Australian government report on inappropriate use of intellectual property rights in medicines

The Australian government last week tabled its report to Parliament on barriers to medicines entering the market through the inappropriate use of intellectual property rights over product information.

The newly-approved Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 was introduced in May as a result of increasing claims by originator drugmakers that product information approved by the Therapeutic Goods Administration (TGA) for generic versions of their products was essentially the same as the original and therefore constituted a breach of copyright.

The new report centers on recent amendments to the Copyright Act (Cth) 1968 that allow the Therapeutic Goods Administration to approve the product information of a follow-on generic medicine in a form that is similar to that of the initial patented brand of the medicine.