Section 25a of Australia’s Therapeutic Goods Act provides for five years of data exclusivity for all medicines. It makes no distinction between biologics and other drugs. Data exclusivity provides an absolute monopoly that, unlike a patent, can’t be revoked or challenged in court.
The powerful biopharmaceutical industry lobby in the United States has been seeking 12 years of market exclusivity for biologics.
It seems clear to everyone except US negotiators – and biopharmaceutical industry lobbyists – that the demand for extending data exclusivity for biologics needs to be dropped if the TPP is to be finalised.