Regeneron and Bayer have moved swiftly to appeal Justice Rofe’s decision denying Regeneron and Bayer’s application for PI on MOT patent AU2012205599 to restrain Sandoz from launching its biosimilar aflibercept (Afqlir® and Enzeevu®) in Australia. Our report on her Honour’s decision can be found here.
On 17 September 2025, Regeneron filed an application for leave to appeal Justice Rofe’s decision. There is no automatic right to appeal from an interlocutory decision of the Federal Court of Australia and Regeneron/Bayer must obtain leave before the Full Court will hear the appeal. Often the leave application and, if leave is granted, the substantive appeal, are heard at the same time.
The Federal Court has listed the matter for hearing of both the leave application and the appeal on 29 October 2025 before Justices Beach, Burley and Moshinsky.
The case is of considerable interest, particularly given the number of biosimilar competitors, including Samsung Bioepis and Celltrion, that are lining up to enter the Australian aflibercept market. Actor Pharmaceuticals, which does not yet have an aflibercept biosimilar approved in Australia, also filed revocation proceedings against Regeneron and Bayer in the Australian Federal Court on 5 August 2025, seeking to invalidate AU2012205599, with a first case management hearing in that matter currently scheduled for 8 October 2025.
About Pearce IP
Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.
Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.
Naomi Pearce
CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.
Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.
Helen Macpherson
Executive, Lawyer (Head of Litigation –Australia)
Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information.
Throughout her career, Helen has maintained a strong focus on high-value patent mandates involving complex technologies. In these mandates, Helen has been able to draw upon her technical training in biochemistry and molecular biology, as well as her ability to up-skill swiftly in relation to diverse technologies. Helen’s patent work has encompassed the technical fields of inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology) and physics.
Helen is a member of the Intellectual Property Committee of the Law Council of Australia, as well as a member of the Intellectual Property Society of Australia and New Zealand.