Regeneron Pharmaceuticals, Inc. v Sandoz Pty Ltd

This was an urgent Federal Court fight about whether a biosimilar aflibercept product should be stopped from launching before the full patent case could be heard. Regeneron owned the patent in suit, Bayer Consumer Care AG was the exclusive licensee from 10 June 2025, and Bayer Australia was authorised to use the relevant intellectual property in connection with distributing, promoting and marketing EYLEA aflibercept products in Australia.

Sandoz planned to launch AFQLIR and ENZEEVU, both biosimilar aflibercept products to EYLEA 2mg. The Court recorded that Sandoz accepted the products and their corresponding product information were the same for the purposes of the proceeding, and because ENZEEVU was not intended to be launched at that stage, the practical focus was AFQLIR. Sandoz had ARTG listings from 27 May 2025 and, according to the judgment, would receive approval for PBS listing from 1 December 2025.

The applicants wanted urgent orders to stop Sandoz from marketing, importing and engaging in launch activities. They also sought an order requiring Sandoz to take reasonable steps to withdraw PBS listing applications. That made this more than a technical patent dispute. It was a commercially urgent attempt to preserve the existing market position before a biosimilar launch could affect pricing, prescribing patterns and market share.

The patent in issue was Australian Patent No. 2012205599, titled “Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders”. The judgment explains the medical setting in some detail because the treatment patterns mattered to both infringement and commercial harm. Aflibercept is used in EYLEA products for retinal and angiogenic eye disorders including wet AMD, DME, CRVO, BRVO and myopic CNV.

The Court’s overview shows that the dispute involved both legal and practical questions. On the patent side, there were issues about claim construction, infringement, section 117 supply liability, and whether there were infringing and non-infringing uses. On the validity side, Sandoz challenged the patent on novelty, inventive step and support. On the commercial side, the Court had to assess what would happen if Sandoz launched before trial, including the effect on PBS pricing, biosimilar uptake, the shift from EYLEA 2mg to EYLEA 8mg, competition from VABYSMO, and whether losses could later be measured in money.

The applicants also sought final relief under the Australian Consumer Law, but the published extract is most detailed on the patent and interlocutory injunction issues. For a business reader, the key point is that urgent launch disputes often become evidence-heavy very quickly. The Court was not only asked to interpret patent claims. It was also asked to assess how ophthalmologists prescribe, what product information communicates, and how a launch would affect a complex market.

The immediate question was whether the Court should grant an interlocutory injunction pending final determination of the proceeding. The catchwords and structure of the reasons show the usual framework: prima facie case and balance of convenience. The Court had to consider whether the applicants had shown a sufficient case on infringement, despite Sandoz’s invalidity challenges, and whether the practical consequences justified restraining the launch before trial.

The contents of the reasons show the infringement analysis included the Sandoz product information, ophthalmologist treatment regimens, construction principles, whether four weeks is equivalent to a month, whether eight weeks is equivalent to two months, and section 117 issues. The Court specifically identified questions about whether the Sandoz product information constituted an “instruction”, whether those instructions were “given” to ophthalmologists, and whether there was reason to believe ophthalmologists would put the products to infringing use.

Validity was also live at the interlocutory stage. The extract lists novelty, inventive step and support challenges, including arguments about the breadth of eye disorders covered, the number of secondary or tertiary doses, and doses of aflibercept. That matters because an urgent injunction application can fail even where infringement is arguable, if the patent position is contested and the balance of convenience does not support interim restraint.

The Court refused the interlocutory injunction. The formal orders state that the applicants’ claim for interlocutory relief was dismissed. Justice Rofe’s summary of conclusion, as reproduced in the extract, says that the balance of convenience did not lie in favour of granting the interim relief sought.

That is the central outcome. The extract does not support saying that the applicants had no arguable case at all, or that Sandoz had definitively defeated the patent claims. The safer reading is that the Court considered the overall practical position and was not persuaded that an interim restraint should be imposed before trial.

The orders also record undertakings from Sandoz. Sandoz AG undertook to submit to the jurisdiction of the Federal Court and to be jointly liable with Sandoz Pty Ltd, to the extent Sandoz Pty Ltd could not meet its obligations for any award of pecuniary relief, up to $100 million. Sandoz also undertook to keep accounts and take reasonable steps to procure that any distributor kept accounts of sales of the Sandoz aflibercept products. Costs were reserved.

