Regeneron Pharmaceuticals, Inc. v Sandoz Pty Ltd
[2025] FCA 1067
•3 September 2025
FEDERAL COURT OF AUSTRALIA
Regeneron Pharmaceuticals, Inc. v Sandoz Pty Ltd [2025] FCA 1067
File number: VID 715 of 2025 Judgment of: ROFE J Date of judgment: 3 September 2025 Catchwords: PRACTICE AND PROCEDURE – patents – interlocutory injunction application – prima facie case – infringement – validity of patents – balance of convenience – application refused
PATENTS – aflibercept – VEGF Antagonist – claim construction – infringement – infringing and non-infringing uses – novelty – inventive step – support
Legislation: Australian Consumer Law (Schedule 2 to the Competition and Consumer Act 2010 (Cth))
Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth)
National Health Act 1953 (Cth), ss 85AB, 85AD(1), 85C
Patents Act 1990 (Cth), ss 7, 13, 18, 40(3), 117(1), 117(2)(b), 117(2)(c)
Therapeutic Goods Act1989 (Cth), s 23B(2)(e)
Cases cited: Allied Pumps Pty Ltd v LAA Industries Pty Ltd (2023) 179 IPR 1
Apotex Pty Ltd v Cipla Ltd [2017] FCA 1627
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (2013) 304 ALR 1
AstraZeneca AB v Apotex Pty Ltd (2014) 226 FCR 324
AstraZeneca AB v Apotex Pty Ltd (2015) 323 ALR 605
Australian Broadcasting Corporation v O’Neill (2006) 227 CLR 57
Beadcrete Pty Ltd v Fe Yu (t/as Jewels 4 Pools) (No 3) (2013) 100 IPR 188
Beecham Group Ltd v Bristol Laboratories Pty Ltd (1968) 118 CLR 618
Décor Corporation Pty Ltd v Dart Industries Inc (1988) 13 IPR 385
Fei Yu (t/as Jewels 4 Pools) v Beadcrete Pty Ltd (2014) 107 IPR 516
Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331
General Tire and Rubber Co v Firestone Tyre and Rubber Co Ltd (1971) 1A IPR 121
Generic Health Pty Ltd v Otsuka Pharmaceutical Co Ltd (2013) 296 ALR 50
Glass Hardware v TCT Group Pty Ltd (2024) 182 IPR 1
Hood v Bush Pharmacy Pty Ltd (2020) 158 IPR 229
Interpharma Pty Ltd v Hospira Inc (No 5) (2019) 149 IPR 182
Jupiters Ltd v Neurizon Pty Ltd (2005) 65 IPR 86
Kirin-Amgen Inc v Hoechst Marion Roussel Ltd (2004) 64 IPR 444
Miele & Cie KG v Bruckbauer [2025] FCA 537
Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd (2020) 279 FCR 354
Neurim Pharmaceuticals (1991) Ltd v Generic Partners Pty Ltd (No 5) [2024] FCA 360
Novozymes A/S v Danisco A/S (2013) 99 IPR 417
Otsuka Pharmaceutical Co Ltd v Generic Health Pty Ltd (2012) 291 ALR 763
Pharmacia Italia SpA & Anor v Interpharma Pty Ltd (2005) 67 IPR 397
Product Management Group Pty Ltd v Blue Gentian LLC (2015) 116 IPR 54
Samsung Electronics Co Ltd v Apple Inc (2011) 217 FCR 238
Sandoz AG v Bayer Intellectual Property GmbH (2024) 183 IPR 309
Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd (2019) 139 IPR 409
Sanofi-Aventis Deutschland GmbH v Alphapharm Pty Ltd (No 3) (2018) 138 IPR 242
ToolGen Incorporated v Fished (No 2) [2023] FCA 794
Tramanco Pty Ltd v BPW Transpec Pty Ltd (2014) 105 IPR 18
Warner-Lambert Co LLC v Apotex Pty Ltd (2014) 106 IPR 59
Division: General Division Registry: Victoria National Practice Area: Intellectual Property Sub-area: Patents and Associated Statutes Number of paragraphs: 321 Date of last submissions: 11 August 2025 Date of hearing: 14 August 2025 Counsel for the Applicants: N Murray SC with K Beattie SC and C Cunliffe Solicitor for the First Applicant: Corrs Chambers Westgarth Solicitor for the Second and Third Applicants: Davies Collison Cave Law Counsel for the Respondent: T Cordiner KC with D Larish and A Surkis Solicitor for the Respondent: MinterEllison ORDERS
VID 715 of 2025 BETWEEN: REGENERON PHARMACEUTICALS, INC.
