In the recent case between Sanofi-Aventis Australia Pty Ltd and Apotex Pty Ltd [2011] FCA 846, the Federal Court of Australia addressed for the first time the issues of copyright subsistence and infringement in relation to product information documents (PI) for pharmaceutical products.

The Court held that the PIs for Sanofi's leflunomide product were works of joint authorship entitled to copyright protection, as their creation involved considerable skill and judgment on the part of Sanofi's employees who worked collaboratively in their creation.

The Court further held that the PI for Apotex's leflunomide product infringed the copyright in Sanofi's PIs as it reproduced the whole or a substantial part of those PIs, and a licence for Apotex to copy Sanofi's PI could not be implied in the circumstances.

However, the Court itself acknowledged that these complex issues have been rendered moot insofar as the future is concerned by the Therapeutic Goods Legislation Amendment (Copyright) Act 2011.

That Act amended the Copyright Act 1968 to insert a new section 44BA which provides that certain acts are not a breach of copyright “in a work that is product information approved under section 25AA of the Therapeutic Goods Act 1989 in relation to medicine”.

The acts which do not constitute breach include acts of supplying, reproducing, publishing, communicating or adapting done under the Therapeutic Goods Act in respect of “some or all” of “product information approved under section 25AA of the Therapeutic Goods Act in relation to medicine”.