is outside the claimed method.

3.4.6.1    Whether the Sandoz PI constitutes an “instruction”

142 Section 117(2)(c) of the Act requires that there be an instruction or inducement. For Sandoz to be liable pursuant to s 117(2)(c), the Applicants must establish that the use of the Sandoz Aflibercept Products by ophthalmologists, undertaken in accordance with any instructions or inducement given by the Sandoz PI, would infringe the Asserted 599 Claims. Because s 117(2)(c) requires the use to be “in accordance with” any instructions or inducement, it follows that “if the instructions do not instruct the user […] there will be no infringement”: Allied Pumps at [622] (Downes J).

143 It may be accepted that specific indications in a product information for a pharmaceutical product listed on the ARTG constitute instructions to do what is indicated: see Interpharma Pty Ltd v Hospira Inc (No 5) (2019) 149 IPR 182 at [229] (Kenny J) citing Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 304 ALR 1 at [303] (Crennan and Kiefel JJ). There is, however, a distinction between a document describing or specifying a use (e.g., use to relieve muscular aches), and the provision of instructions for that use (i.e., how a use is to be carried out, namely via topical application). Justice Nicholas considered this distinction in Hood v Bush Pharmacy Pty Ltd (2020) 158 IPR 229 at [259]–[269], concluding at [267] that only the latter were properly characterised as instructions:

[264] The first of the uses referred to (ie for relieving muscular aches and pains) describes a use for Kunzea ambigua essential oil but says nothing about how the product is to be used. The webpage does not indicate whether or not the product should be applied topically. While the webpage specifies a use, it does not provide any instructions for use.

[…]

[267] In order to infringe claim 5 (the broadest of the relevant claims) the oil must be topically applied. A person familiar with the use of essential oils may well understand that this is how the oil should be used, but in my view the relevant webpage does not seek to encourage or persuade a user to use the oil in any particular way. Although it is true that a reader may infer that the oil is to be topically applied, he or she may just as readily infer that the oil is to be diluted in a bath or administered by inhalation. The website says nothing about how the oil is to be used as a treatment for muscular aches and pains.

(Emphasis added.)

144 Notwithstanding Sandoz’s counterarguments regarding the permissive language of the Sandoz PI and the Overarching Statement, I accept, at this preliminary stage, the Applicants’ submissions that the indications in the Sandoz PI constitute “instructions” within the meaning of s 117(2)(c) of the Act. In Interpharma, Kenny J considered whether the words “may be initiated” in the product information of a generic drug, i.e., the “Amended Generic Products PI”, used in conjunction with statements as to the use of a “loading dose” of dexmedetomidine constituted an “instruction” to use a general recommended loading dose of dexmedetomidine for sedation of initially intubated patients during treatment in an intensive care setting.

145 In that case, Interpharma argued that the inclusion of the word “may” in the Amended Generic Products PI caused the statement regarding the initiation with a loading infusion to fall short of an instruction within the meaning of s 117(2)(c). Interpharma relied on evidence from a clinician that the replacement of the words “is generally” with the word “may” in the Amended Generic Products PI informed him and other clinicians “that the administration of dexmedetomidine using a loading dose or bolus is not a matter of routine” and that the words “may be” would cause to “pause and think more about the risks of the drug versus the benefits”. In contrast, Hospira relied on the majority’s observations in AstraZeneca AB v Apotex Pty Ltd (2014) 226 FCR 324 at [427] (Besanko, Foster, Nicholas and Yates JJ) and Jagot J’s analysis in Beadcrete Pty Ltd v Fe Yu (t/as Jewels 4 Pools) (No 3) (2013) 100 IPR 188 to contend that it was sufficient that the Amended Generic Products PI indicated that dexmedetomidine can be administered in a loading dose to constitute an instruction for the purpose of s 117(2)(c): see Interpharma at [268]. Further, Hospira relied on the evidence of two experts who expressly disagreed with Interpharma’s experts’ understanding of the Amended Generic Products PI, asserting that “[t]he Amended [Generic Products] PI […] provide[d] instructions on how to administer a loading dose, should the clinician do so”.

146 Justice Kenny held at [274] that the Amended Generics Products PI did not discourage clinicians from giving a loading dose or warn against that use. On the contrary, the Amended Generic Products PI “expressly instruct[ed] a clinician that a loading dose of the Generic Products may be administered for the initiation of ICU sedation “if needed””. That the statement regarding the giving of a loading dose was to be qualified by a physician’s judgment did not preclude her Honour’s finding at [280] that the relevant statements were “instructions” within the meaning of s 117(2)(c).

147 Given the similarity of permissive language between the Sandoz PI and the Amended Generic Products PI in Interpharma, I reject Sandoz’s submission that the permissive language of the Sandoz PI is sufficient to render the relevant statements not “instructions” within the meaning of s 117(2)(c). As in Interpharma, that the Overarching Statements qualify the instructions by allowing the ophthalmologist to use the Sandoz Aflibercept Products as they deem appropriate does not preclude the fact that the relevant statements in the Sandoz PI provide instructions for use.

148 Ultimately, whether the Sandoz PI or the approved indications amounts to an instruction for the purposes of s 117(2)(c) is a question for the court. The evidence of expert witnesses may be of assistance but is not necessarily determinative: Neurim Pharmaceuticals (1991) Ltd v Generic Partners Pty Ltd (No 5) [2024] FCA 360 at [289] (Nicholas J). Whilst it may be the case that significant variation and customisation of the dosing regimen may occur in the use of the Sandoz Aflibercept Products due to an ophthalmologist’s judgment and intervention, if one of such uses infringes the 599 Patent, infringement is established under s 117(2)(c). This issue was considered in Beadcrete, where the patent in suit claimed inter alia glass beads of a certain size averaging between 1.5 mm and 4.5 mm. The respondents there supplied glass beads in various colours, wherein the green and ice blue glass beads were found to have had an average size that fell within the relevant claim. In those circumstances, the use of green and ice blue glass beads, either in isolation or in combination with each other, would have infringed the patent in suit. At [126], Jagot J explained that the “instructions” in the respondent’s sales materials were:

[…] to the effect that there are “hundreds of colours and combinations”, “a magnificent range of colours and combinations”, there being “100’s of colours and combinations to choose from and a person may select any combination of colours you wish to choose, there being freedom of choice with colour”. In other words, the respondents instruct that the product may be used as the customer sees fit, either with a single colour or any combination of colours from those available.

(Emphasis added.)

149 In the same paragraph, her Honour found that:

This satisfies that requirement for instructions to use the product in both these ways; that is, by use of a single colour or a combination of colours. It follows that if one of the four colours tested by the applicants infringes the patent, infringement is established under s 117(2)(c).

(Emphasis added.)

150 On appeal, the Full Court referred to the above passage with approval and found that there was “no difficulty in characterising those statements as instructing a use which infringes claim 1”: Fei Yu (t/as Jewels 4 Pools) v Beadcrete Pty Ltd (2014) 107 IPR 516 at [83]–[85] (Dowsett, Middleton and Robertson JJ). For the purposes of “instruction”, it therefore does not matter that several permutations of non-infringing and infringing uses exist. It also does not matter whether an ophthalmologist can, or will in fact, determine how the Sandoz Aflibercept Products are ultimately used.

151 For these reasons, I consider that the Sandoz PI contains statements that are “instructions” within the meaning of s 117(2)(c) of the Act, notwithstanding the qualifications of the permissive language and the Overarching Statement.

152 The only document contained in each package of AFQLIR® is the CMI containing instructions for use with respect to the syringe or vial, as the case may be. These instructions do not contain any details of a treatment regimen or indications for use. Rather, they instruct the temperature at which AFQLIR® must be stored prior to use, and how to prepare the intravitreal injection where the AFQLIR® is provided in a vial or in a PFS form.

3.4.6.2    Whether the instructions in the Sandoz PI are “given” to ophthalmologists

153 As to Sandoz’s third argument on s 117(2)(c), I consider that the relevant statements in the Sandoz PI are instructions that are “given” or made available to the treating ophthalmologists, by Sandoz.

154 Sandoz’s propounded construction of “given” as meaning a direct physical transfer from Sandoz to the ophthalmologist requires an unduly narrow interpretation of “given” that:

(a)    is inconsistent with the practical realities of modern medicine, where pharmaceutical product information is easily accessible via the internet;

(b)    excludes forms of provision previously held to be within the meaning of “given”; and

(c)    is inconsistent with the regulatory requirements of the Department of Health and Aged Care (Department of Health).

155 Mr Behrens’ evidence was that in accordance with the Code of Conduct, any promotional material for the AFQLIR® will include a statement to the effect that HCPs should review the Sandoz PI before prescribing the medication. The Sandoz PI will be available on the Sandoz and TGA websites, and according to Prof Daniell and A/Prof Wickremasinghe, the medical practitioner’s prescribing software ZedMed.

156 Sandoz admits that it will provide the Sandoz PI to an HCP if so requested, but notes that requests for product information are rare. As alluded to above, the Sandoz website also includes a hyperlink to the Sandoz PI, and Sandoz advises via its promotional materials that HCPs ought to review the Sandoz PI before prescribing the Sandoz Aflibercept Products.

157 In Interpharma at [304] and Sanofi-Aventis, this Court and the High Court of Australia had no trouble recognising, implicitly, that the analogous provision of the product information of the relevant therapeutic goods fulfilled the criterion of “given” as required s 117(2)(c).

158 Lastly, Sandoz’s confined construction of “given” is inconsistent with the regulatory requirements under the TG Act and the Department of Health’s guidelines, Australian Regulatory Guidelines for Prescription Medicines: Understanding Requirements for Providing a Product Information (PI) Document (12 November 2024). Section 23B(2)(e) of the TG Act provides that an application for registration of therapeutic goods on the ARTG must be accompanied by product information in the prescribed form. Similarly, the Guidelines for Prescription Medicines delineate the purpose of product information of prescription medicines, along with background information of when and how they must be provided:

Product information is an essential technical document for medicines and ensures their safe and effective use in clinical settings. The document includes:

* details about active ingredients

* approved medical uses

* safety warnings and precautions

* possible side effects

* clinical trial information

* dosage and storage guidelines

The PI informs medical practitioners, pharmacists and other health professionals about the safe and appropriate prescribing and dispending of the medicine.

[…]

How is the Product Information supplied to consumers

Sponsors have an obligation to upload the current approved PI to the TGA website within two weeks of its approval. This allows consumers and health professionals to access the PI at any time”

(Emphasis added.)

