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 have significant implications for Australia’s pharmaceutical patent system.
The case, Otsuka Pharmaceutical Co., Ltd & Ors v Sun Pharma ANZ Pty Ltd, which was heard on 16 June and continues today (17 June), centres on whether patents covering pharmaceutical formulations can qualify for patent term extensions beyond the standard patent period.
The 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 the decision in March this year.
GBMA is the only external organisation to be granted leave to intervene in the proceedings.
GBMA Independent Chair, Hon. Prof. Jane Halton, says the case has implications that extend beyond the individual medicine and the 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,” she says.
“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.”
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”.
“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,” says GBMA CEO Nikki Lorenz.
“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.