The Court further ordered that, until further order, the reasons not be disclosed or published except to the parties’ legal representatives and Court staff, and required the parties to confer on proposed redactions for confidential information. That means some details of the reasoning were initially treated as confidential and may not have been publicly available in full immediately.

This judgment is especially useful because the published structure of the reasons shows how commercially detailed an interlocutory patent dispute can become. The Court’s balance of convenience section expressly addressed the Pharmaceutical Benefits Scheme, mandatory price drop issues, biosimilar uptake drivers, the shift of market from EYLEA 2mg to EYLEA 8mg, VABYSMO’s increasing market share, the possibility of an authorised biosimilar, reduced EYLEA market share, international price ramifications, possible job loss and patient support arguments, Sandoz’s first mover advantage, packaging costs, effects on third parties, Sandoz’s capacity to meet damages, prescribing outside the claimed method, and quantification of damage.

That list matters because it shows what businesses should expect in urgent launch litigation. Courts do not decide these applications in a vacuum. They ask what practical harm each side will suffer if the injunction is granted or refused, whether that harm can later be compensated by damages, and whether undertakings can reduce the risk. In a pharmaceutical market, PBS listing and pricing consequences can be especially important because they may affect not only the parties but also substitution, reimbursement and broader market pricing.

The judgment also records an expedited trial proposal. The applicants proposed that the matter could potentially be ready for trial in December 2025, subject to the Court’s availability. Sandoz did not embrace that proposal and pointed to the effect of appeal timing on any first mover advantage. That is a useful reminder that timing arguments in interlocutory disputes are often tied to the likely path of the whole proceeding, not just the next hearing date.

The contents of the reasons show that the Court paid close attention to the Sandoz product information and to how ophthalmologists actually prescribe and administer aflibercept. That is significant for any business involved in a patent dispute where the alleged infringement depends on use, instructions or customer behaviour rather than simply the physical product itself.

For example, the Court identified issues about whether the product information amounted to an instruction, whether those instructions were given to ophthalmologists, and whether there was reason to believe the products would be put to infringing use. The Court also separately identified the existence of many ophthalmologists prescribing outside the claimed method as part of the balance of convenience analysis. That suggests the real-world pattern of use was relevant both to infringement risk and to the practical consequences of granting or refusing relief.

For businesses outside pharmaceuticals, the same lesson still applies. Product manuals, labels, approved instructions, sales materials and training documents can all become important evidence. If your product can be used in both infringing and non-infringing ways, the way you describe and support that use may become central to the dispute.

Businesses should read this decision as a practical lesson in litigation readiness. A registered patent right can be powerful, but it does not guarantee that a court will freeze a competitor’s launch before trial. The applicant still needs to persuade the Court that interim restraint is justified in the real commercial setting.

If you are the rights holder, prepare early evidence on why damages would not be enough. That may include evidence about pricing consequences, customer switching, market share erosion, international pricing effects, third-party impacts and any harm that would be difficult to reverse. If you are the launch business, be ready to explain the market reality from your side, including whether losses are quantifiable, whether there are non-infringing uses, and what undertakings you can offer to reduce risk.

This case also shows the value of disciplined launch planning. Patent mapping, review of product information, regulatory timing analysis, and evidence preservation should happen well before launch. Once ARTG and PBS milestones are approaching, the window for a calm response can become very short.

The judgment was delivered on 3 September 2025 by Justice Rofe in the Federal Court of Australia. The hearing took place on 14 August 2025, with last submissions dated 11 August 2025. The orders dismissed the interlocutory injunction application, reserved costs, and put in place a process for proposed redactions because the reasons initially contained confidential information that was not to be publicly disclosed.

The public result is clear: the applicants did not obtain the temporary injunction they sought. The underlying proceeding, including final patent and related claims, is separate from that interlocutory outcome.

This page is based on the Federal Court judgment and orders in Regeneron Pharmaceuticals, Inc. v Sandoz Pty Ltd [2025] FCA 1067. The published material clearly identifies the parties, the patent, the interlocutory injunction application, the main issues considered, the undertakings recorded, and the result.

Some details of the reasons were initially subject to non-disclosure and proposed redactions for confidential information. Public readers should therefore understand that not every confidential factual detail may be visible in the publicly available material. The key public point, however, is clear: the interlocutory injunction was refused because the balance of convenience did not favour interim relief.