159 As shown in the above excerpt, the Guidelines for Prescription Medicines expressly contemplate that a product information is considered to be “supplied to” or “given to” consumers upon its upload to the TGA website.

160 Prof Daniell’s evidence is that he accesses the produce information and/or the CMI for any drug he wishes to prescribe via ZedMed, which includes links to product information and CMI leaflets on MIMS, a specialised medical database. A/Prof Wickremasinghe’s evidence is to the same effect, although he deposed that he does not use ZedMed to access product information and/or CMIs. Both experts accept that the Sandoz PI will be readily available to them if they wished to read it.

161 The evidence is that ophthalmologists are very cautious in switching to a biosimilar product. Whilst ophthalmologists may not consult the product information for products that they regularly prescribe and administer with a certain degree of familiarity, it is to be expected that any ophthalmologist considering switching to a biosimilar with which they were not familiar would read the product information for that biosimilar product before administering it to a patient.

162 Accordingly, I consider that the Sandoz PI contains statements that are “instructions” that are “given” to the person, being the ophthalmologist, within the meaning of s 117(2)(c) of the Act.

3.4.7    Conclusion on s 117(2)(c)

163 Notwithstanding my findings above, by reason of my construction of claim integers 1.3 and 1.4 that I have adopted at this stage, I do not consider that the Sandoz PI document instructs persons to use the Sandoz Aflibercept Products, which it proposes to supply, in accordance with the claimed methods. Therefore, the Sandoz PI does not engage s 117(2)(c) of the Act.

3.4.8    Whether there is reason to believe that ophthalmologists would put the Sandoz Aflibercept Products to infringing use – s 117(2)(b)

164 Sections 117(1) and 117(2)(b) of the Act deem a supply of a product to be an infringement of a patent if, but only if, the product is not a staple commercial product, and the supplier has reason to believe that the person to whom the product is or may be supplied will put it to an infringing use.

165 It was not suggested that aflibercept was a staple commercial product. For the purposes of this interlocutory application, I proceed on the basis that aflibercept is not a staple commercial product. The fact that aflibercept may be used for infringing and non-infringing purposes is not conclusive, as there are many such products that cannot be characterised as either raw materials or basic products commonly used for a wide variety of purposes. AstraZeneca at [431]. The uses to which aflibercept may be put appear to be confined to the treatment of retinal and angiogenic eye disorders, and potentially in the oncology context.

166 The High Court considered the scope and history of s 117 of the Act in Sanofi-Aventis at [293]–[305]. In Warner-Lambert Co LLC v Apotex Pty Ltd (2014) 106 IPR 59 at [61], Griffiths J derived the following propositions from the leading joint judgment of Crennan and Kiefel JJ in Sanofi-Aventis (with whom French CJ and Gageler J agreed) on issues relating to a threatened infringement within the terms of s 117(1) and (2)(b) of the Act:

(a) in the context of a claim of infringement under that provision, consideration has to be given to the regulatory regime under the TGA and, in particular, to the requirements for registration or listing of therapeutic goods on the ARTG and the requirement, in the case of a restricted medicine, that the listing be accompanied by approved product information;

(b) therapeutic goods which are entered on the ARTG are taken to be “separate and distinct” from other therapeutic goods if they have a “different name”, “different indications” or “different directions for use, among other things”;

(c) in circumstances where an item registered on the ARTG was described as being indicated for uses which specifically excluded use of a patented method identified in the claim in a patent, which exclusion was also expressed in the relevant approved product information document, that amounted to “an emphatic instruction to recipients [of the alleged infringing product] to restrict use of the product to uses other than use in accordance with the patented method identified [in the claim]” (footnotes omitted) […]; and

(d) in the particular circumstances, the patentee had not shown, nor could it be inferred, that, for the purposes of s 117(2)(b), the supplier had reason to believe that the alleged infringing product would be used by recipients in accordance with the patented method, contrary to the express indications in the supplier’s approved product information document.

(Emphasis added.) (Citations omitted.)

167 In Generic Health Pty Ltd v Otsuka Pharmaceutical Co Ltd (2013) 296 ALR 50, it was argued that the patentee had not produced evidence that the purported infringer had the requisite “reason to believe”. At [35], Emmett J considered that the relevant statutory provision imposed by s 117(2)(b) is an objective test:

The question is whether there were factual matters known to Generic Health that would lead a reasonable person to believe that the GH Products would be put to an infringing use. It is not the point that Generic Health, through its relevant officers, did not actually have such a belief. The question is whether there was material before the primary judge that could support a finding that a reasonable person in the position of Generic Health would have reason to hold such a belief.

(Emphases added.)

168 If I considered that the Sandoz PI constituted instructions for a method of treatment that infringed the Asserted Claims, at this preliminary stage I would not consider that the Sandoz PI contains “emphatic instructions” against uses claimed by the Asserted 599 Claims. Paragraph 4.1 of the Sandoz PI for AFQLIR® notes therapeutic indications for Wet AMD and DME and other angiogenic eye disorders such as CRVO, BRVO and Myopic CNV. The therapeutic indications therefore overlap with claims 4 and 5 of the Asserted 599 claims, which stipulate the angiogenic eye disorders that are subject to the method claims:

CLAIMS:

[…]

4. The method of claim 1, wherein the angiogenic eye disorder is selected from the group consisting of: age related macular degeneration [Wet AMD], diabetic retinopathy, diabetic macular edema [DME], central retinal vein occlusion [CRVO] and corneal neovascularization.

5. The method of claim 4, wherein the angiogenic eye disorder is age related macular degeneration [Wet AMD].

169 However, by reason of the construction of integers 1.3 and 1.4 that I have adopted, I do not consider that the Sandoz PI instructs ophthalmologists to use the claimed method. That construction, coupled with the evidence that many ophthalmologists follow their own treat-and-extend regimen in lieu of the regimen described in the Sandoz PI, leads me to conclude that on the current evidence a reasonable person in Sandoz’s position would not have the requisite reason to believe that AFQLIR® would be put to a use that would infringe the claimed method, for the purposes of s 117(2)(b) of the Act.

3.4.9    Conclusion on prima facie case on infringement

170 It is not for the Court at this stage to determine, as on a final hearing, the scope of the Asserted 599 Claims, or whether the use of the Sandoz Aflibercept Products would infringe those claims. It is necessary to make some evaluation of the strength of the Applicants’ case for infringement of the Asserted 599 Claims, whilst recognising that I do not have the benefit of all the evidence that might be called at the final trial and cross-examination of the expert witnesses.

171 It is sufficient to express the view that, on the present state of the evidence, there is a real prospect that the use of the Sandoz Aflibercept Products in accordance with the Sandoz PI will not infringe the Asserted 599 Claims. Accordingly, I do not consider that the Applicants have established a strong prima facie case on infringement of the Asserted 599 Claims.

3.5    Invalidity

172 In defence of the Applicants’ infringement claim, Sandoz cross-claims that the 599 Patent is invalid due to lack of novelty, inventive step and support.

3.5.1    Novelty

173 Sandoz contends that its lack of novelty claim is unassailable and so significantly undermines the Applicants’ infringement case that an injunction cannot be granted. At this stage, and on the basis of the evidence as it currently stands, I take a different view on the strength of Sandoz’s novelty case.

174 The Applicants contend that neither of the two pieces of prior art anticipates the invention because neither of them provides the amino acid sequence of SEQ ID NO:2, which is an essential integer of the Asserted 599 Claims. Additionally, there is no express or implicit disclosure of the sequence.

175 Sandoz accepts that the SEQ ID NO:2 is not expressly disclosed in the prior art documents but submits that SEQ ID NO:2 sequence is “inherent” in the disclosure of Dixon and Adis by reason of the use of the name “aflibercept”. According to Sandoz, aflibercept and its amino acid sequence was known, and a skilled addressee could—if they had wished—located the amino acid sequences “in an online database or a patent document”.

176 Dr King gave evidence of her ability to identify and locate the SEQ ID NO:2 sequence in the pre-priority date editions of the US Pharmacopeia Dictionary of United States Adopted Name and International Drug Names (USP Dictionary) and the World Health Organisation International Nonproprietary Names List (INN List).

177 It was common ground that the amino acid sequence of aflibercept was not common general knowledge as at the priority date.

3.5.1.1    Adis

178 Adis is a scientific journal article published on Drugs in R&D in 2008. The article sets out general information about aflibercept, defining it as “a fully human recombinant fusion protein composed of the second Ig domain of VEGFR1 and the third Ig domain of VEGFR2, fused to the Fc region of the human IgG1”.

179 Adis then provides information that “[a]flibercept [was] in clinical development […] for the treatment of cancer, while Regeneron and Bayer [were] developing the agent for eye disorders”. On page 263, Adis further discusses the first (VIEW 1) and second (VIEW 2) stages of the Phase III trial of aflibercept. VIEW 1 studies concerned non-inferiority by reference to ranibizumab, whereas VIEW 2 studies evaluated the primary endpoint of the proportion of patients treated with aflibercept who maintained vision at the end of one year compared with ranibizumab patients. Both studies evaluated the safety and efficacy of aflibercept at doses 0.5 mg and 2.0 mg, administered at 4-week dosing intervals, and 2.0mg at an 8-week dosing interval. For example, regarding the VIEW 2 trial, Adis discloses the following dosing regimen:

This study will evaluate the safety and efficacy of aflibercept at 0.5 mg and 2.0 mg administered at 4-week intervals and 2.0 mg at an 8-week dosing interval, including one additional 2.0 mg dose at week 4. Patients randomized to the ranibizumab arm of the trial will receive a 0.5 mg dose every 4 weeks.

(Emphasis added.)

3.5.1.2    Dixon

180 Dixon is a scientific journal article published on Expert Opinion on Investigational Drugs in 2009. The article is a literature review with the objective of: “review[ing] the current literature and clinical trial data regarding VEGF Trap-Eye for the treatment of neovascular AMD”. Dixon describes the contemporaneous options available to treat Wet AMD as at 2009, before aflibercept was used in ophthalmology, as well as additional drugs in the pipeline. One such description is that of the Phase III trials that led to the regulatory approval for ranibizumab, the API of LUCENTIS®.

181 In relation to Dixon’s disclosure of the “new compound”, section 2.2 states that: “VEGF Trap-Eye is a novel anti-VEGF drug currently in commercial development for the treatment of neovascular AMD by Regeneron Pharmaceuticals, Inc. […] in the US and in collaboration with Bayer Healthcare […] in global markets”. Regarding VEGF Trap-Eye’s structure, Dixon states in the same section that: “[s]tructurally, VEGF Trap-Eye is a fusion protein of key binding domains of human VEGFR-1 and -2 combined with a human IgG Fc fragment (Figure 1)”. Regarding VEGF Trap-Eye’s function, section 2.2 further states that “[f]unctionally, VEGF Trap-Eye acts as a receptor decoy with high affinity for all VEGF isoforms, binding more tightly than their native receptors. Unlike anti-VEGF drugs currently in use, VEGF Trap-Eye is designed to inhibit placental growth factors-1 and -2 in addition to all isoforms of VEGF-A”.

