I noted the other day that the Attorney-General had set out the upcoming copyright reform agenda.

And then an email alert crossed my desk – an actual copyright reform, in a dedicated Bill. Australia is to get a new copyright exception! Specifically, we are to get new s 44BA, for ‘acts done in relation to certain medicine’. It’s basically an exception to allow generic medicines producers to use the officially approved “Product Information Document” originally submitted when new drugs are approved by the Therapeutic Goods Administration. The background to this amendment, according to the Explanatory Memorandum, is apparently this case, in which an originator pharmaceutical company got an interlocutory injunction, partly on the basis of an argument that copyright in the approved product information document would be infringed by the competitor’s use of the approved PI for its generic medicine.

This strikes me as perhaps one of the clearest arguments I’ve seen in a while for a fair use exception or other flexible exception in Australia. The very idea that someone has had to draft, and now the legislature has to pass, legislation to add this specific exception in is a clear indication that there just isn’t enough flexibility in the legislation. Is it just me?

3:42 pm - posted by . Categories: Aus , Copyright
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