In Regeneron Pharmaceuticals, Inc. v Sandoz Pty Ltd [2025] FCA 1067, the Federal Court dismissed an interlocutory injunction application brought by Regeneron and Bayer seeking to prevent Sandoz from launching its biosimilar aflibercept products, AFQLIR® and ENZEEVU®. These products are intended for the treatment of neovascular age-related macular degeneration (nAMD), also known as Wet AMD, and diabetic macular oedema (DME), leading causes of vision impairment in patients over 50.

This first stage of the litigation involved five separate court appearances in just six weeks, culminating in the hearing of the injunction application on 14 August 2025 and judgment delivered by Justice Helen Rofe on 3 September 2025.

“This is a key win for our client, and only the third interlocutory injunction application in the pharmaceutical field in the past six years,” said Robert Cooper, lead partner on the matter. "It was a hard-fought case, requiring us to respond to lengthy and complex evidence and submissions in a tight timeframe, while navigating a highly technical patent and regulatory landscape. We welcome the Court's decision, which affirms the strength of our client’s position and clears the way for AFQLIR® to enter the Australian market.”

 The MinterEllison team was led by Robert Cooper (Partner, Dispute Resolution) and Rebecca Pereira (Special Counsel, Dispute Resolution), along with Jonathan Kelp (Partner, Dispute Resolution), Jaquelin Cantarella (Lawyer, Dispute Resolution), and Jose Happell (Lawyer). In Court Sandoz was represented by barristers Tom Cordiner KC, David Larish and Amy Surkis.

The dispute centred on Regeneron and Bayer’s top-selling drug, EYLEA®, with the applicants seeking to block Sandoz’s launch of a first biosimilar competitor. The judgment is expected to have significant implications for future biosimilar market entry in Australia.

This success further reinforces MinterEllison’s national Chambers Band 1 Life Sciences capability, and its reputation for delivering results in complex, high profile disputes. Of the three interlocutory injunction applications brought in the pharmaceutical sector over the past six years, MinterEllison has acted in, and won, two of those cases, reflecting the depth of the firm's expertise and strategic capability in complex patent litigation.