182 In section 2.3, Dixon discusses the biochemistry of VEGF Trap-Eye by comparison to aflibercept:

“VEGF Trap-Eye and aflibercept (the oncology product) have the same molecular structure, but there are substantial differences between the preparation of the purified drug product and their formulations. Both aflibercept and VEGF Trap-Eye are manufactured in bioreactors from industry standard Chinese hamster ovary cells that overexpress the fusion protein. However, VEGF Trap-Eye undergoes further purification steps during manufacturing to minimise risk of irritation to the eye. VEGF Trap-Eye is also formulated with different buffers and at different concentrations (for buffers in common) suitable for the comfortable, non-irritating, direct injection to the eye.”

(Emphasis added.)

183 In other words, Dixon discloses that VEGF Trap-Eye and aflibercept are structurally the same, but their preparation and purification differ.

184 The next section 2.4 discusses the pharmacodynamics of aflibercept and VEGF Trap-Eye, and VEGF Trap-Eye’s intravitreal administration as compared to administration of aflibercept in oncology settings, i.e., intravenously. In observing that the highest intravitreal dose being used in pivotal trials for VEGF Trap-Eye is 2mg/month, which corresponds to at least a 280-fold lower potential systemic exposure than in the oncology setting, Dixon concludes that the low intravitreal dose of 2mg allows for extended blocking of VEGF in the eye, with negligible systemic activity due to its rapid binding to VEGF and subsequent inactivation.

185 In section 2.6, Dixon discusses clinical efficacy of VEGF Trap-Eye as evidenced by Phase I–III studies. The studies demonstrate inter alia that VEGF Trap-Eye is a promising molecule for treatment of Wet AMD, when administered intravitreally. This is because the article reports on favourable results in Phase II studies of VEGF Trap-Eye (as set out at section 2.6.2).

186 Section 2.6.3 states that Phase III studies will be carried out and that participants with neovascular AMD will be recruited in the US and Canada (together, VIEW 1) and Europe, Asia Pacific, Japan and Latin America (together, VIEW 2). The section further discloses that the Phase III trial of VEGF Trap-Eye consists of a non-inferiority study to be evaluated as follows:

This non-inferiority study will evaluate the safety and efficacy of intravitreal VEGF Trap-Eye at doses of 0.5 and 2.0 mg administered at 4-week dosing intervals and 2.0 mg at an 8 week dosing interval (following three monthly doses), compared with 0.5 mg of ranibizumab administered every 4 weeks. After the first year of the study, patients will enter a second year of p.r.n. dosing evaluation.

(Emphasis added.)

187 At section 2.7, Dixon concludes, based on Phase II study data, that VEGF Trap-Eye seems to be generally well tolerated with no serious drug-related adverse events. The article goes on to assert in its conclusion that “VEGF Trap-Eye represents the most promising anti-VEGF investigational drug that is currently in Phase III trial”, and that “[d]ata from the Phase II study […] were positive and the results from the non-inferiority Phase III trials will establish its [(VEGF Trap-Eye)] efficacy versus ranibizumab”. The conclusion also specifies that “[i]f effective at 8 week intervals, VEGF Trap-Eye offers the opportunity to significantly reduce treatment burden on patients and physicians and would probably find wide acceptance”.

3.5.2    Sandoz’s inevitability argument

188 Sandoz submits that each of Dixon and Adis anticipate the claimed invention because the SEQ ID NO:2, or the amino acid sequence of aflibercept was, at the priority date, “inherent” in each of the prior art documents. Sandoz contends that, before the priority date, aflibercept was known and that a skilled addressee could have, if they wished, located the amino acid sequences in the public USP Dictionary or INN List.

189 Sandoz’s contention is not entirely based on the skilled reader resorting to other documents outside Adis or Dixon to provide the missing sequence information. Rather, Sandoz submits that there is anticipation where the prior art describes something in different terms than what is claimed, but where carrying out the directions in the prior art “will inevitably result in something being made or done which […] would constitute an infringement of the patentee’s claim […]” (Inevitability Argument): Novozymes A/S v Danisco A/S (2013) 99 IPR 417 at [145] (Jessup J), citing General Tire and Rubber Co v Firestone Tyre and Rubber Co Ltd (1971) 1A IPR 121 at 138 (Sachs LJ); see also Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd (2020) 279 FCR 354 at [84] (Middleton, Jagot, Yates, Beach and Moshinsky JJ).

190 Sandoz further relies on AstraZeneca to support its Inevitability Argument. Sandoz accepts that where a patentee claims a second medical use of a known substance, as the Applicants do in this case, the claimed use may be novel notwithstanding that said second medical use inevitably arises from use according to a first medical use. However, Sandoz submits that the novelty of such second medical use claims must arise from the purpose of the use. In this case, Sandoz contends that given that the purpose of use for treatment of retinal and angiogenic eye disorders was disclosed in Dixon and Adis before the priority date, the Asserted 599 Claims which claim such previously disclosed second medical use or purpose cannot be novel or inventive.

191 Sandoz also contends that it is a “hard fact” that aflibercept has the SEQ ID NO:2 in the claims. As such, Sandoz submits that the practical inability of a skilled person to obtain the proprietary aflibercept compound at the priority date is not fatal to its anticipation case. Sandoz relies on the proposition that the novelty analysis is hypothetical, being concerned with what would happen if the process were carried out, not the doing, or the ability to do it. The focus is on the content of the information: Novozymes A/S [177] (Jessup J). Sandoz argues that because there is only one compound which is ‘aflibercept’, the use of that one compound according to Adis or Dixon must be anticipatory.

192 Novozymes A/S concerned a process for preparing a foodstuff using an enzyme to produce an emulsifier from a fatty acid ester and in which another functional ingredient was produced from a second constituent of the composition. One of the prior art documents cited by the alleged infringer, the “Novo Patent”, described the use of an enzyme which “inherently possessed” dual phospholipase/lipase activity for baking bread. Further, evidence showed that an emulsifier and a second functional ingredient were produced by the enzyme. However, this dual activity was not explicitly disclosed in the document.

193 The Full Court in Novozymes A/S, considered that where a patent claims a product with certain characteristics, it is not necessary for the prior art to describe those characteristics expressly in order for it to provide novelty-defeating disclosure, if by carrying out the prior art description the claimed product would inevitably be obtained. Justice Jessup (with whom Greenwood and Yates JJ agreed) observed the following:

[177]     Although General Tire is part of Australian Jurisprudence in the relevant area, it must be accommodated to the terms of s 7(1) of the Patents Act, upon which everything depends. That is to say, the inevitability of outcome to which General Tire refers must be such as would arise from recourse to the information referred to in the section. At the expense of repetition, it is here useful to remind ourselves of what the Court of Appeal said in that case (at IPR 138; RPC 485-6):

…if carrying out the directions contained in the prior inventor’s publication will inevitably result in something being made or done which, if the patentee’s patent were valid, would constitute an infringement of the patentee’s claim, this circumstance demonstrates that the patentee’s claim has in fact been anticipated.

This proposition is explicitly hypothetical. It is concerned not with what has happened or with what could have happened, but with what would have happened if the directions were carried out. As such, the proposition is in complete harmony with s 7(1), and with every other presently relevant aspect of the jurisprudence in this area. It is not the doing of it, nor even the ability to do it, that amounts to anticipation: it is the content of the information. If the information contains directions which, if carried out, would constitute an infringement of the patent in suit, the invention under the latter is not novel.

[…]

[186]    […] In my reasons so far, the only respect in which I have departed from the primary judge is that which relates to inevitability of outcome. I have agreed with her Honour that the Novo patent would not have disclosed to the skilled addressee the generation of a second functional ingredient. But I have taken the view that that deficiency would not compromise the appellant’s inevitability case, since I have held that a second functional ingredient would inevitably have been generated in the enzymatic reaction referred to. The question arises: can the appellants piece together a complete case on anticipation by reference to express or implied disclosure for some integers, and inevitable outcome for others? […]

[187]    In my view, the General Tire approach, if taken at all, may only be taken only with respect to the whole of any claim asserted to have been anticipated. The “precise destination” at which the flag must have been planted is one which includes every integer of the claim. […] It is necessary that they show that, if example 20 were worked as directed, it would inevitably, as a matter of hard fact, have involved inactivation of the enzyme […] at the baking stage.

(Emphasis added in bold.) (Emphasis in original in italics.)

194 The difference between the present case and Novozymes A/S is that in that case, the starting enzyme, the phospholipase derived from Fusarium oxysporum, was described and characterised. Such description and characterisation included the amino acid sequence of the phospholipase of interest. Working the process directed in the relevant example, the use of that starting enzyme inevitably involved every integer of the claimed process as the enzyme inherently had the dual activities required.

195 Section 7(1) of the Act provides that an invention is taken to be novel when compared to the prior art base unless it is not novel in light of certain kinds of information, each of which must be considered separately unless the person skilled in the art would treat them as a single source of information. Here, the prior art information must be made publicly available in a single document before it can be novelty defeating.

196 In contrast to Novozymes A/S, Adis and Dixon lack the information as to the amino sequence of aflibercept. The dosing regimen in Dixon cannot be used or applied to treat an angiogenic eye disorder (so as to infringe or satisfy the reverse infringement test) without the person skilled in the art first being in possession of a VEGF antagonist composed of inter alia SEQ ID NO:2 or aflibercept. The person skilled in the art has the name “aflibercept” but has no information on its amino acid sequence. Without that information, the skilled person is unable to work the directions disclosed in Adis or Dixon. It is not merely a matter of the practicality in sourcing reagents.

197 The issue in this case is that the identity and structure of aflibercept, including its primary structure, is not disclosed in any of the cited prior art documents. Further, that information would not otherwise be known to the skilled person without impermissible reference to other public sources of information. That the “identity and structure” of the molecule “goes to the heart of the disclosure and information” disclosed by the prior art was affirmed by the Full Court in Sandoz AG v Bayer Intellectual Property GmbH (2024) 183 IPR 309 at [117] (Yates, Burley and Downes JJ). As the Full Court observed at [118], “[t]his is an information deficiency […] which constrains the skilled person in the hypothetical”. The Full Court’s comments, although made in the context of inventive step, are apposite to the novelty case here. Without the essential integer of the amino acid sequence of aflibercept, the skilled person is unable to work the directions in Adis or Dixon, without impermissible resort to other sources of information. Sandoz’s attempt to plug the information gap in Adis and Dixon with its inherency and inevitability argument must fail at this preliminary stage.