First Applicant
BAYER AUSTRALIA LIMITED (ACN 000 138 714)
Second Applicant
BAYER CONSUMER CARE AG
Third Applicant
AND: SANDOZ PTY LTD (ACN 075 449 553)
Respondent
AND BETWEEN: SANDOZ PTY LTD (ACN 075 449 553)
Cross-Claimant
AND: REGENERON PHARMACEUTICALS, INC (and another named in the Schedule)
First Cross Respondent
ORDER MADE BY:
ROFE J
DATE OF ORDER:
3 SEPTEMBER 2025
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]
1.1 The Parties and the broad issues
[1]
1.2 Undertakings
[6]
1.3 Expedited trial
[10]
1.4 Summary of conclusion
[12]
1.5 The witnesses
[13]
1.6 The Applicants’ corporate relationship and structure
[17]
1.7 Retinal and angiogenic eye disorders
[20]
1.8 VEGF antagonists for treating retinal and angiogenic eye disorders
[25]
1.9 Aflibercept
[31]
1.10 The EYLEA® Aflibercept Products
[34]
1.11 The Sandoz Aflibercept Products
[39]
1.12 Other aflibercept products
[43]
1.13 Biologics v small molecules
[46]
1.14 Idiosyncrasies of the VEGF antagonist market
[51]
1.15 Sandoz proposed conduct
[59]
2 INTERLOCUTORY INJUNCTION PRINCIPLES
[62]
3 PRIMA FACIE CASE
[67]
3.1 The 599 Patent
[67]
3.2 Person skilled in the art
[82]
3.3 The issues
[85]
3.4 Infringement
[89]
3.4.1 Sandoz PI
[98]
3.4.2 Ophthalmologist treatment regimens for EYLEA® 2mg
[103]
3.4.3 Construction principles
[107]
3.4.4 Four weeks is not equivalent to a month
[113]
3.4.5 Eight weeks is not equivalent to two months
[125]
3.4.6 Section 117
[135]
3.4.6.1 Whether the Sandoz PI constitutes an “instruction”
[142]
3.4.6.2 Whether the instructions in the Sandoz PI are “given” to ophthalmologists
[153]
3.4.7 Conclusion on s 117(2)(c)
[163]
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]
3.4.9 Conclusion on prima facie case on infringement
[170]
3.5 Invalidity
[172]
3.5.1 Novelty
[173]
3.5.1.1 Adis
[178]
3.5.1.2 Dixon
[180]
3.5.2 Sandoz’s inevitability argument
[188]
3.5.3 United States cases
[198]
3.5.4 Lack of inventive step
[201]
3.5.5 Lack of support
[208]
3.5.5.1 Broad range of eye disorders
[213]
3.5.5.2 Unlimited number of secondary or tertiary doses
[221]
3.5.5.3 Doses of aflibercept
[224]
4 BALANCE OF CONVENIENCE
[229]
4.1 Pharmaceutical Benefits Scheme
[229]
4.2 Summary of the parties’ balance of convenience arguments
[233]
4.3 Mandatory price drop upon listing of the Sandoz Aflibercept Products
[236]
4.4 Biosimilar uptake drivers
[242]
4.5 Shift of market from EYLEA® 2mg to EYLEA® 8mg
[246]
4.6 VABYSMO®’s increasing market share
[253]
4.7 Authorised biosimilar
[257]
4.8 Reduced EYLEA® market share
[261]
4.9 International price ramifications
[265]
4.9.1 United States
[266]
4.9.2 Taiwan
[272]
4.9.3 Conclusion on international reference pricing
[279]
4.10 Launch Scenario unlikely to lead to Bayer job losses and reduced patient support
[283]
4.11 Loss of Sandoz’ first mover advantage
[287]
4.12 Packaging costs
[294]
4.13 Effects on third parties
[296]
4.14 Sandoz’s capacity to meet damages
[301]
4.15 Many ophthalmologists prescribing outside claimed method
[304]
4.16 Quantification of damage
[308]
5 CONCLUSION AND DISPOSITION
[313]
1. OVERVIEW
1.1 The Parties and the broad issues
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.
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®.
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.
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.
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
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.
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.
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.
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
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.
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
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
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.
The Applicants also tendered a tender bundle and a confidential tender bundle.
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.
Sandoz tendered a confidential tender bundle.
1.6 The Applicants’ corporate relationship and structure
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.
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).
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
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.
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.
