The Generic and Biosimilar Medicines Association (GBMA) has been granted leave to intervene as a ‘friend of the court’ to be heard in a significant High Court proceeding concerning the scope of pharmaceutical patent term extensions in Australia.
The High Court will hear Otsuka Pharmaceutical Co., Ltd & Ors v Sun Pharma ANZ Pty Ltd on 16 and 17 June 2026.
The appeal concerns whether patents directed to pharmaceutical formulations can qualify for an extension beyond the standard patent term, or whether the extension regime is confined to pharmaceutical active substances. No other party has been granted leave to intervene.
GBMA Independent Chair, Hon. Prof. Jane Halton said the case had implications extending beyond the individual medicine and companies 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.”
“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.”
The Full Court of the Federal Court previously held that the relevant extension provisions did not apply to formulation claims and were limited to active pharmaceutical substances. The High Court granted special leave to appeal that decision in March 2026.
GBMA’s 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.
GBMA CEO, Nikki Lorenz, noted “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,” Ms Lorenz said.
“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.
Generic and Biosimilar Medicines Association
Level 17, 1 Denison St, North Sydney, NSW 2060
admin@gbma.com.au
About GBMA
The Generic and Biosimilar Medicines Association (GBMA) is the peak representative body of generic and biosimilar medicine suppliers in Australia. Its members ensure that all Australians are offered the highest quality generic and biosimilar medicines in the world whilst providing affordable community health outcomes that benefit all Australians.