3.5.3    United States cases

198 Sandoz refers to the decision of the Patent Trial and Appeal Board of the United States Patent and Trade Mark Office (PTAB Board) in Mylan Pharmaceuticals Inc, Celltrion Inc and Apotex Inc v Regeneron Pharmaceuticals Inc IPR 2021-00881, which considered inter alia whether Dixon and the 2009 Press Release were novelty defeating. The PTAB Board held that Dixon anticipated claims 1, 3–11, 13, 14, 16–24 and 26 of the United States Patent No. 9,254,338 B2 (US Patent 338). Sandoz contends that some of the foregoing claims of the US Patent 338 are “relevantly identical” to the Asserted 599 Claims.

199 Sandoz also relies on the United States District Court’s decision in Regeneron Pharmaceuticals Inc v Mylan Pharmaceuticals Inc and Biocon Biologics Inc Civil No. 1:22-CV-61, where Kleeh CJ held that the claims of United States Patent No. 10,888,601 and United States Patent No. 11,253,572 (US Patent 572) were obvious in light of Dixon and/or the 2009 Press Release.  More specifically, Sandoz relies on Kleeh CJ’s observations that the parties “do not dispute that Dixon discloses the regimen” in claim 6 of US Patent 572, and that the regimen is relevantly the same as claimed in at least claims 1 and 2 of the 599 Patent.

200 While this Court may find foreign law persuasive in certain cases, it is not bound by the decisions made by foreign courts. At this preliminary stage, the differences between the present case and the United States cases referred to above, such as those pertaining to the evidence and the prior art documents relied upon by the parties, are sufficient for me to conclude that any further consideration will not be of assistance.

3.5.4    Lack of inventive step

201 Sandoz made no oral submissions on its lack of inventive step case and relied on its written submissions. Sandoz’s position in its written submissions is that the Asserted 599 Claims do not involve any “step” over the prior art which can be characterised as inventive. Sandoz submits that the mere inclusion of the aflibercept amino acid sequence in a claim does not render it inventive; it simply characterises the same active ingredient or API. In other words, Sandoz’s obviousness case is premised on a definition of the claimed invention as the mere characterisation of aflibercept.

202 In contrast, the Applicants submit that the claimed invention is to be defined as the pre-clinically and clinically corroborated dosing regimen which allows for inter alia the extension of monthly doses to 8-week doses beyond a certain tertiary dose. In oral submissions, Senior Counsel for the Applicants described the “heart of the invention” as “the move from four-weekly dosing to eight-weekly dosing”.

203 The Applicants contend that even if it was common general knowledge that an extension of time between doses was desirable, without the sequence for the drug disclosed in the prior art, the skilled addressee could not have taken the development of the drug forward. The Applicants argue that even if the person skilled in the art could add the aflibercept sequence to the prior art, the skilled addressee would not be directly led to try the claimed dosage regimen, or to do so with the requisite expectation of success.

204 In seeking to distinguish from AstraZeneca AB v Apotex Pty Ltd (2015) 323 ALR 605 (French CJ, Kiefel, Gageler, Keane and Nettle JJ), the Applicants noted that the present dosing regimen of VEGF antagonist is not one that could safely be made about safety and efficacy. Further, distinguishing from Sandoz AG, the Applicants submit that the claimed dosing regimen in this case had not been identified at the outset as the “ideal dosage regimen”.

205 For the present purposes, it is neither necessary nor desirable to finally define the invention. This is in part because I am not assisted by the benefit of the examination and cross-examination of the experts, and because the fact that Sandoz’s lack of inventive step argument must, at this stage, fail is dispositive. In essence, the inventive step case of the interlocutory injunction application rises or falls with the inherent novelty case. At present, there is no evidence that each of Adis, Dixon and SEQ ID NO:2 as found in the USP Dictionary and INN List were part of the common general knowledge. Alternatively, the current evidence does not appear to suggest that the skilled person would read Adis or Dixon together with the reference documents. A/Prof Wickremasinghe deposes that he “would have located the amino acid sequence for aflibercept had [he] wanted to do so” and that he “would have expected this information to be located in an online database or a patent document”. However, this evidence is, on itself, insufficient to establish that the skilled person would have read any of the cited prior art together with the aflibercept amino acid sequence available at the public dictionaries. The necessity for further and better evidence in this regard is highlighted in light of A/Prof Symons’ evidence to the contrary. A/Prof Symons deposes that he is “not sure what online databases A/Prof Wickremasinghe is referring to”, stating that he "was unaware of any databases, online or otherwise, which could be used to identify the amino acid sequence of a drug”.

206 In the event that, at trial, Sandoz is able to establish that the SEQ ID NO:2 was part of the common general knowledge, or that the skilled person would read Adis or Dixon together with the reference documents containing the amino acid sequence of aflibercept, I consider that Sandoz may have a compelling lack of inventive step case based on the reasoning of the Full Court in Sandoz AG, wherein the entry of a first-in-class molecule into preclinical trials was held to be sufficient to render the relevant claimed invention obvious in the absence of anticipated hurdles.

207 In this regard, and on the evidence before me, I reject the Applicants’ attempt to distinguish Sandoz AG, along with its corresponding submission which characterises the present dosing regimen as not or less than “ideal” in light of the cited prior art documents. Dixon and Adis both demonstrate that before or at the priority date, aflibercept was being tested for treatment of angiogenic eye disorders according to the claimed dosing regimen, in Phase III clinical trials. In other words, the dosing regimen as claimed by the 599 Patent had already undergone pre-clinical trial and Phases I–II of clinical trial. Without more, it does not appear to be open to the Applicants to argue that, considering Dixon or Adis, the skilled person would have an expectation other than that the development process for aflibercept treatment regime would be routine or straightforward.

3.5.5    Lack of support

208 Section 40(3) of the Act requires that the claims must be “[…] supported by matter disclosed in the specification”. The principles to be applied, to determine whether a claim is supported by matter disclosed in the specification, have been discussed in a number of recent cases, including Miele & Cie KG v Bruckbauer [2025] FCA 537 at [409].

209 At [410] of Miele, I held that “[t]he question whether a disclosure in a specification fairly entitles the patentee to a monopoly of the width claimed calls for an assessment of the patentee’s contribution to the art, which must be weighed against the scope of the patentee’s monopoly as defined by the claims”. The claimed monopoly “[…] must be justified by the technical contribution to the art that arises from the disclosure of the specification”: see also ToolGen Incorporated v Fished (No 2) [2023] FCA 794 at [396] (Nicholas J).

210 Sandoz contends that the Asserted 599 Claims are very broad, and not supported by the Patentee’s contribution to the art. In particular, the claims do not limit:

(1)    the eye disorder being treated (other than claims 4 and 5);

(2)    the amount of aflibercept administered (other than claim 12); and

(3)    the number of secondary (other than claim 3) and tertiary doses.

211 Sandoz takes claim 1 as an example and submits that it encompasses a method with a single secondary dose administered 4 weeks after the initial dose and several years’ worth of tertiary doses of aflibercept administered 8-weekly, wherein the amount of aflibercept administered is 0.5 mg and the disease is CRVO. In contrast, the Examples in the Specification are narrow. For instance, the longest treatment regimen in the Examples is for 52 weeks, and the only indications in the clinical studies of the Examples are for Wet AMD and DME.

212 Properly construed, claim 1 of the 599 Patent claims a dosing regimen for the administration of the VEGF antagonist, aflibercept, to treat eye disorders associated with or caused by angiogenesis, involving less frequent dosing than existing treatment regimens.

3.5.5.1    Broad range of eye disorders

213 The broad mechanism of action whereby VEGF antagonists block VEGF’s action and prevent the formation of new blood vessels, thereby inhibiting the angiogenic properties of VEGF was discussed in the Specification. This mechanism was known by each of the experts and would have been part of the common general knowledge of the person skilled in the art at the priority date.

214 The Specification at [0002] discusses eye disorders associated with pathological angiogenesis, giving as examples AMD, DME, CNV and CRVO, along with the mechanisms by which those diseases manifest in the eye. Further in that paragraph, the Specification notes that the release of VEGF contributes to increased vascular permeability in the eye and inappropriate new vessel growth. Thus, inhibiting the angiogenic-promoting properties of VEGF appears to be an effective strategy for treating angiogenic eye disorders.

215 Aflibercept was not the first VEGF antagonist used to treat angiogenic eye disorders. The Specification gives the example of a FDA-approved anti-VEGF drug, ranibizumab (LUCENTIS®) at [0003]. At [0004], the Specification lists five United States patents relating to methods of treating eye disorders using VEGF antagonists. Further discussion of angiogenic eye disorders is found at [0025]. These disorders are said to be “any disease of the eye which is caused by or associated with the growth or proliferation of blood vessels or by blood vessel leakage”.

216 A/Prof Symons’ evidence was that he understood that “growth or proliferation of blood vessels” refers to angiogenesis and “blood vessel leakage” refers to vascular permeability. Each of Wet AMD, DR, DME and CRVO is caused by or is associated with angiogenesis and/or vascular permeability.

217 A/Prof Symons’ evidence was that by the priority date, it was known that VEGF played a key role in the regulation of abnormal and normal angiogenesis and the induction of vascular permeability, in both cancers and other neovascular disorders such as nvAMD. He was aware at the priority date that VEGF antagonist or anti-VEGF therapies were being used and/or investigated to treat various retinal disorders such as nvAMD, DME, DR and RVO due to their therapeutic effects on angiogenesis and/or vascular permeability.

218 At the Priority Date, A/Prof Symons was aware of the anti-VEGF drug ranibizumab (LUCENTIS®) and that it was the primary method of treatment for nvAMD and was approved by the FDA for this indication in 2006 and by the TGA in 2007. He was aware from his own clinical experience that LUCENTIS® was the most effective and widely used treatment available for nvAMD (and later in 2012, for DME) in both Australia and the United States. A/Prof Wickremasinghe’s evidence was that LUCENTIS® had been available in Australia since around 2009.

219 The claims are limited to treating angiogenic eye disorders, with claim 4 being specifically limited to an eye disorder selected from five specific angiogenic eye disorders and claim 5 being limited to age related macular degeneration.  While A/Prof Wickremasinghe deposed that in his experience the treatment of DME is less predictable than that of Wet AMD because factors that influence its progression are multifactorial, rather than being primarily driven by VEGF, there was no evidence of any angiogenic eye disorder that did not respond to treatment with a VEGF antagonist.

