Australia: Pharmaceutical companies can no longer rely on copyright litigation tactics to prevent generic medicines entering the market
Intellectual Property Update

Australian consumers, doctors, pharmacists, health professionals and generic suppliers of medicine are set to benefit as originating pharmaceutical companies can no longer use copyright of product information to delay or prevent generic medicines entering into the market.

Pharmaceutical companies that invest significantly in the research and development of medicines, including the creation of product information, are no longer able to argue that the product information approved by the Therapeutic Goods Administration (TGA) of a generic version of a medicine breaches copyright by essentially being the same as the original.

The introduction of the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 (Bill) means that it is no longer an infringement of copyright for generic pharmaceutical companies to reproduce (or supply, publish, communicate or adapt) product information that has been created by the originator and approved by the TGA.

The amendments to the Copyright Act came into force on 27 May 2011.

Ms Catherine King, the Parliamentary Secretary for Health and Ageing, stated that this is important because 'any difference in text of product information used in relation to different brands of the same medicine could be misrepresented as reflecting differences between the brands where in fact none exists'.

Doctors, pharmacists and other health professionals will also benefit because they are able to safely prescribe, dispense and administer medicines and provide patients with consistent information about the medicine they are being given.

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