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).
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.
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
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.
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.
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.
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.
Each of EYLEA®, LUCENTIS® and VABYSMO® are listed on the PBS for a range of indications, including neovascular AMD, DME, RVO and Myopic CNV.
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
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.
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.
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
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.
Product name
Presentation
Indication
Administration
Covered by the 599 Patent?
Substitutable with AFQLIR®?
EYLEA®
(EYLEA 8mg Vial)
EYLEA aflibercept 114.3 mg/mL solution for intravitreal injection vial with needle
Wet AMD
DME
Intravitreal injection; transfer vial to needle.
Yes
Yes, but no AFQLIR® 8mg available yet.
EYLEA®
(EYLEA 8mg Syringe)
EYLEA aflibercept 114.3 mg/mL solution for intravitreal injection pre-filled syringe with OcuClick dosing system
Wet AMD
DME
Intravitreal injection.
Yes
Yes, but no AFQLIR® 8mg available yet.
EYLEA®
(EYLEA 2mg Syringe)
EYLEA aflibercept (rch) 40 mg/mL solution for intravitreal injection pre-filled syringe
Wet AMD
CRVO
BRVO
DME
Myopic CNV
Intravitreal injection.
Yes
Yes
EYLEA®
(EYLEA 2mg Vial)
EYLEA aflibercept (rch) 40 mg/mL solution for intravitreal injection vial with needle
Wet AMD
CRVO
BRVO
DME
Myopic CNV
Intravitreal injection; transfer vial to needle.
Yes
Yes
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.
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.
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.
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
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.
As I indicated at [2] above, Sandoz intends to supply AFQLIR® from October 2025 but does not intend to supply ENZEEVU® in 2025.
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.
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
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.
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.
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
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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
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.
[Redacted].
Sandoz does not intend to exploit its ENZEEVU® product in Australia during at least 2025.
2. INTERLOCUTORY INJUNCTION PRINCIPLES
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).
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).
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.
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”.
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
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.
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.
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”.
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.”
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.)”.
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-Fc C1 (a)” or “aflibercept”.
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.
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.
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”.
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.
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.
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”).”
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-Fc C1(a), a therapeutically effective amount can be from about 0.05 mg to about 5 mg.
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.
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-Fc C1(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
It was common ground that the person skilled in the art is an ophthalmologist, being the medical practitioner responsible for treating angiogenic eye disorders.
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.
Each of the ophthalmologist witnesses had such specialised knowledge and experience.
3.3 The issues
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.
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.
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.
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
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.
The Applicants allege infringement against Sandoz with respect to treatment of Wet AMD and DME.
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.
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)
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.
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.
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.
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.
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.
3.4.1Sandoz PI
The Sandoz PI is Annexure B to the Amended Statement of Claim dated 18 June 2025.
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.
According to Mr Behrens, the Sandoz PI will also be published on the TGA website in accordance with the Therapeutic Goods Act1989 (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.
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.)
In addition to Wet AMD and DME, the Sandoz PI also discusses treatment using the Sandoz Aflibercept Products for CRVO, BRVO and CNV.
3.4.2Ophthalmologist treatment regimens for EYLEA® 2mg
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)”.
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.
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.)
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.
3.4.3Construction principles
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).
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.
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.
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.
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.
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.
3.4.4Four weeks is not equivalent to a month
The relevant claim integer 1.3 is “wherein each secondary dose is administered 2 to 4 weeks after the immediately preceding dose […]”.
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.
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.
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.
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.
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.
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.
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.
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”.
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.
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.
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.]
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.
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.
4.9.3Conclusion on international reference pricing
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.
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.
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.
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
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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
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.
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
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.
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.
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].
In addition to the cost-benefit analyses of the Launch Scenario above, Sandoz notes that in the Restraint Scenario, [redacted].
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
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”.
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.
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
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.
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”.
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.
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
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.
Notwithstanding the above, the Applicants submit that as their damage would be of a larger absolute quantum, there is more scope for greater uncertainty.
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®.
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.
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
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.
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®.
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.
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.
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.
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.
In my view the balance of convenience does not favour the grant of an injunction to restrain the launch of the Sandoz Aflibercept Products.
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.
Accordingly, the Applicants’ application for interlocutory relief is dismissed.
I certify that the preceding three hundred and twenty-one (321) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Rofe. Associate:
Dated: 3 September 2025
SCHEDULE OF PARTIES
VID 715 of 2025 Cross-Respondents
Second Cross Respondent
BAYER CONSUMER CARE AG
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