The Federal Court of Australia has denied Regeneron Pharmaceuticals and Bayer's application for a preliminary injunction against Sandoz's aflibercept biosimilars, clearing the path for the launch of Afqlir and Enzeevu in the Australian market. Justice Rofe's decision on September 3, 2025, represents a significant victory for Sandoz in the AUD$500 million per year aflibercept market and continues Australia's trend of refusing preliminary injunctions in pharmaceutical patent disputes.
Patent Infringement Claims Fall Short
The court found that Regeneron failed to establish a prima facie case of infringement of patent AU2012205599, which claims methods for treating angiogenic eye disorders using aflibercept via specific dosing regimens. Justice Rofe determined there was "a real prospect that the use of Sandoz's aflibercept products in accordance with the product information will not infringe the Patent."
The critical distinction centered on dosing terminology. Regeneron's patent claims specified dosing regimens measured in weeks, with secondary doses administered "2 to 4 weeks after the immediately preceding dose" and tertiary doses administered "8 weeks after the immediately preceding dose." In contrast, Sandoz's product information instructed dosing "per month" for secondary doses and "every two months" for tertiary doses.
Justice Rofe ruled that "four weeks is not equivalent to a month, and that eight weeks is not equivalent to two months, regardless of whether prescribing practice treated them as equivalent." The court noted that the patent consistently used "weeks" throughout the specification, and "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'."
Real-World Prescribing Practices Impact Assessment
The court also considered that many ophthalmologists follow their own "treat-and-extend" regimen based on clinical judgment rather than the regimen described in product information. This real-world prescribing practice further undermined Regeneron's infringement arguments, as it demonstrated non-infringing use of the Sandoz products.
While Justice Rofe found that Sandoz's product information did constitute "instructions" for indirect infringement purposes, the evidence of individualized prescribing practices meant that a reasonable person in Sandoz's position would not have the requisite belief that the product would be put to infringing use.
Balance of Convenience Favors Market Entry
The court's balance of convenience analysis weighed several factors that ultimately favored allowing Sandoz's market entry. The launch of Sandoz's aflibercept products will trigger the generally irreversible 25% PBS price drop for Eylea 2mg products. However, Justice Rofe found that Regeneron was "actively undermining its own arguments relating to preservation of the status quo by transitioning patients from Eylea 2mg to the 'upgraded' Eylea 8mg through various marketing campaigns."
The court noted that Regeneron's own market disruption strategies, combined with increasing competition from Roche's Vabysmo (faricimab), meant that "the market will have irredeemably changed from its current composition" regardless of the preliminary injunction outcome.
International Pricing Arguments Rejected
Justice Rofe dismissed Regeneron's arguments about international price referencing effects, particularly those related to President Trump's proposed "Most Favored Nation" executive order. The court found these arguments "highly speculative" and "deserving limited to no weight" due to uncertain policy implementation and insufficient evidence of foreign regulatory frameworks.
The proposed executive order would set the price of Eylea in the United States equal to the lowest price among relevant OECD countries, including Australia. However, the court noted the possibility that other reference countries might have the lowest price or be only marginally higher than Australia at the time of launch.
Competitive Landscape and First Mover Advantage
The decision recognized the unique dynamics of biosimilar markets compared to generic small molecule markets. Justice Rofe noted that there is "no or limited opportunity for pharmacists to substitute" biosimilars, as ophthalmologists prescribe and administer the products directly to clinics. This limited substitution capability makes first mover advantage particularly significant in biosimilar markets.
The court acknowledged that multiple competitors including Samsung Bioepis, Biocon, Amgen, Formycon AG, and Apotex have aflibercept biosimilars prepared for market entry across various jurisdictions, meaning a preliminary injunction would likely eliminate Sandoz's competitive advantage.
Broader Implications for Pharmaceutical Patent Disputes
This decision fortifies the trend of Australian courts refusing preliminary injunctions in pharmaceutical patent cases since mid-2018. Justice Rofe's ruling recognizes that "the assessment of damages for wrongly granted PIs is often more complex and expensive than allowing patentees to prove their losses post a biosimilar launch."
Sandoz has provided undertakings for its parent company to submit to Australian jurisdiction with joint liability up to $100 million and to maintain detailed sales records. The company obtained ARTG listings for its 2mg aflibercept biosimilars in May 2025, with PBS-listing taking effect from December 1, 2025.
The decision demonstrates how strong non-infringement positions can be powerful tools for resisting preliminary injunctions, particularly when combined with evidence of real-world prescribing practices that fall outside claimed methods. Regeneron and Bayer have sought leave to appeal the decision.
