Sanofi-Aventis Case: Product information for pharmaceutical products

In the recent case Sanofi-Aventis Australia Pty Ltd and Apotex Pty Ltd [2011] FCA 846 the court has considered the subsistence of copyright in product information documents for pharmaceutical drugs and whether these were original literary works attracting copyright protection. It also considered whether product information documents were works of joint authorship attracting copyright protection. It then looked at whether there had been an infringement where the respondent had reproduced the whole or a substantial part of product information documents and considered whether the respondent had an implied licence to reproduce the product information documents.

The Court found that the Product Information for Sanofi's leflunomide products were jointly authored works attracting copyright protection. This was because their creation involved considerable skill and judgment by Sanofi's employees who worked together to create the information. By reproducing them in whole or in part Apotex's leflunomide product infringed the copyright in Sanofi's Product Information documents as it reproduced the whole or a substantial part of those documents. A licence for Apotex to copy Sanofi's PI could not be implied in the circumstances.

Note: however (as the Court itself did) that the future application of this case is affected by the Therapeutic Goods Legislation Amendment (Copyright) Act 2011(No 39) which inserted a new s 44BA (Acts done in relation to certain medicines) in the Copyright Act 1968 providing that certain things are not a breach of copyright with respect to product information approved under s 25AA of the Therapeutic Goods Act 1989. This includes supplying, reproducing, publishing, communicating or adapting done under the Therapeutic Goods Act in respect of “some or all” of “product information approved under s 25AA of the Therapeutic Goods Act in relation to medicine”.

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