Australian Federal Court Clears Samsung Bioepis in Pfizer Enbrel Patent Dispute
The court ruled that manufacturing processes for biosimilar Brenzys do not infringe Pfizer's biological process patent
The Federal Court of Australia has ruled that manufacturing processes for biosimilar Brenzys products do not infringe a Pfizer process patent. The decision in Pfizer Ireland Pharmaceuticals Unlimited Company v Samsung Bioepis Co., Ltd resolves claims over the production methods for the etanercept therapy Enbrel. The ruling provides clarity on the scope of intellectual property rights governing biosimilar manufacturing.
Court rules on biosimilar manufacturing methods
The Federal Court of Australia evaluated whether methods used to manufacture biosimilar treatments infringed intellectual property owned by Pfizer, as reported by The IPKat. The dispute pitted Pfizer Ireland Pharmaceuticals Unlimited Company against Samsung Bioepis Co., Ltd in the proceedings titled Pfizer Ireland Pharmaceuticals Unlimited Company v Samsung Bioepis Co., Ltd (Infringement and Validity) [2026] FCA 1244.
Process patent claims dismissed for Brenzys
At issue was a patent relating to the manufacturing process for Pfizer's ENBREL (etanercept) drug, according to The IPKat. The court determined that the involvement of the respondents in producing the biosimilar BRENZYS products did not infringe the process claims, establishing that the biosimilar production route stayed outside the protected scope of the asserted patents.
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