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- The Generic and Biosimilar Medicines Association (GBMA) has been granted leave to intervene as a 'friend of the court' in a High Court case that could reshape Australia's pharmaceutical patent extension regime. - The case, Otsuka Pharmaceutical Co., Ltd & Ors v Sun Pharma ANZ Pty Ltd, examines whether patents covering pharmaceutical formulations—rather than only active pharmaceutical substances—qualify for patent term extensions. - GBMA argues that clear and predictable patent rules are essential for generic and biosimilar medicine suppliers making long-term decisions about product development and market entry. - The outcome will determine how Australia balances protection of genuine pharmaceutical innovation with the public interest in timely generic competition once patent protection expires.
- The Full Court of the Federal Court of Australia ruled that only patents claiming active pharmaceutical ingredients are eligible for patent term extensions, not pharmaceutical formulations. - The decision in Otsuka Pharmaceutical Co Ltd v Sun Pharma ANZ Pty Ltd invalidates existing patent term extensions for formulation patents, creating "zombie PTEs" vulnerable to challenge. - Pharmaceutical companies must urgently review their patent portfolios as the ruling affects loss of exclusivity dates and may accelerate generic drug market entry across Australia.