220 On the evidence as it currently stands, I consider that there is support for the claims to the treatment of angiogenic eye disorders using the VEGF antagonist, aflibercept.

3.5.5.2    Unlimited number of secondary or tertiary doses

221 Sandoz contends that there is no support for the unlimited number of secondary or tertiary doses that are claimed in claim 1. Sandoz also submits that there is no scientific or technical explanation or data in the Specification to support the invention claimed, and that the longest length of administration time mentioned in the Specification is 104 weeks at [0032].

222 The Applicants’ respond to the complaint about the number of secondary and tertiary doses by reference to [0019] of the Specification, which they submit clearly provides a basis for the claim. Regardless of the number of secondary or tertiary doses applied, the relationship between the timing of the secondary dose and the timing of the tertiary dose is maintained.

223 On the evidence before me, I consider that there is support for the claims to the non-limited number of secondary or tertiary doses. This is because the person skilled in the art possesses the common general knowledge to employ routine experiments to assess the efficacy and progression of treatment, as evidenced by the “treat-and-extend” regimen applied by the expert witnesses. This knowledge would likely inform the skilled addressee of the requisite number of secondary and tertiary doses that are necessary for the safe and effective use of VEGF antagonists. I elaborate this point further in the below paragraphs.

3.5.5.3    Doses of aflibercept

224 When used in the context of a claim to a method of treating human patients, I consider that the phrase “a method for treating” imports, at a minimum, an expectation that the dose of the pharmaceutical compound being administered as the treatment is an amount that is safe and efficacious. A/Prof Symons considered that “there is an inherent limitation in claim 1 that the dose required to be administered must be safe and effective”.

225 At [0030] the Specification notes that the amount of VEGF antagonist administered to the patient in each dose is, in most cases, a “therapeutically effective amount”. The Specification describes the phrase “therapeutically effective amount” as meaning “a dose of VEGF antagonist that results in a detectable improvement in one or more symptoms or indicia of an angiogenic eye disorder, or a dose of a VEGF antagonist that inhibits, prevents, lessens, or delays the progression of an angiogenic eye disorder”. Examples of “therapeutically effective amount” dose are provided from about 0.05mg to about 5mg.

226 Efficacy is discussed at [0032] of the Specification and in certain embodiments “efficacy” means a gain of one or more letters on the ETDRS visual acuity chart from the time of initial treatment.

227 At [0009], the Specification notes that Aflibercept in the form of EYLEATM was approved by the FDA for use in November 2011 with a recommended intravitreal dose of 2mg for the treatment of patients with nvAMD or Wet AMD. At [0043], the Specification discloses that the patients in Study 1 who received 2mg doses of VEGFT (aflibercept) (2Q8) every 4 weeks to week 8 and then every 8 weeks (with sham injection at the interim 4-week visit) in the nvAMD Phase III trial discussed in Example 4, achieved an improvement in visual acuity at 52 weeks compared to baseline.

228 On the limited evidence as it currently stands, I consider that there is support for the claims to a method of treatment of angiogenic eye disorders using a safe and effective amount of the VEGF antagonist, aflibercept. What constitutes a safe and effective dose of aflibercept could be determined by a person skilled in the art using only routine techniques on the basis of the information in the Specification, supplemented by their common general knowledge.

4.    BALANCE OF CONVENIENCE

4.1    Pharmaceutical Benefits Scheme

229 An overview of the PBS was set out in detail by Burley J in Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd (No 3) (2018) 138 IPR 242 at [120]–[127].

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

(a)    Formulary 1 (F1): which comprises single branded medicines that are generally not directly interchangeable with other branded medicines at the patient level; or

(b)    Formulary 2 (F2): which comprises multiple branded medicines with the same API that are interchangeable at the patient level due to their bioequivalence / therapeutic equivalence (or biosimilarity).

231 A drug can only be on F1 if there is only one listed brand of a pharmaceutical item containing that drug. When a second brand of a pharmaceutical item obtains PBS listing, provided that item is a bioequivalent or biosimilar to the pharmaceutical item, the pharmaceutical item originally on F1 will be re-allocated to F2.

232 The consequence of listing the first generic or biosimilar brand, on the PBS Schedule, and the re-allocation to F2, is a mandatory price drop of 25% for the original brand, being EYLEA® in this case.

4.2    Summary of the parties’ balance of convenience arguments

233 The Applicants contend that the magnitude of damage they will suffer if no injunction is granted (the Launch Scenario) is much greater, in absolute terms, than any detriment to Sandoz through being delayed in its launch should an injunction be granted (the Restraint Scenario). The Applicants submit that the launch of the Sandoz Aflibercept Products would cause:

(1)    an immediate minimum 25% mandatory statutory reduction of the price under the PBS, affecting the EYLEA Aflibercept Products with no guarantee of reversal. Although theoretically reversible, the Applicants contend that it is unlikely that any price reduction will be reversed;

(2)    “accelerated” price disclosure related reductions as a result of the mandatory price disclosure regime, which would affect the price of EYLEA Aflibercept Products, and would also be unlikely to be reversed. The magnitude of reductions will depend on the volume of products sold;

(3)    loss of volume of sales for EYLEA® 2mg and EYLEA® 8mg, albeit to a relatively limited extent due to the confined scope for pharmacists to substitute anti-VEGF reference products with “a”-flagged biosimilar products such as the Sandoz Aflibercept Products. This is considering the manner in which anti-VEGF drugs are generally supplied directly to ophthalmology clinics, bypassing opportunities for pharmacist substitution;

(4)    loss of employees for the Bayer Australia, and an impact on its ability to continue the sponsoring and funding of various medical education and patient support programs, investigator-initiated research studies and clinical research fellows. The Applicants submit that this will compel the Bayer Australia to withdraw from such sponsoring and funding activities, which has flow-on unquantifiable and irreparable reputation damage to the Second Applicant due to the perception that it is withdrawing support for the community of Australians suffering from vision loss;

(5)    loss and damage to third-parties, including the responsible persons and sponsors for other anti-VEGF drugs in the market, namely LUCENTIS® and VABYSMO®; and

(6)    price drops for the Applicants’ aflibercept products in overseas markets such as the United States and Taiwan, by virtue of local international reference pricing regime.

234 Sandoz submits that it will suffer the following loss if an injunction is granted:

(1)    loss of its first mover advantage, as by the time Sandoz is able to enter the market, other biosimilar competitors will also be in a position to enter the market;

(2)    the possibility that the Applicants will launch an “authorised biosimilar”. The launch of other biosimilars on the market, including an authorised biosimilar, and the nature of the competition between those biosimilars and AFQLIR® is another matter which is not possible to predict in advance;

(3)    the Applicants are actively transitioning patients across to EYLEA® 8mg, such that by the time Sandoz is able to enter the market, much or all of the 2mg market may be lost; and

(4)    lost expenditure on stock and on overseas supply and packaging.

235 Sandoz submits that the detriment to it will be greater on a relative basis than any damage suffered by the Applicants.

4.3    Mandatory price drop upon listing of the Sandoz Aflibercept Products

236 The EYLEA Aflibercept Products are presently listed on the F1 of the PBS Schedule.

237 As a consequence of the operation of the price reduction regimes, subject to the exercise of ministerial discretion, the listing of the Sandoz Aflibercept Products on the PBS Schedule in the Launch Scenario will result in the movement of the EYLEA Aflibercept Products to the F2, and at least a 25% price drop and price disclosure associated price reductions for all of Bayer Australia’s PBS listed products, i.e., EYLEA® 2mg and 8mg vials and PFS, even though there is no 8mg Sandoz Aflibercept Product.

238 Mr Behrens gave an example of where the PBS price drop had been reversed where the supply of the pharmaceutical item which triggered the PBS price drop could no longer be guaranteed by the manufacturer. On 30 July 2020, the PBS price drop was taken not to have applied to the MERCAPTOPURINE-LINK® brand of mercaptopurine (an oral tablet containing 50mg of mercaptopurine monohydrate). On the same date, mercaptopurine was moved from F2 back to F1. Ms Zha’s evidence was that she considered that the statutory price reduction was generally irreversible. Increases to PBS prices are very rare and Ms Zha had never seen a First New Brand (FNB) statutory price reduction be reversed absent a failure to supply a guaranteed brand , which she has only seen occur once.

239 Ms Zha considered that once the EYLEA Aflibercept Products move from F1 to F2, certain special agreements between the Applicants and the Government will cease. The repercussions are that the effective price, as reduced by the FNB statutory price reduction, will become publicly available and therefore referable by international reference pricing regimes. Additionally, there may be further price drops, as Sandoz may be prompted to enter pricing negotiations with the Government. Under the s 85C of the NH Act, if there are two or more listed brands of a pharmaceutical item (as will be the case for the Launch Scenario) the Minister has an obligation to ensure the Approved Ex-Manufacturer Price (AEMP) of each listed brand of a pharmaceutical item is the same, before entering into a price agreement with a responsible person in relation to a brand of that pharmaceutical item under s 85AD(1) of the NH Act. Ms Zha gave the example that if the listing of the Sandoz Aflibercept Products were to trigger a 25% price reduction, Sandoz may offer the Government a 30% price reduction. The Government would then ask Bayer Australia to offer the same 30% reduced AEMP for the matching EYLEA® pharmaceutical items.

240 Although the Minister has a discretion not to reduce the PBS price, or reverse the price drop, there was no evidence that the Minister had ever done so where a generic product has launched with supply.  I consider it unlikely that the Minister would reinstate the F1 AEMP price of EYLEA® if the Sandoz Aflibercept Products were later removed from the market if Sandoz was ultimately restrained from selling them.

241 Ms Zha deposes that further price disclosure related reductions may also occur. The magnitude of these reductions depends on the market share of the biosimilar and originator products and the level of incentives provided by the biosimilar and originator suppliers. Unlike the 25% price drop, the Department of Health does not appear to have any discretion to reverse these subsequent price decreases.

4.4    Biosimilar uptake drivers

242 Biosimilar uptake drivers are measures which aim to encourage the use of biosimilar medicines through improving awareness of, and confidence in, biosimilars. Two specific biosimilar uptake drivers are:

* encouraging prescribing of a biosimilar brand rather than the reference biological brand for treatment-naïve patients; and

* providing for a simpler and faster approval process for prescribing biosimilar brands (e.g. streamlined authority) while maintaining an existing higher level authority requirement for the reference biological brand (e.g. written authority).

