Federal Court rules on copyright in pharmaceutical product information documents

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.