GBMA Intervenes in Landmark Australian High Court Case on Pharmaceutical Patent Term Extensions
Key Insights
The Generic and Biosimilar Medicines Association (search) (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 Generic and Biosimilar Medicines Association (search) (GBMA) has been granted leave to intervene as a 'friend of the court' in a High Court case that could fundamentally reshape the boundaries of Australia's pharmaceutical patent term extension system. The case, Otsuka Pharmaceutical Co., Ltd & Ors v Sun Pharma ANZ Pty Ltd, was heard on 16 June and continues today, 17 June.
The central legal question is whether patents covering pharmaceutical formulations can qualify for patent term extensions beyond the standard patent period. This appeal follows a Full Court of the Federal Court ruling that patent term extensions apply only to active pharmaceutical substances and not to formulation claims. The High Court granted special leave to appeal that decision in March of this year.
GBMA is the only external organisation to be granted leave to intervene in the proceedings, underscoring the sector-wide significance of the case.
Balancing innovation and competition
GBMA Independent Chair, Hon. Prof. Jane Halton, emphasized that the case carries implications extending well beyond the individual medicine and the companies directly involved. "This case raises an important question about how Australia balances the protection of genuine pharmaceutical innovation with the public interest in timely and predictable competition once the relevant patent protection has expired," she said.
According to GBMA, its submissions "address the purpose of the patent term extension regime and the balance it seeks to establish between the rights of a patentee and the public interest in timely market entry of generics."
Industry-wide implications for market entry
GBMA CEO Nikki Lorenz highlighted the practical consequences for the generic and biosimilar sector. "Generic and biosimilar medicine suppliers make significant, long-term decisions about product development, regulatory approval, manufacturing and Australian market entry. Clear and predictable patent rules are essential to those decisions," Lorenz stated.
Lorenz further noted that "GBMA's role is to ensure that the experience and perspective of generic and biosimilar medicine suppliers is represented when legal and policy decisions have consequences across the entire sector." She added, "Our participation demonstrates the importance of having a strong, coordinated industry voice on the issues that affect competition, medicine supply and patient access."
The matter will be determined by the High Court following the hearing, with the ruling expected to set a precedent for how pharmaceutical patent term extensions are interpreted across Australia's intellectual property landscape.