243 The PBAC has recommended that the listing of AFQLIR® and ENZEEVU® be accompanied by a broad administrative note encouraging their use.

244 Other than appealing to public-spirited ophthalmologists concerned to save the Commonwealth money, in the circumstances of the present market for VEGF antagonists, it is questionable whether such uptake drivers would have any effect on the prescribing habits of ophthalmologists.

245 Ms Zha’s evidence suggests the uptake drivers will have little effect in this case. Ms Zha considers that it is unlikely that the Sandoz Aflibercept Products will be listed with a lower level of authority for the initial treatment compared to EYLEA®, given the type of drug, the manner of administration, and the restricted nature of aflibercept’s PBS listings (i.e. that certain diagnostic criteria need to be satisfied for the prescription of aflibercept under the PBS).

4.5    Shift of market from EYLEA® 2mg to EYLEA® 8mg

246 The evidence before me suggests that EYLEA® 2mg and EYLEA® 8mg are distinct markets. As Ms Zha deposes, the launch of EYLEA® 8mg did not trigger a FNB statutory price drop on EYLEA® 2mg because “8mg aflibercept is not bioequivalent to 2mg aflibercept”. That the two dosages consist of separate markets is also axiomatic considering the significant marketing efforts engaged by the Applicants to encourage EYLEA® 2mg consumers to move to EYLEA® 8mg.

247 Sandoz contends that the Applicants are cannibalising their own EYLEA® 2mg market by actively transitioning prescribing ophthalmologists and patients across to EYLEA® 8mg. Sandoz argues that by that conduct, the Applicants are destabilising the status quo.

248 [Redacted.]

249 At present, the Applicants do not have an EYLEA® 8mg product in the form of PFS in Australia. [Redacted]. Prof Daniell deposes that “pre-filled syringes are generally preferred over vials by ophthalmologists due to their relative convenience”, and that he expects that “switching from Eylea 2mg to Eylea 8mg would accelerate significantly if Regeneron/Bayer enters the market with an Eylea 8mg pre-filled syringe product”.  [Redacted.]

250 A sample advertisement for the EYLEA® 8mg product spruiked the benefits of the 8mg against Bayer Australia’s own EYLEA® 2mg product for Wet AMD patients. Based on the evidence before me, I consider that ophthalmologists are being encouraged to “upgrade” their Wet AMD patients currently on EYLEA® 2mg to the “superior” EYLEA® 8mg product.

251 Whilst it is a legitimate commercial tactic for the Applicants to seek to transition the market for their product from EYLEA® 2mg to EYLEA® 8mg in order to mitigate what they see as the impact of biosimilar entry, if Sandoz is enjoined from entering the market until late 2027 or beyond, and Bayer continues with, and potentially accelerates its transitioning process, the market will have irredeemably changed from its current composition. The EYLEA® 2mg market would be considerably smaller than it is now, and the potential share, in terms of numbers of prescriptions, of that dwindled market that Sandoz might obtain when it is finally able to enter the market will be correspondingly smaller.

252 On the Launch Scenario, Sandoz submits that any loss of EYLEA® 2mg and EYLEA® 8mg profit and/or market share will not be wholly attributable to the launch of the Sandoz Aflibercept Products, as some shrinking of the EYLEA® 2mg market will be due to the Applicants’ own cannibalisation of its 2mg market by transitioning patients to EYLEA® 8mg.

4.6    VABYSMO®’s increasing market share

253 VABYSMO®’s, Roche’s faricimab product, market share is increasingly expanding even though until recently the VABYSMO® 2mg product was only offered in vial form. A PFS form of VABYSMO® was launched in Australia in May 2025.

254 Sandoz expects that the VABYSMO® market share will increase more rapidly because of the launch of the PFS form.

255 On the Launch Scenario Sandoz submits that any loss of EYLEA® 2mg and 8mg profit and/or market share would not be wholly attributable to the launch of the Sandoz Aflibercept Products, as some shrinking of the market for EYLEA® 2mg will be due to the increased market share of VABYSMO® particularly following the launch of its PFS form.

256 If Sandoz is enjoined, Sandoz contends that the status quo will irredeemably change due to the continued increase of the VABYSMO® market share during the period in which Sandoz is prevented from launching. Sandoz contends that this will necessarily mean that the potential market share available for Sandoz will be smaller by the time Sandoz is able to launch.

4.7    Authorised biosimilar

257 Sandoz submits that it is possible that if it launches its AFQLIR® product, the Applicants may launch their own “authorised” biosimilar (sometimes referred to as a “clone” or a “biosame” product) in response to competition in the market for aflibercept.

258 Alternatively, if Sandoz is enjoined, the Applicants may launch an authorised biosimilar shortly before the expiry of any period during which Sandoz is enjoined.

259 Mr Behrens gave the example of the insulin glargine market, wherein Sanofi launched a second brand to its LANTIS and LANTIS SOLOSTAR products, known as OPTISULIN®. After Alphapharm entered the market, Sanofi withdrew its Lantis products and instead sold OPTISULIN®.

260 On either case, the authorised biosimilar would take a share of the 2mg aflibercept market, and Sandoz would lose its first mover advantage.

4.8    Reduced EYLEA® market share

261 Following the launch of Sandoz’s AFQLIR®, there is likely to be a reduction in the market share of EYLEA® 2mg. However, as I have described above, Sandoz submits that any reduction in the market share cannot be solely attributed to the launch of a biosimilar. The market share of EYLEA® 2mg is under challenge from several sources, not just from the imminent launch of the biosimilar Sandoz Aflibercept Products.

262 The VABYSMO® market share has been increasing and that is likely to continue and perhaps accelerate following the recent approval of a PFS VABYSMO® on the PBS.

263 As I note above, the Applicants are themselves transitioning ophthalmologists and patients away from EYLEA® 2mg to the 8mg product, [redacted]. [Redacted.]

264 Given the idiosyncrasies of the aflibercept market, the biosimilar is likely to achieve only a modest market. Unlike a generic small molecule, there is no or limited opportunity for pharmacists to substitute the reference biologic with the biosimilar, and there is no price pressure on ophthalmologists or patients that drives substitution. As discussed above, Sandoz’s penetration of the market is likely to be gradual and only via new “treatment-naïve” patients, or patients that have experienced complications with LUCENTIS® or VABYSMO®.

4.9    International price ramifications

265 The Applicants contend that the PBS price drop will also cause a significant loss for the Applicants in countries other than Australia. This is because:

(a)    an Executive Order in force in the United States (and follow up letter from the President) directs various heads of key departments to implement “Most Favored Nation” drug pricing, which would set the price of EYLEA® in the United States as equal to the lowest price among relevant OECD countries, including Australia (MFN Referencing Pricing); and

(b)    the price for EYLEA®2 mg (from September 2026) and for EYLEA® 8mg (from March 2027) in Taiwan will be based on the price for EYLEA® in comparable jurisdictions, including Australia.

4.9.1    United States

266 On 12 May 2025, United States President Donald Trump issued Executive Order 14297 “Delivering Most Favored-Nation Prescription Drug Pricing to American Patients”.

267 On 20 May 2025, the United States Department of Health and Human Services (DHHS) issued a press release outlining its intention to take action to implement the Executive Order, which stated:

For too long, Americans have been forced to pay exorbitant prices for the same drugs that are sold overseas for far less,” said Secretary Kennedy. “That ends today. We expect pharmaceutical manufacturers to fulfill their commitment to lower prices for American patients, or we will take action to ensure they do.”

HHS expects each manufacturer to commit to aligning US pricing for all brand products across all markets that do not currently have generic or biosimilar competition with the lowest price of a set of economic peer countries. The MFN target price is the lowest price in an OECD country with a GDP per capita of at least 60 percent of the U.S. GDP per capita. These targets will drastically bring down U.S. drug prices, which are often three to five times higher than prices abroad, while preserving innovation by simply ensuring that Americans bear no greater burden than patients receiving the same drugs in other countries.

268 Mr Gritzmann notes that details of the “most favoured nation” pricing policy have not yet been released. Based on certain information provided by Jeff Zheng, Vice President Global Pricing and Distribution at Regeneron, Mr Gritzmann gives the following evidence:

[…] if the proposed US reference pricing policy comes into effect it will likely consist of the Federal Government reducing the price at which it reimburses purchasers of EYLEA under Medicare to the lowest price among OECD countries with at least 60% of the USA’s GDP per capita. Additionally, while the DHHS press release refers to the reduction of prices in markets which do not have biosimilar competition, that wording does not appear in the Executive Order, and it is not clear if that limitation would be implemented in policy, nor how it would apply in circumstances where there is no biosimilar to EYLEA 8 mg anywhere in the world but the price for EYLEA 8 mg would still be reduced in Australia by the listing of the Sandoz Aflibercept Products on the PBS.

269 [Redacted.]

270 The Applicants accept that the details of how MFN pricing will be applied in the United States is currently uncertain. Further, it may not be applied in relation to aflibercept, as there are already biosimilar products to aflibercept on the United States market.

271 Sandoz submits that there are at least five reasons why the loss allegedly suffered by the Applicants are unfounded and must be disregarded due to uncertainties as to whether: (i) the Executive Order will come into effect; (ii) the Executive Order will apply to a biosimilar market; (iii) the Executive Order will come into effect before the substantive proceedings have concluded; (iv) Australia’s EYLEA price will be the lowest, and therefore the reference point of the United States’ international reference pricing regime at the time the Executive Order comes into effect, and; (v)(a) EYLEA pricing in Ireland will be lower than the Australian pricing after the Launch Scenario and (v)(b) whether the figures as to pricing provided by the Applicants account for future pricing.

4.9.2    Taiwan

272 The Applicants submit that even if the loss arising from the United States’s international reference pricing is too uncertain, the position with respect to Taiwan is “far less amorphous […] than in the USA”.

273 Ms Zha gives evidence of Taiwan’s international reference pricing system, noting that in Taiwan, EYLEA® prescriptions are reimbursed under the Taiwan’s National Health Insurance (NHI) system. Ms Zha is employed by Bayer Consumer Care, and her affidavit provides scant basis for her possessing any specialised knowledge of Taiwan’s pharmaceutical pricing system and the relevant legislative and regulatory schemes.

274 According to Ms Zha, the legislation and regulation governing the NHI system contain rules for setting prices of “pharmaceutical items” that are reimbursed under the NHI system. According to Ms Zha, on the basis of a translation of the relevant statutory provisions into English, one such rule is that prices of pharmaceutical items reimbursed under the NHI system are adjusted based on the price of those items reported in ten reference countries (A10 Reference Countries).

