All Eyes on EYLEA–Sandoz Defeats Preliminary Injunction

The recent decision in Regeneron Pharmaceuticals, Inc v Sandoz shows how a strong noninfringement position can be powerful to resisting a preliminary injunction. The dismissal of the Regeneron Pharmaceuticals, Inc. (Regeneron) and Bayer Australia Ltd and Bayer Consumer Care AG (together Bayer) parties’ application for interlocutory relief aligns with the recent trend away from granting preliminary (interlocutory) injunctions in pharmaceutical patent cases. While the trend has primarily arisen from the court’s recognition that the calculation of damages for a new market entrant is likely to be more difficult than that for the patentee, this was a, but not the main driving, factor in this case.

Key points to be aware of are:

• A strong prima facie noninfringement case puts the new market entrant on strong footing to resisting a preliminary injunction.
• Patent claims need to be construed by reference to the specification and not the product or conduct of the alleged infringer.
• The product information for pharmaceuticals is likely to constitute “instructions” for the purpose of indirect infringement. However, real-world prescribing practices are relevant to the question as to whether the new market entrant has reason to believe the product will be put to an infringing use.
• Calculating the patentee’s and new market entrant’s loss will be subject to difficulties, with each scenario giving rise to its own unique complexities, with the latter involving more unknowns.
• Regeneron and Bayer have sought leave to the appeal decision.

Background

Regeneron is the patentee of an Australian patent entitled “Use of a VEGF Antagonist to Treat Angigogenic Eye Disorders” (Patent). The Patent covers a dosing regimen for aflibercept, sold by Bayer Australia under the brand name EYLEA, to treat wet macular degeneration and diabetic macular oedema.

In May 2025, Sandoz obtained regulatory listing for its aflibercept products, AFQLIR and ENZEEVU. As from 1 December 2025, Sandoz will receive PBS approval for its aflibercept products. Sandoz indicated that it only intended to launch the AFQLIR at this stage.

Regeneron and Bayer commenced proceedings against Sandoz seeking final relief and interlocutory relief, to prevent Sandoz’s launch of AFQLIR aflibercept in Australia.

Prima Facie Case

The prima facie case involved an assessment of the strength of Regeneron’s infringement case against that of Sandoz’s revocation case. We focus here on infringement given the impact it had on the outcome.

On infringement, Justice Rofe considered that there was a real prospect that the use of the Sandoz aflibercept products in accordance with Sandoz’s product information would not infringe the Patent. It was the court’s findings on claim construction and the real-world prescribing practices of ophthalmologists which led to Regeneron failing to establish a prima facie case on infringement.

Claim Construction – “Weeks” Are Not Equivalent to “Months”

The decision reaffirms the established and uncontroversial principles concerning claim construction (i.e. purposive construction) and the fact that “it is trite to say that the … Patent should be construed as if the alleged infringer had never been born”.

The dosing regimen claimed by the Patent was measured in terms of weeks. The dosing described in Sandoz’s product information was measured by reference to months. Focusing on the deliberate words and language used in the specification, being “weeks”, the court held that weeks are not equivalent to months, meaning that Sandoz’s dosing regimen did not fall within the scope of claim 1 of the Patent.

Indirect Infringement

Regeneron argued that Sandoz had reason to believe that a person would put the Sandoz aflibercept to infringing use (s 117(2)(b) of the Patents Act 1990 (Cth) (Patents Act)) or would infringe because of the instructions contained in the Sandoz product information (s 117(2)(c)).

The court found that Sandoz’s product information did constitute “instructions” as per s 117(2)(c). However, because of the claim construction finding, and evidence that ophthalmologists follow their own treat-and-extend regimen instead of the one described in the Sandoz product information, a reasonable person in Sandoz’s position would not have the requisite belief pursuant to s 117(2)(b).]

Balance of Convenience

The key balance of convenience factors assessed by the court were:

PBS Price Drop

The 25% price drop would occur to EYLEA 2mg products, and it is unlikely that the Minister would reverse the price drop.

Market

Sandoz’s aflibercept would cause a reduction in the market share of EYLEA 2mg, but this market share was under challenge from several sources, including from other products and Bayer’s own “cannibalisation of its 2mg market by transitioning patients to EYLEA 8mg”.

International Price Ramifications

The loss Regeneron alleged it would suffer in the United States and Taiwan was “so highly speculative” and “too remote” to be relevant.

First Mover Advantage

If restrained, Sandoz would lose a “real and lasting” first mover advantage.

Quantification of Damage

While it was not possible at this provisional stage to determine with certainty which damages calculation would be more complex, there were more unknowns if Sandoz was restrained and the repercussions to the market caused by Sandoz’s launch of its aflibercept would be relatively quantifiable.

Injunction Would Be Disproportionate

Even if Regeneron was successful at trial, an injunction would likely be disproportionate as many ophthalmologists prescribe outside the claimed method.

The above, plus the weakness of Regeneron’s prima facie case on infringement, meant that the circumstances did not justify the grant of the broad injunction sought.

By Rachelle Downie and James Wallace