Last week Pfizer filed a lawsuit in a federal court of Australia against respondents Samsung Bioepis, Merck, Sharp & Dohme, Organon, and Arrow, to halt sales of their biosimilar BRENZYS (etanercept). Pfizer alleges that the respondents infringe Australian Patent No. 2005280034, titled "Production of polypeptides," with claims directed to cell culture methods. BRENZYS is a biosimilar to ENBREL (etanercept), and was approved by Australia's Therapeutic Goods Administration in 2016. Pfizer is seeking damages from sales of BRENZYS in Australia, and a court order barring the sale of the drug until Pfizer's patent expires.
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