275 Ms Zha gives evidence that in Taiwan, EYLEA® is categorised as a Category III drug because it is not currently the subject of Taiwan patent protection for the API. Ms Zha says that that categorisation enlivens art 20 of the Regulations Governing the Adjustment of Drug Prices under the National Health Insurance (Tw), which purportedly stipulates that EYLEA®’s price ought to be determined as follows: in the first year EYLEA® becomes a Category III drug, 115% of the weighted average selling price of other aflibercept in the same dosage form (Group Weighted Average Price) or via the lowest EYLEA® price in the A10 Reference Countries (Lowest International Reference EYLEA Price); in the fourth year and every subsequent three years, 115% of the Group Weighted Average Price or the Lowest International Reference EYLEA Price, and; in all other years that the drug remains a Category III drug, 115% of the Group Weighted Average Price.

276 According to Ms Zha, the above price reductions are set to take effect in September 2026 and again in 2027 for EYLEA® 2mg, and March 2027 for EYLEA® 8mg. [Redacted.]

277 Even presuming that Taiwan’s drug price-setting regime is as per Ms Zha’s understanding, the Applicants have not provided corroborating evidence of sufficient certainty to support the Lowest Reference Price Assumption. Additionally, there is no evidence as to whether the Taiwan market currently has any biosimilar aflibercept product or whether any biosimilar aflibercept product may become available by September 2026 or thereafter. This information appears to be particularly relevant considering that EYLEA®’s pricing in Taiwan may also be determined by way of the Group Weighted Average Price.

278 For those reasons, and from the limited material before me, I consider that the Applicants’ purported loss arising from Taiwan’s international reference pricing ought to be given limited to no weight in the balance of convenience assessment.

4.9.3    Conclusion on international reference pricing

279 At [153] of Sanofi, Burley J noted the prospect that a price reduction in Australia could also trigger commensurate price reductions in other countries which adopt international reference pricing. However, Burley J considered that there was insufficient evidence as to the nature, size and consequences of the relevant “International Price Referencing” for it to play a significant role in his assessment of the balance of convenience. The Applicants have sought to remedy any evidentiary deficiency of that kind by way of filing evidence from Ms Zha and Mr Gritzmann, including on information and belief from others.

280 However, in the case of the United States, the fate of the Executive Order and how it might be applied is currently uncertain, particularly as there are already biosimilars to aflibercept on the market. I consider that the purported position in the United States is so highly speculative that it can play no significant role in my assessment of the balance of convenience.

281 In relation to both the United States and Taiwan, there is no evidence as to the market circumstances in any of the other reference countries, whether there are already biosimilars on the market or not, and their applicable regulatory and pricing schemes. It is entirely unknown whether there might be circumstances (such as the launch of a biosimilar) in those countries that may result in any of them being the lowest price at the relevant time, or if not the lowest, then the second lowest to Australia, by a matter of a minute amount.

282 Finally, the Applicants refer to losses by Regeneron, Bayer Australia and Bayer Consumer Care. It does not appear that any of the threatened losses in the United States or Taiwan are asserted to be suffered by any of the Applicants directly. Ms Zha says she is informed of matters in her affidavit by an employee of Bayer Taiwan Company Ltd. There is no evidence, other than at a very high level, of the relevant Bayer group and Regeneron corporate structures and financial arrangements (including transfer pricing arrangements), whereby it would be possible to ascertain whether and how losses to Bayer Taiwan Company would flow to the Applicants. On the present evidence, these threatened losses appear to be suffered by companies that are sufficiently remote so as to be considered losses accruable by third-parties.

4.10    Launch Scenario unlikely to lead to Bayer job losses and reduced patient support

283 The Applicants contend that if Sandoz enters the market, there is a real risk of job losses at Bayer Australia and Bayer Consumer Care. The team responsible for the success and growth of EYLEA® in Australia is currently around thirteen staff, comprising nine full-time equivalent (FTE) employees in sales roles and six FTE employees acting as medical advisors and medical liaisons.

284 Mr Rock’s evidence is that if Sandoz is not restrained from listing the Sandoz Aflibercept Products on the PBS, there is a real risk that at least some of those employment positions will be lost. Further, the Second and Third Applicants purport that they will need to cut marketing, commercialisation and support activities for EYLEA® (its second-best selling pharmaceutical product after Xarelto®), including education and patient support programs, research funding and partnerships with industry and patient support societies. All of this will be to the detriment of patients, ophthalmologists and researchers.

285 However, Ms Zha’s evidence is that if the Applicants’ application to restrain the launch of the Sandoz Aflibercept Products is unsuccessful, the Second and Third Applicants will likely [redacted] EYLEA® 8mg PFS was recommended for listing of treatment of Wet AMD and DME during the November 2024 PBAC meeting.

286 Given the idiosyncrasies of the VEGF antagonist market I discussed above, I consider that for Bayer Australia and Bayer Consumer Care to accelerate the transition of patients and ophthalmologists from the EYLEA® 2mg to the “upgraded” EYLEA® 8mg would require two things. First, it would require a substantial education program which advertises and promotes the benefits of the higher dose EYLEA®. Secondly, it would require [redacted]. In those circumstances, it is likely that the employees of the Second and Third Applicants currently conducting marketing and support activities for EYLEA® 2mg, would or could pivot to conducting similar activities focussed on EYLEA® 8mg [redacted]. I also consider it unlikely that Bayer Australia and Bayer Consumer Care would cease sponsoring research and educational events for ophthalmologists at a time they are seeking to transition ophthalmologist and patients to the EYLEA® 8mg product, of which there is currently no approved biosimilar in Australia.

4.11    Loss of Sandoz’ first mover advantage

287 Sandoz submits that if it is the first biosimilar entrant to the market, all other things being equal, the general reluctance to switch between biosimilars means that the head start afforded to Sandoz as the first entrant is far more significant than for small molecule generics. Sandoz asserts that its first mover advantage has the potential to springboard long lasting impacts on market share. Afterall, evidence suggests that once a patient is switched to a biosimilar, they are unlikely to be switched to another.

288 Sandoz contends that it has a significant head start, as the earliest any other aflibercept biosimilar could enter the market with PBS listing is April 2026. Sandoz submits that its strategy of educating ophthalmologists prior to a December 2025 PBS launch is critical to the securement of market share. This is due to the extensive familiarisation and education required for ophthalmologists and patients to begin using AFQLIR® or consider switching to AFQLIR®. Thus, the longer the period between Sandoz’s launch and the launch of the next biosimilar, the greater the first mover advantage and market share will be retained by Sandoz.

289 However, if Sandoz is prevented from launching its biosimilar aflibercept, by the time it is eventually able to launch, other pharmaceutical companies are likely to also be in a position to simultaneously launch their own competitor biosimilar.

290 Currently, the only other approved aflibercept biosimilar in Australia is Celltrion’s EYDENZELT®. Should Sandoz be enjoined, I consider it unlikely that Celltrion will launch at risk given EYDENZELT®’s narrow indication, i.e., for visual impairment due to Myopic CNV. The very small Myopic CNV market share is unlikely to justify the cost of defending any potential infringement action or launching revocation proceedings. However, according to Mr Behrens, there are a number of substantial competitors (including Samsung Bioepis, Biocon, Amgen, Formycon AG and Apotex) who already have biosimilar aflibercept products which have been approved in foreign jurisdictions, including the EU, the United States and Canada.  Amgen and Celltrion currently compete with Sandoz in Australia in relation to other biosimilar products such as adalimumab, rituximab, bevacizumab and trastuzumab.

291 It is noteworthy that Actor Pharmaceuticals Pty Ltd has recently filed proceedings to revoke the 599 Patent, suggesting that it may have an interest in launching an aflibercept biosimilar.

292 Further, as I alluded to above, there is also the possibility that the Applicants might launch their own authorised biosimilar product prior to Sandoz entering the market. This would effectively deny Sandoz any first mover advantage.

293 The law recognises that the first mover advantage is a benefit sought to be derived at the expense of the Applicants’ asserted monopoly rights: see Otsuka Pharmaceutical Co Ltd v Generic Health Pty Ltd (2012) 291 ALR 763 at [178] (Yates J), cited with approval in Apotex Pty Ltd v Cipla Ltd [2017] FCA 1627 at [142] (Beach J). However, I consider that where the Applicants do not have a strong prima facie case on infringement, Sandoz’s loss of first mover advantage remains a relevant factor to be considered in assessing where the balance of convenience lies. This is particularly so having regard to the idiosyncrasies of the biosimilars and VEGF antagonist markets, including the higher barriers of entry and the constraints of any biosimilar in gaining market share.

4.12    Packaging costs

294 In preparation for the launch in October 2025, Sandoz asserts that it has incurred considerable expenses in ensuring that there is sufficient supply of the Sandoz Aflibercept Products at 2mg. Sandoz submits that if it is enjoined, the expenditure on packaging and product will be wasted, as depending upon the period in which Sandoz is enjoined, all such stock may need to be destroyed. This is particularly so given that Sandoz will not be permitted to sell a pharmaceutical product with less than a window of six months before expiry.

295 Where a party elects to enter a market in full knowledge of the risk that its conduct may infringe patent rights and be subject to an injunction, it cannot thereafter invoke the disruption to its business arrangements—knowingly undertaken in the face of that risk—as a shield to resist or mitigate the consequences of such injunction: Pharmacia Italia SpA & Anor v Interpharma Pty Ltd (2005) 67 IPR 397 at [52] (Sundberg J). The sunk packaging costs are therefore not a relevant factor in considering whether to grant the interlocutory injunctive relief sought. Accordingly, I have given no weight to any loss arising from packaging costs.

4.13    Effects on third parties

296 Ms Zha understands that the Department of Health seeks to cost-minimise drugs which are alternative treatments for the same indications, on the basis of PBAC advice that these treatments are alternatives, even if they are not biosimilar, bioequivalent or “a”-flagged. Ms Zha’s evidence is that EYLEA® has been subject to cost-minimisation price reductions previously. By way of example, price reductions that have applied to LUCENTIS® have previously flowed on to EYLEA® on a cost-minimisation basis.

297 In the Launch Scenario, Ms Zha expects that cost-minimisation price reductions following any reduction in the cost of EYLEA® would flow on to VABYSMO®. The Applicants submit that Roche is likely to suffer loss arising from lost sales of VABYSMO® in relation to new patients for which they cannot recover. Novartis’ LUCENTIS®, which competes with EYLEA® and VABYSMO® can also be expected to suffer similar loss in sales and lost profits due to price reduction. Of course, VABYSMO® and LUCENTIS® are also likely to lose market share as a result of the Applicants’ transitioning of patients from the EYLEA® 2mg to the “upgraded” EYLEA® 8mg, if ophthalmologists are convinced of the benefits of EYLEA® 8mg such as less injections per year.

