Debate over definition of a biologic


A new leaked draft of the Trans Pacific Partnership's intellectual property chapter reveals the complexity of the negotiations involving intellectual property and data exclusivity.

A US push for the 12 TPP countries to agree to longer data exclusivity periods for biologics has generated opposition, including from the Australian Government.

Australia currently maintains a five year data exclusivity period of pharmaceuticals. The Abbott Government is opposing the US push, going so far as to leak the details of a private telephone conversation between the Prime Minister and US President Barack Obama.

News Limited reported earlier this week that during the telephone call, Prime Minister Abbott rebuffed President Obama's request for Australia to accept the longer data exclusivity period.

While Australian politicians, including the Government, have argued that extending data exclusivity would increase the cost of medicines, the public debate appears to be confusing the difference between data exclusivity periods and patent terms.

In Australia, pharmaceutical patents terms are 20 years, plus five for new molecules to compensate companies for the time taken to develop and commercialise new drugs. The five year data exclusivity period operates in isolation of patent terms and is only rarely a factor delaying the access of generics, usually in cases where originator drugs took a very long time develop or have no patent at all.

BiotechDispatch understands the Department of Health has done modelling that claims to show higher PBS costs if the data exclusivity period is extended. However, the claim has been met with significant cynicism given the Department's refusal to share the modelling.

The newly-leaked chapter shows significant disagreement between the 12 countries on the definition of a biologic.

The US and Japan appeared in broad agreement, wanting to define a biologic as at least a vaccine, a protein, or a blood­derivative/blood­derived product for use in human beings for the prevention, treatment, or, cure of a disease or condition.

Other options not attributed to any country included, "a pharmaceutical product that is a biologic means a peptide or protein produced using biotechnology processes for use in human beings for the prevention, treatment, or sure of a disease or condition" and "Biotechnology means any technological application that uses biological systems, living organisms or derivatives thereof, to make or modify products or processes for specific uses."

The text shows Australia and New Zealand pushing for each country to be given the ability to define a biologic under its own domestic law, which would obviously give countries significant power to make the definition very narrow.