298 If Sandoz is permitted to enter the aflibercept market, the price reductions resulting from AFQLIR®’s launch will result in substantial benefit to the Commonwealth because it will pay less for reimbursement in relation to aflibercept prescriptions. Similarly, if Sandoz is prevented from entering the market, the Commonwealth will continue to pay the higher PBS reimbursement price. Sandoz notes that the governments of the United States and Taiwan will also benefit from any price reduction, if the Applicants’ submissions as to international price referencing are correct, [redacted].

299 In addition to the cost-benefit analyses of the Launch Scenario above, Sandoz notes that in the Restraint Scenario, [redacted].

300 On both scenarios there are potential benefits to some third parties and detriments to others. For that reason, I place no weight on the effects on third parties.

4.14    Sandoz’s capacity to meet damages

301 The Applicants submit that, on several occasions, Sandoz has been invited to demonstrate that it has the capacity to meet an award of damages against it, but Sandoz has not done so. The Applicants refer to Mr Behrens’ evidence to contend that the global business of Sandoz is irrelevant to the assessment of Sandoz’s capacity to meet damages, as the party liable for damages will be Sandoz only. The Applicants further rely on Mr Behrens’ confidential evidence on Sandoz’s assets in Australia to argue that such assets are “woefully inadequate”.

302 At the hearing, Sandoz indicated its willingness to undertake that Sandoz AG would consent to submit to the Australian jurisdiction and be jointly and severally liable with Sandoz for any damages award.

303 The Applicants submit that the proffered undertaking is not a total answer to the question of Sandoz’s capacity to pay, as there would still be difficulties in enforcing an order for damages on a company located in a foreign jurisdiction.

4.15    Many ophthalmologists prescribing outside claimed method

304 Sandoz submits that even if there were a prima facie case for infringement, there is no prima facie case in respect of the final injunctive relief sought, i.e., restraining the exploitation of the Sandoz Aflibercept Products. Sandoz submits that the evidence is that overwhelmingly, the Sandoz Aflibercept Products will be used in a non-infringing way. That is because the typical Wet AMD and DME treatments, will not on the face of the evidence fall within the Asserted 599 Claims. Further, the Sandoz Aflibercept Products will also be used to treat other eye disorders that are not the subject of the Asserted 599 Claims, such as Myopic CNV and RVO. As most ophthalmologists prescribe and administer aflibercept for Wet AMD and DME on a treat-and-extend basis according to their clinical judgment and patient response to the drug, most administration regimens are likely to fall outside the claimed method of treatment.

305 The Full Court in AstraZeneca observed at [443] that if s 117(1) of the Act is engaged in circumstances where some but not all persons to whom the product is supplied will put it to an infringing use, then “some consideration of proportionality as between the extent of the infringing use that is forecast and the scope of any injunctive relief is warranted”. The Full Court continued at [444] that “[i]t may be undesirable to impose a blanket restraint upon a supplier who has reason to believe that only some consumers, perhaps a very small minority, may put the product that is or may be supplied to them to an infringing use”. In the same paragraph, their Honours concluded that “all other things being equal, the more difficult it is for the patentee to establish that there is a likelihood of widespread infringing use, the more difficult it should be for the patentee to obtain injunctive relief in the broad terms restraining any supply of the relevant product”.

306 Sandoz relies on the relative proportion of infringing and non-infringing use to contend that it would be disproportionate for the court to grant injunctive relief that restrains the supply of the Sandoz Aflibercept Product.

307 In light of my conclusion that there is a real prospect that the use of the Sandoz Aflibercept Products in accordance with the Sandoz PI will not infringe the Asserted 599 Claims, I accept Sandoz’s submission that the broad relief sought by the Applicants is disproportionate. It is therefore not necessary for me to consider what other injunctive relief, if any, might have been appropriate in lieu of that sought by the Applicants.

4.16    Quantification of damage

308 The forensic accountants’ evidence is that calculating the Applicants’ loss and Sandoz’s loss will be subject to similar difficulties, with each scenario giving rise to its own unique complexities. The assessment of loss and damage in both scenarios is complex, time consuming, will require considerable estimation and will therefore be subject to uncertainty. One task is not significantly more complex than the other.

309 Notwithstanding the above, the Applicants submit that as their damage would be of a larger absolute quantum, there is more scope for greater uncertainty.

310 Sandoz submits that as there would be more unknowns and counterfactuals in the Restraint Scenario, there would be greater scope for uncertainty in quantifying its damage. In particular, Mr Ross identified the following real-world factors that would be known in the Launch Scenario, all of which would be unknown in the Restraint Scenario:

(1)    the extent to which the 2mg Sandoz Aflibercept Products will have obtained market share;

(2)    the response to competition in the aflibercept market from other suppliers with the capability to launch an aflibercept biosimilar, and the extent of market share gained by them;

(3)    the pricing behaviour of the relevant suppliers in the market, including the Applicants; and

(4)    the extent to which the market shifts from EYLEA® 2mg to EYLEA® 8mg or VABYSMO®.

311 Sandoz submits that any risk to the Applicants is further reduced in circumstances where Sandoz will keep detailed records of its sales to evidence the sales volume, prices and incentives relating to other suppliers due to the requirements of the PBS Price Disclosure Guidelines. In the event that Sandoz is required to withdraw the 2mg Sandoz Aflibercept Products following trial, there would be no ongoing impact to the Applicants in terms of volume. This is because it is foreseeable that there would be a return to the status quo with the Applicants re-capturing near 100% of the aflibercept market, provided that there is no other lawful aflibercept product entry.

312 Based on the provisional evidence before me, it is not possible to conclusively determine that the complexity of estimating the loss of one side is more complex than that of the other. However, the great number of unknowns in the Restraint Scenario suggests that it would be more difficult to calculate the damage suffered by Sandoz in that scenario, than the Applicants in the Launch Scenario.

5.    Conclusion and disposition

313 On the Launch Scenario, there is likely to be a 25% price drop that would affect all the EYLEA® 2mg products. The price drop is less certain regarding EYLEA® 8mg. While there may be further price discounting, any such discount is likely to be small when compared to the usual small molecule generic price discounts. This is due to the limited prospects of a competitor biosimilar entering the market any time soon, the limited opportunity—if any—for pharmacists to substitute EYLEA® with AFQLIR®, and the lack of any apparent benefit to ophthalmologists in substituting.

314 There will likely be some loss of market share for EYLEA® 2mg, but that loss will be capped given that there is no significant pool of undiagnosed patients or diagnosed but untreated patients. As such, Sandoz is likely to only capture new treatment-naïve patients and any patients transferring from LUCENTIS® or VABYSMO®. Furthermore, not all market shares would be lost to the Sandoz Aflibercept Products. In addition to the Second and Third Applicants’ own migration of patients from the EYLEA® 2mg to EYLEA® 8 mg [redacted], VABYSMO® is increasing its market share. Since the recent launch of the PFS VABYSMO®, the market uptake of VABYSMO® is expected to increase. In the event that the Applicants were successful at trial, I consider that they are likely to regain the market share temporarily occupied by the biosimilar Sandoz Aflibercept Products due to inter alia the established reputation of EYLEA®.

315 The loss suffered by the Applicants on the Launch Scenario is principally loss of revenue due to the mandatory price drop following the listing and launch of the Sandoz Aflibercept Products. As explained above, I do not consider that there will be job losses or reduced sponsorship or research as consequence of the Launch Scenario. I further consider that the alleged losses in the United States and Taiwan are too speculative and too remote to be relevant factors in the present balance of convenience exercise. As such, I consider that the Applicants’ loss is likely to be compensable by a damages award.

316 In contrast, if Sandoz is restrained, what would have happened in the market will be highly speculative. Further, Sandoz will lose the first mover advantage. In the circumstances of this case, the first mover advantage is likely to bestow a real and lasting advantage that Sandoz would likely retain over any subsequent biosimilar competitor to enter the market. Evidence suggests that patients are very unlikely to be switched between biosimilars.

317 On the evidence before me, the calculation of loss in either the Restraint Scenario or Launch Scenario is of comparable complexity, such that it is not possible at this provisional stage to determine with certainty which damages calculation exercise would be more complex. However, I consider that the calculation of the loss in the Restraint Scenario is likely to involve more unknowns in the relevant counterfactual scenarios. In the event that Sandoz enters the market and is subsequently found to infringe the 599 Patent, it will be open to the Applicants to pursue damages or an account of profits, or both. The repercussions to the market caused by the launch of the Sandoz Aflibercept Products will be relatively quantifiable, notwithstanding certain difficulties outlined by the Applicants.

318 An additional consideration is the changing market dynamic. In the Restraint Scenario, the possibility for dramatic and irremediable change in the market from the status quo during the period of any injunction is a relevant factor. This change would be substantially due to the Applicants’ likely accelerated migration of patients across from the EYLEA® 2mg to 8mg. Further contributing to the change in market dynamic is the increasing market share captured by VABYSMO®, particularly since the launch of the PFS form. The combined effect of these changes to the market is such that the market for the Sandoz Aflibercept Products (i.e., new patients for 2mg aflibercept and patients considering switching to a 2mg aflibercept biosimilar) would be very different—and likely much smaller—to the current state. In the Restraint Scenario, and as a result of the loss of its first mover advantage, Sandoz will only achieve a smaller market share in a much smaller market.

319 In my view the balance of convenience does not favour the grant of an injunction to restrain the launch of the Sandoz Aflibercept Products.

320 To my consideration of the balance of convenience, I also add my conclusion as to the weakness of the Applicants’ prima facie case on infringement given my provisional construction of integers 1.3 and 1.4. Taken together, these considerations lead me to conclude that there is insufficient likelihood of success in all the circumstances to justify the grant of the broad injunction sought. I am further fortified in this conclusion by the fact that, even if the Applicants were successful at trial, they may very well not succeed in establishing widespread infringing use such as to justify an injunction. This is because of the use of the Sandoz Aflibercept Products for indications other than Wet AMD and DME, and the practice of ophthalmologists to employ treat-and-extend regimens based on their clinical judgment and patient response, both of which will take uses of the Sandoz Aflibercept Products outside the scope of the claimed method.

321 Accordingly, the Applicants’ application for interlocutory relief is dismissed.

Associate:

Dated:    3 September 2025

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